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.

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.

Experienced QPPV, certified lead auditor, and certified trainer with over 28 years in the pharmaceutical consultancy and industry, holding an MSc in pharmacovigilance. Auditing since 2005 and have participated in numerous regulatory pre-inspections and inspections, including those by the EMA, FDA, and various national regulatory authorities such as Swedish, Spanish, French, Irish, German, Croatian, Turkish, and Hungarian, as well as several MHRA inspections. Conducted over 290 audits, accruing more than 670 days of experience auditing headquarters, affiliates, licensing partners, PV processes, computerized system validations, and PV service providers across the EU, US, Middle East, Central and South America, Asia, and Australia. In the past five years, focused primarily on remote and process PV audits, with a particular interest in aRMM/PASS/signal management/compassionate use/artificial intelligence. Additionally, performed over 140 gap analyses of PSMF/PSMF processes. Passionate about training and serve as a Visiting Lecturer at the University of Hertfordshire and the University of Oxford in the UK.

Mircea Ciuca, MD, is an expert in global drug safety and pharmacovigilance with over 20 years of experience, currently serving as the Global Head of Safety at Organon. After graduating from the Carol Davila University of Medicine and Pharmacy, he specialized in emergency medicine and obstetrics-gynecology, spending 12 years in clinical practice and academic teaching before transitioning to the pharmaceutical industry. Throughout his career, he has held senior leadership and QPPV roles at major firms like Vifor Pharma, CSL Behring, and Astellas, complemented by a postgraduate diploma in pharmacovigilance with honors from the University of Hertfordshire.

With over 25 years of experience in the pharmaceutical and biotech industries, Michael is a leader in pharmacovigilance, pharmacoepidemiology, and patient safety. Throughout his career, he has contributed to seven successful MAAs/NDAs/BLAs for innovative medicines and biosimilars by implementing cost-effective risk management systems. Beyond corporate leadership—having managed departments of over 75 FTEs and restored global regulatory compliance—he is a prominent figure in the scientific community, representing the industry at the EMA/PRAC and leading ICH working groups. As a creative entrepreneur and co-founder of startups in AI-driven medicine and digital health, he combines deep technical expertise with a proven track record of building high-performing global teams and driving innovation in drug safety.

With over twenty years of progressive experience in Pharmacovigilance and Drug Safety, Dr. Marco Sardella is a distinguished leader in global biopharmaceutical safety governance. As Chief Pharmacovigilance Officer and EU-UK Qualified Person for Pharmacovigilance (QPPV), and Head of Global Safety and Pharmacovigilance, he holds executive responsibility for the strategic design, implementation, and continuous oversight of comprehensive Pharmacovigilance and Risk Management Systems in full alignment with international regulatory frameworks. Throughout his career, Dr. Sardella has led pharmacovigilance strategy and execution for numerous therapies targeting rare and ultra-rare diseases, applying deep expertise in both biologic and small-molecule products. His therapeutic experience spans complex and high-risk indications. His portfolio encompasses global Drug Safety Management responsibilities across international clinical trials (Phase I–IV), post-authorization safety studies (PASS), and expanded access programs, including Compassionate Use and Named Patient Programs. Recognized for his strategic vision and collaborative leadership style, Dr. Sardella partners closely with regulatory authorities, executive leadership teams, and cross-functional stakeholders to uphold the highest standards of patient safety and pharmacovigilance governance worldwide. Since 2016, Dr. Sardella serves as the Chairperson of the European Pharmacovigilance Congress.

Visionary and dynamic. A purposeful senior Pharmacovigilance (PV) Leader and safety (GvP) expert with strategic skills, operating at the forefront of the global PV landscape (including UK), with extensive detailed experience spanning over 22 years across multiple functions within Drug Safety including global/local positions, currently employed as Director, Head of Pharmacovigilance. Previous posts include senior management/leadership positions, primarily alongside the QPPV/VP of PV to ensure strict compliance to GvP (Global, Regional and Local) through robust implementation and oversight of the PV system. At the forefront of PV intelligence and regulation landscapes, a proactive and meticulous leader with local and regional experience to facilitate strong cross-functional collaboration for GvP successes. Strong MHRA/FDA inspection experience and safety strategy implementation from global to regional and local affiliate level. Chairman of the ABPI PV expert network (PEN). Member of the International Society of Pharmacovigilance (ISoP)

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.