Clinical Trials: Addressing Challenges Through Global Expertise and Best Practices

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Thursday, September 11, 2014 | 10:30 - 11:45 | Vidigal A+B+C

Successful clinical trials processes ensure that effective, innovative products reach patients as safely and swiftly as possible. However, each nation manages its own process, providing a variety of approaches from which to learn. Regulatory officials, clinical trials experts and industry representatives from around the world will analyze current regulatory requirements and future trends. Speakers will discuss their experiences with clinical trials procedures in several countries, including implementation of fast track mechanisms for rare and orphan diseases.

Speakers

  • Lic. Mikel Arriola, Commissioner, Federal Commission for the Protection Against Sanitary Risks (COFEPRIS), Mexico*
  • Carlos Gil Ferreira, Coordinator of Clinical Research at the Brazilian National Cancer Institute (INCA) and Member of the Scientific Committee on Sanitary Surveillance at ANVISA
  • Maria Cristina Paganini, Counselor, Comissão Nacional de Ética em Pesquisa do Conselho, Nacional de Saúde (CONEP), Brazil
  • Andrew Robertson, Director for U.S. Regulatory Policy, Merck & Co. (moderator)
  • María Eugenia Sánchez, Regional Director Clinical Ops Latin America, Lilly, Mexico

*Invited