The Pharmaceutical Regulatory Process (Paperback)
Language: English
Published by Taylor & Francis Ltd, London, 2019
Series: Book 31 of 80 - Drugs and the Pharmaceutical Sciences
- Softcover
- New
Seller: Grand Eagle Retail, Bensenville, IL, U.S.A.Grand Eagle Retail
AbeBooks seller since October 12, 2005
Condition: New
£ 85.99
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Add to basketItem description from seller
Seller Inventory # 9781138381285
- Title
- The Pharmaceutical Regulatory Process (Paperback)
- Author
- Ira R. Berry
- Publisher
- Taylor & Francis Ltd, London
- Publication year
- 2019
- Condition
- new
- Binding
- Paperback
- Language
- English
- ISBN 10
- 1138381284
- ISBN 13
- 9781138381285
- Edition
- 2nd Edition
- Series
- Book 31 of 80: Drugs and the Pharmaceutical Sciences
This Second Edition examines the mechanisms and means to establish regulatory compliance for pharmaceutical products and company practices. It focuses on major legislative revisions that impact requirements for drug safety reviews, product regulatory approvals, and marketing practices. Written by top industry professionals, practicing attorneys, and FDA regulators, it includes policies and procedures that pharmaceutical companies need to implement regulatory compliance post-approval.
New chapters cover:
- the marketing of unapproved new drugs and FDA efforts to keep them in regulatory compliance
- pharmacovigilance programs designed to prevent widespread safety issues
- legal issues surrounding the sourcing of foreign APIs
- the issues of counterfeit drugs
- updates on quality standards
"Synopsis" may belong to another edition of this title.
About the Author
IRA R. BERRY is President and Founder of International Regulatory Business Consultants, L.L.C., Freehold, New Jersey, USA. Ira Berry received his M.A. in Biology from Hofstra University, Hempstead, New York, USA and his M.B.A. in Management from Adelphi University, Garden City, New York, USA. He has created a consulting business with his extensive experience in the global areas of pharmaceutical manufacturing operations, quality systems, compliance, regulatory affairs and business development―for APIs and dosage forms. He provides instructions and conducts plant audits for CGMP compliance, quality systems evaluation, SOPs, preparing and filing Drug Master Files and dosage form product registrations and personnel training. His professional affiliations include his membership in the Generic Pharmaceutical Association and International Generic Pharmaceutical Association. Berry has worked extensively with Development and Task Force committees with the FDA and is a recognized health care manufacturing industry expert. He was Co-editor of Informa Healthcare’s first edition of The Pharmaceutical Regulatory Process, as well as the titles Pharmaceutical Process Validation and Validation of Active Pharmaceutical Ingredients. Berry also contributed to several chapters in the Encyclopedia of Pharmaceutical Technology.
ROBERT P. MARTIN is a consultant at RPMartin Consulting, Lebanon, Pennsylvania, USA. Dr. Martin received both his M.S. and Ph.D degrees from the University of California, Riverside, California, USA. Throughout his career, he has held positions at many pharmaceutical companies, including Forest Laboratories (as Associate Director of Quality Assurance), Duramed Pharmaceuticals (as Director of Quality Services), Merck & Co. (as Senior Scientist), and Johnson & Johnson (in several positions, including Manager of Quality Services). In these positions, he led efforts to improve performance in Research and Development by developing and implementing compliance and quality systems. At his consulting firm, he currently provides an array of pharmaceutical consulting services, including, such as vendor risk analysis and management, bioanalytical and analytical laboratory qualification/validation, manufacturing qualification/validation, auditing, documentation, CMC preparation, DMF preparation, and training.
"About the title" may belong to another edition of this title.
Grand Eagle Retail
Bensenville, IL, U.S.A.
AbeBooks seller since October 12, 2005
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