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.

With 10 years in research and >30 in safety, Margaret is currently the Deputy EU Qualified Person for Pharmacovigilance at MSD Ltd. Activities include input to the EFPIA PV EWG, ICH, MedDRA (pre-ICH), the EMA EudraVigilance Steering Committee and the EWG, plus authoring papers on parasitology and drug safety

Maria qualified in Medicine from Cambridge University and became an Anaesthetist, working in the UK National Health Service. Her early industry career included roles in phase I clinical trials and in PET imaging as part of the GlaxoSmithKline Translational Medicine team. In 2004 joined the Global Clinical Safety & PV department, working in the neurosciences area and managing a team providing clinical safety for a portfolio of investigational & marketed products. In 2012, she became Deputy EU QPPV and in 2016 she joined AstraZeneca as Deputy EU QPPV. In 2019 Maria moved roles into therapy area-aligned clinical safety. She is now responsible for clinical-strategic leadership for assigned products in the oncology area.

Dr. Monika M. Pietrek is a medical doctor and epidemiologist with more than 30 years of experience in international drug development and post-authorization safety monitoring/risk management. She has worked in clinical care, pharmaceutical and CRO industries as well as at the German regulatory agency responsible for vaccines and biologics. Founder of Pietrek Associates GmbH, an independent consultancy firm to the pharmaceutical, biotechnology and medical device industry, focussing on B/R product assessment, PV system performance and organisational excellence. She has been co-chairing the EU Pharmacovigilance (PV) Working Group of industry experts for more than 12 years.

Françoise is a medical doctor as background, working in Pharmacovigilance for more than 30 years in big Pharmaceutical companies with different managerial roles, interactions with Health Authorities, and coordination of international networks of Pharmacovigilance. She has spent 15 Years on Vaccine Pharmacovigilance where she contributed to the development of standards definitions and methods through CIOMS WHO working groups on vaccine safety. Within the EFPIA Pharmacovigilance expert group, she analysed the influence of EU pharmacovigilance regulations outside Europe and of non EU regulations on the EUQPPV role.

Mette is a Medical Doctor by training with more than 20 years of hands on experience within Headquarter pharmacovigilance in small to large sized pharmaceutical companies and has worked in the USA, Switzerland and in Denmark. She has been heading up global operational and scientific safety functions and been the Qualified Person for Pharmacovigilance and Deputy QPPV and Head of PV Compliance. Currently overseeing the safety function in a small company working within rare diseases.

Menno van der Elst is PRAC member for the Netherlands. He was trained as community pharmacist and obtained his PhD at Utrecht University at the Department of Pharmaceutical Sciences. Menno joined the MEB in 2007 as pharmacovigilance assessor. He participated in the PhVWP since 2009 and joined PRAC at its establishment in 2012. As a member of EMA’s GPAG (Granularity and Periodicity Advisory Group) and SMART WG (Signal Management Review Technical working group) and of CMDh’s PhV WSP WP (Pharmacovigilance Worksharing Procedures Working Party), he has a special interest in PSURs and PSUSAs, signal detection and management, and Risk Management Planning.

To date, the majority of Clare’s career has been in Regulatory Affairs working for companies such as Boehringer Ingelheim and Johnson & Johnson. Clare’s broad regulatory experience has been gained at the local affiliate level, in EU and US Regulatory Affairs supporting drug development and maintenance projects and in EU Regulatory Policy. Three years ago Clare moved to a Patient Safety role at AstraZeneca, joining the QPPV Office and one of her responsibilities is coordinating PSMF maintenance.

Elspeth McIntosh began her career in the pharmaceutical industry in 1993, initially working in clinical research, before moving into Pharmacovigilance. She has extensive experience of all aspects of pharmacovigilance and has been a small company QPPV since 1999, dealing with innovative, generic and biotech/biological products. Elspeth set up Castle Pharmacovigilance in 2009 and post Brexit she is a UK QPPV and UK National Contact Person for several small pharma companies and provides general PV support to a wide range of pharma companies.

Dionne works in the Office of the EU QPPV for MSD in the UK as the PSMF Owner. Interested in “all things PSMF” and other primary areas of support are EudraVigilance access management, PV Audits and Inspections and ad hoc EU QPPV Office projects and activities.

Responsible for Pharmacovigilance activities in the EU and Balkans, as well as PV Intelligence and Operational activities within the International PV organization. As part of the Operational activities she holds responsibility for the PSMF. She previously served as Intelligence and Training expert in PV as part of the Quality Standards and Training Group in Bristol Myers Squibb and managed PV projects. Willemijn is a member of the EFPIA Pharmacovigilance Expert Working Group and the International Pharmacovigilance Group where she chairs the CIS and Balkan sub-teams. She started her career in Quintiles, followed by Aventis where she was involved in GCP activities.

Elsa has a Master Degree in Pharmaceutical Sciences. She worked five years as a Pharmacist. In 2013 she joined the Inspections Unit at INFARMED and is working as a Pharmacovigilance inspector since. Her core focus is on GCP/GVP/GDP/GMP, Internal Audits, Quality Alerts and Recalls, Shortages and Medicines Availability.

Britt Jørgensen is a Medical Doctor with more than 10 years’ experience in the Pharmaceutical Industry. She has worked in larger pharmaceutical companies as well as biotech companies in different specialist and managerial roles. She currently holds a specialist position at Novo Nordisk A/S, where she in relation to safety surveillance processes is responsible for inspection activities, compliance monitoring and implementation of new regulatory requirements.

Shahin Kauser also has a Certificate in Pharmacoepidemiology & Pharmacovigilance from the London School of Hygiene and Tropical Medicine. Shahin is a Leading Senior Scientific Assessor and joined the MHRA Agency (former MCA) in 2001. She has extensive experience of the ‘life-cycle’ of pharmacovigilance both nationally and in Europe. Her current portfolio includes monitoring the post-marketing safety of medicines in various therapeutic areas including blood disorders, multiple myeloma and malignant melanoma. Shahin has expertise in assessing benefit/risk, PSURs, safety Variations and risk management plans, additional risk minimisation measures and assessing their effectiveness.

My background is one of a Nursing degree and Masters in Clinical Pharmacology. I have been in the Pharmaceutical Industry for almost 30 years. Most spent in Pharmacovigilance in all areas, globally and locally. I spent some time as Director Regulatory Operations. My career has been spent mainly in Big Pharma although I have covered most therapeutic areas including generics, biosimilars, innovators etc. I have been a deputy QPPV for 8 years and most recently in Novartis since 2018. I have experience in different external committees and industry partnerships.

Kiernan joined Roche as a Principal Quality Lead focussing on pharmacovigilance quality assurance strategies. Previously, she worked as a GPvP Inspector at the MHRA for 1O years, with her most recent role being Expert GPvP Inspector. She contributed to the development of the EU GVP, had a role in the training of GPvP Inspectors in other EU Member States and contributed significantly to the MHRA’s preparedness work in relation to the UK’s withdrawal from the EU. Before joining the MHRA, Kiernan worked as a certified Quality Assurance auditor for a central laboratory that provided services for Phase I-III pharmaceutical clinical trials. Kiernan has a Master of Biomedical Sciences degree from the University of Southampton.

With more than 20 years of experience in Pharmacovigilance of which 15 years expertise gathered in Safety agreement strategies and management for global and local market contracts, Sandra is currently the Global Head of PV Partnering in Safety Operations 4.0 @ F.Hoffmann-La Roche Ltd. As Global Head PV Partnering Sandra is accountable for developing and deploying operational strategies for the elements of collection and provision of safety data/information via external sources that require contractual arrangements and drive effective delivery with a key focus in developing relationships and establishing fit for purpose agreements.

Her current position (since 2009) is CMDh member (EU-representative)/Policy adviser of the department Policy, Governance and Regulatory Affairs. Since May 2009 she is acting as Member and official representative in the CMDh on behalf of the MEB. She is member of several working parties of CMDh with issues related to (the new) Pharmacovigilance legislation (like RMPs/PSURs) as an area for special attention. She graduated MSc Pharmacy (in 1983) and as a pharmacist (in 1985).

David has worked in the Pharmaceutical Industry for 20 years and has been a Pfizer employee for 15 years. His early career was in Information Technology specialising in statistical and clinical systems, including designing and implementing a safety review & signal detection system for ongoing clinical studies. David joined Pfizer’s Pharmacovigilance department in 2012 and leads a team of Process Analysist focused on maintaining compliance with safety regulations. Responsibilities include maintaining the Signal management system, signals detection systems such as EVDAS and the documentation of safety reviews. David is based at Pfizer R&D UK office in Sandwich.

Maarten Lagendijk is currently Deputy EU QPPV at MSD. Previously he has held different positions in pharmacovigilance at the Medicines Evaluation Board (MEB), the Dutch Regulatory Authority, with increasing responsibilities. With over 15 years of experience in pharmacovigilance, Maarten has a good understanding of all different aspects of safety and risk evaluation of medicines in a broad range of therapeutic areas, most notably in oncology and hematology, as well as in immunology and pulmonology. Through the years he has also focused on developments around risk communication and additional risk minimisation, as well as the evolution of risk management and efforts to streamline and harmonise risk management plans.

Dr. Elena Prokofyeva is head of drug safety unit at the Department of Research & Development, DG PRE, the FAMHP, Brussels, Belgium. She represents Belgium within the CTFG safety subgroup. She initiated and led an update of the Q&A-RSI document within the CTFG. Dr. Prokofyeva holds a research doctorate from the University of Tuebingen, Germany, a Ph.D. and an M.D. from the Northern State Medical University, Arkhangelsk, Russia, and a Master of Public Health from the University of Umeå, Sweden. Harmonization of safety assessment across members of states in Europe, preparation for the implementation of a safety related part of clinical trial regulation, and safeguarding the safety of trial participants are main objectives of her work.

Currently Director of Global Safety Compliance, with responsibility to set strategic direction for an optimised pharmacovigilance quality management system. Carrie holds a BSc Biochemistry with Pharmacology. Carrie worked at the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK, holding a variety of positions, including Pharmacovigilance Inspectorate Operations Manager & Senior Pharmacovigilance Inspector, and other roles in the Enforcement and Post-Licensing Divisions. Carrie took a lead role in the publication of the MHRA's Good Pharmacovigilance Practice Guide and also contributed to the development of the EU Good Vigilance Practice modules. Carrie has also held other PV Compliance and Quality Assurance roles.

Over 25 years of experience in areas of Pharmacovigilance and Drug safety at both global and regional positions in multi-national companies, such as Merck KGaA, Astellas, Mylan. Currently, he has global responsibility for setting up, directing, managing and improving the Global Product Safety & Risk Management function to provide medical-safety governance to protect patients, healthcare providers, products and the organizational reputation. He is responsible for developing the overall safety strategy for global PV & providing functional leadership for the Global PV Functions PV Assessment, PV Operations & Systems, Safety Surveillance, as well as Compliance & Business Excellence for world-wide territories.

Dana is a pharmacist, with more than 10 years of experience in regulatory affairs and pharmacovigilance in big Pharmaceutical Companies. Dana’s broad pharmacovigilance experience has been gained in Bristol Myers Squibb as being responsible for the Pharmacovigilance activities in Middle East and Africa Region. Dana is a member of the EFPIA International Pharmacovigilance Group and part of the Middle East and Africa sub-teams.

Barbara has more than 20 years of experience in global clinical trial management, started as CRA in a CRO, continued as Clinical Trial Manager and Project Manager in global development and worked in different companies in the pharma industry locally and abroad. In her current role as Safety Scientist Barbara has 10 years of experience in clinical trials safety management with knowledge of safety management procedures and safety reporting requirements.

Doris Stenver is the founder of Unique Advice and she is specialised in internal medicine and has a master degree in public administration. She is former Chief Medical Officer at the Danish Medicines Agency and former member of the EU Pharmacovigilance Risk Assessment Committee (PRAC). Her regulatory experience comprises all aspects of pharmacovigilance, including scientific evaluation of drug safety issues, development of risk management strategies, policies and guidelines, provision of scientific advice to the pharmaceutical industry, and communication to health care professionals and the public.

Sarra has worked more than 10 years in Genetics and in Gastroenterology with different positions at the University of Rome “Tor Vergata”. Also working for the Italian Medicine Agency (AIFA) since 2013 and obtained a permanent position in the Agency in 2018. Currently working as Preclinical and Clinical Assessor in the Pre-marketing department of the AIFA with various responsibilities as VHP coordinator, CTFG delegate and secretary. Bachelor’s degree in Molecular Biology, PhD in mucosal immunology, Master degree in Regulatory Affairs.