Whether you are a student, a newcomer to the pharmaceutical industry or a seasoned professional, the second edition of this book has something for everyone. The book presents a condensed overview of the regulatory systems and processes for marketing a drug product in the three major global regions: Japan, the United States and the European Union.
Content for each chapter has been updated and expanded by authors with significant regulatory and pharmaceutical experience. Two new chapters have been added that cover regional requirements for CTD-Module 1 and post-approval changes.
Subject matter is written in an easy-to-read style with added figures and tables which make it easy to compare differences in complex regulatory systems and key legislation. Suggested guidances are given throughout for further reading. Filled with useful information, this book is a great resource for any level of expertise.
Table of Contents:
Click here to download >>>Detailed Table of Contents
Chapter 1: Pharmaceutical Legislation
Chapter 2: Regulatory Bodies
Chapter 3: Market Authorization and Licensing
Chapter 4: Drug Master File Systems
Chapter 5: Post-Approval Changes
Chapter 6: Regional Administrative Requirements For Module 1
Figures and Tables
About the Authors
Barbara Jentges, PhD She is a Senior Drug Regulatory Affairs Expert and Managing Director at PhACT GmH Switzerland and is also a pharmacist with more than 22 years of experience in regulatory affairs. She teaches at the ETH (Swiss Federal Institute of Technology) in Zurich/Switzerland in the Master's curriculum 'Medicinal and Industrial Pharmaceutical Sciences (MIPS)' and at the University of Applied Sciences and Arts Northwestern Switzerland, Basel. Barbara has worked as an expert/assessor of the Federal Institute for Drugs and Medical Devices (BfArM, Bundesinstitut für Arzneimittel und Medizinprodukte) in Germany. She was also a member of PDA's Regulatory Affairs and Quality Advisory Board and served as the European co-chair of PDA's Regulatory Affairs Interest Group.
Denyse Baker, She is Director of Scientific and Regulatory Affairs with PDA and has 25 years of experience in the pharmaceutical industry. Denyse's experience includes leadership roles in engineering, parenteral manufacturing operations, and regulatory affairs, both in the United States and Europe. In addition, Denyse was responsible for the development and implementation of CDER Quality Systems for CMC Review at the FDA Office of New Drug Quality Assessment. Denyse has obtained RAC designation in both U.S. and European regulatory affairs. She holds a degree in Mechanical Engineering from Northwestern University and is a registered professional engineer.
Takayoshi Matsumura He is an advisor, consultant, lecturer and speaker for the pharmaceutical industry. Takayoshi has 34 years of experience in the pharmaceutical industry with 25 years in the area of quality assurance. His experience includes regulatory inspections, supplier quality audits, development of test methods/prescriptions, change control, in Japan and other countries. In addition, he is active in industry bodies such as the NPO Drug and Food Quality Assurance Support Center in Japan. He has authored numerous books on topics such as electronic records and signature, quality risk management and cleaning validation. His past memberships include the GMP Committee in the Japan Pharmaceutical Manufacturers Association (JPMA), the Federation of Pharmaceutical Manufacturer's Association of Japan (FPMAJ), where he participated in authoring ICH Q7A and was topic leader of ICH Q9, and the Investigative Commission, established by the MHLW, to develop guidelines for electronic record and electronic signatures, where he was a member of the Commission. Takayoshi holds a master's degree in Chemical Ecology from Okayama University and is a certified auditor.
Joanne S. Hawana, J.D., M.S. She is counsel for the law firm of Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C., and is an experienced attorney and advisor of global companies engaged in manufacturing and distributing regulated products in the United States. Her extensive areas of expertise include Federal drug regulations; premarket and postmarket requirements; compliance; prescription drug supply chain and traceability; import and export of regulated products; and restrictions on advertising and sampling. She has authored numerous publications related to regulation of the biopharmaceutical industry, including "Rx Distribution Licenses: A Matter of State," in the April 2012 issue of the PDA Letter. Her most recent article on naming nonproprietary biosimilar products was published by Law360 in July 2015. Joanne is an active member of the Food and Drug Law Institute (FDLI), the American Bar Association (ABA) Health Law Section, and the American Health Lawyers Association (AHLA) Life Sciences Practice Group. Formerly an assistant managing editor of a biomedical research trade publication, she now contributes regularly to Mintz Levin's Health Law & Policy Matters Blog.