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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 1: Regional and Global Regulatory Priority Updates

Session Chair(s)

Peter  Baker

Peter Baker

International Relations Specialist, OIP, OGROP, FDA, United States

This session is intended for each National Regulatory Authority (NRA) to provide a summary of the progress made on regional regulatory projects. Each NRA will be allotted approximately 10-20 minutes to provide an update on progress made on various domestic and regional projects (e.g. PAHO, PANDRH) that affect regulators and manufacturers in Latin America. The session will culminate in a Q&A panel discussion to provide additional clarification where necessary.

Learning Objective : At the conclusion of this session, participants should be able to:
  • Understand the various regional regulatory initiatives currently ongoing, including timelines for completion
  • Understand the various regional organizations (e.g. PAHO) and their role in promoting regional initiatives
  • Receive information regarding future regional regulatory initiatives
  • Speaker(s)

    Ariel  Arias

    Speaker

    Senior Advisor, Centre for Biologics Evaluation, BGTD, Health Canada, Canada

    Ana  Pineda Zavaleta, MSC

    Speaker

    International Regulatory Analyst, LAO, OGPS, OPLIA, OC, FDA, United States

    Daniela  Marreco Cerqueira, MS

    Speaker

    Associate Director, Third Directorate, ANVISA, Brazil

    Reina  de Acosta

    Speaker

    Directora Nacional, Direccion Nacinal de Medicamentos, El Salvador

    Patricia  Aprea, MD

    Speaker

    Director, Evaluation and Control of Biológicals/Research, ANMAT, Argentina

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