Speakers
Barry Arnold, MD
EU Qualified Person for Pharmacovigilance, AstraZeneca, United Kingdom
Qualified MD 1980. Joined industry 1986 - experience in all phases of clinical development. Head Drug Safety (ICI/ Zeneca/AstraZeneca) 1992-2006; EU Qualified Person for PV in June 06. Chairs EFPIA PV ad hoc group; represented EFPIA on MedDRA Management Board, ICH E2E and ICH E2F EWGs.
Sabine Brosch, PharmD, PhD, MPharm
Data Protection Officer, European Medicines Agency, Netherlands
Sabine Brosch was appointed DPO at EMA in January 2022. She joined EMA in 1996 and has been working in pharmacovigilance, clinical trials and international harmonisation (ICH) and standardisation (ISO) focusing on the development of the Individual Case Safety Report and Identification of Medicinal Products standards as well as the medical terminology MedDRA. She holds a master’s degree in pharmacy and a doctor of natural sciences degree of the University of Vienna, Austria.
Jerome Calmejane, PharmD
Director - Bioresearch Regulatory Compliance, Bioresearch Quality & Compliance - Janssen France, France
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.
Georgy Genov, MD
Head of PHV Office, ad-interim Head of Quality & Safety of Medicines Department, European Medicines Agency, Netherlands
Dr Georgy Genov is the Head of Pharmacovigilance Office, within Quality and Safety of Medicines Department, European Medicines Agency (EMA). The office oversees and manages lifecycle pharmacovigilance activities in the EU, including signal detection and management; evaluates the impact of regulatory interventions and develops pharmacovigilance guidelines and standards; ensures leadership, coordination and clear roles and responsibilities for a quality assured EMA’s and EU pharmacovigilance systems; collaborates closely with EMA scientific committees and working parties, in particular the Pharmacovigilance Risk Assessment Committee (PRAC). Oversees the development and maintenance of IT systems for pharmacovigilance.
Thomas Goedecke, PharmD, PhD
Senior Pharmacovigilance Specialist, European Medicines Agency, Netherlands
Since joining EMA in 2006, Thomas Goedecke has worked in all major areas of pharmacovigilance. His roles encompassed data collection and management in EudraVigilance, risk management for authorized medicines, with a focus on medication errors. Since 2015, he spearheads the implementation of the PRAC Impact Strategy,coordinating impact assessments and regulatory research for the European medicines regulatory network. He has contributed to the ENCePP Methods Guide and GVP guidelines on RMM effectiveness evaluation. Additionally, he oversees medication error reporting guidelines.
William Gregory, PhD
Senior Director, Safety and Risk Management, Pfizer Inc, United States
He received formal training in infectious diseases and molecular mechanisms of pathogenesis and has more than 15 years of experience directing global product development and registration programs. He also has extensive experience in pharmacovigilance and health informatics as well as the evaluation and exchange of safety data. He has served with other experts and senior scientists on many consensus panels, including ICH, CIOMS, ISO, and HL7.
Jan Petracek, MD, MSc
CEO, Ivigee, Czech Republic
Jan is a passionate and visionary leader in the field of pharmacovigilance, with over 20 years of experience in the industry. He is the CEO of iVigee, a company that provides innovative and sustainable solutions for drug safety and risk management. He is also a Fellow of the International Society of Pharmacovigilance (FISoP), a Global Fellow in Medicines Development (GFMD), and a Qualified Person for Pharmacovigilance (QPPV). Jan has a proven track record of establishing, growing, and selling successful organizations, both for-profit and non-profit, in the pharmacovigilance sector. He has received multiple awards and recognitions, including the DIA Excellence in Service Award in 2018 and HM Queen's Award for International Trade in 2019.
Patrice Verpillat, DrMed, MD, PhD, MPH
Head of Real World Evidence, European Medicines Agency, Netherlands
He is a medical doctor, specialist in epidemiology. He has worked during 20 years in the pharmaceutical industry where he had positions in several international companies, always dealing with real world data (RWD) and non-interventional studies (NIS) in order to bring RWE into research, access and life-cycle product management. Dr. Verpillat has published over 70 articles in Medline referenced journals. He has been involved in many organisations such as ENCePP, ICH M14 working group, European pharma association (efpia) and ISPE.
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