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DIA 2018 Global Annual Meeting


Global Development Using Expedited Pathways in Established and Emerging Markets

    Session Chair(s)
      Maria Cristina  Mota Pina, MBA

      Maria Cristina Mota Pina, MBA

      • Director, Scientific Regulatory Policy and Intelligence - Latin America
      • AbbVie, Inc., United States
    FFDA, EMA, and PMDA have well-established pathways for approval of innovative products that are for unmet medical needs. Some emerging markets are establishing such pathways as well. This session will discuss how governments accelerate the access of such type of products in the emerging markets as well as in established markets. What are the challenges and opportunities that regulators and industry face around the world when filing for expedited approval of a product that is for high unmet need, where access is a priority for patients?
    Learning Objective : Discuss how expedited pathways work in established markets and how emerging markets are developing new pathways to expedite approval of products for high unmet medical need; Describe how regulators and industry shared their experiences with these pathways, market prioritization, and circumstances when the review is independent or when using pathways such as mutual reliance and mutual recognition.
    Speaker(s)
      Representative Invited

      ANVISA Perspective

      Representative Invited

      • Agência Nacional De Vigilância Sanitária (ANVISA), Brazil
      Lawrence Eugene Liberti, MS, RPh, RAC

      Facilitated Regulatory Pathways in Maturing Agenices: The Benefits of Reliance and Alignment

      Lawrence Eugene Liberti, MS, RPh, RAC

      • Executive Director
      • Centre for Innovation in Regulatory Science (CIRS), United States
      Alberto  Grignolo, DIAFellow, PhD

      Update on the Status of Expedited Pathways in the Mature Markets

      Alberto Grignolo, DIAFellow, PhD

      • Corporate Vice President
      • PAREXEL, United States
      Denise  Bonamici, MSc

      EFPIA Position Paper: White Paper on Reliance and Expedited Pathways in Emerging Markets

      Denise Bonamici, MSc

      • Head of Regulatory Science and Poliy - LATAM
      • Sanofi, Brazil