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Wednesday, June 27 • 10:30am - 11:45am
#340: Harmonization Beyond ICH

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-649-L04-P; CME 1.25; IACET 1.25; RN 1.25

This forum will include representatives from ewmerging markets to discuss 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.

Learning Objectives

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

Chair

Camille Jackson, MS

Speaker

Panelist
C. Michelle Limoli, PharmD

Panelist
Jerry Stewart, JD, MS, RPh

Panelist
Angelika Joos, MPharm

Panelist
Celia Lourenco, PhD

Panelist
Carol Zhu, MBA


Speakers
CJ

Camille Jackson

Associate Vice President, Science and Regulatory Advocacy, Pharmaceutical Research and Manufacturers of America (PhRMA)
Camille Jackson is currently Associate Vice President of Science and Regulatory Advocacy at PhRMA. In this role, she manages PhRMA’s international regulatory policy initiatives including engagement in the International Council for Harmonization (ICH) and the APEC Regulatory Harmonization... Read More →
avatar for Angelika Joos

Angelika Joos

Executive Director, Global Regulatory Policy, MSD, Belgium
Angelika Joos is a trained pharmacist. She is responsible for Regulatory Policy issues within MSD's Global Regulatory Affairs and Clinical Safety department. This role includes identifying regulatory policy priorities that align with MSD’s business priorities, leading cross-functional... 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 →
CL

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 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 Carol Zhu

Carol Zhu

Senior Vice President and Managing Director, DIA China

Wednesday June 27, 2018 10:30am - 11:45am EDT
Room 206AB Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  09: Regulatory, Forum