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Session 3: Lifecycle Management – Walking Towards Harmonized and Efficient Procedures to Manage Post-Approval Changes in Benefit of Patients
Session Chair(s)
Susan Koepke, MBA
Head of Regulatory Affairs LATAM, EMD Serono, Inc., United States
The session will be composed by two presentations about WHO guidelines on procedures and data requirements for changes to approved biotherapeutics from WHO and Health Canada, to explain the content of the guideline and how to use it from regulatory body point of view. To complement the session, an industry representative will bring case studies using WHO guidelines on procedures and data requirements for changes to approved biotherapeutics and other complementary guidelines as per ICH Q12.
Learning Objective :
At the conclusion of this session, participants should be able to:
- Apply WHO guidelines on procedures and data requirements for changes to approved biotherapeutics in a work basis
- Identify opportunities to achieve harmonized and efficient procedures to manage post-approval changes in benefit of patients
- Develop regulatory risk and science-based strategies for post-approval changes putting patients at the center of the decision
Speaker(s)
Hugo Hamel, MBA, MSC
Associate Director, BRDD, Health Canada, Canada
How to Apply WHO Guidelines on Procedures and Data Requirements for Changes to Approved Biotherapeutics
Omar Ruiz
Sr. Director Regulatory Affairs , Pfizer, United States
Cases Studies to Apply WHO Guidelines on Procedures and Data Requirements for Changes to Approved Biotherapeutics and ICH Q12
Patricia Aprea, MD
Director, Evaluation and Control of Biológicals/Research, ANMAT, Argentina
Speaker
Renata De Lima Soares
Regulation and Health Surveillance Specialist, Anvisa, Brazil
Panelist
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