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Meet Confirmed Speakers from the European Medicines Agency

DIA Europe 2024 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.



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.




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.




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).




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.




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.




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.




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.




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.




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

 

 


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.




Andrej Segec,
Scientific administrator and Project manager

Andrej Segec is a pharmacist by training with an MSc in Golderiolooy. He has worked for the European Medicines Agency (EMA) since 2008 holding a number of roles in pharmacovigilance.

 

 


Catherine Cohet,
RWE Senior Spec, Data Analytics and Methods Task Force

Catherine is a senior pharmacoepidemiologist in the Real-World Evidence Workstream, Data Analytics & Methods Task Force of the European Medicines Agency. She previously held various industry positions, generating and evaluating RWE across all phases of development. She also worked as an epidemiologist at the Centre for Public Health Research and the Malaghan Institute for Medical Research in Wellington, New Zealand, and the WHO International Agency for Research on Cancer in Lyon, France. Her work at EMA focuses on international guidance on RWE, and on public health crisis preparedness as Steering Group member of the EU Vaccine Monitoring Platform. She is co-chair of the ENCePP Steering Group and represents EMA in RWE-related ICH initiatives




Corinne de Vries,
Head of Translational Sciences Office

Corinne is a pharmacist and an epidemiologist (PhD) and has an MA in medical ethics and law. She has gained 20 years’ research experience in academia before making the move to the regulatory environment. Throughout her career, she has worked in multinational and multicultural environments, acquired scientific and regulatory expertise, communication, education and presentation skills, as well as a thorough understanding of project and budget management. She is an active member of the International Society for Pharmacoepidemiology with previous roles as Board member, VP Finance, and various committees. She is visiting professor of pharmacoepidemiology at the University of Bath in the UK.



Chrissi Pallidis, Senior Scientific Specialist, Paediatric Medicines



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. In 2023 he was appointed as Scientific adviser for oncology. His main regulatory science interests include cancer clinical trial methodology, benefit-risk analysis, and stated preference studies.




Florian Lasch,
Biostatistics Specialist, Data Analytics and Methods Task Force

Florian Lasch is Biostatistics Specialist in the Task Force for Data Analytics and Methods at the European Medicines Agency, providing scientific support to development and evaluation throughout all stages of marketing authorisation assessments of medicinal products, and leads the ACT EU Priority Action on Clinical Trial Methodologies.



 


Hannes Kulovits,
Digital Business Transformation Manager

 

 



Kristina Larsson,
Head of Orphan Medicines, Division for Human Medicines Evidence Generation

Kristina Larsson joined the orphan team of the EMA as the Head of Office in July 2014. Before that she spent 8 years as a scientific officer in the scientific advice team of the EMA in charge of the Scientific Advice Working Party secretariat. Before joining the agency she worked three years in clinical research for AstraZeneca in Mölndal, Sweden. Kristina has a master of Medicine in Pharmaceutical Bioscience from the University of Gothenburg.




Laura Pioppo,
Scientific Administrator, CTIS expert

Laura qualified as pharmacist before joining the EMA in 2009 in the Compliance and Inspection Department where she was responsible for the coordination and follow up of GCP and Pharmacovigilance inspections requested by CHMP. Since 2017 she has been working on the development of the Clinical Trial Information system (CTIS), defining and testing the system functionalities in collaboration with the MS and sponsors product owners and the European Commission.




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.




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.




Noemie Manent,
Scientific Administrator, Compliance and Inspection

Noémie Manent is the Operations Lead in the Clinical Trial Transformation team at the European Medicines Agency, facilitating change management for member states and sponsors with the implementation of the clinical trial Regulation. She has played an essential role in the set up of structured summary results for clinical trials. Also, she has experience in the coordination of inspections for marketing authorisation application. Noemie has more than 15 years experience working in clinical R&D for small and medium enterprises in industry and academia mainly in France and the United Kingdom.




Priya Bahri, 
Principal Scientific Officer

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", published in 2020.




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.




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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