Viola Macolic Sarinic, MD, PhD

Dr Viola Macolić Šarinić is a medical doctor specializing in clinical pharmacology, with a PhD in pharmacogenomics and over 20 years of experience in pharmacovigilance and regulatory science. She has held senior roles at the Croatian medicines agency (HALMED), including Head of Pharmacovigilance and Director, leading Croatia's integration into the EU medicines regulatory network. She subsequently worked at the European Medicines Agency (EMA) in scientific advice and at the World Health Organization (WHO) headquarters, supporting pharmacovigilance systems in low- and middle-income countries. Since 2019, she has served at the EMA as PRAC Scientific Lead and Scientific Adviser, contributing to the development of international pharmacovigilance policy and the safe use of medicines.

Ji Yoon Park, MSc

She graduated with a Bachelor's degree in Pharmacy in 2010 and worked as a community pharmacist for approximately three years. Since 2014, she has been working at KIDS, performing pharmacovigilance activities, including the review of ICSRs, and providing guidance in accordance with ICH guidelines and Korean regulations. She completed a Master of Science in Clinical Pharmacy in 2020.

Gerald Dal Pan, MD, MHS

Dr. Gerald Dal Pan is the Director of the Office of Surveillance and Epidemiology in the Center for Drug Evaluation and Research at the US Food and Drug Administration, where since 2005 he has been responsible for the Center’s program in pharmacovigilance, pharmacoepidemiology, medication error prevention, and risk management. In this capacity, he has been involved in multiple initiatives to advance the field of postmarket drug safety at both national and international levels. As a medical doctor, he is trained in internal medicine, neurology, and epidemiology.

Priya Bahri, RPh, PostGradDipEpi, PhD, FISoP

Priya Bahri, RPh, PostGradDipEpi, PhD, FISoP, at EMA since 1996, is now EMA's Lead Pharmacovigilance and Risk Management Guidance and Policy. In this role, she oversees the developement of the EU Good Pharmacovigilance Practices (EU-GVP) and also instigates frameworks, research and engagement 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 at Utrecht University. She is the editor of the Springer textbook "Communicating about Risks and Safe Use of Medicines - Real Life and Applied Research".

Carlos Melgarejo

I graduated in Pharmacy at the University of Barcelona and obtained a postgraduate degree in Pharmacovigilance. Worked as a drug safety officer at a consultancy and regulatory service provider for marketing authorization holders. I later joined the Uppsala Monitoring Centre, a WHO collaborating centre, where my main role lies in the detection and assessment of medicines and vaccines safety signals from VigiBase to support the WHO’s Programme for International Drug Monitoring. I am currently undertaking an MSc in Biostatistics and Bioinformatics.

Juyoung Shin, PhD

Dr. Ju-Young Shin is current chair professor of department of biohealth regulatory science at school of pharmacy, SungKyunKwan University (SKKU). She also serves as an associate editor of SCIE journal including ‘Pharmacoepidemiolgoy and Drug Safety’, and ‘Epidemiology and Health’. She received her B.S. in pharmacy from Seoul National University, MPH in health policy and Ph.D. in pharmacoepidemiology from the Seoul National University College of Medicine. She was working as a director at Korea Institute of Drug Safety and Risk Management (KIDS), university of South Australia as a visiting fellow and McGill University as a postdoctoral fellow. She also led several governmental projects funded by Ministry of Food and Drug Safety, Ministry of Health and Welfare, and Health Insurance Review and Assessment Service and projects sponsored by pharmaceutical industry. 

Angnis Margreta Schmidt-May, PhD

I am originally from Germany where I completed my undergraduate degree in Physics at the University of Heidelberg in 2010. I received my PhD in Theoretical Physics from Stockholm University in 2014. From 2015 to 2020, I worked as an academic researcher and lecturer at ETH Zurich, LMU Munich & the Max-Planck-Institute for Physics. Then I transitioned into the private sector and became a Data Scientist, first in a tech start-up and later in a consultancy in Stockholm, Sweden. I led the Analytics department in a tech company for 2 years, before joining Uppsala Monitoring Centre as Head of Data Science earlier this year. I also support the Swedish Innovation Agency with reviewing grant applications in the area of Artificial Intelligence and advanced digitalization.

Calin Adrian Lungu, MD

Dr. Calin A. Lungu is the Chief Executive Officer of Drug Development Consulting Services (DDCS), a pharmacovigilance quality assurance consulting firm located in Windhof, in the Grand-Duchy of Luxembourg. He has worked for 15 years in drug development, clinical research, pharmacovigilance and quality assurance. Dr. Lungu has worked for a biotechnology company since 1993, and since 1995, as an independent consultant. Since 1999, he founded Drug Development Consulting Services of which he is presently CEO and which provides services in the area of quality assurance for pharmacovigilance.

Dr. Lungu has conducted over 190 pharmacovigilance audits for various pharmaceutical companies as well as National Competent Authorities in the EU, has participated in the preparation, conduct and follow-up of various regulatory inspections in the area of pharmacovigilance in Europe, has advised several EU and non-EU pharmaceutical companies in establishing/improving a pharmacovigilance system in conformity with current regulatory requirements. He is also a contracted expert for the Luxemburg and Malta national competent authorities.