Meet Confirmed Speakers from 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.

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.

Steffen Thirstrup, Chief Medical Officer

Steffen Thirstrup is a medical doctor and board certified specialist in clinical pharmacology and therapeutics. He holds a PhD in pharmacology and has a long background in clinical internal medicine. He is an adjunct professor at the Faculty of Health Sciences, University of Copenhagen. From 2004-9 ST worked at the Danish Medicines Agency acting as member of CHMP and additionally CAT at the European Medicines Agency. Following a short period involved in developing best practice guidelines for primary care ST rejoined the DKMA as Head of the Licensing. From 2013-22, Prof Thirstrup worked asdirector and strategic consultant for NDA Group AB. From June 2022 Prof Thistrup is the Chief Medical Officer of the European Medicines Agency.

Alberto Ganan, Head of Service, Procedure Management and Business Support Division

Alberto Ganan Jimenez is a Pharmacist and a Biochemist and holds a PhD on Molecular and Cell Biology from University of Zaragoza (Spain). After working in Pharmaceutical Industry in Business Intelligence positions for 3 years, Alberto joined the EMA as a Product Lead in the Quality of Medicines Office in 2006. Since 2013, he works as the Head of Service of Procedures Office. This service is currently responsible for the validation of all Initial MAAs for human medicinal products at EMA, the management of minor variations and administrative procedures, the notifications of parallel distribution and certificates of medicinal products issued by EMA.

Ana Zanoletty, Head of Clinical Trials Transformation Workstream

Ana qualified as a pharmacist and following various roles managing clinical trials for the biopharmaceutical industry joined EMA in 2006. At EMA she spent her initial years coordinating initial marketing authorisation procedures, and later transitioned into the management of post-authorisation procedures. Ana has been Programme Manager for the Accelerating Clinical Trials in the EU (ACT EU), a European clinical trials transformation initiative which is co-lead by EC, HMA and EMA, and is currently the Head of the Clinical Trials Transformation workstream at EMA.

Caroline Pothet, Head of Advanced Therapies and Haematological Diseases

Caroline Pothet is head of the office for advanced therapies and haematological diseases at the European Medicines Agency. Caroline joined EMA in 2020; prior to this, Caroline worked in the Industry for 20 years in a variety of sectors such as regulatory policy, regulatory science and drug development, including 10 years in oncology; During these years, Caroline was privileged to be involved in the development and registration of several drugs (e.g. cervical cancer, melanoma, T-ALL/LBL). Caroline is also a member of the Regulatory Scientific Committee in the International Rare Disease Research Consortium.

Evdokia Korakianiti, Head of Quality and Safety of Medicines

Head of Procedure Management department as of July 2014. Head of the Chemicals Section in the Quality of Medicines Sector till July 2014. She has been working for the Agency for 11 years and she is heavily involved with the EMA PAT Team activities. She is a pharmacist and has received a M.Sc. and a Ph.D. in Pharm. Technology from the School of Pharmacy in Athens

Falk Ehmann, Head of Innovation and Development Accelerator (ad interim), Regulatory Science and 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.

Michael Berntgen, Head of Scientific Evidence Generation

The Scientific Evidence Generation Department aims to support the development of medicines to ensure generation of robust and relevant scientific evidence, also in collaboration with other stakeholders. Activities include the provision of scientific advice & methodology qualification, support to medicines for the paediatric population & for orphan diseases, provision of expertise & support in translational sciences. The department monitors the portfolio related to human medicines, manages the PRIME scheme and facilitates collaboration with downstream decision-makers, to foster timely access to medicines. 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.

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.

Monica Dias, Head of Supply and Availability of Medicines and Devices

Dr. Dias, Head of Supply and Availability at EMA since 2021, leads key initiatives including co-chairing the HMA/EMA Task Force and chairing the Medicine Shortages SPOC Working Party. With a pharmacy degree from Lisbon and a PhD from Cardiff, she joined EMA in 2004, specialising in quality for 10 years before leading policy and crisis coordination. Dr. Dias now oversees EMA's extended mandate on shortages under Regulation (EU) 2022/123.

Patrice Verpillat, Head of Real World Evidence

He is a medical doctor, specialist in epidemiology. He has worked during 20 years in the pharmaceutical industry where he had positions in several international companies, always dealing with real world data (RWD) and non-interventional studies (NIS) in order to bring RWE into research, access and life-cycle product management. Dr. Verpillat has published over 70 articles in Medline referenced journals. He has been involved in many organisations such as ENCePP, ICH M14 working group, European pharma association (efpia) and ISPE.

Ralph Bax, Head of the Paediatric Medicines Office

After studying medicine and health care management in Germany, Dr Ralph Bax completed his training as a paediatrician at the Children’s University Hospital in Munich/Germany. There he specialised in neonatology and led the department of developmental neurology. In 2007 he joined the paediatric team at the European Medicines Agency in London supporting the Paediatric Committee (PDCO) in the area of neonatology, neurology and child psychiatry and working on public health issues such as paediatric needs for medicines within the international co-operation with WHO and the International Neonatal Consortium. Dr Bax is the contact point for neonatology and since 2017 Head of the Paediatric Medicines office at EMA.

Ralf Herold, Head of Regulatory Science and Academia Workstream (ad interim)

Ralf is a Senior scientific officer in the Regulatory Science & Innovation Task Force of the European Medicines Agency, Amsterdam, responsible for Horizon scanning, Academia liaison and Regulatory science project involvement. Previously, he worked with stakeholders on Oncology, Haematology & Diagnostic as well as Paediatric medicines, starting 2007 at the Agency. Ralf was the Pediatric development leader of Bayer AG, Regulatory affairs (2017 to 2018). At Humboldt University in Berlin, Germany, he obtained an experimental research PhD, board-certified in 2004 in paediatric and adolescent medicine, trained in Paediatric oncology and haematology, and managed a publicly-funded national clinical research network.

Veronika Jekerle, Head of Pharmaceutical Quality

Veronika Jekerle joined the European Medicines Agency in 2006 as a Product Team Leader for Recombinant proteins, Vaccines, ATMPs and Biosimilar applications. She held various positions including Quality Specialist and Scientific secretary for the Biologics working party and coordinated numerous guidelines in the area of Biologicals, ATMPs and vaccines as well as initiatives such as interested parties meetings, PRIME toolbox guidance and prior knowledge. Since 2020 she is Head of Office for EMA’s Pharmaceutical Quality Office in the Human medicines Division.

Zaide Frias, Head of Digital Business Transformation Task Force

Zaïde Frias has degrees in Pharmacy and Business Administration. Prior to joining the European Medicines Agency she worked in Pharmaceutical Industry. She joined the EMA in 1999; she was appointed Head of Human Medicines Research & Development Support Division in 2013 and Head of Head of Human Medicines Evaluation Division in 2016. In 2020, she took the position of Head of Digital Business Transformation Task Force. The Digital Business Transformation Task Force was created to drive complex, disruptive change initiatives that have a profound impact on the strategy of EMA, its operational structure and operation in relation to the EU medicines regulatory network, its partners and stakeholders.

Ana Trullas, Senior Scientific Specialist

Ana is a Senior Scientific Specialist who works as a Product Lead in the Oncology and Haematology Office at EMA. Responsible for clinical and regulatory science input for a portfolio of products from pre-submission of initial marketing authorisation through post-authorisation. Further to this, she worked on the implementation of the IVDR and is currently one of the main point of reference for regulatory guidance on companion diagnostics at the Agency. Previously 2003-2014 Ana worked as Product Team Leader in the area of Quality of Medicines at EMA. Prior to joining the Agency, Ana was a pharmaceutical assessor in the Chemical and Pharmaceutical Technology Division at the AEMPs. Ana has over 20 y. of experience within the Pharma. framework.

Brendan Cuddy, Lead Scientific Officer

Brendan Cuddy joined the European Medicines Agency in October 2002. He was Head of the Manufacturing and Quality Compliance Service at the Agency from 2014 – 2020. Brendan is currently the Chairman of the Good Manufacturing and Distribution Practice Inspectors Working Group (GMDP IWG). Brendan obtained his degree in Chemistry from University of Dublin, Trinity College in Ireland. He holds a Master’s degree from the National University of Ireland in Quality and Operations Management and a postgraduate diploma in Pharmaceutical Manufacturing Technology from University of Dublin, Trinity College which satisfies the educational requirements for Qualified Person.

Elizabeth Scanlan, ePI Product Owner

Elizabeth Scanlan is Product Owner for electronic product information (ePI) at the European Medicines Agency. Prior to joining EMA in 2016, she worked in communication roles in the biotechnology industry and not-for-profit sector. She holds a PhD in molecular biology from Trinity College Dublin.

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 coordinated the PRIME scheme, the digital therapeutic matrix, and the geriatric medicines strategy activities.

Luis Pinheiro, Senior Epidemiology Expert, RWE, Data Analytics and Methods Taskforce

Luis Pinheiro, PharmD, MEpi, is responsible for developing and running real-world data analytics studies and is tasked with methods development and learning within the team. Luis is also a co-chair of the AI Technical Group at EMA. Before moving to the Data Analytics Workstream, he worked 8 years in drug safety. Prior to joining the EMA, he was the Head of the Signal Detection Unit at Infarmed and the Portuguese representative at the PV Working Party at EMA. Before that, he worked in the PV Unit of the Faculty of Pharmacy of Lisbon for 8 years where he assisted in the teaching of Pharmacoepidemiology and Public health in undergraduate and postgraduate courses.

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.

Victoria Palmi Reig, Scientific administrator

Victoria Palmi, Senior International Affairs officer, has over 20 years of experience at the European Medicines Agency (EMA). She supports international collaboration programs and reliance as part of her role in the International Affairs office. Previously, Victoria worked as Product Lead in different therapeutic areas within the Evaluation of Medicines department. During this time, she led initiatives that accelerated assessment and early access to priority medications.

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