17-20 September 2016, San Jose
  • There are overarching themes that span the entire regulatory field. With so many disciplines, these valuable sessions provide key insights into multiple program tracks.


  • Monday, 19 September

    8:30–10:00 am

    Efficient Registration of Medical Products through Asia-Pacific Economic Cooperation (APEC) Good Registration Management (GRM)

    GRM is referred to as a concept to promote efficient registration process for medical products by promoting good review practices and good submission practices cooperatively between regulatory authorities and applicants. This session will address the goal of the planned APEC GRM CoE, an overview of the training program, and its expected impact on the quality and efficiency of the medical product registration process. The participants can apply what they learn to improve their review practices, submission practices and develop related training programs in their respective organizations.

    Tuesday, 20 September

    8:30–10:00 am

    Latin America: Perspectives and Challenges Moving Forward, Part 1

    The Pan-American Health Organization initiative to facilitate the registration process across Central America and the Caribbean (CA&C) is key for governments and industry. Our experts will share what you need to know about the new regulations in the CA&C region. The regulations on the advertisement of medicines and medical devices changed in the recent years and national regulatory agencies are monitoring the industry more actively than in previous years. Join us to get the necessary information and tools to work in alignment with current national regulations in the two largest and potential Latin American markets avoiding costly sanctions for companies and brands.

    10:30 am–12:00 pm

    Latin America: Perspectives and Challenges Moving Forward, Part 2

    For the first time at RAPS' Regulatory Convergence the Cuban top regulatory authority will present the country’s regulatory environment and robust biotechnology industry. For many years Cuba was actively working in pharmaceuticals and commercializing products and technologies around the world. Cuba has developed and produced millions of doses of vaccines that have successfully prevented deadly infectious diseases.  Join us to discuss the current status of Cuba in the life science sector to learn about the key factors that will influence the future of the business in the PAN American region.

    With a population of over 85 million people, Central America and the Caribbean (CA&C) is an important market for companies expanding their outreach into Latin America. El Salvador is an example of a positive transformation of a national regulatory agency in the CA&C region. Learn how this change has positively impacted the regulatory landscape and outlook in this growing regional market.

    1:00–2:30 pm

    Companion Diagnostics

    In the past decade the number of companion diagnostics on the market has grown exponentially. Therefore, the economic incentives for the continued development of companion diagnostics are compelling. Join us as we take a deeper look into the changing global regulatory landscape. Our experts from pharmaceutical and medical device companies will share lessons learned about their challenges of selecting partners and bringing companion diagnostics to market.