Hedvig Nordeng is a professor and Head of Pharmacoepidemiology and Drug Safety Research Group, Dept of Pharmacy, University of Oslo (Ui0), Norway. Also Head of PharmaTox Strategic Research Initiative at Faculty of Mathematics and Natural Sciences, and Head of the Norwegian PhD School of Pharmacy. Her expertise lies within perinatal pharmacovigilance and pharmacotherapeutics in pregnancy and breast-feeding women. As of 2018, PRAC independent scientific expert, (re)appointed by the European Commission (with 2nd mandate up to July 2024). Member of ENTIS, executive committee member of NorPEN, chair of the Medication in Pregnancy and Lactation special interest group at the International Society of Pharmacoepidemiology (ISPE) and fellow of ISPE.

Dr Martin Huber is the Vice Chair of the Pharmacovigilance Risk Assessment Committee (PRAC) and has been a member of the Pharmacovigilance Working Party (PhVWP) before. He has been actively involved in many pharmacovigilance procedures including important referrals at PRAC and also contributes to the work of several working groups at the European level. Being a pharmacist by training and holding a degree in public health he gathered detailed experience in pharmacovigilance in a hospital setting before entering BfArM in 2010. Since 2013 he is head of the unit 'PRAC, Legal Status, Adverse Reaction Reports, Medication Errors'.

Priya Bahri, RPh, PostGradDipEpi, PhD, at EMA since 1996, is now EMA's Lead Pharmacovigilance and Risk Management Guidance and Policy. In this role, she also instigates research and regulatory frameworks for risk communication, stakeholder engagement for pharmacovigilance and implementation of risk minimisation in healthcare. Pro bono, she is active in the learned societies ISoP and ISPE and as associated researcher at Utrecht University. She is the editor of the Springer textbook "Communicating about Risks and Safe Use of Medicines - Real Life and Applied Research", published in 2020.

Viola Macolic Sarinic is a medical doctor, clinical pharmacologist by specialisation who holds a PhD in Pharmacogenomics applied to Biosciences and a master’s in Clinical pharmacology (pharmacokinetics). More than 20 years’ experience as a clinical pharmacologist and pharmacovigilance specialist, both in university hospital and in the medicines regulatory authority in Croatia working at the positions of a clinical and pharmacovigilance assessor, head of the PV department, national PRAC and CHMP member at the European medicines agency (EMA) and served for four years as the director of the Croatian medicines agency (HALMED). Currently at EMA as the PRAC Scientific Committee Lead and Scientific adviser on safety of medicines in the PV office.

Maria Giovanna Satta obtained a Master’s degree in Pharmacy from the University of Sassari, an MSc in Pharmacovigilance from the University of Florence and later specialised in Hospital Pharmacy. After over 12 years of experience in the pharmaceutical industry, covering several roles and responsibilities mainly focused on drug development and risk management, she joined the European Medicines Agency (EMA) in 2015 as Risk Management Specialist (RMS) in the Oncology, Haematology and Diagnostics (ONC) office. In 2017 she was appointed as RMS in the office of Therapies for Neurological and Psychiatric Disorders (H-NEU), where she currently works. Additionally, she coordinated EMA Risk Management Community (RMC) from 2019 until recently.

Medicine, Charles Univ. Prague, Cz Rep 1984-5 paediatrician 1985- 97 maternity leave (4 children) 1997- 2004 Clinical Pharmacologist 2004 - Pharmacovigilance Unit, State Institute for Drug Control, participant at PhVWPs at EMA Since 1999 interest in medicines during breastfeeding, 10 publ.

Dr Paul Ryan works as a GP in Cork City, Ireland. Paul is also a qualified pharmacist for the last 15 years and has lectured in the school of Pharmacy UCC for the last 13 years. He is the founder of www.GPConsult.ie and www.GPConsult.co.uk which has a collection of over 250 evidence based consultation templates seen in everyday GP practice. He is also founder of www.prescriptionrevision.ie which runs live and online tutorials on evidence based prescribing in GP practice. Paul is currently the ICGP therapeutics lead.

Dr Ulla Wändel Liminga is a pharmacist, and has a Doctoral thesis in Medical Sciences from Uppsala University in Sweden. In 1994, she started at the Medical Products Agency (MPA), Sweden, as a non-clinical assessor. She has since then worked with non-clinical as well as clinical efficacy and safety assessments. In 2007, she became Scientific director pharmacology and toxicology at the MPA, and in March 2020, her position has changed to Scientific director pharmacovigilance. From July 2012, she has been one of the Swedish members of the Pharmacovigilance Risk Assessment Committee (PRAC) at the European Medicines Agency.

Evdokia has joined the Agency in 2002. Since 2020, she is leading the Quality and Safety Department, which ensures that patients take medicine that are safe, are of the best possible quality and are manufactured in compliance with EU and international standards. She leads the Agency’s strategic priority to facilitate the uptake of advanced manufacturing approaches in EU and is part of the ICMRA PQKMS group. She has trained as a pharmacist in the School of Pharmacy of the University of Athens and has received a M.Sc. and a Ph.D. in Pharm. Technology from the same Faculty.

Corinne is a pharmacist and an epidemiologist (PhD) and has an MA in medical ethics and law. She has gained 20 years’ research experience in academia before making the move to the regulatory environment. Throughout her career, she has worked in multinational and multicultural environments, acquired scientific and regulatory expertise, communication, education and presentation skills, as well as a thorough understanding of project and budget management. She is an active member of the International Society for Pharmacoepidemiology with previous roles as Board member, VP Finance, and various committees. She is visiting professor of pharmacoepidemiology at the University of Bath in the UK.

Liana Martirosyan has been with Medicines Evaluation board since 2012 in the field of pharmacovigilance. Since 2008 she is the alternate PRAC member from the Netherlands. Liana is a medical doctor and holds MPH degree and PhD in pharmacoepidemiology. Special interests of Liana include interventions in clinical practice to minimize the drug safety risks and evaluation of additional risk minimization measures’ effectiveness.

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.

Dr Dave Lewis is Visiting Professor of Pharmacovigilance within the School of Life and Medical Sciences at the University of Hertfordshire, UK. Dave worked for over forty years in Patient Safety and Pharmacovigilance at GSK, Shire and Novartis. He was an active contributor to the ICH E2B (electronic reporting) and E2D (post-marketing data management) Expert Working Groups. He led the Innovative Medicines Initiative WEB-RADR project focusing on pharmacovigilance and social media, and was Co-Lead for Work Package 2 of the IHI ConcePTION project, researching pharmacovigilance in pregnancy and breastfeeding. PUBLICATIONS: Bibliography of ~40 publications on pharmacovigilance can be provided upon request.