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Nov 26, 2018 9:00 AM - Nov 26, 2018 5:00 PM

Changes in the Regulation Model/Working Model after the Implementation of ICH E2B

Faculty

Xue  TANG

Xue TANG

Drug Safety Unit Regional Head (DRH), APAC,, Pfizer, China

Junji  MORIYA, MD, PhD

Junji MORIYA, MD, PhD

Deputy Coordination Director, Office of Research Administration, Center for Regu, Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Phil  Tregunno

Phil Tregunno

Deputy Director - Patient Safety Monitoring, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom

Phil is the Deputy Director of Patient Safety Monitoring within MHRA’s Safety & Surveillance function and has over twenty years of experience working in pharmacovigilance. Prior to his current role Phil spent fourteen years leading and developing the pharmacovigilance system, including technology, processes, and relevant aspects of Pharmacovigilance Legislation. He is now accountable for Patient Safety Monitoring across medicines, vaccines, devices, defects and blood products. Phil was responsible delivery of MHRA systems for COVID-19 vaccine surveillance and their integration into the healthcare system. For several years he has led international projects to develop and deliver tools for global pharmacovigilance.

Jun  Zhao

Jun Zhao

IT, Medical Information Systems , Boehringer Ingelheim Pharmaceuticals Inc., United States

Rong  Zhu, DrMed

Rong Zhu, DrMed

PV Medical Director, dmedglobal, China

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