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Wednesday, June 27 • 8:00am - 9:15am
#312: Harmonizing Regulatory Science Through the International Council for Harmonisation (ICH)

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-631-L04-P; CME 1.25; IACET 1.25; RN 1.25

Since its inception in 1990, the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) has been unique in bringing together the regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of drug development, manufacture, and registration. ICH has gradually evolved to respond to the increasingly global face of medicines development and regulation, which included a set of reforms completed in 2015 designed to enhance its governance and sustainability, while opening its doors to new regulatory authorities and industry sector partners. While the ICH mission remains unchanged --- to achieve greater regulatory harmonization worldwide to ensure that safe, effective, and high quality medicines are developed and registered in the most resource-efficient manner --- the value of ICH continues to expand beyond the US, Europe, and Japan to further benefit patients, regulatory authorities, and industry around the globe through the development and maintenance of harmonized regulatory guidelines that help advance new regulatory science. This session will provide an overview of the ICH association and offer insight into current harmonization efforts including strategic, long-term views on advancing global convergence of regulatory science through ICH. A panel of experts will discuss the benefits of ICH and global harmonization, including views on key strategic topics that will enhance simultaneous global drug development.

Learning Objectives

Recognize the value and benefits of global regulatory harmonization and the ICH; Discuss opportunities to advance regulatory science through ICH; Describe the current harmonization initiatives that are currently underway and the impact on global drug development.


Amanda Marie Roache, MS


Theresa Mullin, PhD

C. Michelle Limoli, PharmD

Jerry Stewart, JD, MS, RPh

Toshiyoshi Tominaga, PhD

Celia Lourenco, PhD

Nicholas Cappuccino, PhD, MBA

Wassim Nashabeh, PhD


Nicholas Cappuccino

Consultant, Compliance, Quality and Scientific Affairs, Dr. Reddy's Laboratories
Dr. Cappuccino is currently a Consultant for Dr. Reddy’s Laboratories Inc., located in Princeton, NJ, USA. Dr. Cappuccino currently serves as the Chair of the Science Committee for the International Generic and Biosimilar Medicines Association (IGBA) and represents IGBA on the ICH... Read More →
avatar for Michelle Limoli

Michelle Limoli

Senior International Health Science Advisor, Office of the Director, CBER, FDA, United States
Michelle Limoli is the Senior International Health Science Advisor in FDA’s CBER. She is responsible for coordinating and collaborating on activities and strategic programs with various international organizations and governments, as well as within the CBER. During her career at... Read More →

Celia Lourenco

Interim Senior Executive Director, Therapeutic Products Directorate, Health Canada
Dr. Celia Lourenco is the Interim Senior Executive Director for the Therapeutic Products Directorate. She has been in management roles at Health Canada since 2007 and was until recently the director of the Bureau of Gastroenterology, Infection and Viral Diseases. She currently also... Read More →
avatar for Celia Lourenco

Celia Lourenco

Director General, Biologic and Radiopharmaceutical Drugs Directorate, HPFB, Health Canada, Canada
Celia Lourenco, PhD is the Director General of the Biologic and Radiopharmaceutical Drugs Directorate (BRDD) of the Health Products and Food Branch of Health Canada. She was previously the Senior Executive Director of the Therapeutic Products Directorate (TPD) and held other management... Read More →
avatar for Theresa Mullin

Theresa Mullin

Associate Director for Strategic Initiatives, CDER, FDA, United States
Dr. Mullin is Associate Center Director for Strategic Initiatives. She leads efforts including Patient-Focused Drug Development, Rare Disease Cures Accelerator, and CDER’s International Program. She leads the FDA delegation to ICH and currently chairs the ICH Management Committee... Read More →
avatar for Wassim Nashabeh

Wassim Nashabeh

Vice President, Technical Regulatory Policy and International Operations, F. Hoffmann-La Roche
Wassim Nashabeh is the VP of Regulatory Policy & International Operations for Roche Pharmaceutical Group. Wassim is an assembly member of the International Council on Harmonization (ICH), the President of the CASSS Board of Directors, and a member of several advisory boards including... Read More →
avatar for Amanda Roache

Amanda Roache

Senior Director, Science and Regulatory Advocacy, Pharmaceutical Research and Manufacturers of America (PhRMA), United States
Amanda Roache, MPP, is a Senior Director in PhRMA’s Science and Regulatory Advocacy Department. She leads PhRMA’s work under the International Council for Harmonisation (ICH) as well as key science and regulatory activities related international regulatory policy, advocacy in... Read More →
avatar for Jerry Stewart

Jerry Stewart

Deputy Vice President, Scientific and Regulatory Advocacy, Pharmaceutical Research and Manufacturers of America (PhRMA)
Mr. Jerry Stewart, JD, MS, RPh, is Deputy Vice President at the Pharmaceutical Research and Manufacturers of America (PhRMA), located in Washington, DC, USA. He is responsible for international regulatory science policy and advocacy, and the global pharmaceutical manufacturing and... 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 →

Wednesday June 27, 2018 8:00am - 9:15am EDT
Room 206AB Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  09: Regulatory, Forum