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Tuesday, June 26 • 2:00pm - 3:15pm
#264: Global Development Using Expedited Pathways in Established and Emerging Markets

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Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-599-L04-P; CME 1.25; IACET 1.25; RN 1.25

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 Objectives

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.

Chair

Maria Cristina Mota Pina, MBA

Speaker

ANVISA Perspective
Jarbas Barbosa, MD, PhD

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

Update on the Status of Expedited Pathways in the Mature Markets
Alberto Grignolo, DIAFellow, PhD

EFPIA Position Paper: White Paper on Reliance and Expedited Pathways in Emerging Markets
Denise Bonamici, MSc


Speakers
avatar for Jarbas Barbosa

Jarbas Barbosa

Director- President, Agência Nacional De Vigilância Sanitária (ANVISA)
Jarbas Barbosa da Silva Jr. is a public health physician and epidemiologist, with national and international experience in public health, epidemiology applied to health services, health surveillance, prevention and control of diseases and illnesses, and management of health systems... Read More →
avatar for Denise Bonamici

Denise Bonamici

Head of Regulatory Science and Policy - LATAM, Sanofi
More than 20 years of experience in Regulatory Affairs setting regulatory strategies and managing a diverse portfolio. She is member of major Industry Associations and has a network of strong relationships with Regulatory Agencies. In her role as Head of Regulatory Science & Policy... Read More →
avatar for Alberto Grignolo

Alberto Grignolo

Corporate Vice President, Parexel
Alberto Grignolo, PhD is a Corporate Vice President at Parexel, and established the firm's Japan Consulting Services during a two-year assignment in Tokyo. Dr. Grignolo has served as an adviser on human subject protection in clinical trials to the Institute of Medicine of the National... Read More →
avatar for Lawrence Liberti

Lawrence Liberti

Executive Director, Centre for Innovation in Regulatory Science (CIRS)
Dr Liberti has worked in pharmaceutical regulatory affairs, communications and clinical R&D for the past four decades. Since 2009 he has served as the Executive Director of CIRS (the Centre for Innovation in Regulatory Science, Ltd, forming part of Clarivate Analytics). He has been... Read More →
avatar for Maria Cristina Mota Pina

Maria Cristina Mota Pina

Director, Scientific Regulatory Policy and Intelligence - Latin America, AbbVie, Inc.
Cristina is currently Director at AbbVie where she coordinates regulatory policy and intelligence activities for Latin America. Cristina worked for Boehringer Ingelheim for 13 years in different roles including Quality, Validation and Regulatory Affairs. Cristina attended Universidad... Read More →

Tuesday June 26, 2018 2:00pm - 3:15pm
Room 206AB Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  09: Regulatory, Session