Peter got his medical degree from the Catholic University of Leuven in Belgium and until the end of 2003, Peter practised as a General Practitioner in the UK. In 2004, he joined Roche as a drug safety physician in the local organisation. Taking up roles with increasing responsibility, Peter was appointed Qualified Person for Pharmacovigilance for Roche in 2011. He left Roche at the end of 2014 to take a role at Daichii Sankyo and moved on to be the Head of Global Drug Safety & QPPV for Grunenthal. Peter has extensive experience in pre-approval and post-marketing pharmacovigilance.

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.

Qualified as a pharmacist in 1981 and started her career in hospital pharmacy. In 1983 she specialised in Drug Information Services and moved to Kuwait to set up and run the first National Drug Information Centre. On her return to the UK, Vicki spent the next four years in community pharmacy. In 1996 Vicki joined GlaxoWellcome and started her career in pharmacovigilance. In 2002 she moved to AstraZeneca UK Ltd as the Drug Safety Manager moving on to become Head of Drug Safety & Medical Information. Vicki joined Abbott in 2005 as European Qualified Person for Pharmacovigilance (EU QPPV). In 2013 moved to AbbVie as EU QPPV and Head of Affiliate Safety Excellence (ASE) and is now VP, Pharmacovigilance Excellence and I-QPPV.

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.

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.

Pharmacist with >20 years’ experience in pharmacy & pharmaceutical business, started as clinical pharmacist in Cairo Univ. Med-School Teaching Hospital integrating with top HCPs of different specialties where safety monitoring is an integral part of clinical practice. Using her expertise, she joined the pharmaceutical industry working in RA & regional positions before focusing on Pharmacovigilance. Actively working in PV Reg-Intel in a role enabling her to interact with industry colleagues and Competent Authority PV departments. Contributed to several international initiatives and partnerships to support patient safety & improve drug safety monitoring. She’s an active ISOP member collaborating in the initiation of the Global PV Certificate.

Magnus Ysander is the EU and UK QPPV for the AstraZeneca group of companies since 2015 and is based in Gothenburg, Sweden. He joined the company in 2002 and have had several specialist, oversight and line managerial roles within the AstraZeneca pharmacovigilance organisation. Magnus is a MD and has previously worked as a certified Orthopedic Surgeon. He is a member of EFPIA Pharmacovigilance Expert Group and the Program Committee for the DIA QPPV Forum.

Also Head of Pharmacovigilance Working Group of EUCROF. Nicolas received his medical degree from the University of Würzburg, Germany, in 1985 and worked as a physician in Greece and Austria until 1989. In 1989, he joined Schering Plough Greece as Medical Director and Pharmacovigilance Manager. In 1995, he moved to Rhone Poulenc Rorer Greece, initially as Medical Director and Pharmacovigilance Manager and, following the merger with Hoechst in 1999, as Regional Medical Director of Aventis for the Balkan countries. Since 2005, he is the Scientific Director of Medwork Greece. Nicolas has extensive experience in pre-approval and post-marketing pharmacovigilance and is a contracted QPPV.

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.

Angela has over 15 years of experience in PV with more than a decade of functioning as a QPPV. She provides customized pharmacovigilance support, including QPPV provision and responsibility for the clients pharmacovigilance systems. After completing her PhD in 2005, she started her career in pharmacovigilance and in 2008, she joined Organon to gain experience in PV during the different mergers taking place at that time. In 2010, she joined DADA Consultancy to start up a department of PV consultants to take on global and local responsibilities from clients in need of PV support. Her personal interests lie with Compliance management and auditing, as well as Risk Management, and she recently obtained a MSc in Epidemiology.

Gemma Jimenez Sese is the EUQPPV for Almirall since 2011 and is based in Barcelona, Spain. Pharmacist by education, after a short period in hospital research moved to pharma industry working in UK and Spain, first in regulatory affairs and for the last 15 years in pharmacovigilance taking up roles with increasing responsibility. In PV she has been involved in a broad scope of activities, from safety in development to marketed medicinal products support, from small mollecules to biologics. Passionate about science and strong believer in our mission of putting always the patient first.

Katarzyna qualified as a pharmacist and joined GlaxoSmithKline in 2017 as the Safety Evaluation Risk Management Scientist in a central team supporting established products. She is responsible for a broad range of pharmacovigilance activities, such as the global signal detection, preparation of periodic safety reports, RMPs and safety input to queries from regulatory agencies. Katarzyna has been extensively involved in associative work throughout her whole pharmacy studies, up to the European level when she was the President of the European Pharmaceutical Students’ Association (EPSA), representing 160 000 European pharmacy students and young professionals.

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.

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.

Peter Arlett is Head of the Data Analytics and Methods Taskforce at the European Medicines Agency. In this role he leads on operations and transformation on clinical evidence at the EMA including clinical trials, real world evidence, safety reporting and data science including AI. He is Chair of the EMA Data Board, Co-Chair of the HMA-EMA Big Data Steering Group, Co-chair of the EMA AI Coordination Group, Co-chair of the Vaccine Monitoring Platform Steering Group and Member of the ACT EU Steering Group In addition to his role at EMA, Peter is Honorary Professor at the London School of Hygiene and Tropical Medicine. He is also a Fellow of the Royal College of Physicians of Edinburgh and of the Faculty of Pharmaceutical Medicines of London

Chris Foreman is the Deputy Chief Privacy Officer of the US-based Merck & Co., Inc. He is a lawyer, having spent 20 years in the Company’s Office of General Counsel, before joining the Global Privacy Office in Sept. 2018. Based in Brussels, Chris has practiced law in London, Washington DC, Istanbul, New York, Brussels and Moscow, focusing on pharmacovigilance, pharmaceutical regulations, trademarks and general corporate work.

Achint Kumar is the EU QPPV at Biogen. He is a physician by training and has been working in Pharmacovigilance since 2005. Currently, he is also an active member at EFPIA PV Expert Group.

Zurab Koberidze has over 20 years of experience in clinical trials, health care management, donor liaison and pharmacovigilance. Having gained his degrees from Tajik State Medical University and University of California at Berkeley and before joining FGK, Dr. Koberidze worked in clinical settings and later on for a charity, where he advised humanitarian field projects in developing countries. His safety and pharmacovigilance expertise covers among others oncology, cardiology, dermatology and cardiovascular diseases. Dr. Koberidze is a highly experienced professional with a truly global perspective on medical practice.

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.

Frederic Bouder is Assistant Professor at Maastricht University in the Department of Technology and Society Studies and Research Associate at King's College London. For over ten years he has developed policy oriented research on risk communication and risk regulation. Frederic has focused on a range of pharmaceutical issues including cardiovascular conditions, impurities in drugs, antivirals, vaccines, biotechnologies and genetic testing.

Guy Demol is the European Qualified Person for Pharmacovigilance (EU QPPV) for MSD since October 2013. Previously, he was Vice President Development for sanofi pasteur MSD (SPMSD) as of 2009. As such he was leading SPMSD’s activities in Clinical Research, Epidemiology, Regulatory Affairs, Pharmacovigilance and Risk Management, and Quality and Pharmaceutical Affairs. He joined SPMSD in 2007 as Executive Director Pharmacovigilance and Risk Management and EU QPPV. Before joining SPMSD, he was the franchise head for vaccines in the European Regulatory Affairs Department of MSD in Brussels.

Line Michan is currently Medicines Inspector with main responsibility for pharmacovigilance inspections at the Danish Medicines Agency and she is part of the EU Pharmacovigilance Inspectors Working Group. Line Michan has been working with patient safety, risk management and pharmacovigilance at the Danish Medicines Agency for the last 12 years. She has been involved in both national safety surveillance as well as in the EU Pharmacovigilance Risk Assessment committee. Since 2017, she has been part of the inspectorate at the agency. Line Michan holds a Master degree and a PhD in Science from the University of Copenhagen.

Pharmacologist and toxicologist with over 20 years experience in the industry. She started work in the laboratories as a senior scientist and then moved into the field of Pharmacovigilance. She has lived and worked in three countries and was very involved with the implementation of electronic reporting to EMA back in 2005 and has progressed in several management roles to her current role of Head of Compliance in the Global QPPV Office at Pfizer, based in Italy. She is a member of the International Pharmacovigilance Working Group and the sub group SiGiR within EFPIA.

Dr. Sabine Straus has been with the Medicines Evaluation Board (MEB) in the Netherlands since 1997, where she started as an Assessor Pharmacovigilance. Prior to working at the MEB she held different positions in the pharmaceutical industry, her last job as Medical Director at Searle Monsanto in the Netherlands. As of July 2012 she is the Dutch member in the Pharmacovigilance Risk Assessment Committee (PRAC). In addition to her work at the MEB she holds a position as associate professor at the Erasmus Medical Center, department of Medical Informatics in Rotterdam. Her main research focus is on additional risk minimisation, pregnancy prevention programs, biologicals, signal detection and signal management.

Pfizer Arab League QPPV & Cluster Safety Lead for North West Africa & ME region, Marouane is a Pharmacist by training University of UCAD in Dakar and holds a university Diploma in pharmaceutical quality assurance from Pharmacy and Medicine University (Rabat). Before joining Pfizer, occupied various positions in pharmaceutical industry, Pharmacovigilance and safety training, quality assurance, and regulatory. Marouane is also a Board member of the Moroccan society of pharmacovigilance, with the society and the support of Morocco WHO CC, he participated to development of several pharmacovigilance training courses to support local & regional pharmacovigilance understanding and development across the North West African region.

Ermishina Olga is the Pharmacovigilance Country Head, EAEU Qualified Person for Pharmacovigilance in Bayer company. She graduated from Russian State Medical University, biophysics course. Olga is in pharmaceutical business since 1997, being involved in product promotion, medical support, non-interventional studies and interventional clinical trials. For the last 15 years she is in pharmacovigilance function. Olga is the chair of Russian AIPM Pharmacovigilance task force and the EFPIA CIS Pharmacovigilance team.

Over the past 25 years Wendy has been dedicated to pharmacovigilance. She has broad experience as EU QPPV for generic and innovative products in complex companies. She also has wealth of experience in lobbying and networking in trade associations/working groups. In her current role, Wendy provides pharmacovigilance support to Pharmaceutical Industry and SMEs (startups). She enjoys setting up the PV system and supports in the development of the PSMF with associated documents. Since 2020 Wendy is a trained professional in Transactional Analysis (TA). TA is a theory of human personality and social behavior. TA gives a wealth of options to work with challenges and changes in organisational and personal development.

Dr S Pal has a Masters in Pharmacy with a PhD in Pharmacology. Been with WHO for nearly 2 decades, and leads the Medicines Safety Programme in WHO, to support pharmacovigilance activities in low and middle income countries and in priority programmes such as HIV, TB, malaria. WHO representative in platforms such as ICH, CIOMS, ICMRA, and a Deputy Board Member of the Uppsala Monitoring Centre, Sweden.

Sue has been in the pharmaceutical industry for over 25 years. Sue joined Amgen in 2013 as EU QPPV. Sue works closely with the Global Patient Safety team and a network of local safety officers to provide oversight of patient safety across the EU. Sue sits on the Efpia Pharmacovigilance Expert Group and is an honorary Fellow of PIPA (Pharmaceutical Information and Pharmacovigilance Association). Prior to joining Amgen Sue spent 3 years at Eisai Europe Ltd as Head of International Pharmacovigilance and EU QPPV having previously held various roles in safety, medical information and marketing for GlaxoSmithKline and AstraZeneca operating at both the affiliate and global level. Sue holds a BSc (Hons) in Biochemistry and MSc in Immunology.

Gabrielle got a pharmaceutical degree from the University Paris-Sud in France and has a 4-year experience in Pharmacovigilance. At Alexion since 2016, she has taken up different roles, first being the Local Safety Officer for France then joining the QPPV Office in 2018. Gabrielle coordinates compliance activities within the QPPV office and is also the PSMF manager. She was appointed Deputy QPPV for Alexion in early 2019.

Judith has almost 10 years of experience in pharmacovigilance and is member of the EFPIA Pharmacovigilance Expert Group since 2012. After studying pharmacy and two years in the biomaterial development area, she started working for a contract research organization where she was responsible for safety reporting in the clinical development. Within vfa, the German association for researched-based pharmaceutical companies, Judith covers pharmacovigilance and the interface to regulatory affairs. Judith holds a MSc in Consumer Health Care.