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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
Senior Manager, Corporate Affairs Analytics & Insights
Novartis AG, 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)
Speaker
Nicholas Richardson, DO, MPH
FDA, United States
Clinical Team Leader, Division of Hematologic Malignancies 2, OND, CDER
Speaker
Kazuhiko Mori, PhD, MSc
Japan Pharmaceutical Manufacturers Association (JPMA), Japan
Senior Managing Director
Effective Use of Complex Innovative Designs: MHRA Experience with Platform Trials
Kirsty Wydenbach, DrMed, MSc
Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
Expert Medical Assessor