Meet Confirmed Speakers from the European Medicines Agency
We are honored to have several EMA representatives taking part of our programme at DIA Europe 2020!
Join us to hear top European regulators addressing the current affairs in healthcare and European Medicines Agency's key recommendations to the Industry. Learn more below about the confirmed EMA representatives, and the programme sessions they are involved in.
Guido Rasi, Executive Director
Professor Guido Rasi began his second term as Executive Director of EMA on 16 November 2015. From November 2014 to mid-November 2015, he served as EMA’s Principal Adviser in Charge of Strategy. From November 2011 to November 2014 he was the Executive Director of the EMA and a member of its Management Board in the three years prior to this. He was Director-General of the Italian Medicines Agency (2008-2011) and member of the Management Board (2004-2008). He was made full professor of microbiology at the University of Rome 'Tor Vergata' in 2008. He holds a degree in medicine and surgery, with specialisations in internal medicine, allergology and clinical immunology, from the University of Rome.
Noël Wathion, Deputy Executive Director
Noël Wathion is the Deputy Executive Director of the EMA since February 2016. He is also the Chief of Policy and Chair of the ORP Task Force. He joined the Agency in 1996, and has since held several senior managerial positions, including Head of the Post-Authorisation Evaluation of Medicines for Human Use Unit, Head of the Patient Health Protection Unit, and EMA’s Chief Policy Adviser. He started his career in a retail pharmacy. He was later appointed to the Belgian Pharmaceutical Inspectorate in Brussels as a Chief Inspector, acting as the Secretary of the Belgian Medicines Commission. He is a former Belgian Member of the CPMP and CVMP, and Belgian representative on the Pharmaceutical Committee, Standing Committee and NTA working group.
Fergus Sweeney, Head of Inspections and Human Medicines Pharmacovigilance DivisionFergus Sweeney holds a PhD degree in Pharmacology from the University College Dublin and has held various positions at the EMA since 1999. Fergus Sweeney is the Head of Inspections, Human Medicines Pharmacovigilance and Committees at the European Medicines Agency since 2016.
Anthony Humphreys, Head of Scientific Committees Regulatory Science StrategyAnthony Humphreys is the Head of Scientific Committees Regulatory Science Strategy Division (SciRS). He is responsible for providing leadership in the Agency in the areas of Scientific Committees Coordination and Regulatory Science Strategy in support of delivering the EMRN 2020 Strategy. He chairs the Scientific Committee Coordination Board.
Michael Berntgen, Head of Development SupportMichael Berntgen is Head of Product Development Scientific Support at the EMA. This department aims at facilitating timely availability of safe and effective medicines by promoting development, research and innovation. The activities include collaboration with other decision makers to support that relevant data for later medicine evaluation is generated. Michael is a pharmacist with a PhD and a Master of Regulatory Affairs. From 1999 to 2006, he worked in the industry in Germany and the UK.
Juan Garcia Burgos, Head of Public Engagement Department
Juan Garcia Burgos is Head of Public Engagement Department and Co-chair of the EMA patients’ & healthcare professionals’ working parties. He is a Medical Doctor specialised in urology. In 2002 he joined the EMA to coordinate the preparation of EU clinical guidelines for drug development. In 2005 he was appointed Head of Medical & Health Information interacting with patients, consumers & Healthcare professionals and preparing information on benefit-risk of medicines for lay audiences.
Jordi Llinares Garcia, Head of Scientific and Regulatory ManagementDr Jordi Llinares is the Head of Scientific and Regulatory Management at the European Medicines Agency (EMA). He was the Head of Orphan Medicines between 2009 and 2013 and Head of Scientific Support Development between 2013 and 2016. Dr Llinares graduated as a Medical Doctor from the University of Barcelona and specialised (MIR) as clinical pharmacologist at Hospital Vall d’Hebron. He has a Masters in Science in Epidemiology from the London School of Hygiene and Tropical Medicine (London). Before joining the Agency he worked as clinical pharmacologist at Hospital de Sant Pau (Barcelona) and was member of the Ethics Committee of the IAS (Institut d’Assistencia Sanitaria).
Zaide Frias, Head of Human Medicines Evaluation DivisionZaïde Frias has degrees in Pharmacy and Business Administration. She joined the EMA in 1999. In 2016 she was appointed as Head of Human Medicines Evaluation Division, which is responsible for activities related to the scientific, regulatory and procedural management, including risk management and product information as well as support to Scientific Committees, Working parties and SAGs on product life-cycle activities across therapeutic areas, covering pre-submission to post-authorisation phase.
Agnès Saint-Raymond, Head of International Affairs, Head of Portfolio BoardDr Agnès Saint-Raymond is Head of International Affairs and Head of Portfolio Board. Dr Saint-Raymond is an MD and qualified Paediatrician who joined EMA in 2000. She was Head of Special Areas for Human Medicines (Paediatric Medicines, Orphan Medicines, Scientific Advice, SME Office, and Scientific Support & Projects) until 2013. She is Head of Portfolio Board since Aug 2013 and Head of International Affairs since Nov 2016.
Sabine Haubenreisser, Principal Scientific AdministratorSabine Haubenreisser, MSc, PhD, facilitates cooperation between the European Regulatory Network for medicines and the US FDA, promoting shared regulatory and scientific understanding and convergence between both regions, as EMA Liaison Official at the FDA in White Oak, MD. Dr. Haubenreisser previously served as a scientific team leader and external communications officer in the European Medicines Agency. She earned her Masters Degree in Pharmaceutical Science from Johan Wolfgang Goethe Universität and her PhD in Pharmacology from the Pharmackologisches Intitut für Naturwissenschaftler; she also holds a certificate in Epidemiology from the London School of Hygiene and Tropical Medicine.
Armin Ritzhaupt, Scientific AdministratorArmin Ritzhaupt, is a scientific administrator in the Regulatory Affairs Office at EMA providing regulatory support to development, evaluation and surveillance of medicinal products for human use with a focus on activities related to the implementation of the new medical device and in vitro diagnostic regulations. Armin worked in industry from 2002 to 2015 gaining broad European and global regulatory experience before joining EMA. He holds PhD in biochemistry from the University of Liverpool, UK and a Masters of Global Public Health from the University of Manchester. He completed a postdoctoral fellowship at the Center for Biologics Evaluation and Research (CBER), FDA.
Andrei Spinei, Scientific AdministratorAndrei Spinei is a Scientific Administrator in the Manufacturing Quality and Supply Chain Integrity service at EMA working on GMP, quality defects and product recalls, sampling and testing and international collaborations on GMP and inspections. He holds an MSc. in Pharmacy and before joining the European Medicines Agency he has worked for several years in regulatory affairs in the pharmaceutical industry.
Falk Ehmann, Head Innovation Task ForceFalk Ehmann is a medical doctor with a PhD in Experimental Medicine and expertise in European and International law. He is currently chairing the EMA’s Innovation Task Force (ITF). His main areas of expertise include Pharmacogenomics, Nanomedicines and Borderline and Combined Medicinal Products and other -omics especially in connection with Personalized Medicine. Falk worked for the EMA since 2004 including manager of Scientific Advice teams and working as Product Team Leader in the Oncology and Anti-Invectives therapeutic areas.
As part of post graduate studies at King’s College Falk created a cost-benefit decision model, designed protocols for First in Man clinical studies and proposed a definition for Innovation in Health which has been shared with the National Institute for Health and Care Excellence (NICE) and the UK ministry of Health. Falk published more than 25 articles in peer reviewed journals.
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