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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

Cristiana Mayer, DrSc, PhD

  • Head of Biostatistics
  • Johnson & Johnson Vision, United States
Amy  Xia, PhD

Amy Xia, PhD

  • Vice President, Center for Design and Analysis
  • Amgen Inc., United States
John  Scott, PhD, MA

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)

John  Scott, PhD, MA

Speaker

John Scott, PhD, MA

  • Director, Division of Biostatistics, OBPV, CBER
  • FDA, United States
Frank  Petavy, MS

Speaker

Frank Petavy, MS

  • Head of Methodology
  • European Medicines Agency, Netherlands
Yuki  Ando, PhD

Speaker

Yuki Ando, PhD

  • Senior Scientist for Biostatistics
  • Pharmaceuticals and Medical Devices Agency, Japan

Contact us

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Additional Information

Complex Innovative Clinical Trial Designs Resource Kit


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Recent Regulatory Efforts on Complex Innovative Clinical Trial Design
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