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Hilton Washington DC/Rockville Hotel & Executive Meeting Ctr.

2017 年 04 月 24 日 7:30 上午 - 2017 年 04 月 26 日 12:00 下午

1750 Rockville Pike, , Rockville, MD 20852 , USA

CMC Workshop

Session 7C: Regional Updates - Part 1: Latin America Regional Convergence Opportunities and Challenges

Session Chair(s)

Rebecca E. Thomas, MS

Rebecca E. Thomas, MS

Owner

Bekki Thomas Consulting, LLC, United States

This session will be a discussion of regional convergence opportunities and challenges in Latin America. The session will focus on clinical trials through all facets of development and commercialization-full life cycle of the product. The session will include an industry representative and invited PAHO and Health Authority representatives with overview presentations with an opportunity for audience participation. This session could generate good discussions and actions toward harmonization.

Speaker(s)

Maria Cristina  Mota Pina, MBA

Challenges and Opportunities from Initial Application Through Life Cycle in Latin America

Maria Cristina Mota Pina, MBA

AbbVie, United States

Head, Regulatory Policy for Emerging Markets -Japan and Australia

Tatiana  Gaban, MPHARM

Regulatory Challenges and Scenarios in Brazil

Tatiana Gaban, MPHARM

Merck & Co., Inc., United States

Executive Director, Regulatory Affairs - CMC

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