Digital Pathology 2020 will be the world's best and the first platform for all the Doctors, Cytopathologists,Pathologists, Students and Clinical research organizations to gather on a single platform and present their work, encourage and explore the best referred cases to infer and strategize novel methodologies in treatment and therapy.The main theme of the conference is Digital Pathology 2020 is" Digital Pathology Image Analysis: Advancement,Opportunities and Challenges for 21st Century".

Date:
Aug 13, 2020 - 09:00 AM - Aug 14, 06:00 PM

Link to Website:
https://digitalpathology.euroscicon.com/

Venue:  Crowne Plaza Madrid Airport

Location:

Madrid, Spain
ZIP: 28027
Phone: +44-2033182512

9th International Conference on Pharmaceutical GMP, GCP & Regulatory Affairs

About

2020 Key ThemesRegulatory Affairs 2020 conference will focus on new strategies, amendments, innovations, developments in the fields of regulatory affairs, intellectual property rights and medical devices with the theme: “Current challenges of Pharmaceutical & Biopharmaceutical Industries in regulatory framework” which reflects new strategies in the field of regulatory affairs. This conference includes workshops, symposiums, special sessions, key note sessions, conducted by eminent and renowned speakers who excel in the field of regulatory affairs, medical devices, intellectual property rights which include the topics regulatory affairs in pharmacovigilance, clinical affairs & regulatory strategies, regulatory strategies and developments, penalties of regulatory Non-compliance, biologics & biosimilars, global regulatory intelligence, Impact of Brexit on regulatory framework, regulatory requirements in pharmaceuticals, regulatory challenges for medical devices, medical device and combination products regulation, Intellectual property rights etc. This International Regulatory Affairs Conference also encourages the active participation of Young Researchers, Students as we are hosting Poster Award Competition and Young Research Forum at the conference venue.

Product Registration & Submission
Global Guidelines for the Development of Biologics
Medical Device & Combination Products Regulations
Accelerating Approval of New Drugs
ASEAN Labelling Harmonisation
Regulatory & Clinical Affairs
Regulatory & Pharmacovigilance
Regulatory Enforcement & Inspection

Target Audience:

Regulatory Affairs experts
Clinical Research Associates
Medical Devices experts
Quality Assurance experts
Intellectual Property Rights attorneys
Scientists
Researchers
Academicians
Industrialists

Continent wise participation Analysis for Regulatory Affairs 2020 conference

Session/Tracks

Track 1: Regulatory Affairs

Regulatory Affairs profession was developed by the government regulatory bodies to regulate the safety and efficacy of products to protect the health of public. This was developed in all most all divisions of health care industry like pharmaceuticals, veterinary medicines, medical devices, pesticides, agrochemicals, cosmetics, complimentary medicines etc. This profession involves development of new and existing products from early on, preparation and till submission to the relevant regulatory bodies of health authorities by inputting regulatory principles.

Regulatory Affairs is involved actively from early stage of development to post marketing activities of new and existing products. This department is one of the integral parts within the organization structure of pharmaceutical industry. Internally it collaborates at the interphase of drug development, manufacturing, marketing and clinical research. Externally it is the key interface between the commercial industry which undergoes drug development to clinical research and the regulatory authorities.

Track 2: Regulatory Affairs in Pharmacovigilance

Regulatory Affairs (RA), likewise called government issues, are a calling inside managed enterprises, for example, pharmaceuticals, medicinal gadgets, vitality, saving money, telecom and so on. Administrative Affairs likewise has a certain importance inside the human services enterprises (pharmaceuticals, therapeutic gadgets, biologics and useful nourishments). Administrative issues (therapeutic issues) experts (otherwise known as administrative experts) typically have duty regarding the accompanying general territories.

Pharmacovigilance evaluates the adverse effects in turn speaking about the efficacy and safety data of particular drug product thus, collaboration of pharmacovigilance with regulatory bodies provides all the adverse reactions, safety data to regulatory authorities.

Working with government, state and neighborhood administrative offices and faculty on particular issues influencing their business i.e., working with so much office as the Food and Drug Administration or European Medicines Agency (pharmaceuticals and restorative gadgets); The Department of Energy; or the Securities and Exchange Commission (banking). Advising their organizations on the administrative angles and atmosphere that would influence proposed exercises. i.e., portraying the "administrative atmosphere" around issues, for example, the advancement of professionally prescribed medications and Sarbanes-Oxley consistence.

Track 3: Clinical Affairs & Regulatory Strategies

An administrative science driven administrative procedure is crucial as a component of today's biopharmaceutical item early advancement arranging. An all-around arranged administrative methodology will adjust the proposed clinical advancement arrangement with business targets, and pre-emptively distinguish challenges, and also, proposed elective/creative ways to deal with new item improvement which influence new measures for confirmation era supporting proceeding with improvement and worldwide business sector approval. An administrative methodology characterizes key issues/difficulties to proactively talk about with Regulatory powers furthermore characterizes key system points of reference that are frequently considered business impetuses driving speculator intrigue and financing. In particular, an auspicious, very much arranged and all around kept up administrative technique, with proactive and collective cooperation with administrative powers, is regularly a separating element for industry pioneers putting up monetarily fruitful and creative items for sale to the public in today's aggressive commercial center. Administrative procedure is a noteworthy segment of fruitful biopharmaceutical item improvement. Covance Global Regulatory Affairs gets ready and keeps up administrative science driven and item particular worldwide administrative systems for some item sorts, e.g., drugs, biologics, drug-gadget mixes, antibodies, quality treatments, cell-treatments, over a scope of restorative territories and full administrative technique support for item improvement activities.

Track 4: Regulatory Strategies and Developments

Regulatory strategies are formal documents that include series of regulatory activities to discover an innovative product or a modified product to market with business strategy for that product. This provides description and course to project team for the product being developed with identification of important regulatory elements which are addressed to market the product. Within a firm there are many regulatory strategists from different departments that involve all aspects of a drug and individuals with expertise in chemical synthesis, toxicology, biology, clinical and regulatory affairs, marketing, government affairs and reimbursement inputs into the regulatory strategy ensuring it is comprehensive.

Regulatory strategy document has three purposes, it acts as a:

A tracking tool to summarize key agreements reached with health authorities
A planning tool that documents timelines and lists topics to address in future meetings with health authorities
A risk register to record key issues that could impact timelines, costs or commercial value for the project

Track 5: Penalties for Regulatory Non-compliance:

Non-compliance costs are costs which result from a failure to comply with regulation. These costs are not considered to be part of the regulatory burden for the purposes of the Risk Based Monitoring. This includes penalties and activities associated with those penalties that are required to be undertaken because of noncompliance with regulation. Regulatory impacts that arise, up to the point that action is taken to respond to the suspicion of a specific instance of noncompliance, are included in RBM framework. This includes risk based frameworks that may target certain populations without a specific instance of suspicion. Failure to comply with the law can lead to enforcement action including one or more of the following: on-the-spot fines, prosecution, which carries a maximum fine of $12,110, disciplinary action, ranging from fines to cancellation of the license.

Track 6: Biologics & Biosimilars

A biopharmaceutical, otherwise called a biologic therapeutic item or biologic, is any restorative item made in, extricated from, or semi orchestrated from organic sources. Not quite the same as synthetically incorporated pharmaceuticals, they incorporate immunizations, blood, or blood segments, allergenic, substantial cells, quality treatments, tissues, recombinant restorative protein, and living cells utilized as a part of cell treatment. Biologics can be made out of sugars, proteins, or nucleic acids or complex mixes of these substances, or might live cells or tissues. They are confined from normal sources—human, creature, or microorganism. Phrasing encompassing biopharmaceuticals fluctuates amongst gatherings and elements, with various terms alluding to various subsets of therapeutics inside the general biopharmaceutical class. Some administrative offices utilize the terms natural restorative items or remedial organic item to allude particularly to designed macromolecular items like protein-and nucleic acid–based drugs, recognizing them from items like blood, blood segments, or antibodies, which are typically extricated specifically from a natural source Gene-based and cell biologics, for instance, frequently are at the front line of biomedical research, and might be utilized to treat an assortment of therapeutic conditions for which no different medications are accessible.

Track 7: Global Regulatory Intelligence

Ever-proliferating and changing global regulations generate complex challenges of execution in global market clearance operations.

Mission-critical decisions are delayed, trapping new international revenue until market clearance process issues are resolved. Workflow is confounded as information conflicts from sales-focused distributors, newly-appointed foreign regulators, and legacy resources are reconciled- and as definitive answers are sought. Governance is compromised as information gaps reduce assurance levels and impair risk management of clearance-related penalties, fines, and legal costs.

And the high level of business performance required to create value from ongoing medtech industry consolidation is not achievable, since global market clearance operations are incapable of rapidly completing new market clearance submissions for newly-acquired product lines.

Unlike repackaged RI databases designed for the pharmaceutical industry, the clinivation Worldview Enterprise Solution for On-Demand Global Regulatory Intelligence accelerates the market clearance cycle.

Track 8: Impact of Brexit on Regulatory Framework

The most important piece of UK legislation that would need to be repealed is the European Communities Act 1972 (ECA), which provides for the supremacy of EU law. Repealing the ECA will bring an end to the constitutional relationship that exists between EU and UK law. Moreover, the vast amounts of secondary legislation that have been passed with the objective and justification of implementing EU law would have to be considered by the Government. EU Regulations rely on the principle of direct applicability, which means that unlike EU Directives, they are directly implemented into UK law without the need for legislation from the UK Parliament. In this light, Regulations are more powerful legislative tools for the EU because of their immediate applicability. The status of existing Regulations will be addressed in the Great Repeal Bill, although as noted above, in many cases amendments will likely be needed to take into account the UK’s new relationship with the EU. The Court of Justice of the European Union (CJEU) situated in Luxembourg is the final arbiter on questions of the interpretation of EU law. In her first speech setting out the UK Government’s priorities for Brexit on 17 January 2020, the Prime Minister restated her position that the UK is not prepared to continue to be subject to the jurisdiction of the CJEU.

Track 9: Regulatory Communications and Submissions

Due to the growing interest in marketing new products, it is pivotal to establish a superior level of medical writing and regulatory operations. Executives within these roles need to create and manage successful submissions, as well as streamline timelines, to accelerate approval.

Attending the Optimizing Regulatory Communications and Submissions conference will aid delegates in expediting the approval of drugs while meeting requirements for different regulatory agencies worldwide. In addition, attendees will overcome key operational challenges impacting the approval process to enhance the quality of submissions.

Track 10: Marketing Authorizations-Affordable Healthcare and Fair Trade

This establishment level module is the perfect acquaintance for new participants with the field of pharmaceutical administrative issues and consistence. It portrays the central prerequisites that must be fulfilled to pick up and keep up endorsement to advertise restorative items in the USA and Europe. The lawful structure and the parts of significant players in control are displayed. The life-cycle of a medication is sketched out. The different systems accessible for appraisal and endorsement of items are depicted and their prerequisites laid out. Commitments to be satisfied in the wake of promoting endorsement are examined. Worldwide administrative undertakings bunches in industry give around the world, key initiative in and far reaching course of the legislature administrative necessities for item presentation and commercialization, using administrative learning to guarantee consistence and administrative knowledge and make open doors in an exceedingly controlled environment. The worldwide administrative undertakings bunch has vital and operational capacities, requiring accuracy and faultless execution, as an organization's prosperity depends on, partially, the direction and thorough appraisal gave by the administrative issues group. The key item advancement, assembling and enlistment turning points, (for example, Investigational New Drug documenting, end of stage II, stage III, New Drug Application entries, administrative office audit timetable and item endorsements), which are the corporate valuation and choice focuses, depend on basic administrative interface goalposts and developments. This underscores the significance of key administrative commitment to the business. Keeping in mind the end goal to be profitable donors and basic business accomplices, the worldwide administrative undertakings association must create instruments and build up frameworks to guarantee it has the right individuals and ability, capable procedures, productive profitability, sensational execution and accuracy in arranging.

Track 11: Regulatory Requirements for Pharmaceuticals

The new medication endorsement process have been made into three stages for improvement in comprehension - the principal stage is pre-advertising implied for revelation, advancement and clinical concentrates, second stage for promoting approval of medication and third is for post showcasing. Firstly, preclinical investigations of a medication are finished to guarantee adequacy and security, and after that application for behavior of clinical trials is submitted to the CDSCO. From that point, the clinical trials can be led (stage I to stage IV). These studies are performed to guarantee the viability, wellbeing and upgrading the measurements of medication in people. After the culmination of clinical investigations of the medication, then an application to the skilled power of India for the endorsement of medication for advertising is submitted. The able power audit the application and affirm the medication for advertising just if the medication is observed to be sheltered and successful in individual or the medication have more alluring impact as contrast with the danger.

Track 12: Regulatory Challenges for Medical Devices

As therapeutic gadget quality certification and administrative undertakings experts, it can test to remain focused of changes occurrence in our industry. Administrative controls for restorative gadgets are rare in the creating scene, despite the fact that usage of national medicinal gadget directions will frequently address the very issues brought up in nations as significant attentiveness toward patient wellbeing. Case of these issues incorporate the unlawful re-preparing and re-bundling of utilized syringes for re-deal; the accessibility available of hardware that fizzles least quality and security benchmarks; or just no hint of what gadgets are being sold in the nation, nor by whom. Such a posting is crucial to empower governments to issue cautions or reviews for perilous or inadequate things.

Track 13: Medical Device & Combination Products Regulations

Blend items are remedial and indicative items that consolidate medications, gadgets, and/or organic items. FDA hopes to get expansive quantities of blend items for audit as innovative advances keep on merging item sorts and obscure the verifiable lines of partition between FDA's therapeutic item focuses, which are comprised of the Center for Biologics Evaluation and Research (CBER), the Center for Drug Evaluation and Research (CDER), and the Center for Devices and Radiological Health (CDRH). Since mix items include parts that would regularly be controlled under various sorts of administrative powers, and much of the time by various FDA Centers, they raise testing administrative, strategy, and audit administration challenges. Contrasts in administrative pathways for every part can affect the administrative procedures for all parts of item improvement and administration, including preclinical testing, clinical examination, showcasing applications, assembling and quality control, antagonistic occasion reporting, advancement and promoting, and post-endorsement alterations.

Track 14: Best Industry Practices

Drug business is one in everything about nation's most critical monetary motors, trade $15 billion in stock yearly and a couple of its processing plants region unit preeminent. The government office has built up a progression of tips for creating GXP (which incorporates GCP, GLP and GMP directions) that shield each the life sciences business furthermore the clients they serve. In order to help FDA-directed firms, expert control offers partner in incorporated quality and consistence administration code that guarantees GLP, GCP and GMP rules consistence. Industry practices is likewise some portion of value danger administration framework, Pharma Regulatory Affairs, Audits and assessments, acceptance strategies (process approval and expository approval), Qualification, acceptance, adjustment, upkeep, hazard investigation Drug Safety and Good Pharmacovigilance hones. Some of our product framework applications which will encourage with GLP GCP GMP rules epitomize the resulting arrangements: Document Control/Document Management, Corrective Action Preventive Action (CAPA), alteration administration, guiding Management, resistance Automation programming framework, Audit Management in venture with GLP GCP GMP rules, customer protests programming framework, shapes based strategy robotization, electronic entries.

Track 15: Intellectual Property Rights

In the EU, an organic thoughtful item is one amongst the dynamic substance(s) made from or separated from a natural (living) framework, and requirements, also to physico-compound testing, natural testing for full characterization. The characterization of a natural medicative item could be a blend of testing the dynamic substance and hence the last medicative item along the edge of the get together strategy and its administration. Central thoughts of Intellectual Property Management (IPM) and its significance is a goad to human force and in this manner is the headway of financial and social improvement. It furthermore gives defense on the occasion Associate in usage of an IPM technique together with the administration of material ownership (IP) in a web setting. Investigative control law more often than not gives the creator of partner in scholarly creation restrictive rights for abusing and taking advantage of their creation. Experimental order insurance is intended to fortify the force of the human personality for the upside of all by verifying that benefits got from misusing a creation advantage the maker. This may energize action and allow financial specialists in investigation and improvement a decent go ahead their speculation. Experimental order presents on individuals, undertakings or option elements the right to bar others from the vocation of their manifestations wellbeing and quality control in naming. Therefore, material ownership rights (IPRs) could have an on the spot Associate in generous effect on exchange on the grounds that the proprietor of an IPR could - through the social control of such a privilege - prevent the assembling, use or offer of an item which incorporates the IPR. Therefore administration over the immaterial (IPR) suggests administration of the stock and markets. Exploratory order security energizes the production, conveyance and discourse demonstration of the creation to the overall population, rather than keeping it mystery though at indistinguishable time urging mechanical endeavours to choose imaginative works for abuse. Material ownership lawful titles identifies with the securing and utilization of an assortment of rights covering totally distinctive type of manifestations. Licenses in the pharmaceutical business incorporate both lawful and moral issues.

Please contact the event manager Marilyn (marilyn.b.turner(at)nyeventslist.com ) below for:
- Multiple participant discounts
- Price quotations or visa invitation letters
- Payment by alternate channels (PayPal, check, Western Union, wire transfers etc)
- Event sponsorship

NO REFUNDS ALLOWED ON REGISTRATIONS
Prices may go up any time. Service fees included in pricing.
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2nd International Conference on Pharmaceutical Analysis & Analytical Chemistry

About

After the fruitful execution of the International Conference on Pharmaceutical Analysis and Quality Control Strategies, Conference Series with great pride and honour announcing its International Conference on Pharmaceutical Analysis & Analytical Chemistry which is going to held in Chicago, USA during August 02-03, 2020.

Pharmaceutical Analysis 2020 serves as a podium for the interaction between experts in the area of pharmaceutical analysis and analytical chemistry around the world. We cordially invite all the eminent researchers, academicians, students, industry representatives working in these exciting areas.

This Conference is mainly focused on the theme “New paradigms in Pharmaceutical Analytical Techniques”. The conference includes workshops, symposiums, special keynote sessions conducted by eminent and renowned speakers who excel in the field of Pharmaceutical Analysis and Drug Discovery This International Pediatric Conference also encourages the active participation of young student researchers as we are hosting Poster Award Competition and Young research Forum at the conference venue.

Target Audience:

Pharmaceutical Analysis Researchers

Analytical Chemists

Noble Laureates

Directors, Presidents, CEO’s of Organizations/Companies

Pharmaceutical Associations and Societies

Academicians (Professors, Associate & Assistant professors, Deans, Directors)

Graduates and Post graduates

Sessions/Tracks

Track 1: Modern Pharmaceutical Analysis

Generally, Pharmaceutical Analysis alluded to the synthetic examination of medication atoms. Be that as it may, throughout the years, present day pharmaceutical investigation has advanced past this to envelop mix systems, high-throughput innovations, chemo metrics, micro dosing studies, scaling down and nanotechnology. These logical advances are currently being utilized in all phases of medication disclosure and the concentration of this survey will be on how these advances are being utilized inside this procedure. With new, enhanced and advancing innovations, and in addition new applications for existing innovation, the scan for new medications for the aversion and treatment of human maladies proceeds.

Track 2: Chromatography & Separation Techniques

Chromatography strategy for isolating the parts, or solutes, of a blend on the premise of the relative measures of every solute appropriated between a moving liquid streams, called the versatile stage, and a touching stationary stage. The versatile stage might be either a fluid or a gas, while the stationary stage is either a strong or a liquid. Increase in advances in Biotechnology sector augments the production of variety of valuable bio products. Molecules such as therapeutic proteins, enzymes, and other important products require combination of chromatography so as to purify them in purest form. Combination of these novel technologies minimizing the purification steps plays a crucial role for getting maximum purification of the biomolecules.

Track 3: Analytical Method Development and Validation

Analytic method development and validation are persistent and interconnected exercises directed all through the drug development process. The act of validation checks that a given method measures a parameter as planned and sets up the execution furthest reaches of the estimation. Albeit clearly conflicting, approved methods create comes about inside known vulnerabilities. These outcomes are essential to proceeding with drug development, as they characterize the rising learning base supporting the product. The time and exertion that are put into growing logically solid, hearty, and transferrable analytic methods ought to be lined up with the drug development arrange. The assets that are consumed on method validation must be constantly balanced with regulatory requirements and the likelihood for product commercialization.

Track 4: Spectroscopy and its Techniques

Spectroscopy deals with surplus of different techniques that employ electromagnetic radiation on materials in order to measure and interpret data, which is used for elucidating a variety of analytical problems. It includes absorption, emission, or scattering of electromagnetic radiation by atoms or molecules. Types of spectroscopy are IR & NIR, UV/visible, NMR, Atomic Emission Spectroscopy, Fluorescence Spectroscopy etc. Spectroscopic methods are used for Environmental Analysis, Biomedical studies, astronomy. UV-Visible Spectrometer is used for a varied range of applications.

Track 5: Pharmaceutical and Biomedical Analysis

Analytical biochemistry is the study of biochemical components found in a cell or other biological sample. This field uses a broad vary of techniques for separation, identification, quantification and practical characterization of biological molecules like nucleic acids, enzymes, proteins, pigments, carbohydrates and additional. The main ways involved in analytical biochemistry to separate the biological components are qualitative analysis techniques, chromate graphical Techniques, super molecule Estimation & Purification Techniques and medicine Techniques.

Track 6: Mass Spectroscopy: Approaches and Challenges

New mass spectrometry (MS) methods, collectively known as data independent analysis and hyper reaction monitoring. Last decade has witnessed remarkable technological advances in mass spectrometry based proteomics and Biologics. Specific advances include high throughput protein identification by multidimensional chromatography, automated tandem mass spectrometry and sequence data base searching, accurate quantification by the application of stable isotope dilution theory to protein analysis, and the targeted isolation of selected analytes by the use of highly selective chemistries.

Track 7: Bioanalysis

Bioanalysis involves the quantitative measurement of xenobiotics (drugs and their metabolites, and biological molecules in unnatural locations or concentrations) and biotics (macromolecules, proteins, DNA, large molecule drugs, metabolites) in biological systems. In the past two decades, has seen increase in the field of Biopharmaceuticals. Bioanalysis applies to the drugs used for anti-doping testing in sports, illicit purposes and Environmental concerns. The most frequently used techniques are liquid chromatography coupled with tandem mass spectrometry (LC–MS/MS) for micro molecules and enzyme-linked immunosorbent assay (ELISA) for macromolecules.

Track 8: Electro chemical and Thermo analytical techniques

Electrochemical Analysis is a powerful technique that is increasing in utility in the Pharmaceutical Industry due to its high sensitivity, speed of analysis, reduction in solvent and sample consumption, and low operating cost compared to other analytical methods. The modern Electrochemical Analytical techniques are cyclic, linear sweep, differential pulse, square wave and stripping voltammetric techniques. Thermo Analytical techniques are mainly used to detect compound purity, polymorphism, solvation, degradation, and excipient compatibility. It is extensively used in conducting Preformulation studies.

Track 9: Analytical Chemistry

Analytical Chemistry has many applications in Forensic Sciences, environmental analysis, and materials analysis. Analytical Chemistry research is mainly driven by the performance and cost. In these days, great efforts are being put to shrinken the analytical techniques to chip size. In this technology, the most used technique is lab-on-a-chip. The ongoing developments of computer automation and information technologies have broadened the analytical chemistry into a number of new biological fields.

Track 10: Preformulation Studies

Preformulation is considered as critical decision-making tool during both – drug discovery and development phase. Preformulation studies help in assessing the drugability of a molecule. To generate Preformulation data analytical techniques like Spectroscopic, Chromatographic, Thermal methods and some specific detection methods like Capillary electrophoresis are used.

Track 11: Hyphenated Techniques in Analytical chemistry

Hyphenated technique is developed from the coupling of a separation technique and an on-line spectroscopic detection technology. These techniques are mainly broadened their applications in the analysis of natural products.

Track 12: Quality Assurance and Quality Control

Quality assurance is defined as a procedure or set of procedures intended to ensure that a product or service under development meets specified requirements. Quality control (QC) is a procedure or set of procedures intended to ensure that a manufactured product or performed service adheres to a defined set of quality criteria that meets the requirements of the client or customer. The two approaches can be thought of simply as failure detection (QC) and failure prevention (QA). The ISO 9000 family of quality management systems standards is designed to help organizations ensure that they meet the needs of customers and other stakeholders while meeting statutory and regulatory requirements related to a product or service.

Track 13: Pharmaceutical Analysis Errors and Validation

Analytical errors are fundamental before submitting your report and results with the required level of confidence. However, we should have clarity regarding accuracy and precision before we are talking pharmaceutical error. Most of us believe that these terms have the same meaning but the example of arrows striking a target. Any measurement is limited by the precision of the measuring instruments and the technique and the skill of the observer. Where a measurement consists of a single reading on a simple piece of laboratory equipment, for example, a burette or a thermometer, one would expect the quantity of factors adding to vulnerabilities in that estimation to be less than an estimation which is the consequence of a multi-step process comprising of at least two weight estimations, a titration and the utilization of an variety of reagents.

Track 14: GLP and GMP Method Development, Validation and Remediation

Good manufacturing practice is the piece of quality assurance which ensures that things are reliably made and controlled to the quality standard proper to their proposed use and as required by the Marketing Authorization or item particular. GMP is stressed over both generation and quality control, consistency with this standard gives open assurance that the rights, security, and prosperity of trial subjects are ensured; predictable with the rule that have their starting point in the Declaration of Helsinki, and that the clinical information is valid.

Track 15: Biosensors

Biosensor is a device which converts the information regarding the presence of a compound into electro analytical Signal. The biosensor research areas include modern Bio specific analytical techniques. In the recent years, micro fabrication techniques have showed a significant improvement in biosensor systems. The modern methods of the biosensor discoveries range from electrochemical, electromechanical, and fluorescence-­cum-optical-based biosensors and genetically engineered microbes.

Track 16: Pharmaceutical Microbiology

Modern microbiology is unmistakably a branch of biotechnology and incorporates the customary and nucleic corrosive aspects. Pharmaceutical microbiology is the connected branch of microbiology which enables drug specialists to make pharmaceuticals from microorganisms either straightforwardly or with the utilization of some item delivered by them. Different parts of pharmaceutical microbiology incorporate innovative work for assembling of different hostile to tumours, against microbial specialists.

Track 17: Forensic Analysis

Multiply hyphenated techniques, such as gas chromatography/ mass spectrometry with retention time locking (GC/MS/RTL), liquid chromatography/time-of-flight mass spectrometry (LC/ MS/TOF), micro fluidic-based capillary electrophoretic analysis of mitochondrial DNA (mtDNA), and laser ablation inductively coupled plasma mass spectrometry (LA/ICP/MS), are able to uncover forensically germane information by providing unprecedented levels of analytical selectivity and sensitivity

Track 18: Radio Analytical Techniques

Radio analytical Techniques focuses on analysis of sample for their radionuclide content. The Radio analytical Chemistry Capability (RACC) combines radioanalytical chemistry and medium level gamma-ray spectrometry. It has wide applications in the field of forensics, atmospheric sciences, health protection, archeology, and engineering.

Please contact the event manager Marilyn (marilyn.b.turner(at)nyeventslist.com ) below for:
- Multiple participant discounts
- Price quotations or visa invitation letters
- Payment by alternate channels (PayPal, check, Western Union, wire transfers etc)
- Event sponsorship

NO REFUNDS ALLOWED ON REGISTRATIONS
Prices may go up any time. Service fees included in pricing.
-----------------------------------------------------------------
This event is brought to you by:
Conference Series - NewYorkEventsList
http://www.NyEventsList.com
http://www.BostonEventsList.com
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VIO180910CRE

Reference:

https://www.eventbrite.com/e/2nd-international-conference-on-pharmaceutical-analysis-analytical-chemistry-cse-a-tickets-50077169161

9th International Conference on Pharmaceutical GMP, GCP & Regulatory Affairs

About

2020 Key ThemesRegulatory Affairs 2020 conference will focus on new strategies, amendments, innovations, developments in the fields of regulatory affairs, intellectual property rights and medical devices with the theme: “Current challenges of Pharmaceutical & Biopharmaceutical Industries in regulatory framework” which reflects new strategies in the field of regulatory affairs. This conference includes workshops, symposiums, special sessions, key note sessions, conducted by eminent and renowned speakers who excel in the field of regulatory affairs, medical devices, intellectual property rights which include the topics regulatory affairs in pharmacovigilance, clinical affairs & regulatory strategies, regulatory strategies and developments, penalties of regulatory Non-compliance, biologics & biosimilars, global regulatory intelligence, Impact of Brexit on regulatory framework, regulatory requirements in pharmaceuticals, regulatory challenges for medical devices, medical device and combination products regulation, Intellectual property rights etc. This International Regulatory Affairs Conference also encourages the active participation of Young Researchers, Students as we are hosting Poster Award Competition and Young Research Forum at the conference venue.

Product Registration & Submission
Global Guidelines for the Development of Biologics
Medical Device & Combination Products Regulations
Accelerating Approval of New Drugs
ASEAN Labelling Harmonisation
Regulatory & Clinical Affairs
Regulatory & Pharmacovigilance
Regulatory Enforcement & Inspection

Target Audience:

Regulatory Affairs experts
Clinical Research Associates
Medical Devices experts
Quality Assurance experts
Intellectual Property Rights attorneys
Scientists
Researchers
Academicians
Industrialists

Continent wise participation Analysis for Regulatory Affairs 2020 conference

Session/Tracks

Track 1: Regulatory Affairs

Regulatory Affairs profession was developed by the government regulatory bodies to regulate the safety and efficacy of products to protect the health of public. This was developed in all most all divisions of health care industry like pharmaceuticals, veterinary medicines, medical devices, pesticides, agrochemicals, cosmetics, complimentary medicines etc. This profession involves development of new and existing products from early on, preparation and till submission to the relevant regulatory bodies of health authorities by inputting regulatory principles.

Regulatory Affairs is involved actively from early stage of development to post marketing activities of new and existing products. This department is one of the integral parts within the organization structure of pharmaceutical industry. Internally it collaborates at the interphase of drug development, manufacturing, marketing and clinical research. Externally it is the key interface between the commercial industry which undergoes drug development to clinical research and the regulatory authorities.

Track 2: Regulatory Affairs in Pharmacovigilance

Regulatory Affairs (RA), likewise called government issues, are a calling inside managed enterprises, for example, pharmaceuticals, medicinal gadgets, vitality, saving money, telecom and so on. Administrative Affairs likewise has a certain importance inside the human services enterprises (pharmaceuticals, therapeutic gadgets, biologics and useful nourishments). Administrative issues (therapeutic issues) experts (otherwise known as administrative experts) typically have duty regarding the accompanying general territories.

Pharmacovigilance evaluates the adverse effects in turn speaking about the efficacy and safety data of particular drug product thus, collaboration of pharmacovigilance with regulatory bodies provides all the adverse reactions, safety data to regulatory authorities.

Working with government, state and neighborhood administrative offices and faculty on particular issues influencing their business i.e., working with so much office as the Food and Drug Administration or European Medicines Agency (pharmaceuticals and restorative gadgets); The Department of Energy; or the Securities and Exchange Commission (banking). Advising their organizations on the administrative angles and atmosphere that would influence proposed exercises. i.e., portraying the "administrative atmosphere" around issues, for example, the advancement of professionally prescribed medications and Sarbanes-Oxley consistence.

Track 3: Clinical Affairs & Regulatory Strategies

An administrative science driven administrative procedure is crucial as a component of today's biopharmaceutical item early advancement arranging. An all-around arranged administrative methodology will adjust the proposed clinical advancement arrangement with business targets, and pre-emptively distinguish challenges, and also, proposed elective/creative ways to deal with new item improvement which influence new measures for confirmation era supporting proceeding with improvement and worldwide business sector approval. An administrative methodology characterizes key issues/difficulties to proactively talk about with Regulatory powers furthermore characterizes key system points of reference that are frequently considered business impetuses driving speculator intrigue and financing. In particular, an auspicious, very much arranged and all around kept up administrative technique, with proactive and collective cooperation with administrative powers, is regularly a separating element for industry pioneers putting up monetarily fruitful and creative items for sale to the public in today's aggressive commercial center. Administrative procedure is a noteworthy segment of fruitful biopharmaceutical item improvement. Covance Global Regulatory Affairs gets ready and keeps up administrative science driven and item particular worldwide administrative systems for some item sorts, e.g., drugs, biologics, drug-gadget mixes, antibodies, quality treatments, cell-treatments, over a scope of restorative territories and full administrative technique support for item improvement activities.

Track 4: Regulatory Strategies and Developments

Regulatory strategies are formal documents that include series of regulatory activities to discover an innovative product or a modified product to market with business strategy for that product. This provides description and course to project team for the product being developed with identification of important regulatory elements which are addressed to market the product. Within a firm there are many regulatory strategists from different departments that involve all aspects of a drug and individuals with expertise in chemical synthesis, toxicology, biology, clinical and regulatory affairs, marketing, government affairs and reimbursement inputs into the regulatory strategy ensuring it is comprehensive.

Regulatory strategy document has three purposes, it acts as a:

A tracking tool to summarize key agreements reached with health authorities
A planning tool that documents timelines and lists topics to address in future meetings with health authorities
A risk register to record key issues that could impact timelines, costs or commercial value for the project

Track 5: Penalties for Regulatory Non-compliance:

Non-compliance costs are costs which result from a failure to comply with regulation. These costs are not considered to be part of the regulatory burden for the purposes of the Risk Based Monitoring. This includes penalties and activities associated with those penalties that are required to be undertaken because of noncompliance with regulation. Regulatory impacts that arise, up to the point that action is taken to respond to the suspicion of a specific instance of noncompliance, are included in RBM framework. This includes risk based frameworks that may target certain populations without a specific instance of suspicion. Failure to comply with the law can lead to enforcement action including one or more of the following: on-the-spot fines, prosecution, which carries a maximum fine of $12,110, disciplinary action, ranging from fines to cancellation of the license.

Track 6: Biologics & Biosimilars

A biopharmaceutical, otherwise called a biologic therapeutic item or biologic, is any restorative item made in, extricated from, or semi orchestrated from organic sources. Not quite the same as synthetically incorporated pharmaceuticals, they incorporate immunizations, blood, or blood segments, allergenic, substantial cells, quality treatments, tissues, recombinant restorative protein, and living cells utilized as a part of cell treatment. Biologics can be made out of sugars, proteins, or nucleic acids or complex mixes of these substances, or might live cells or tissues. They are confined from normal sources—human, creature, or microorganism. Phrasing encompassing biopharmaceuticals fluctuates amongst gatherings and elements, with various terms alluding to various subsets of therapeutics inside the general biopharmaceutical class. Some administrative offices utilize the terms natural restorative items or remedial organic item to allude particularly to designed macromolecular items like protein-and nucleic acid–based drugs, recognizing them from items like blood, blood segments, or antibodies, which are typically extricated specifically from a natural source Gene-based and cell biologics, for instance, frequently are at the front line of biomedical research, and might be utilized to treat an assortment of therapeutic conditions for which no different medications are accessible.

Track 7: Global Regulatory Intelligence

Ever-proliferating and changing global regulations generate complex challenges of execution in global market clearance operations.

Mission-critical decisions are delayed, trapping new international revenue until market clearance process issues are resolved. Workflow is confounded as information conflicts from sales-focused distributors, newly-appointed foreign regulators, and legacy resources are reconciled- and as definitive answers are sought. Governance is compromised as information gaps reduce assurance levels and impair risk management of clearance-related penalties, fines, and legal costs.

And the high level of business performance required to create value from ongoing medtech industry consolidation is not achievable, since global market clearance operations are incapable of rapidly completing new market clearance submissions for newly-acquired product lines.

Unlike repackaged RI databases designed for the pharmaceutical industry, the clinivation Worldview Enterprise Solution for On-Demand Global Regulatory Intelligence accelerates the market clearance cycle.

Track 8: Impact of Brexit on Regulatory Framework

The most important piece of UK legislation that would need to be repealed is the European Communities Act 1972 (ECA), which provides for the supremacy of EU law. Repealing the ECA will bring an end to the constitutional relationship that exists between EU and UK law. Moreover, the vast amounts of secondary legislation that have been passed with the objective and justification of implementing EU law would have to be considered by the Government. EU Regulations rely on the principle of direct applicability, which means that unlike EU Directives, they are directly implemented into UK law without the need for legislation from the UK Parliament. In this light, Regulations are more powerful legislative tools for the EU because of their immediate applicability. The status of existing Regulations will be addressed in the Great Repeal Bill, although as noted above, in many cases amendments will likely be needed to take into account the UK’s new relationship with the EU. The Court of Justice of the European Union (CJEU) situated in Luxembourg is the final arbiter on questions of the interpretation of EU law. In her first speech setting out the UK Government’s priorities for Brexit on 17 January 2020, the Prime Minister restated her position that the UK is not prepared to continue to be subject to the jurisdiction of the CJEU.

Track 9: Regulatory Communications and Submissions

Due to the growing interest in marketing new products, it is pivotal to establish a superior level of medical writing and regulatory operations. Executives within these roles need to create and manage successful submissions, as well as streamline timelines, to accelerate approval.

Attending the Optimizing Regulatory Communications and Submissions conference will aid delegates in expediting the approval of drugs while meeting requirements for different regulatory agencies worldwide. In addition, attendees will overcome key operational challenges impacting the approval process to enhance the quality of submissions.

Track 10: Marketing Authorizations-Affordable Healthcare and Fair Trade

This establishment level module is the perfect acquaintance for new participants with the field of pharmaceutical administrative issues and consistence. It portrays the central prerequisites that must be fulfilled to pick up and keep up endorsement to advertise restorative items in the USA and Europe. The lawful structure and the parts of significant players in control are displayed. The life-cycle of a medication is sketched out. The different systems accessible for appraisal and endorsement of items are depicted and their prerequisites laid out. Commitments to be satisfied in the wake of promoting endorsement are examined. Worldwide administrative undertakings bunches in industry give around the world, key initiative in and far reaching course of the legislature administrative necessities for item presentation and commercialization, using administrative learning to guarantee consistence and administrative knowledge and make open doors in an exceedingly controlled environment. The worldwide administrative undertakings bunch has vital and operational capacities, requiring accuracy and faultless execution, as an organization's prosperity depends on, partially, the direction and thorough appraisal gave by the administrative issues group. The key item advancement, assembling and enlistment turning points, (for example, Investigational New Drug documenting, end of stage II, stage III, New Drug Application entries, administrative office audit timetable and item endorsements), which are the corporate valuation and choice focuses, depend on basic administrative interface goalposts and developments. This underscores the significance of key administrative commitment to the business. Keeping in mind the end goal to be profitable donors and basic business accomplices, the worldwide administrative undertakings association must create instruments and build up frameworks to guarantee it has the right individuals and ability, capable procedures, productive profitability, sensational execution and accuracy in arranging.

Track 11: Regulatory Requirements for Pharmaceuticals

The new medication endorsement process have been made into three stages for improvement in comprehension - the principal stage is pre-advertising implied for revelation, advancement and clinical concentrates, second stage for promoting approval of medication and third is for post showcasing. Firstly, preclinical investigations of a medication are finished to guarantee adequacy and security, and after that application for behavior of clinical trials is submitted to the CDSCO. From that point, the clinical trials can be led (stage I to stage IV). These studies are performed to guarantee the viability, wellbeing and upgrading the measurements of medication in people. After the culmination of clinical investigations of the medication, then an application to the skilled power of India for the endorsement of medication for advertising is submitted. The able power audit the application and affirm the medication for advertising just if the medication is observed to be sheltered and successful in individual or the medication have more alluring impact as contrast with the danger.

Track 12: Regulatory Challenges for Medical Devices

As therapeutic gadget quality certification and administrative undertakings experts, it can test to remain focused of changes occurrence in our industry. Administrative controls for restorative gadgets are rare in the creating scene, despite the fact that usage of national medicinal gadget directions will frequently address the very issues brought up in nations as significant attentiveness toward patient wellbeing. Case of these issues incorporate the unlawful re-preparing and re-bundling of utilized syringes for re-deal; the accessibility available of hardware that fizzles least quality and security benchmarks; or just no hint of what gadgets are being sold in the nation, nor by whom. Such a posting is crucial to empower governments to issue cautions or reviews for perilous or inadequate things.

Track 13: Medical Device & Combination Products Regulations

Blend items are remedial and indicative items that consolidate medications, gadgets, and/or organic items. FDA hopes to get expansive quantities of blend items for audit as innovative advances keep on merging item sorts and obscure the verifiable lines of partition between FDA's therapeutic item focuses, which are comprised of the Center for Biologics Evaluation and Research (CBER), the Center for Drug Evaluation and Research (CDER), and the Center for Devices and Radiological Health (CDRH). Since mix items include parts that would regularly be controlled under various sorts of administrative powers, and much of the time by various FDA Centers, they raise testing administrative, strategy, and audit administration challenges. Contrasts in administrative pathways for every part can affect the administrative procedures for all parts of item improvement and administration, including preclinical testing, clinical examination, showcasing applications, assembling and quality control, antagonistic occasion reporting, advancement and promoting, and post-endorsement alterations.

Track 14: Best Industry Practices

Drug business is one in everything about nation's most critical monetary motors, trade $15 billion in stock yearly and a couple of its processing plants region unit preeminent. The government office has built up a progression of tips for creating GXP (which incorporates GCP, GLP and GMP directions) that shield each the life sciences business furthermore the clients they serve. In order to help FDA-directed firms, expert control offers partner in incorporated quality and consistence administration code that guarantees GLP, GCP and GMP rules consistence. Industry practices is likewise some portion of value danger administration framework, Pharma Regulatory Affairs, Audits and assessments, acceptance strategies (process approval and expository approval), Qualification, acceptance, adjustment, upkeep, hazard investigation Drug Safety and Good Pharmacovigilance hones. Some of our product framework applications which will encourage with GLP GCP GMP rules epitomize the resulting arrangements: Document Control/Document Management, Corrective Action Preventive Action (CAPA), alteration administration, guiding Management, resistance Automation programming framework, Audit Management in venture with GLP GCP GMP rules, customer protests programming framework, shapes based strategy robotization, electronic entries.

Track 15: Intellectual Property Rights

In the EU, an organic thoughtful item is one amongst the dynamic substance(s) made from or separated from a natural (living) framework, and requirements, also to physico-compound testing, natural testing for full characterization. The characterization of a natural medicative item could be a blend of testing the dynamic substance and hence the last medicative item along the edge of the get together strategy and its administration. Central thoughts of Intellectual Property Management (IPM) and its significance is a goad to human force and in this manner is the headway of financial and social improvement. It furthermore gives defense on the occasion Associate in usage of an IPM technique together with the administration of material ownership (IP) in a web setting. Investigative control law more often than not gives the creator of partner in scholarly creation restrictive rights for abusing and taking advantage of their creation. Experimental order insurance is intended to fortify the force of the human personality for the upside of all by verifying that benefits got from misusing a creation advantage the maker. This may energize action and allow financial specialists in investigation and improvement a decent go ahead their speculation. Experimental order presents on individuals, undertakings or option elements the right to bar others from the vocation of their manifestations wellbeing and quality control in naming. Therefore, material ownership rights (IPRs) could have an on the spot Associate in generous effect on exchange on the grounds that the proprietor of an IPR could - through the social control of such a privilege - prevent the assembling, use or offer of an item which incorporates the IPR. Therefore administration over the immaterial (IPR) suggests administration of the stock and markets. Exploratory order security energizes the production, conveyance and discourse demonstration of the creation to the overall population, rather than keeping it mystery though at indistinguishable time urging mechanical endeavours to choose imaginative works for abuse. Material ownership lawful titles identifies with the securing and utilization of an assortment of rights covering totally distinctive type of manifestations. Licenses in the pharmaceutical business incorporate both lawful and moral issues.

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2nd International Conference on Pharmaceutical Analysis & Analytical Chemistry

About

After the fruitful execution of the International Conference on Pharmaceutical Analysis and Quality Control Strategies, Conference Series with great pride and honour announcing its International Conference on Pharmaceutical Analysis & Analytical Chemistry which is going to held in Chicago, USA during August 02-03, 2020.

Pharmaceutical Analysis 2020 serves as a podium for the interaction between experts in the area of pharmaceutical analysis and analytical chemistry around the world. We cordially invite all the eminent researchers, academicians, students, industry representatives working in these exciting areas.

This Conference is mainly focused on the theme “New paradigms in Pharmaceutical Analytical Techniques”. The conference includes workshops, symposiums, special keynote sessions conducted by eminent and renowned speakers who excel in the field of Pharmaceutical Analysis and Drug Discovery This International Pediatric Conference also encourages the active participation of young student researchers as we are hosting Poster Award Competition and Young research Forum at the conference venue.

Target Audience:

Pharmaceutical Analysis Researchers

Analytical Chemists

Noble Laureates

Directors, Presidents, CEO’s of Organizations/Companies

Pharmaceutical Associations and Societies

Academicians (Professors, Associate & Assistant professors, Deans, Directors)

Graduates and Post graduates

Sessions/Tracks

Track 1: Modern Pharmaceutical Analysis

Generally, Pharmaceutical Analysis alluded to the synthetic examination of medication atoms. Be that as it may, throughout the years, present day pharmaceutical investigation has advanced past this to envelop mix systems, high-throughput innovations, chemo metrics, micro dosing studies, scaling down and nanotechnology. These logical advances are currently being utilized in all phases of medication disclosure and the concentration of this survey will be on how these advances are being utilized inside this procedure. With new, enhanced and advancing innovations, and in addition new applications for existing innovation, the scan for new medications for the aversion and treatment of human maladies proceeds.

Track 2: Chromatography & Separation Techniques

Chromatography strategy for isolating the parts, or solutes, of a blend on the premise of the relative measures of every solute appropriated between a moving liquid streams, called the versatile stage, and a touching stationary stage. The versatile stage might be either a fluid or a gas, while the stationary stage is either a strong or a liquid. Increase in advances in Biotechnology sector augments the production of variety of valuable bio products. Molecules such as therapeutic proteins, enzymes, and other important products require combination of chromatography so as to purify them in purest form. Combination of these novel technologies minimizing the purification steps plays a crucial role for getting maximum purification of the biomolecules.

Track 3: Analytical Method Development and Validation

Analytic method development and validation are persistent and interconnected exercises directed all through the drug development process. The act of validation checks that a given method measures a parameter as planned and sets up the execution furthest reaches of the estimation. Albeit clearly conflicting, approved methods create comes about inside known vulnerabilities. These outcomes are essential to proceeding with drug development, as they characterize the rising learning base supporting the product. The time and exertion that are put into growing logically solid, hearty, and transferrable analytic methods ought to be lined up with the drug development arrange. The assets that are consumed on method validation must be constantly balanced with regulatory requirements and the likelihood for product commercialization.

Track 4: Spectroscopy and its Techniques

Spectroscopy deals with surplus of different techniques that employ electromagnetic radiation on materials in order to measure and interpret data, which is used for elucidating a variety of analytical problems. It includes absorption, emission, or scattering of electromagnetic radiation by atoms or molecules. Types of spectroscopy are IR & NIR, UV/visible, NMR, Atomic Emission Spectroscopy, Fluorescence Spectroscopy etc. Spectroscopic methods are used for Environmental Analysis, Biomedical studies, astronomy. UV-Visible Spectrometer is used for a varied range of applications.

Track 5: Pharmaceutical and Biomedical Analysis

Analytical biochemistry is the study of biochemical components found in a cell or other biological sample. This field uses a broad vary of techniques for separation, identification, quantification and practical characterization of biological molecules like nucleic acids, enzymes, proteins, pigments, carbohydrates and additional. The main ways involved in analytical biochemistry to separate the biological components are qualitative analysis techniques, chromate graphical Techniques, super molecule Estimation & Purification Techniques and medicine Techniques.

Track 6: Mass Spectroscopy: Approaches and Challenges

New mass spectrometry (MS) methods, collectively known as data independent analysis and hyper reaction monitoring. Last decade has witnessed remarkable technological advances in mass spectrometry based proteomics and Biologics. Specific advances include high throughput protein identification by multidimensional chromatography, automated tandem mass spectrometry and sequence data base searching, accurate quantification by the application of stable isotope dilution theory to protein analysis, and the targeted isolation of selected analytes by the use of highly selective chemistries.

Track 7: Bioanalysis

Bioanalysis involves the quantitative measurement of xenobiotics (drugs and their metabolites, and biological molecules in unnatural locations or concentrations) and biotics (macromolecules, proteins, DNA, large molecule drugs, metabolites) in biological systems. In the past two decades, has seen increase in the field of Biopharmaceuticals. Bioanalysis applies to the drugs used for anti-doping testing in sports, illicit purposes and Environmental concerns. The most frequently used techniques are liquid chromatography coupled with tandem mass spectrometry (LC–MS/MS) for micro molecules and enzyme-linked immunosorbent assay (ELISA) for macromolecules.

Track 8: Electro chemical and Thermo analytical techniques

Electrochemical Analysis is a powerful technique that is increasing in utility in the Pharmaceutical Industry due to its high sensitivity, speed of analysis, reduction in solvent and sample consumption, and low operating cost compared to other analytical methods. The modern Electrochemical Analytical techniques are cyclic, linear sweep, differential pulse, square wave and stripping voltammetric techniques. Thermo Analytical techniques are mainly used to detect compound purity, polymorphism, solvation, degradation, and excipient compatibility. It is extensively used in conducting Preformulation studies.

Track 9: Analytical Chemistry

Analytical Chemistry has many applications in Forensic Sciences, environmental analysis, and materials analysis. Analytical Chemistry research is mainly driven by the performance and cost. In these days, great efforts are being put to shrinken the analytical techniques to chip size. In this technology, the most used technique is lab-on-a-chip. The ongoing developments of computer automation and information technologies have broadened the analytical chemistry into a number of new biological fields.

Track 10: Preformulation Studies

Preformulation is considered as critical decision-making tool during both – drug discovery and development phase. Preformulation studies help in assessing the drugability of a molecule. To generate Preformulation data analytical techniques like Spectroscopic, Chromatographic, Thermal methods and some specific detection methods like Capillary electrophoresis are used.

Track 11: Hyphenated Techniques in Analytical chemistry

Hyphenated technique is developed from the coupling of a separation technique and an on-line spectroscopic detection technology. These techniques are mainly broadened their applications in the analysis of natural products.

Track 12: Quality Assurance and Quality Control

Quality assurance is defined as a procedure or set of procedures intended to ensure that a product or service under development meets specified requirements. Quality control (QC) is a procedure or set of procedures intended to ensure that a manufactured product or performed service adheres to a defined set of quality criteria that meets the requirements of the client or customer. The two approaches can be thought of simply as failure detection (QC) and failure prevention (QA). The ISO 9000 family of quality management systems standards is designed to help organizations ensure that they meet the needs of customers and other stakeholders while meeting statutory and regulatory requirements related to a product or service.

Track 13: Pharmaceutical Analysis Errors and Validation

Analytical errors are fundamental before submitting your report and results with the required level of confidence. However, we should have clarity regarding accuracy and precision before we are talking pharmaceutical error. Most of us believe that these terms have the same meaning but the example of arrows striking a target. Any measurement is limited by the precision of the measuring instruments and the technique and the skill of the observer. Where a measurement consists of a single reading on a simple piece of laboratory equipment, for example, a burette or a thermometer, one would expect the quantity of factors adding to vulnerabilities in that estimation to be less than an estimation which is the consequence of a multi-step process comprising of at least two weight estimations, a titration and the utilization of an variety of reagents.

Track 14: GLP and GMP Method Development, Validation and Remediation

Good manufacturing practice is the piece of quality assurance which ensures that things are reliably made and controlled to the quality standard proper to their proposed use and as required by the Marketing Authorization or item particular. GMP is stressed over both generation and quality control, consistency with this standard gives open assurance that the rights, security, and prosperity of trial subjects are ensured; predictable with the rule that have their starting point in the Declaration of Helsinki, and that the clinical information is valid.

Track 15: Biosensors

Biosensor is a device which converts the information regarding the presence of a compound into electro analytical Signal. The biosensor research areas include modern Bio specific analytical techniques. In the recent years, micro fabrication techniques have showed a significant improvement in biosensor systems. The modern methods of the biosensor discoveries range from electrochemical, electromechanical, and fluorescence-­cum-optical-based biosensors and genetically engineered microbes.

Track 16: Pharmaceutical Microbiology

Modern microbiology is unmistakably a branch of biotechnology and incorporates the customary and nucleic corrosive aspects. Pharmaceutical microbiology is the connected branch of microbiology which enables drug specialists to make pharmaceuticals from microorganisms either straightforwardly or with the utilization of some item delivered by them. Different parts of pharmaceutical microbiology incorporate innovative work for assembling of different hostile to tumours, against microbial specialists.

Track 17: Forensic Analysis

Multiply hyphenated techniques, such as gas chromatography/ mass spectrometry with retention time locking (GC/MS/RTL), liquid chromatography/time-of-flight mass spectrometry (LC/ MS/TOF), micro fluidic-based capillary electrophoretic analysis of mitochondrial DNA (mtDNA), and laser ablation inductively coupled plasma mass spectrometry (LA/ICP/MS), are able to uncover forensically germane information by providing unprecedented levels of analytical selectivity and sensitivity

Track 18: Radio Analytical Techniques

Radio analytical Techniques focuses on analysis of sample for their radionuclide content. The Radio analytical Chemistry Capability (RACC) combines radioanalytical chemistry and medium level gamma-ray spectrometry. It has wide applications in the field of forensics, atmospheric sciences, health protection, archeology, and engineering.

Please contact the event manager Marilyn (marilyn.b.turner(at)nyeventslist.com ) below for:
- Multiple participant discounts
- Price quotations or visa invitation letters
- Payment by alternate channels (PayPal, check, Western Union, wire transfers etc)
- Event sponsorship

NO REFUNDS ALLOWED ON REGISTRATIONS
Prices may go up any time. Service fees included in pricing.
-----------------------------------------------------------------
This event is brought to you by:
Conference Series - NewYorkEventsList
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Reference:

https://www.eventbrite.com/e/2nd-international-conference-on-pharmaceutical-analysis-analytical-chemistry-cse-a-tickets-50077169161