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Session 9: Clinical Trials Adaptative Designs Protocols: Ethics and Regulatory Perspectives
Session Chair(s)
Heloisa Fostinone
Regulatory Affairs Sr. Manager
Amgen, Brazil
This session is intended to provide an overview of the challenges faced by the Health Authorities and Ethics Committees when reviewing clinical trial protocols that are based on the concept of adaptive designs. Moreover, it intends to provide a sponsor perspective on what is being considered to design such clinical trials. A discussion between health authorities, ethics committees representatives, and sponsor representatives will help clarifying what are the biggest concerns and hurdles faced when designing and reviewing such protocols.
Learning Objective : At the completion of this session, participants should be able to:- Understand what is the intention of clinical trials with new adaptive designs
- Hear the challenges faced by the regulators and ethics committees when reviewing such clinical trials
- Analyze the key topics in future adaptive design protocols to anticipate HAs or ECs questions
Speaker(s)
Health Authority Perspective and Challenges
Carla Caligaris
Brazilian Health Regulatory Agency (ANVISA), Brazil
Clinical Trials Office - COPEC
Regional Regulatory Challenges and Oportunities from a Sponsor Perspective
Rosana M. Mastellaro, PharmD, RPh
Sindusfarma, Brazil
Director, Technical Regulatory Affairs and Inovation
Challenges from Sponsor Perspective
Jackie Kline, PhD
Amgen, United States
Vice President, Global Regulatory Affairs Oncology
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