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What is the Value of Reference Agency Assessment Reports in Enabling Reliance and What do Relying Agencies Require?
Session Chair(s)
Magda Bujar, PHD, MSC
Associate Director, Regulatory Programme and Strategic Partnerships, Centre for Innovation in Regulatory Science (CIRS), United Kingdom
Challenges remain in the implementation of reliance. This session will bring together stakeholders to discuss the utilisation of assessment reports, and recommend ways to ensure effective and efficient systems in the future.
Learning Objective : Recognize the value of assessment reports in enabling reliance; Describe current use of public and non-public information for enabling regulatory reviews; Discuss how documentation and information sharing could improve to ensure reliance becomes successful.
Speaker(s)
Reference Agency Viewpoint
Chair, ICMRA; Executive Director, European Medicines Agency, Netherlands
Relying Agency Viewpoint
Associate Director of the Second Directorate, ANVISA, Brazil
Industry Viewpoint
Global Head International Regulatory Policy, Roche, Switzerland
WHO Update
Senior Adviser, Council For International Organizations of Medical Sciences (CIOMS), Switzerland
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