Pharmacovigilance Training VI Edition, Barcelona and Online 12-13 May 2025

Dr. Lungu has worked for more than 20 years in drug development, clinical research, pharmacovigilance and quality assurance. He has done over 150 PV audits. Since 2004 he is a EudraVigilance trainer and trained more than 250 Eudravigilance and XEVMPD courses at the EMA, selected European cities and also in the US. He has also trained from 2008 to 2012 the EudraVigilance Data Analysis System course at the EMA and including participants from the EMA and the National Competent Authorities. 

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.

Jan is a passionate and visionary leader in the field of pharmacovigilance, with over 20 years of experience in the industry. He is the CEO of iVigee, a company that provides innovative and sustainable solutions for drug safety and risk management. He is also a Fellow of the International Society of Pharmacovigilance (FISoP), a Global Fellow in Medicines Development (GFMD), and a Qualified Person for Pharmacovigilance (QPPV). Jan has a proven track record of establishing, growing, and selling successful organizations, both for-profit and non-profit, in the pharmacovigilance sector. He has received multiple awards and recognitions, including the DIA Excellence in Service Award in 2018 and the Queen's Award for International Trade in 2019. He is also a lecturer, trainer, auditor, and advisor for various pharmacovigilance courses and initiatives, and a founder of the Institute of Pharmacovigilance. Jan's mission is to elevate the recognition and competence of the pharmacovigilance profession, and to deliver sensible and pragmatic solutions to his clients and partners.

José Alberto Ayala Ortiz (M.Sc. Pharm. and M.Sc. IT) has been working for 20 years in Pharmacovigilance and Drug Safety. He has experience both from the Regulatory (Danish Medicines Agency), and from the Pharmaceutical Industry, where he has been responsible for Pharmacovigilance IT systems, databases and electronic transmissions. Besides his day-to-day Pharmacovigilance work as a consultant and PV auditor, he is trainer of EVWeb, XEVMPD and the DIA Signal Management training courses. He provides EU QPPV services and local QPPV in Spain for Pharmaceutical Companies and other consultancies through PVpharm, where he is the CEO.

Omar is a Pharmacovigilance SME based in Montreal, Canada. He is an Executive Committee member and Treasurer of the International Society of Pharmacovigilance (ISoP), North American chapter President and serves as a Leader of the Medical Device Safety – Special Interest Group. He previously held leadership roles in pharmaceutical companies in Algeria, France and Canada. He holds a Degree in Pharmacy and PhD in Pharmacology from Algiers University, Algeria and a Master in Pharmacovigilance and Drug Safety from Paris Descartes University, France. Omar has presented in multiple scientific forums with interest in new technologies, medical device safety and the improvement of pharmacovigilance around the world

Dr Felix Arellano is the Global Head of Safety & Risk Management in Roche, a position he has held for 10 years. Dr Arellano studied medicine at the Universidad Autonóma de Madrid, Spain, and Boston University, United States, followed by postgraduate studies in pharmacoepidemiology at Macgill University, Montreal, Canada and in pharmaceutical medicine (combined Strasbourg, Basel and Freiburg universities). He has in excess of 30 years of experience in Safety in the pharmaceutical industry, having worked in global roles for top 10 pharma in pharmacovigilance of medicines, consumer products, devices and vaccines. In Roche he has overseen the development of Safety to an industry leading team where innovation and compliance are equally important. Dr Arellano has a vision for the future of PV and safety; he believes in building the capabilities needed for new treatment paradigms, patient focus and the use of technology such as AI. Whilst always advocating that the most important element for the future of safety are the people in the team.

Angela has almost 20 years experience in PV with 15 years of functioning as a (deputy) QPPV. With her company, she provides customized pharmacovigilance support, including QPPV provision and responsibility for the clients’ pharmacovigilance systems, as set-up within DADA’s PV department. After her PhD in 2005, she started her career in pharmacovigilance at a generic pharmaceutical company and in 2008, she joined an innovator to gain experience in PV during the different mergers taking place at that time. In 2010, she was invited by 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 Medication Errors, and she recently obtained a MSc in Clinical Epidemiology.