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The Crystal

Oct 02, 2017 8:00 AM - Oct 02, 2017 7:00 PM

1 Siemens Brothers Way, Royal Victoria Dock, London, E16 1GB, United Kingdom

Definitions and Methods in Pharmacovigilance

This Module is now fully booked. Next Definitions and Methods in Pharmacovigilance module takes place 5 February 2018.

Faculty

Gaby L. Danan, MD, PhD

Gaby L. Danan, MD, PhD

Pharmacovigilance Expert, GLD, France

Gaby Danan, MD, PhD, was the EU QPPV for Sanofi until his retirement in 2010. He has served on the Council for International Organizations of Medical Sciences and International Conference on Harmonisation Expert Working Groups, as the European Federation of Pharmaceutical Industries and Associations Clinical Safety E2B topic leader and co-chaired the EudraVigilance Expert Working Group from its inception until 2009. Dr. Danan co-published the Roussel Uclaf Causality Assessment Method for drug-induced liver injury, has authored papers on pharmacovigilance definitions and methodologies, chaired the DIA 2010 Annual Meeting, serves on the DIA Safety Training Committee, and instructs several DIA training courses.

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.

Mick  Foy

Mick Foy

Director of Delivery, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom

Mick Foy has been with the MHRA for more than 35 years, he is a member of the MHRA’s Executive Committee and has recently been appointed Director of Delivery . Amongst his responsibilities is to drive initiatives to introduce new and improved services to stakeholders. Mick is SRO for the SafetyConnect and RegulatoryConnect programmes. He also leads MHRA efforts to build PV capabilities in other countries particularly low and middle income countries as part of a global initiative with the Bill and Melinda Gates Foundation.

Suzie  Seabroke, PhD, MSc

Suzie Seabroke, PhD, MSc

Senior Pharmacoepidemiologist, Vigilance and Risk Management Division, MHRA, United Kingdom

Suzie is a senior pharmacoepidemiologist working in the MHRA's Benefit/Risk Management Group. She joined the MHRA in 2003 and has a specific interests in vaccines, medicines used in pregnancy and signal detection methodology. Suzie has responsibility for optimising methods for drug/vaccine safety signal detection at the MHRA, conducting observational research studies to support regulatory decision making and assessing post-authorisation safety studies.

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