Volunteer Opportunity Details

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Call for Authors - Global Postapproval Changes for Drugs

Signup Deadline: 22-Sep-2021
Starts: 20-Oct-2021
Ends: 31-Mar-2022

Description:

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 Contents

Section 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, Gloria Hall at ghall@raps.org.

Qualifications:

2010-2014
Pharmaceuticals

Volunteers Needed:

12 (12 open slots)

Experience Required:

8 - 12 Years Industry Experience

Volunteer Stars:

60

Contact:

Wesley Carr
Director of Stakeholder Engagement