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.

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).

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.

Priya Bahri, Lead Pharmacovigilance and Risk Management Guidance and Policy
Priya Bahri, RPh, PostGradDipEpi, PhD, at EMA since 1996, is now EMA's Lead Pharmacovigilance and Risk Management Guidance and Policy. In this role, she also instigates research and regulatory frameworks for risk communication, stakeholder engagement for pharmacovigilance and implementation of risk minimisation in healthcare. Pro bono, she is active in the learned societies ISoP and ISPE and as associated researcher at Utrecht University. She is the editor of the Springer textbook "Communicating about Risks and Safe Use of Medicines - Real Life and Applied Research

 

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.

 

Christelle Bouygues,
Acting Head of Regulatory Affairs, Office Scientific and Regulatory Management 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.

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.

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.

Brendan Cuddy, Head of Manufacturing and Quality Compliance
Brendan Cuddy joined the EMA in 2002. In 2014 he was appointed Head of MQC Service, which is responsible for inter alia, co-ordination of GMP inspections, assessments of quality defects and product recalls, and sampling/testing for initial marketing authorisation and post-authorisation procedures involving centrally authorised medicinal products. The Service provides the Chair and secretariat of the GMDP IWG and the secretariat for the Quality Working Party.

Kevin Cunningham, Scientific Officer
Dr. Kevin Cunningham is the PRIME Scientific Coordinator at the European Medicines Agency. He is responsible for coordination of the PRIME scheme, including management of eligibility procedures, as well as support to PRIME-eligible medicinal products. Previously worked as a non-clinical assessor at the Health Products Regulatory Authority (HPRA), Ireland, before joining EMA in 2015 to work on the implementation of the EU Clinical Trials Regulation through the development of the Clinical Trials Information System (CTIS), and most recently as a scientific officer in the EMA Scientific Advice Office.

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.

Barbara Freischem, Executive Director
Barbara Freischem joined European Biopharmaceutical Enterprises (EBE) as Executive Director in July 2015. EBE represents the voice of biopharmaceutical companies of all sizes in Europe and is a specialised group within EFPIA. Prior to joining EBE, Barbara served at the World Organisation for Animal Health (OIE) with responsibilities in authorisation of veterinary medicines, research coordination, whole genome sequencing in animal health and antimicrobial resistance. Her previous positions include leading the global trade association for the animal health industry, working in a global pharmaceutical company, as well as working as a Regulator at the European Medicines Agency and the German Regulatory Authority for Veterinary Medicines.

Lorenzo Guizzaro, Scientific Officer
Lorenzo Guizzaro is a medical doctor and statistician working in the CNS area at the European Medicines Agency. He holds a master’s degree in drug development science from King’s College London.

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.

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.

Anne-Sophie Henry-Eude, Head of Access to Documents Department

Anne-Sophie Henry-Eude is a doctor in pharmacy with post-graduate degrees in Regulatory Affairs and Pharmacovigilance & Pharmacoepidemiology. She worked in the pharma industry then joined EMA as product team leader for anti-infectives. She then worked on paediatric investigation plans in the HIV field. In 2013 she became Head of the new Access to Documents Service and with the implementation of the policy on Clinical Data Publication, she is now Head of Documents Access & Publication at EMA.

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.

Veronika Jekerle, Head of Pharmaceutical Quality
Veronika Jekerle joined the European Medicines Agency in 2006. She has been a Product Team Leader for numerous Biological medicinal products applications including Recombinant proteins, Vaccines, ATMPs and Biosimilar applications. In 2014 she became a Quality Specialist within the Specialised Scientific Disciplines Department where she provides specialised scientific input to various procedures including ITF, scientific advice, PRIME, marketing authorisation and post-marketing procedures. She has also coordinated the development of a number nt guidelines in the area of Advanced Therapies, Recombinant proteins and Biosimilars.

Francesco Pignatti, Head of Oncology and Hematology

Francesco Pignatti graduated as Medical Doctor at the University of Rome La Sapienza, Italy. In 1995 he became Research Fellow at the EORTC Data Center in Brussels, Belgium In 1997 he obtained a Master of Science degree in Biostatistics from the University of Limburg, Belgium. In 1999 he joined the European Medicines Agency (EMA) in London, UK. Since 2009, he has held the position of Head of Oncology, Haematology and Diagnostics in the Human Medicines Evaluation Division. His main regulatory science interests include cancer clinical trial methodology, benefit-risk analysis, and stated preference studies.

Karen Quigley, Clinical Data Publication Manager
Dr Karen Quigley has a degree in pharmacy from Trinity College Dublin and a postgraduate Masters in Science degree from the same university specialising in the field of controlled drug delivery and rheology. She subsequently obtained her PhD from the Faculty of Medicine, University of London. Karen joined the EMA 15 years ago working in the areas of mutual recognition, scientific advice, veterinary medicines authorisation and availability of medicines. In 2016 she joined the Clinical Data Publication team working on Policy 0070. Prior to joining the Agency, she worked at the Council of Europe in Strasbourg and with the Health Products Regulatory Agency in Dublin.

Elizabeth Scanlan, Scientific Communication Officer
Elizabeth Scanlan joined the European Medicines Agency in 2016 where she is a Scientific Communication Specialist with a focus on communication of information on safe and effective use of medicines to patients and healthcare professionals. Prior to joining EMA, she worked in communication roles in the biotechnology industry and not-for-profit sector. Elizabeth holds a PhD in molecular biology from Trinity College Dublin.

Andrei Spinei, Scientific Administrator
Andrei Spinei is a Scientific Administrator in the Quality and Safety of Medicines Department 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.

Andrew Thomson, Statistician, Methodology Taskforce
Andrew Thomson is a statistician in the Taskforce dedicated to Data, Analytics and Methodology at the European Medicines Agency. He provides methodological advice and guidance across all stages of development, and across all therapeutic areas. He also is the lead of the Statistics subgroup of ICH E11A on pediatric extrapolation, as well as the Regulatory Chair. Before joining EMA, he headed the Epidemiology Unit in the Vigilance and Risk Management of Medicines Division of the MHRA, the UK regulator and was also previously a Statistical Assessor within the Licensing Division of the MHRA.

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