Theme: "Regulatory Challenges & Implications"

Regulatory Affairs 2017
Past Report of Regulatory Affairs 2016

Regulatory Affairs 2017

Sessions/Tracks

Track 1: Regulatory Affairs

Regulatory affairs is a comparatively new profession which developed from the desire of governments to protect public health by controlling the safety and efficacy of products in areas including pharmaceuticals, veterinary medicines, medical devices, pesticides, agrochemicals, cosmetics and complementary medicines. Regulatory Affairs is involved in the development of new medicinal products from early on, by integrating regulatory principles and by preparing and submitting the relevant regulatory dossiers to health authorities.

Regulatory Affairs is actively involved in every stage of development of a new medicine and in the post-marketing activities with authorized medicinal products. The Regulatory Affairs department is an important part of the organizational structure of pharmaceutical industry. Internally it liaises at the interphase of drug development, manufacturing, marketing and clinical research. Externally it is the key interface between the company and the regulatory authorities.

Track 2: Regulatory & 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:

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

A regulatory strategy is a formal document that aligns the regulatory activities to bring a new or modified product to market with the business strategy for that product. It provides overall definition and direction to the project team for the product being developed by identifying the important regulatory elements to be addressed to market the device. Within a company, there are usually many players from a variety of departments who work on developing the regulatory strategy. Since this strategy involves all aspects of a drug, individuals with expertise in chemical synthesis, toxicology, biology, clinical and regulatory affairs, marketing, government affairs, and reimbursement should all provide input into the regulatory strategy to ensure it is as comprehensive as possible.

The regulatory strategy document has three main purposes. It needs to be:

  • 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: 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 6: 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 7: 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 8: 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 9: 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 10: 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 11: 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 12: 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 13: 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.

 





About Conference

Conference Series LLC is a renowned organization that organizes highly notable pharmaceutical conferences throughout the globe. After a successful conference of RegulatoryAffairs 2016, Conference Series LLC is currently bringing forth "7th International Conference and Exhibition on Pharmaceutical Regulatory Affairs & IPR” (Regulatory Affairs 2017) slated on September 25-26, 2017 at Chicago, USA.

Conference Series LLC invites all the participants across the globe to attend the 2017 conference which provides the perfect one-stop resource with the information and knowledge resources to help you develop skills and learn proven strategies and techniques to help you overcome the challenges you face in the Regulatory profession.

2017 Key Themes

  • 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

Top Reasons to Attend

  • Gain critical advise from industry experts on regulation matters
  • Meet and network 100+ industry leaders and peers, with co-located events under PharmaCon
  • Get detailed information of the new regulation and its foreseen challenges in Asia Pacific
  • Benchmark your regulatory strategies with the other leaders
  • Breadth and depth of key topics on production registration, submission, pharmacovigilance, clinical regulatory requirements will be addressed




Market Anaysis

Summary:
Regulatory Affairs Professionals Society (RAPS) Professional Development Framework (PD Framework) for the healthcare product regulatory affairs (RA) profession. The PD Framework offers a model for describing the basic body of knowledge and relevant skills of the RA profession across product lines, geographic locations and employer types at four major career stages. The framework is the result of years of research and development carried out by RAPS with the involvement of members worldwide. The studies’ results provide valuable insights into the nature of the profession. The framework defines the profession by professional/career levels, domains that reflect steps in the healthcare product lifecycle, the responsibilities and tasks of the RA professional at each step and the associated core knowledge and skills required of the professional.

Importance & Scope:

Regulatory Affairs is a profession which developed from the desire of governments to protect public health by controlling the safety and efficacy of products in areas including pharmaceuticals, veterinary medicines, medical devices, cosmetics.

Regulatory Affairs importance is to provide the strategic regulatory framework for the submission, to advise on procedures and formats, to collect, evaluate and compile the scientific data and information on the product. Conference share knowledge to the Pharma Industry Professionals, Professors and Students. Both Pharma companies and Bulk drug industries can be involved.

The regulation of medical products has been expanding since early 20th century. Regulatory agencies are being established in an ever increasing number of countries across the globe. Those that have established are reorganizing their systems and attempting to harmonize with organizations of other countries. The pharmaceutical, biotechnology and medical devices are among the most highly regulated industries in the world.

Why Florida?

After years of aggressive, coordinated effort, Florida has firmly established itself as a true hub for the Pharma industries. Today, Florida is home to some of the nation's most highly regarded research centers; over 1,000 biotech, pharmaceutical and medical devices companies; industry leaders - including Actavis, Arthrex, Bristol Meyers Squibb, Johnson & Johnson, Medtronic, Noven, and Steripak.

Florida’s 200+ pharmaceutical and medicine manufacturing companies specialize in the development and manufacture of novel treatments, generics, nutraceuticals and OTC drugs. They employ nearly 4,500 researchers, engineers, technicians and workers.

Florida boasts the 2 largest medical device manufacturing industry in the U.S. Nearly 19,000 Floridians work in this industry, with a majority of companies located along the I-4 Corridor in Central Florida, the Jacksonville area, and in South Florida. Florida is home to more than 250 biotech companies and world renowned R&D institutes specializing in therapeutics, diagnostics, industrial/ag biotech and other areas. Florida has the science, talent, and support structure biotechs need to succeed.

Conference Highlights:

  • Regulatory Affairs
  • Fundamentals of Regulatory Affairs
  • Clinical Regulatory Strategies
  • Novel Strategies for Growth in the Pharma and Regulatory Affairs
  • Pharmaceutical Regulatory Environment
  • Regulation and the Global Regulatory Affairs
  • Biologics and Other Products
  • Best Industry Practices
  • Interllectual Property Rights
  • Marketing Authorizations, Advertising and Marketing Practices
  • Requirements for Medical Devices
  • Regulatory Strategies and Developments
  • Regulatory Requirements for Pharmaceuticals

Why to attend??

A deep understanding of legal, ethical and policy context is required to effectively navigate through today's regulatory environment. The Florida focuses in pharmacy with concentration in Pharmaceutical Outcomes & Policy to enable regulatory professionals, as well as health systems and insurance administrators, pharmacists, and lawyers to effectively create, manufacture and deliver pharmaceuticals that are safe for patient use and meet the policy and laws in place.

Major Associations in Florida

  • Florida Society of Health-System Pharmacists
  • Central Florida Pharmacy Association
  • FPA - Florida Pharmacy Association
  • Escambia County Pharmacy Association
  • National Alliance of State Pharmacy Associations
  • Dade County Pharmacy Association
  • The Asia-Pacific Professional Services Marketing Association (APSMA)
  • Association of Internet Marketing and Sales (AIMS)-Canada

Major Associations in USA

  • Regulatory Affairs Professionals Society
  • Regulatory Affairs-American Chemical Society
  • TOPRA-The Organization for Professionals in Regulatory Affairs
  • Orange County Regulatory Affairs Discussion Group (OCRA)
  • The Canadian Association of Professionals in Regulatory Affairs (CAPRA)
  • AAPS Regulatory Affairs
  • American Bakers Association
  • American Association of meat processors
  • American Herbal Products Association (AHPA)

Statistical Analysis of Associations

Target Audience:

Directors/Managers & Business Intelligence Experts, Departmental Managers, Vice Presidents/ Directors, Pharmaceutical Scientist, Scientist, Policy Analyst, Pharmaceutical Companies, Bulk drug Industries, Pharmaceutical regulatory agencies, Professors and Students from Academia in the study of Pharmaceutical  regulatory affairs.

Top Universities in Florida:

  • Nova Southeastern University - College of Pharmacy
  • University of Florida College of Pharmacy
  • University of South Florida - College of Pharmacy
  • Lake Erie College of Pharmacy
  • Palm Beach Atlantic University - School of Pharmacy

Figure 2: Statistical Analysis of universities in Florida, USA and World wide

 

Companies Associated with Regulatory Affairs

Figure 3:  Companies Associated with Regulatory Affairs in Florida, USA and World wide

Marketing Analysis for Drug Approval:

Regulatory Affairs Department is the backbone of Pharmaceutical Industry. It is the revenue generator for pharmaceutical Industry. The Regulatory Affairs department is an important part of the pharmaceutical companies.

More than 15 years span is required to develop and launch a new pharmaceutical product in the market. The Regulatory Affairs Agencies explains expenditure spent on each drug annually is $850 million in US. The Indian Pharmaceutical industry is one of the fastest growing industries in India, with a compounded annual growth rate (CAGR) of over 13 % in last 5 years and it is expected to grow at a higher rate in coming 10 years India spends around $300 million, united kingdom $700 , Brazil $200 million , France $550, Italy $400 As per cabinet decision in June 2010 in Japan amended a new policy i.e., Health power strategy through “Life Innovation” and expenditure spent on each drug was $450 million .

Internally it cooperates with other department like drug development, manufacturing, marketing and clinical research. Externally, it is the key interface between the company and the regulatory authorities. Industrialized regulatory affairs is to drive compliance, speed to market, and cost efficiency.

Statistics which shows Expenditure spent on each drug for approval global, USA & Florida

Figure 4: Expenditure spent on each drug for approval Florida, USA & global

 

Figure 5: Expenditure spent on each drug country wise for drug approval





Past Conference Report

Regulatory Affairs 2016

Conference Series LLC 6th International Conference and Exhibition on Pharmaceutical Regulatory Affairs at Orlando, Florida, USA during September 29-30, 2016 was organized with a focus on “Novel Regulatory Environments and Requirements was a great success where eminent keynote speakers from various reputed companies made their resplendent presence and addressed the gathering.

Regulatory Affairs 2016 witnessed an amalgamation of peerless speakers who enlightened the crowd with their knowledge and confabulated on various new-fangled topics related to the field of Pharma and Regulatory Affairs.

Conference Series LLC would like to convey a warm gratitude to all the Honourable guests and Keynote Speakers of Regulatory Affairs 2016:

  • Ramnarayan Randad, Food and Drug Administration, USA
  • Jelena Gankina, NPF Material Medical Holding, Russia
  • Mohammed R Khan, Synergex Consulting, Canada
  • Michael Drues, Vascular Sciences, USA

Regulatory Affairs 2016 Organizing Committee would like to thank the Moderator of the conference and all other attendees who contributed a lot for the smooth functioning of the event

Conference Series LLC also took the privilege of felicitating Regulatory Affairs 2016 Organizing Committee, Keynote Speakers, and Chair and Co-Chairs whose support made conference a great success.

6th International Conference and Exhibition on Pharmaceutical Regulatory Affairs was a great success with the support of International multi professional steering committee and coordinated by the Pharmaceutical Regulatory Affairs: Open AccessPharmacoeconomics: Open Access, Advances in Pharmacoepidemiology & Drug Safety.

With the enormous feedback from the participants and supporters of Regulatory Affairs 2016, Conference Series LLC Conferences is glad to announce 7th International Conference and Exhibition on Pharmaceutical Regulatory Affairs and IPR Sep 25-26, Chicago, USA.


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Past Conference Report

Regulatory Affairs 2015

Conferenceseries LLC 5th International Conference and Exhibition on Pharmaceutical Regulatory Affairs at Orlando, Florida, USA during August 03-05, 2015 was organized with a focus on “Share and Enhance the Aspects on Novel Policies in Regulatory Affairs” was a great success where eminent keynote speakers from various reputed companies made their resplendent presence and addressed the gathering.

Regulatory Affairs 2015 witnessed an amalgamation of peerless speakers who enlightened the crowd with their knowledge and confabulated on various newfangled topics related to the field of Pharma and Regulatory Affairs.

Conferenceseries LLC would like to convey a warm gratitude to all the Honorable guests and Keynote Speakers of Regulatory Affairs 2015:

  • Ting-Chao Chou, PD Science LLC, USA
  • James J Hickman, University of Central Florida, USA
  • Michael Drues, Vascular Sciences, USA
  • Kishor K Chakraborty, Riyadh Pharma, Saudi Arabia

Regulatory Affairs 2015 Organizing Committee would like to thank the Moderator of the conference and all other attendees who contributed a lot for the smooth functioning of the event

Conferenceseries LLC also took the privilege of felicitating Regulatory Affairs 2015 Organizing Committee, Keynote Speakers, Chair and Co-Chairs whose support made conference a great success.

5th International Conference and Exhibition on Pharmaceutical Regulatory Affairs was a great success with the support of International multi professional steering committee and coordinated by the Pharmaceutical Regulatory Affairs: Open AccessJournal of Bioanalysis & Biomedicine and Advances in Pharmacoepidemiology & Drug Safety.

With the enormous feedback from the participants and supporters of Regulatory Affairs 2015, Conferenceseries LLC Conferences is glad to announce 6th International Conference and Exhibition on Pharmaceutical Regulatory Affairs and IPR Sep 29- Oct 01, Orlando, USA.


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Past Conference Report

Regulatory Affairs-2014

Conference Series LLC's  4th International Conference on Pharmaceutical Regulatory Affairs at  DoubleTree by Hilton Hotel Raleigh-Brownstone-University, USA during September 08-10, 2014 was organized with a focus on Key implications in Regulatory environment was a great success where eminent keynote speakers from various reputed institutions made their resplendent presence and addressed the gathering.

Regulatory Affairs-2014 witnessed an amalgamation of peerless speakers who enlightened the crowd with their knowledge and confabulated on various new-fangled topics related to the field of Pharma sectors.

Regulatory Affairs-2014 Organizing Committee would like to thank the Moderator of the conference, Ms. Mariam Aslam, ESCOP, UK who contributed a lot for the smooth functioning of this event.

Conference Series LLC would like to convey a warm gratitude to all the Honorable guests of Regulatory Affairs -2014:

  • Jerry Xu, WuXi Apptec, China.
  • David Hawley, IS Compliance and Validation, North America
  • Michael Drues, Vascular Sciences, USA
  • Donald Min, United States Pharmacopeial Convention, USA

The highlights of the conference were its educative and effectual keynote lectures by:

  • Adam Sabouni, PharmaConsultz, USA
  • David Hawley, IS Compliance and Validation, North America
  • Michael Drues, Vascular Sciences, USA
  • Jerry Xu, WuXi Apptec, China

Conference Series LLC, on behalf of the conference, congratulates the Best Poster awardees for their outstanding performance in the field of  Regulatory Affairs and appreciates all the participants who put their efforts in poster presentations and sincerely wishes them success in future endeavours. We would like to thank the Poster Competition Judge Dr. David Hawley, IS Compliance and Validation, North America for his valuable time.

Best Poster Winners:

  • Krasimira Pekova, Artisan Healthcare Consulting, Inc., USA
  • Varley Dias Sousa, University of Brasilia, Brazil

Conference Series LLC also took the privilege of felicitating Regulatory Affairs-2014 Organizing CommitteeEditorial Board Members of Pharmaceutical Regulatory Affairs: Open AccessJournal of Bioanalysis & Biomedicine  &  Advances in Pharmacoepidemiology & Drug Safety, Keynote Speakers, Chair and Co-Chairs and Moderator whose support made conference a great success.

With the enormous feedback from the participants and supporters of Regulatory Affairs-2014, Conference Series LLC Conferences is glad to announce its 5th International Conference on Pharmaceutical Regulatory Affairs (Regulatory Affairs-2015) from Aug 3-5, 2015 at Florida, USA with the theme “Current Research & Advancements in Pharmaceutical Regulatory Affairs”.


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Past Conference Report

Regulatory Affairs-2013

3rd International Conference on Pharmaceutical Regulatory Affairs was held during October 21-23, 2013, at San Francisco, USA with a theme “Embracing Recent Strategies in Global Regulatory Affairs” brought together the International blend of people from regulatory affairs industry making it the largest endeavour from Conference Series LLC. All the papers presented at this conference were published in special issue of Pharmaceutical Regulatory Affairs: Open Access.

Regulatory Affairs-2013 opened up new vistas and fostered collaborations in the industry and academia.

The conference was embarked with an opening ceremony followed by a series of lectures delivered by both Honorable Guests and members of the Keynote forum. The adepts who promulgated the theme with their exquisite talk were;

  • Mohammed R Khan, Synergex Consulting, Canada,
  • Steve Jwanouskos, OptiMedica, USA
  • Chitra Edwin, Cleveland HeartLab, Inc., USA
  • Rama K Pidaparti, Wipro Technologies, USA

Conference Series LLC has taken the privilege of felicitating Regulatory Affairs-2013 Organizing Committee, Keynote Speakers and business delegates who supported for the success of this event.

Conference Series LLC, on behalf of the conference, congratulates the Best Poster awardees for their outstanding performance in the field of pharma regulatory affairs and appreciates all the participants who put their efforts in poster presentations and sincerely wishes them success in future endeavours. Our warmest gratitude to our sponsors, exhibitors & media partners for associating with the conference and making it a success.

Following on the heels of this successful event we are excited to announce 4th International Conference on Pharmaceutical Regulatory Affairs to be held during September 08-10, 2014 at Raleigh, USA with a theme “Key Implications in Regulatory Environment” and wish that with your overwhelming support for Regulatory Affairs-2013 will become an outstanding event.


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