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Monday, June 27 • 10:45am - 12:00pm
#133: Take Advantage of Global Expedited Pathways: Breakthrough, Sakigake, PRIME!

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Limited Capacity seats available
Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-543-L04-P; CME 1.25; IACET 1.25; RN 1.25

The Breakthrough Designation (US), PRIME (Europe), and Sakigake (Japan) aim to reduce overall drug development times for certain products. This session shows you how to take advantage of these and other global expedited development programs.

Learning Objectives

Compare and contrast global expedited development pathways; Discuss ways to adapt global development programs to take advantage of all expedited pathways.

Chair

Khyati Roberts, RPh

Speaker

The New Japanese “Sakigake” Strategy for Accelerated Development and Approval: Status, Procedure, and Prospects for Industry
Alberto Grignolo, PhD

Strategies for Using the New European PRIME Pathway
Sharon N. Olmstead


Chair
avatar for Khyati Roberts

Khyati Roberts

Head US/Canada, Regulatory Policy and Intelligence, AbbVie, United States
Khyati Roberts leads regulatory policy advocacy efforts for U.S. and Canada and co-leads the day-to-day operations of the global regulatory policy and intelligence team at AbbVie. She has over 30 years of regulatory experience including nearly 14 years at the U.S. FDA/Center for Drug... Read More →

Speakers
avatar for Alberto Grignolo

Alberto Grignolo

Corporate Vice President, Corporate Strategy and Thought Leadership, Parexel, United States
Alberto Grignolo, Ph.D. FDIA is Corporate Vice President, Corporate Strategy and Thought Leadership at Parexel, and established the Company's Japan Regulatory Consulting Services during a two-year assignment in Tokyo. He is a champion of Diversity, Equity and Inclusion within and... Read More →
avatar for Sharon Olmstead

Sharon Olmstead

Global Head, Regulatory & Development Policy, Novartis Pharmaceuticals Corporation, United States
Sharon Olmstead is the Global Head of Development & Regulatory Policy at Novartis. She first joined Novartis in 1997, in their FDA Liaison Office. From 2002 until returning to Novartis in 2011, she held leadership positions at Merck, Schering-Plough, and Pharmacia. She built a foundation... Read More →

Monday June 27, 2016 10:45am - 12:00pm EDT
201B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 08: Reg Affairs, Session