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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, Inc.
Khyati is currently Senior Director at AbbVie where she coordinates regulatory policy and intelligence activities for the US regulatory environment. She also oversees regulatory policy initiatives in Japan, Asia-Pacific, China, Australia, and Latin America. Khyati also worked at the... Read More →

Speakers
avatar for Alberto Grignolo

Alberto Grignolo

Corporate VP PAREXEL Consulting, PAREXEL
Alberto Grignolo has 36+ years of experience as a regulatory and drug development professional including consulting for pharmaceutical and biotechnology companies. He is a driver of a successful worldwide consulting business and established PAREXEL’s Japan Consulting Services. He... Read More →
avatar for Sharon Olmstead

Sharon Olmstead

Global Head, Development and Regulatory Policy, Novartis Pharmaceuticals Corporation
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
201B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA