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DIA/FDA Advancing Complex Innovative Clinical Trial Designs to Efficiently Deliver Medicines to Patients
Session 6: Global Regulatory Affairs
Session Chair(s)
Cristiana Mayer, DrSc, PhD
- Head of Biostatistics
- Johnson & Johnson Vision, United States
Amy Xia, PhD
- Vice President, Center for Design and Analysis
- Amgen Inc., United States
John Scott, PhD, MA
- Director, Division of Biostatistics, OBPV, CBER
- FDA, United States
This session will consist of two presentations from EMA, and PMDA followed by a panel from FDA, EMA, and PMDA to discuss their perspectives on use of complex innovative designs (CID). We will highlight the regulatory principles, current thinking and activities related to utilization and evaluation of innovative designs in various regulatory agencies. Challenges, opportunities and best practices in applying CID will be described. Furthermore, we will discuss key aspects on how to interact with regulatory agencies in different regions on global trials with CID for the purpose of global registration.
Learning Objective :
At the conclusion of this session, participants should be able to:
- Get familiar with regulatory guidance documents and activities related to CID in different regions
- Articulate the regulatory principles of CID
- Describe challenges, opportunities and best practices in applying CID
- Discuss considerations for the planning and implementation of clinical trials with CID and the interactions between sponsors and regulatory agencies
Speaker(s)
Speaker
John Scott, PhD, MA
- Director, Division of Biostatistics, OBPV, CBER
- FDA, United States
Speaker
Frank Petavy, MS
- Head of Methodology
- European Medicines Agency, Netherlands
Speaker
Yuki Ando, PhD
- Senior Scientist for Biostatistics
- Pharmaceuticals and Medical Devices Agency, Japan
Contact us
Registration Questions?
Additional Information
Complex Innovative Clinical Trial Designs Resource Kit
View Infographic
On Demand Content Preview Webinar
Recent Regulatory Efforts on Complex Innovative Clinical Trial Design
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