RAPS is developing a new topic focused book, global postapproval changes for drugs, which is intended to provide a comprehensive look at postapproval submissions globally for drug products. Divided regionally, each chapter will include the submissions required to keep the marketing application content up-to-date for marketing application holders as required by the national authorities. The book will reference the legal framework for postapproval submission activities, such as, but not limited to, labeling updates, marketing holder transfers, and manufacturing changes. In addition, the book will capture the expectations for postmarketing surveillance and risk management as well as commitments made during the marketing application review.
Table of ContentsSection I: MA Transfers, Renewals, and Administrative Changes- Americas (Argentina, Brazil, Canada, Chile, Mexico, United States)
- Europe (European Union, Switzerland, United Kingdom)
- ASEAN (Australia, China, India, Japan, Korea, New Zealand, Russia, Singapore, Vietnam)
- MENA (Middle East North Africa)
- Africa
Section II: Quality/CMC Changes- Americas (Argentina, Brazil, Canada, Chile, Mexico, United States)
- Europe (European Union, Switzerland, United Kingdom)
- ASEAN (Australia, China, India, Japan, Korea, New Zealand, Russia, Singapore, Vietnam)
- MENA (Middle East North Africa)
- Africa
Section III: Safety and Product Information Related Changes - Americas (Argentina, Brazil, Canada, Chile, Mexico, United States)
- Europe (European Union, Switzerland, United Kingdom)
- ASEAN (Australia, China, India, Japan, Korea, New Zealand, Russia, Singapore, Vietnam)
- MENA (Middle East North Africa)
- Africa
Section IV: Post Authorisation Commitments and Studies
Section V: Postmarketing Surveillance and Risk Management
Do you have experience in postapproval changes for drugs? Would you like to contribute to this new topic-focused reference book for RAPS? To be considered for this opportunity, click the “Apply Today!” button (only appears after you’ve logged in) to submit your
resume/CV and provide a
brief statement describing your experience with postapproval changes.
For more detailed information about this opportunity, contact the Senior Editor of Publications, Glori
a Hall at ghall@raps.org.