Pharmaceutical Industry Regulatory Affairs by iap13635

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									                                    "EU-FDA: CMC Differences"
                           Presented by Mary Y. Jarosz, RPh, RAC, FTOPRA,
                    President & Principal Consultant, Jarosz Regulatory Services, Inc.


                                                 Abstract

        The Common Technical Document (CTD) format provides a harmonized structure for drug
product applications and this has become the standard in the EU and in the US. Although the CTD
structure is well outlined and has been adopted by the EU and the US FDA, differences remain in
content, review styles, and local particulars for these 2 regions. The presentation will highlight the
overall distinctions between the EU and the US FDA in Module 2.3 (Quality Overall Summary) and
Module 3 (Quality). The presentation will begin with an overview of the EU agencies and the FDA in
order to appreciate the reasons why differences in content continue. Further in the presentation, details
of Module 3 are addressed, including Drug Master Files, EDQM Certificates of Suitability (CEP and
TSE CEP), and sections specific to drug substance 3.2.S, drug product 3.2.P, appendices 3.2.A, and
regional particulars 3.2.R (EU and FDA). The presentation is designed to aid the attendees in
understanding and constructing Module 2.3 and Module 3 for the EU agency while being aware of the
FDA requirements. The learning objectives are the following:
         To understand the general differences between the EU and the US FDA CMC CTD
         To take home practical suggestions for constructing CMC Module 2.3 and Module 3



                                                Biography

         Mary Y. Jarosz, RPh, RAC, FTOPRA is the President and Principal Consultant of Jarosz
Regulatory Services, Inc. She is responsible for regulatory strategy, submissions, and post-approval
activities for drugs worldwide. Prior to founding Jarosz Regulatory Services, Inc. in 1996, Ms. Jarosz
worked in the pharmaceutical industry in product development and in international regulatory affairs.
She has focused her regulatory expertise in the international arena since 1991. Ms. Jarosz also has a
considerable clinical background acquired during practice as a pharmacist and clinical instructor in an
academic hospital setting and has been in health care for 24 years. She has received a bachelor’s degree
in Pharmacy from the University of Illinois at Chicago, is a Registered Pharmacist, and an active member
of DIA, RAPS, and a Fellow of TOPRA (FTOPRA).
                                  "Regulatory Landscape in India"
                          Presented by Romi Singh, Ph.D., Executive Director,
                            Global Regulatory Affairs & Safety, Amgen Inc.


                                               Abstract

         Multinational human healthcare companies have started looking to countries such as India and
China for access to new markets, talent, patients and cost savings. These countries have a strong growing
economy, large pool of scientists and doctors, rapidly improving infrastructure and growing government
support—all these factors make these two Asian giants a preferred R&D destination for healthcare
multinational companies. However there are still challenges and differences in operating in India
compared to the West. This presentation will provide an update on the evolving regulatory landscape in
India and its potential impact on multinational companies intending to conduct R&D and product
registration in these two countries. The presentation will also highlight differences between the
regulatory requirements in these two countries vis-à-vis the ICH requirements.



                                              Biography

         Dr. Romi Singh has over 14 years of extensive scientific and management experience in top-tier
pharmaceutical and biotechnology companies such as Burroughs/GlaxoWellcome, Merck and Amgen.
His experience spans across the spectrum of drug development-basic research to regulatory/clinical
sciences. He is well published and recognized in field of drug metabolism and is an expert on clinical
trials and drug registrations in developing countries. Dr. Singh is currently an Executive Director of
Global Regulatory & Safety and Amgen heading the group that supports expansion into new emerging
markets including Latin America and Asia. He holds an undergraduate degree from St. Stephen's
College, doctorate from the University of Kansas and has received postdoctoral training from the
University of Washington.
              "Regulatory Requirements for Pharmaceutical Submissions in Japan"
             Presented by Satoshi Koike, Ph.D., Director - Regulatory Affairs Department,
             Medical, Regulatory and Safety Affairs Division, Janssen Pharmaceutical K.K.


                                                 Abstract

         After agreement of Common Technical Document (CTD) by ICH tripartite regions, US, EU and
Japan in 2001, Health Authority in each region has accepted standardized and harmonized CTD Modules
2 to 5. Although format and contents of CTD Module 2 were standardized, Pharmaceuticals and Medical
Devices Agency, a Japanese Health Authority, is requesting additional data listing and/or summary tables
for individual safety data in pivotal clinical trials conducted in ex-Japan as well as in Japan. On the other
hand, CTD Module 1 is prepared based on country-specific requirements by each Health Authority.
However, some contents of CTD Module 1 such as GLP and GCP compliance statements in preclinical
and clinical studies conducted in ex-Japan are always requested by Japanese subsidiary to the global in a
few months before NDA submission. Therefore, understanding of Japan-specific requirements for CTD
Modules 1 and 2 by global members is one of key factors to facilitate CTD dossier preparation. In this
presentation, Japan-specific requirements for CTD Modules 1 and 2 are presented with tangible
examples.
Understanding of NDA review processes in Japan is also important to know factors or rationales behind
the requirements. Therefore, key points of NDA review processes are also explained.



                                                Biography

         Dr. Satoshi Koike is a Director of Regulatory Affairs in Janssen Pharmaceutical K.K. (JPKK) in
Japan. Current responsibilities are to facilitate drug development and NDA/sNDA approval of medicinal
products through negotiation with Japanese Health Authorities and to create regulatory infrastructure for
multinational and Asian clinical trials in JPKK with Global Regulatory Affairs. Dr. Koike graduated
Saitama University in 1983 with a B.S. in biology and then received a M.S. in biology in 1985. After
graduated Saitama University, he joined Upjohn Pharmaceutical Limited, Tsukuba Research
Laboratories, Japan, as a research scientist in Reproductive Toxicology and Teratology Lab. He had
worked for preclinical drug development of candidate compounds including biologics and attended NDA
review meetings organized by Japanese Health Authorities. During the service in Upjohn, he researched
roles of growth factors on reproductive functions in animal and received a Doctor degree of Science from
Saitama University in 1994. After merger of Upjohn and Pharmacia in 1996, he managed Toxicology
Group in the Tsukuba Research Laboratories and was also assigned to a Deputy Director of Worldwide
Regulatory Toxicology. In 1999, he transferred to Pharmacia Research Laboratory in Michigan, US to
learn global drug development processes and worked in several different functions over 3 years;
toxicology, project management, clinical research, and drug regulatory affairs. After this assignment, he
had responsibilities for project management in Japan and then for documentation of preclinical parts of
IND and NDA as an Associate Director of Preclinical Document Operations and Strategy in Pharmacia
Japan. In 2003, he moved to Novartis Japan and worked for Drug Regulatory Affairs as a Group
Manager of Respiratory, Dermatology and Infectious Disease Group. In Novartis, he managed
NDA/sNDA submissions and Pharmaceuticals and Medical Devices Agency (PMDA) consultations for
developing projects. Dr. Koike had lectured at Saitama University in 1994 and a couple of seminars for
successful PMDA consultations and CTD preparations for NDA in Japan last year. Currently, he is a
member of Drug Information Association, Regulatory Affairs Committee in Japan Pharmaceutical
Manufactures Association, Society for the Study of Reproduction, and other several scientific societies in
both Japan and US.
               "Development of a Harmonized Dossier for use Across Latin America"
                               Presented by Mariza Moncayo, Manager,
                      International Regulatory Affairs, Astellas Pharma US, Inc.


                                                Abstract

        One of the areas of the world that pharmaceutical companies are planning to make or already
making regulatory submissions is Latin America. However, the companies might not know or understand
the local requirements in the Latin American region. Today’s presentation will highlight the following:
      Promote a brief understanding of the local requirements in the Latin American region
      Assist in the understanding of the development of a harmonized dossier that can be used across
        Latin America



                                               Biography

         Maritza Moncayo joined the Astellas International Regulatory team in February, 2007 as
Manager of Regulatory Affairs for Latin America. She was born in Ecuador and raised in Chicago; she
obtained her degree in Business Commerce in Ecuador and is a Bilingual Professional with ten years of
experience within the pharmaceutical industry. Currently she is responsible for providing expertise and
leadership for all aspects of the development of the International Regulatory Affairs department within
APUS and the development of a short and long term strategy for the Caribbean, Central, and South
America regions for new product registrations and maintenance (life cycle). Prior to joining Astellas, she
worked with Hospira with the international spin-off process from Abbott Laboratories to Hospira, Inc.,
setting up a global product database that enhanced the international product registration strategies. Prior
to Hospira, she worked with Searle, Pharmacia, and Pfizer. She is an active member of RAPS
(Regulatory Affairs Professional Society), ORCA (Organization of Regulatory and Clinical Associates)
and Toastmasters International.
                                 "Regulatory Landscape in China"
                             Presented by Romi Singh, Ph.D., Executive Director,
                            Global Regulatory Affairs & Safety, Amgen Inc.


                                               Abstract

         Multinational human healthcare companies have started looking to countries such as India and
China f0r access to new markets, talent, patients and cost savings. These countries have a strong growing
economy, large pool of scientists and doctors, rapidly improving infrastructure and growing government
support—all these factors make these two Asian giants a preferred R&D destination for healthcare
multinational companies. However there are still challenges and differences in operating in China
compared to the West. This presentation will provide an update on the evolving regulatory landscape in
China and its potential impact on multinational companies intending to conduct R&D and product
registration in these two countries. The presentation will also highlight differences between the
regulatory requirements in these two countries vis-à-vis the ICH requirements.



                                              Biography

         Dr. Romi Singh has over 14 years of extensive scientific and management experience in top-tier
pharmaceutical and biotechnology companies such as Burroughs/GlaxoWellcome, Merck and Amgen.
His experience spans across the spectrum of drug development-basic research to regulatory/clinical
sciences. He is well published and recognized in field of drug metabolism and is an expert on clinical
trials and drug registrations in developing countries. Dr. Singh is currently an Executive Director of
Global Regulatory & Safety and Amgen heading the group that supports expansion into new emerging
markets including Latin America and Asia. He holds an undergraduate degree from St. Stephen's
College, doctorate from the University of Kansas and has received postdoctoral training from the
University of Washington.
                                     "International Patent Law"
                 Presented by Joseph Fuchs, Of Counsel, Rockey, Depke & Lyons, LLC


                                                Abstract

         For most life sciences, pharmaceutical and medical products companies, intellectual property
assets, particularly patents, are of substantial importance for such companies to achieve commercial
success. With the world’s economies becoming ever more so entangled it is critical for technology
companies to have a global strategy for obtaining, maintaining and enforcing its patent rights. The
United States patent law is in the state of dynamic flux within the U.S. Patent and Trademark Office and
outside the USPTO. Sweeping changes to the rules governing the prosecution of U.S. Patent applications
have been enacted by the Legislative and Executive Branches but on the eve of their implementation the
United Stated District Court for the Eastern District of Virginia entered an order halting their
implementation pending a more detailed hearing on the matter. This lawsuit is still pending. The Patent
Reform Act of 2007, being reviewed by the U.S. Congress proposes to make substantial changes in the
U.S. Patent law to harmonize U.S. law with the patent laws of most other countries. The Patent Reform
Act could bring such substantial changes as moving from a first-to-invent system to a first-to-file-system.
Other proposed changes could impact the amount of monetary damages and injunctive available to a
patentee whose patent has been found to be infringed. The United States Supreme Court has rendered a
recent opinion in KSR v. Teleflex that may bring changes to how the USPTO and federal courts
determine whether a claim is obvious. While domestic U.S. patent laws are in a state of turmoil, the
United States continues to urge China, India and other countries to increase their enforcement of patent
rights of foreign entities. Whether the United States efforts will lead to substantial policy changes in
these countries is yet to be seen. These and other variables must be taken into consideration in
developing a global patent filing strategy.



                                               Biography

        Joseph Fuchs has been a patent attorney since 1989. Mr. Fuchs focuses his practice primarily on
patent prosecution and patent litigation. Mr. Fuchs has prepared patent applications in various complex
technology areas including material sciences, nanotechnologies, medical plastics, medication delivery,
pharmaceutical formulations and medication error reduction technologies. Mr. Fuchs has extensive
experience in obtaining and maintaining patent protection in numerous countries throughout the world.
Mr. Fuchs also has experience in implementing patent prosecution strategies for optimizing patent
protection for patents in the pharmaceutical area under the Hatch-Waxman act. Mr. Fuchs also has
experience in patent litigation including enforcing and defending patents including defending patent
infringement lawsuits brought against generic drug companies arising from the filing of Amended New
Drug Applications. Mr. Fuchs also has experience in preparing freedom to operate opinions on
pharmaceutical inventions and Paragraph IV certification notification letters in accordance with the
Hatch-Waxman Act. Prior to practicing law, Mr. Fuchs was a Station Chemist at the LaSalle Nuclear
Power Plant of Commonwealth Edison. Mr. Fuchs is admitted to practice before the U.S. Patent and
Trademark Office, Illinois State Bar and other federal courts. He received his Bachelor’s Degree of
Science in Chemistry from University of Illinois, Urbana-Champaign, and a J.D. degree from Loyola
University of Chicago.

								
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