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Wednesday, June 21 • 2:00pm - 3:15pm
#345: Global Perspective on ICH: Part 1 of 2

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Component Type: Forum
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

This forum will provide an overview of the ICH association and offer insight into strategic, long-term views on advancing global convergence of regulatory science through ICH, including important enablers such as stakeholder partnerships and greater connection to other harmonization initiatives. A panel of experts will discuss the benefits of ICH and global regulatory harmonization, including views on key strategic topics that will enhance simultaneous global drug development.

Learning Objectives

Describe the structure of the ICH association, the process for developing a harmonized guideline, and the purpose for the recent reforms; Discuss ICH’s strategic approach in the selection of topics for guidance development; Explain the current state and the future trajectory of ICH; Discuss the value of ICH to regulatory authorities; Identify some of the areas of current ICH guideline development.

Chair

Amanda Marie Roache

Speaker

Regulatory Perspective on ICH
Toshiyoshi Tominaga, PhD

Recap of Recent ICH Meeting
Cathy A. Parker

Panelist
Theresa M. Mullin, PhD

Panelist
Gabriela Zenhausern, DrSc


Speakers
avatar for Theresa Mullin

Theresa Mullin

Associate Director for Strategic Initiatives, OCD, CDER, FDA
Principal advisor on strategy including CDER international cooperation and harmonization, application of decision science, and other initiatives. Leads FDA Patient Focused Drug Development, and heads the FDA delegation to ICH. Previous work includes leading FDA negotiations for 2002... Read More →
avatar for Cathy Parker

Cathy Parker

Director General, Biologics & Genetic Therapies Directorate HPFB, Health Canada
Catherine Parker Director of the Office of Policy and International Collaboration within the Biologics and Genetic Therapies Directorate of Health CanadaHer Office has overall responsibility for all policy and regulatory development respecting biologic drugs. She played a key role... Read More →
avatar for Amanda Roache

Amanda Roache

Operations Research Analyst, OCD, CDER, FDA
Amanda Roache is FDA's ICH Coordinator and has served as an Operations Research Analyst in the Center for Drug Evaluation and Research (CDER) at the US Food and Drug Administration since 2012. Ms. Roache works in CDER's International Program and facilitates scientific exchanges with... Read More →
avatar for Toshiyoshi Tominaga

Toshiyoshi Tominaga

Associate Executive Director (for International Programs), Pharmaceuticals and Medical Devices Agency (PMDA)
Dr. Tominaga is Associate Executive Director for International Programs. He supervises the overall strategy and conduct of international operations by PMDA. He joined MHLW after acquired PhD from Faculty of Pharmaceutical Sciences, the University of Tokyo. As a career official, he... Read More →
GZ

Gabriela Zenhausern

Technical Officer, Regulatory Networks and Harmonization Team, World Health Organization (WHO)
Gabriela Zenhausern has worked for Swissmedic before joining WHO in December 2015. As a technical officer in the Regulatory Systems Strengthening Team (RSS), she provides support to various regulatory harmonization initiatives and regulatory networks in different WHO regions. Gabriela... Read More →

Wednesday June 21, 2017 2:00pm - 3:15pm
N228 McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616
  05: Regulatory, Forum