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Wednesday, June 29 • 2:00pm - 3:15pm
#343: Strategies, Enablers, and Barriers to Medicine Development in the Emerging Markets: The 2025 Global Regulatory Landscape

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Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-546-L04-P; CME 1.25; IACET 1.25; RN 1.25

Companies’ global development strategies and the competency of many maturing regulatory authorities are evolving. Which practices and processes will lead to an optimal future regulatory environment that expedite availability of new medicines?

Learning Objectives

Identify current global development and submission strategies for new medicines; Describe potential changes to the global regulatory landscape over the next ten years and realistic scenarios for regulatory review as medicines regulation evolves based on regulatory science; Discuss current and future regulatory barriers to global development and licensing and possible potential solutions.


Prisha Patel, MSc


Industry Perspective
Joseph C. Scheeren, PharmD

WHO Perspective on Medicines Development in the Emerging Markets
Mike Ward


Prisha Patel

Manager, Global Development Programme, Centre For Innovation In Regulatory Science (CIRS)
Prisha Patel is the Manager for the Global Development programme at the Centre for Innovation in Regulatory Science (CIRS), London, focusing on emerging markets. Her responsibilities include managing the emerging markets industry benchmarking and agency benchmarking projects and working... Read More →

avatar for Joseph Scheeren

Joseph Scheeren

Senior Vice President, Head Regulatory Affairs, Pharma and Consumer Health, Bayer
Joseph Scheeren, Pharm.D. is Senior Vice President, Global Head of Regulatory Affairs Pharma & Consumer Health at Bayer. He has 30+ yrs exp. as Global Regulatory Affairs professional (France, Germany, Switzerland, US & China). He is an active member of the DIA Board of Directors... Read More →
avatar for Mike Ward

Mike Ward

Coordinator, Regulatory Systems Strengthening, EMP, World Health Organization (WHO)
Mike Ward is Coordinator of the Regulatory System Strengthening Team, Department of Essential Medicines and Health Technologies, Health Systems and Innovation Cluster, WHO Headquarters; he joined WHO as the Coordinator, Prequalification Team, in this same Department. He previously... Read More →

Wednesday June 29, 2016 2:00pm - 3:15pm EDT
201B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 08: Reg Affairs, Session