Meet Confirmed Speakers from the European Medicines Agency
DIA Europe 2022 is the only event where you can hear from nearly all top executives at the European Medicines Agency
We are honored to have them partner so closely with us, especially at such a momentous period for Europe. Learn more below about these leaders of today.
Peter Arlett, Head Data Analytics and Methods Task Force
Dr Peter Arlett - Head, Data Analytics and Methods Task Force, European Medicines Agency. Education: Medical Degree, University College London 1991; Member, Royal College of Physicians (MRCP) of London 1994; Fellow of the Faculty of Pharmaceutical Medicine (FFPM) of the Royal College of Physicians of London 2007; Fellow of the Royal College of Physicians of Edinburg 2017; Honorary Professor, London School of Hygiene and Tropic Medicine (2020). Career to date: Head of Pharmacovigilance and Epidemiology Department, EMA 2008 – 2020; Principal Administrator, Pharmaceuticals Unit, European Commission 2003-2008; UK MHRA 1996-2003; Hospital Physician, Oxford and London, UK NHS 1991-1996.
Ralph Bax, Head of the Paediatric Medicines Office
After studying medicine and health care management, Ralph Bax completed his training as a paediatrician at the Children’s University Hospital in Munich, Germany. He specialised in neonatology and neonatal neurology and led the department of developmental neurology. His main research interests were in the field of brain electrophysiology and haemodynamics in preterm neonates. In 2007 he joined the paediatric team at the EMA, where he mainly worked in the field of assessing PIPs in neonatology, neuropaediatrics and on public health aspects such as unmet paediatric medical needs. Ralph is the neonatal contact point at EMA and is the Agency’s liaison to the International Neonatal Consortium. Since January 2016 he has taken on his current role.
Michael Berntgen, Head of Scientific Evidence Generation
Christelle Bouygues,
European Medicines Agency, Netherlands
Degree in Pharmacy and Regulatory Affairs. Joined the EMA in 2004 as Regulatory Affairs Adviser. She is responsible for provision of regulatory and procedural advice in relation to centralised procedures and referrals.
Melanie Carr,
Head of Stakeholders and Communication Division
Melanie Carr is Head of the Stakeholders and Communication Division and a member of the Executive Board at the European Medicines Agency (EMA). She joined EMA in 1996 and has held various roles in pharmacovigilance, the centralised procedure for marketing authorisation, orphan medicines, the SME office and corporate stakeholders department. In her current role she is responsible for stakeholder relations management and communication. She has a degree in Pharmacy from the University of Nottingham in the UK and worked as a regulatory professional in the pharmaceutical industry prior to joining EMA.
Francesca Cerreta,
Principal Scientific Officer
After working for Lilly And Merck, Francesca Cerreta joined the EMA in 1996. There, she has set up the parallel scientific advice programme with FDA, worked in CNS and Scientific Advice, and is currently coordinating the PRIME scheme, the digital therapeutic matrix, and the geriatric medicines strategy activities.
Isabel Chicharo,
Head of Regulatory Data Management
Isabel is the Head of Data and Information Lifecycle Management Service in the Business Data and Analytics department.
She leads the service responsible for the implementation and management of the Master Data Management services on Substances, Products, Organisations and Referential data (also known as SPOR). She is also responsible for the management of the enterprise content (including unstructured information, records and documents) by implementing and managing an integrated Productivity and Collaboration platform.
Isabel has a Pharmacy degree, a post graduate degree in Pharmaceutical regulation and 17 years of data management experience in the field of Medicines. Isabel started her career in a Hospital and also worked for a Software company producing medical dictionaries for Pharmacies. She then moved on to work for the Portuguese authority where she was involved in different data management tasks, she took on a leading role in digital publications and in coordinating European working groups. For the last 11 years Isabel has worked for EMA where she has further developed her experience by taking on key roles in EU wide data related projects. She has coordinated data migration projects, ranging from procedural data to medicinal product data as well as data cleaning exercises on different data domains. She has coordinated complex projects and teams on various internal and international projects.
Ivo Claassen,
Deputy Executive Director and Head of Veterinary Medicines Division
Dr Claassen is a biomedical scientist by training and obtained his PhD in Virology and Immunology at the Erasmus University in Rotterdam.He started his career in different positions related to R&D,production,QA/QC and regulatory aspects of human and veterinary medicines.For the past 13 years he was responsible for the development and management of international projects in Asia,Africa and the Middle-East.Ivo joined the European Medicines Agency as Head of the Veterinary Medicines on 1 March 2018.
Emil Andrei Cochino,
Scientific Officer, Risk Management Specialist, Office of vaccines and therapies
Dr Emil Andrei Cochino is a Specialist in Public Health and Health Services Management. He has been a scientific officer at EMA from 2009, and is working in the Human Medicines Department as a Scientific Senior Specialist (Risk Management), where he is responsible for peer-reviewing risk management plans for centrally authorised products (ATMPs and vaccines) and improving the access of ATMPs to the market by supporting the collaboration with the HTA and payers organisations. Furthermore, he has overseen the revision 2 update of GVP Module V – Risk Management Systems and coreRMP19 guidance.
Emer Cooke,
Chair, ICMRA; Executive Director
Ms Cooke was nominated as Executive Director with a renewable five-year mandate by the Agency’s Management Board on 25 June 2020 and is the first woman at the helm of EMA. "I take up the role of Executive Director of EMA amid a public health crisis of unprecedented scale,” said Emer Cooke on her first day in office. “My number one priority will be to drive forward EMA’s response to the pandemic and the work already ongoing to support the development and approval of safe and effective COVID-19 vaccines and treatments.” Ms. Cooke obtained her degree in pharmacy from Trinity College in Dublin, Ireland. She has additional Masters degrees in Science and Business Admin., also from Trinity.
Monica Dias,
Principal Policy and Crisis Coordinating Officer
Dr. Monica Dias studied pharmacy in Lisbon and obtained her PhD from the University of Cardiff. She has subsequently worked in industry in R&D. In 2004 Dr. Dias joined the EMA Quality Office as Scientific Administrator and in 2013 moved to the Office of the Deputy Executive Director where she was Principal Policy and Crisis Coordinating Officer. She was involved in the development of policies and coordinated the Brexit operational preparedness activities at EMA. During the COVID-19 pandemic Dr. Dias coordinated activities in relation to shortages. Since 1 October 2021, Dr. Dias is Head of supply and availability of medicines and devices, a.i. and she is Co-Chair of the HMA/EMA Task Force on the availability of authorised medicines.
Falk Ehmann,
Chair of Innovation Task Force
Falk 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.
Juan Garcia-Burgos,
Head of Public and Stakeholders Engagement
Juan García Burgos is a Qualified Medical Doctor from Autonoma University in Madrid, specialised in urology. Juan worked as a urologist surgeon at the Maranon hospital in Madrid. He joined the European Medicines Agency in 2002 and was responsible for coordinating the preparation of EU clinical guidelines for drug development. In 2005 he was appointed Head of Medical and Health Information, being directly involved in the interaction with Patients, Consumers and Healthcare Professionals' Organisations and the preparation of information on benefit-risk of medicines for lay audiences. In 2017, he was appointed Head of Public and Stakeholders Engagement Department and is Co-chair of the EMA patients’ and healthcare professionals’ working party.
Iordanis Gravanis,
Scientififc Advice, Scientific Evidence Generation, Human Medicines
Iordanis Gravanis is a medical doctor by training and has a PhD in molecular and cellular pharmacology. He has been at the European Medicines Agency for almost 13 years, having worked initially as scientific officer in the oncology office for 5.5 years managing managing new authorisations and the post-authorisation lifecycle of oncology drugs. He then spent 6 years in a management role helping to improve the management of authorisation and post-authorisation processes and the EMA IT tools which support them. In his current role and for a little over a year he has been the Head of the Scientific Advice Office of the EMA.
Hilmar Hamann,
Head of Information Management Division
Dr. Hilmar Hamann is the Head of Information Management at the European Medicines Agency with a focus on modernizing IM capabilities for the EMA, NCAs and its stakeholders to implement the vision for a modern, efficient and data-driven Agency of the future. Prior to joining EMA, from 2011 to 2020, he served as the Director for Business Informatics at the U.S. Food and Drug Administration leading the transformation of medicines regulatory data, advancing data analytics, and modernizing the scientific computational and collaboration platforms that underpin operations.
Martin Harvey Allchurch,
Head of International Affairs
Martin Harvey is EMA Head of International Affairs since October 2021. He joined EMA in 1995 as part of the legal team after beginning his career as a European affairs consultant in Brussels. Past EMA roles include Head of the Office of the Executive Director and Head of Communication, before moving to the Agency's International Affairs team in 2014. He took an 18-month career break with Unitaid, the WHO-hosted partnership for innovation in global health from 2019-2020. Martin is a DIA Fellow, and has served on the DIA Advisory Council for EMEA and as program adviser for DIA's EuroMeeting and Global Annual Meeting. He has law degrees from the University of Dundee (UK) and Vrije Universiteit Brussels (Belgium).
Sabine Haubenreisser,
Principal Scientific Administrator, Stakeholders and Communication Division
Sabine Haubenreisser is a pharmacologist with special interest in scientific cooperation and regulatory convergence to the benefit of public health, through engagement with external stakeholders, the European network of experts and international partners and regulators. She has held positions at EMA in scientific divisions, international affairs and (currently) stakeholder engagement. She served 5 years as EMA Liaison Official at the US FDA, where she facilitated cooperation between the European Regulatory Network and the FDA. During this time, she oversaw completion of the EU/US Mutual Recognition Agreement on GMP inspections and development of new platforms for cooperation such as on patient engagement, rare diseases and pharmacometrics.
Tony Humphreys,
Head of the Regulatory Science and Innovation Task Force
He is the Head of the Regulatory Science and Innovation Task Force (TRS). He is responsible for providing leadership in the taskforce and the Agency to enable it’s continuous future proofing through operation of a regulatory science observatory, addressing key scientific and technological trends and their translation through the development of regulatory science strategy, planning and governance.
Viola Macolic Sarinic,
PRAC Scientific Lead
Doctorate in Biomedicine and Health Sciences; Specialist of clinical pharmacology and toxicology; Degree in medicine from the University of Zagreb, Croatia She has been Head of HALMED since December 2011. Her field of expertise is pharmacovigilance in which she has been active more than 20 years, and today she is also the Croatian PRAC delegate in EMA. She held more than 50 invited lectures in the fields of pharmacovigilance, regulatory science, pharmacoeconomics and clinical pharmacology
Fergus Sweeney,
Head of Clinical Studies and Manufacturing Task Force
Fergus Sweeney is Head, Clinical Studies and Manufacturing Taskforce at the European Medicines Agency since March 2020, covering Clinical Studies (Clinical Trial Information System), Biological Health Threats and Vaccine Strategy and supports strategy development in manufacturing and personal data protection in health research on medicines. He joined the EMA Inspections Service in 1999, and became Head of Compliance and Inspections (2009) and Head of Division Inspections and Human Medicines Pharmacovigilance in 2013 (including Scientific Committee Services from 2016). He has a BA (Physiology 1979) a Dr de 3eme Cycle (cancer biology 1982), and PhD (Pharmacology 1986). Fergus worked in clinical research mainly in QA from 1982 to 1999.
Fia Westerholm,
Programme Assurance Manager
Programme Assurance Manager within the Clinical Trials Information System (CTIS) programme that is managed by the European Medicines Agency to enable implementation of the Clinical Trials Regulation (CTR). Education in veterinary medicine, toxicology and social sciences. Professional with more than 20+ years of experience mostly at EU level but also at national level, encompassing both private and public sector in areas of research and development, assessment and regulation of medicines as well as management.
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