"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.
Pages to are hidden for
"Pharmaceutical Industry Regulatory Affairs"Please download to view full document