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DoubleTree by Hilton Grand Biscayne Bay

Feb 21, 2019 7:00 AM - Feb 22, 2019 5:00 PM

1717 N Bayshore Drive, Miami, FL 33132

Latin America Regulatory Conference

Join global regulators, industry, and academia to engage in a series of strategic discussions on current regulatory landscape, globalization, and harmonization initiatives in Latin America.

Session 9: Clinical Trials Adaptative Designs Protocols: Ethics and Regulatory Perspectives

Session Chair(s)

Heloisa  Fostinone

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)

    Carla  Caligaris

    Health Authority Perspective and Challenges

    Carla Caligaris

    Brazilian Health Regulatory Agency (ANVISA), Brazil

    Clinical Trials Office - COPEC

    Rosana M. Mastellaro, PharmD, RPh

    Regional Regulatory Challenges and Oportunities from a Sponsor Perspective

    Rosana M. Mastellaro, PharmD, RPh

    Sindusfarma, Brazil

    Director, Technical Regulatory Affairs and Innovation

    Jackie  Kline, PhD

    Challenges from Sponsor Perspective

    Jackie Kline, PhD

    Amgen, United States

    Vice President, Global Regulatory Affairs Oncology

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