Lifecycle Management: Updates and Insight on Post-Approval Changes, ICH Q12 Guidance and PAC iAM Activities

Pharmaceutical and biotechnology companies routinely make post-approval changes and updates to a drug’s manufacturing and operating systems to improve the therapy and ensure safe, reliable and compliant production and distribution. Manufacturers are encouraged by regulatory authorities to make such revisions, innovations and upgrades; however, companies are often deterred by the amount of time, cost and complexity necessary to report such alterations, as harmonized standards for post-approval change control are limited. ICH recognized these concerns and has spearheaded the development ICH Q12, which aims to establish a common approach for product lifecycle management including universal post-approval reporting categories and definitions and instructions for listing Established Conditions (ECs) in dossiers.  Like other industry associations, PDA is supportive of these changes and the potential for important impacts on reducing drug shortages and increasing implementation of new technology.  PDA started the PAC iAM initiative to support the discussion and future implementation including sharing examples of how these ICH concepts can be applied to real world changes.

This webinar will provide visibility to the current status of these important initiatives including:

• Status update and future forecast on post-approval guidance: ICH and FDA
• Working definitions of Established Conditions
• Results of the PDA PAC iAM Survey data
• Updates on PDA Technical Reports and other key initiatives meant to provide industry the tools to fully leverage upcoming regulations

 

Speakers:
Melissa Seymour, MBA
Vice President, Global Quality Control
Biogen

Emma Ramnarine
Senior Director, Head Global Analytical Science & Technology
Genentech/Roche

Anders Vinther
Chief Quality Officer
Sanofi Pasteur

Contact:

Brooke Akins | Division Director, Life Science Programs
312.224.1693 | webinars@q1productions.com