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.

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.

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.

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. 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.

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.