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Welcome Remarks and Session 6: Global Regulatory Discussion - Perspectives from Cross-Region Regulatory Authorities
Session Chair(s)
Daniel Millar, MBA
Senior Director, Strategic Business Transformation, Johnson & Johnson, United States
Pritibha Singh, MBA, MSC
Principal Investigator for Doctoral Research, ETH Zurich, Switzerland
Master Protocols and Complex Innovative Designs have been increasingly embraced by drug developers, patient advocates and regulators to overcome limitations of traditional clinical development approaches. Experience from the COVID-19 pandemic as well as sponsor consultation with multiple global regulator authorities has highlighted the importance of harmonized regulatory processes and standards which enable innovation for patients. This session will address important aspects of regulatory requirements.
Learning Objective : - Identify similarities and differences in regulator experience, procedures, and opportunities for consultation
- Understand how the regulatory environment for Master Protocols and Complex Innovative Designs has evolved
- Identify specific points of attention to be successful with Master Protocol approaches and Complex Innovative Designs to meet regulatory requirements
Speaker(s)
Nicholas Richardson, DO, MPH
Clinical Team Leader, Division of Hematologic Malignancies 2, OND, CDER, FDA, United States
Speaker
Kazuhiko Mori, PHD, MSC
Business Manager, "Toyama, the Silicon Valley of Medicine" Creative Consortium Management Office, Japan
Speaker
Kirsty Wydenbach, DrMed, MSC
Expert Medical Assessor, Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
Effective Use of Complex Innovative Designs: MHRA Experience with Platform Trials
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