Faculty
Michael Forstner, PhD, MPH, MSc
Head of Global Safety Science, SOBI, Switzerland
Michael's main focus areas are the planning, development, implementation and evaluation of benefit-risk management solutions, as well as the optimization of processes around benefit-risk management. He is engaged in developing and applying (benefit-) risk analysis and signal management methodologies in order to make RM planning more formally reproducible. Furthermore, he supports the development, implementation and evaluation of effectiveness of additional risk minimization and PV measures in the context of RMPs, as well as post-authorization studies to optimize the benefit-risk profiles of medicines.
Julie Williams, PhD
Expert Assessor, MHRA, United Kingdom
She has worked in pharmacovigilance for almost 17 years having the joined the then Medicines Control Agency in 1998. Following realignment and formation of the MHRA she became a Unit Manager within the Risk Management Group and held that role until September 2013. She has been actively involved in providing expert advice to the UK representative at the Council Working Group influencing the UK’s position at the negotiations on the EU Pharmacovigilance legislation and more recently involved in work on transposition of the EU Directive into national legislation. Since September 2012 she has been the UK delegate of the EU PRAC and been actively involved in the work of the committee.
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
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.
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