The DIA 2018 Global Annual Meeting brings together thousands of innovators from around the globe.
Global Development Using Expedited Pathways in Established and Emerging Markets
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 : Identify 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 and market prioritization; Compare the differences when the review is independent or when using pathways such as mutual reliance and mutual recognition.
Jarbas Barbosa, MD, PhD
Agência Nacional De Vigilância Sanitária (ANVISA), Brazil
Facilitated Regulatory Pathways in Maturing Agenices: The Benefits of Reliance and Alignment
Lawrence Eugene Liberti, PhD, RPh, RAC
Centre for Innovation in Regulatory Science (CIRS), United States
Update on the Status of Expedited Pathways in the Mature Markets
Alberto Grignolo, DIAFellow, PhD
Corporate VP PAREXEL Consulting
PAREXEL, United States
EFPIA Position Paper: White Paper on Reliance and Expedited Pathways in Emerging Markets
Denise Bonamici, MSc
Head of Regulatory Science and Policy - LATAM