Meet Confirmed Speakers from the National Authorities
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.
Samvel Azatyan, Team Lead, Regulatory Convergence and Networks (RCN/REG)
World Health Organization (WHO), Switzerland
Dr Samvel Azatyan is a Paediatrician with a PhD in clinical pharmacology and medical products regulation. Over his more than 20 years at WHO, he has had a wide range of leadership roles associated with the regulation of medical products, including supporting regulatory collaboration, convergence and harmonization, as well as regulatory capacity building and facilitation of products introduction in the countries. Dr Azatyan has also led various projects aiming at development of national regulatory systems, as well as the development and implementation of the concept of reliance in regulation of medical products. Dr Azatyan is currently leading the Regulatory Convergence and Networks Team at the WHO's Headquarters in Geneva, Switzerland.
Peter Bachmann, Deputy-Head, European Union and International Affairs
Federal Institute for Drugs and Medical Devices (BfArM), Germany
Peter Bachmann is acting as the German NtA Member, a Member of the European Union Network Data Board and the EU IDMP/SPOR Task Force, the HMA WG ‘Better Use of Medicines’/'ePI Task Force', the International Pharmaceutical Regulators Programme (IPRP) Management Committee, and the European Lead of the ICH IGDG (Informal Generic Discussion Group). He has studied biology and chemistry and has a PhD in Pharmaceutical Biology, University of Wuerzburg (Germany). Following a JSPS postdoctoral fellowship at Kyoto University and a DFG Fellowship at the Institute of Food Research Norwich/UK, he has worked at the Institute of Pharmaceutical Biology, TU Braunschweig/Germany, until he joined in 1999 the BfArM, Department of Drug Approval.
Sean Barry, Executive Pharmaceutical Assessor
Health Products Regulatory Authority (HPRA), Ireland
Dr Barry is an Executive Pharmaceutical assessor at the HPRA and a member of the EMA BMWP and an alternate member of the EMA BWP. His regulatory expertise includes evaluation of quality/CMC data of new product applications, scientific advice, variations and clinical trials for biological products (mAbs, recombinant proteins, biosimilars and ATMPs). He is Rapporteur/Co-Rapporteur (quality) for several EMA centralised biological products. He is actively involved in developing the use of Prior Knowledge in regulatory filings and in new regulatory approaches to address CMC challenges in accelerated and adaptive pathways. Seán has a degree in genetics from Trinity College Dublin and a PhD in Molecular Biology from University College London.
Karl Broich,
President
Federal Institute for Drugs and Medical Devices (BfArM), Germany
Physician, MD (certifications in Neurology, Psychiatry, Behavioural Psychotherapy). BfArM in Bonn (Germany): 2000 to 2014 several executive functions, since 08/2014 head (President). Work in several EMA committees. Current research: clinical trials methodology CNS, biomarkers in drug development, Alzheimer’s disease and other neurodegenerative disorders.
Alison Cave,
Chief Safety Officer
Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
Dr Cave joined the Medicines and Healthcare products Regulatory Agency (MHRA) in July 2021 as the Chief Safety Officer with responsibility for the safety of medicines and devices in the UK. She holds a BSc Honours degree and PhD from the University of London and has significant academic research and regulatory experience, the latter at both the European Medicines Agency (EMA) and MHRA. Previously she was Head of Cellular, Developmental and Physiological Sciences at the Wellcome Trust and most recently an Industrial Strategy Challenge Fund Director at UK Research and Innovation.
John Concato,
Associate Director for Real-World Evidence Analytics, OMP, CDER
FDA, United States
Dr. Concato is Associate Director for Real-World Evidence Analytics in the Office of Medical Policy (OMP), Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA). After conducting clinical research studies for more than 25 years as an independent investigator and research center director at Yale University & the Department of Veterans Affairs, he now develops, coordinates, and implements medical policy programs and strategic initiatives, with a focus on real-world evidence (RWE). His RWE-related efforts include consulting on submissions, helping to engage external stakeholders, and overseeing demonstration projects as well as guidance development in support of the agency’s evaluation of RWE.
Marcin Czech,
ISPOR Poland,
Former Deputy Minister of Health, Poland
Marcin Czech is a full professor and head of the Department of Pharmacoeconomics at the Institute
of Mother and Child in Warsaw, President- elect of ISPOR, Poland Chapter, course director of
postgraduate programmes at the Business School, Warsaw University of Technology, former
Undersecretary of State/ Vice Minister at the Ministry of Health responsible for medicines policy and
international co-operation.
He is the author of over 250 articles and reports in the field of management, health economics,
pharmacoeconomics and quality of life, published both in foreign and Polish journals. He promoted
over 150 master's and diploma theses, he is a member of working groups (including the Polish
Academy of Sciences), editorial boards and scientific specialist journals, he is a reviewer of research
works (also as expert of the National Science Centre, the Agency of Medical Research), PhD theses
and books, scientific articles, he participated in the implementation of scientific grants also those
financed by the European Union. He worked in international business and advisory environment
where he was responsible for health economics and Real World Evidence.
A medical doctor by education (specialist in epidemiology and specialist in public health) holding PhD
degrees in medicine and management, MBA; completed postgraduate studies in Health Economics,
Leadership Academy, university trainings in socio-economic evaluation of medicines at the University
of York, University of St. Andrews, Mc. Master University and several certified specialty courses.
Ton de Boer,
Medicines Evaluation Board, Netherlands
Anthonius (Ton) de Boer obtained his MD degree from the Free University in Amsterdam. After his graduation he was trained in Internal Medicine, followed by a PhD research and training period in clinical pharmacology and clinical epidemiology at Leiden University. In 2001 he was appointed as Professor of Pharmacotherapy at the Faculty of Pharmaceutical Sciences in Utrecht. With great pleasure he combines educational, research and management activities within the department of Pharmaceutical Sciences. In line with his background (MD, PhD, epidemiologist B and clinical pharmacologist) he has a great and broad interest in drug knowlegde and drug research from the development of drugs in phase 1 studies up to and including pharmacoepidemiological research after marketing of drugs. He was and is frequently asked for memberships of different editorial, research and societal committees. He is involved in graduate, postgraduate and post academic training for pharmacists and medical doctors.
From the first of august 2017 he is also the Chairman of the Dutch Medicines Evaluation Board and member of several editorial, research and societal committees..
Katherine Donegan,
Pharmacoepidemiology, Research & Intelligence Unit Manager
Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Katherine Donegan holds a PhD in statistics and spent 4 years working for the UK Medical Research Council in HIV research, working with both clinical trial and observational data. She joined the MHRA in 2010 and now manages the Pharmacoepidemiology research and Intelligence Unit. She has worked on a range of drug safety issues, including vaccines, with a recent focus on new approaches to proactive pharmacovigilance and monitoring outcomes and the effectiveness of risk minimisation measures using electronic healthcare record data.
Maria Elgaard Sørensen, Danish Medicines Agency, Denmark
Harald Enzmann,
Chair, CHMP; Head of European and International Affairs
Federal Institute for Drugs and Medical Devices (BfArM), Germany
Harald Enzmann is chairperson of EMA’s Committee for Medicinal Products for Human Use (CHMP). A physician by training, Harald held positions at the German Cancer Research Center (dkfz), at the Intitute of Pharmacology and Toxicology at the University of Erlangen, at R&D at Bayer and at the American Health Foundation in Valhalla, NY, USA. He received the dkfz award for outstanding research and the Animal Welfare Research Award of the German Ministry of Health. In 2002, Harald joined the Federal Institute for Drugs and Medical Devices (BfArM) and is currently head of European and International Affairs.
Mick Foy,
Head of Pharmacovigilance Strategy
Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
Mick Foy has been with the MHRA for more than 30 years, he is a member of the MHRA’s Senior Leadership team as since 2019 Head of PV Strategy. Amongst his responsibilities is to lead MHRA efforts to build PV capabilities in other countries particularly low and middle income countries as part of a global initiative with the Bill and Melinda Gates Foundation and WHO. Mick continues to have oversight of the operation of the UK’s Yellow Card Scheme and the MHRA’s signal detection systems. He is currently leading the MHRA’s transformation of vigilance systems with a remit to develop common IT and methodologies for medicines and devices. Mick is Chair of the MedDRA Management Committee, and a member of the Uppsala Monitoring Centre Board.
Yasuhiro Fujiwara,
Chief Executive
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Dr. Yasuhiro Fujiwara was previously Director-General, Strategic Planning Bureau of the National Cancer Center, and the Deputy Director of the Hospital (Research), National Cancer Center Hospital. He is a medical oncologist, specializing in breast cancer. Before joining NCCH, he was a deputy director of the Evaluation Division II of PMDEC, later merged with other organization to form PMDA of the Ministry of Health and Welfare and Labor between 1997 – 2002, making his current position as Chief Executive his second appointment. Between Jan 2011 to Feb 2013, he was a Deputy Secretary General of Office of Medical Innovation, Cabinet Secretariat of Japan, and led health policy issues regarding life science.
Rogerio S. Gaspar,
Director, Regulation and Prequalification Department
World Health Organization (WHO), Switzerland
Dr. Rogério Gaspar from Portugal joined WHO January 6, 2021, as the Director of Regulation and Prequalification Department. He obtained his PhD in Pharmaceutical Sciences from the Catholic University of Louvain Belgium in 1991, after a graduation as pharmacist from the University of Coimbra Portugal. He was a Full Professor at the Faculty of Pharmacy University of Lisbon until the end 2020, where he was Head of Department and President of the School Council. He was a member of the management board of EMA and VP of the management board at Portugal’s NRA (INFARMED). He also participated in activities against medicines counterfeiting and from 2000-2002 lead the participation of Portugal within International Narcotics Control Board (INCB).
Cesar Hernandez Garcia,
Head of Department, Department of Medicines for Human Use
Spanish Agency For Medicines and Medical Devices, Spain
Dr. César Hernández MD, PhD. joined the Spanish Agency for Medicines and Medical Devices as a Head of the Human Medicines Department in 2009. Prior to joining, he was the deputy Medical Director of the Hospital Clínico San Carlos in Madrid for three years. He previously worked as rheumatologist at the same Hospital for 16 years also developing functions as associate professor of Medicine and principal and associate investigator in several research projects financed by public and/or private funds in areas such as basic research, clinical research and health care services. He graduated from medicine and surgery, specialist in Rheumatology in 1987 at the Complutense University of Madrid and received his PhD in 1996 at the same university.
Asim Hocaoglu,
Vice President of Medicines and Pharmacy
Turkey Pharmaceuticals and Medical Devices Agency (TITCK), Turkey
Jesper Kjær,
Head of Danish Medicines Agency’s Data Analytics Centre
Danish Medicines Agency (DKMA), Denmark
Director of Data Analytics Centre at the Danish Medicines Agency and co-chair of HMA / EMA Big Data Steering Group. 20 years for life science experience in academia and industry. Been leading EU framework programme workpackages, IMI and TransCelerate Biopharma workstreams in the past. Currently active in development of FHIR for clinical research and use of AI/ML in life science.
Sandy Kweder,
Deputy Director and Liaison to the European Medicines Agency
FDA, USA
Deputy Director, Europe Office, Office of Global Programs and Strategies, FDA
Sandra L. Kweder, MD, is Deputy Director of the Europe Office in the FDA. She is posted in Amsterdam, working alongside colleagues in the European Medicines Agency (EMA) to oversee a large portfolio of regulatory science working partnerships and collaborations that include experts from FDA, EMA and other medicines agencies. She previously served for over a decade as Deputy Director, Office of New Drugs, in FDA’s Center for Drug Evaluation & Research. Dr. Kweder is a retired Rear Admiral of the US Public Health Service.
Sarah Mee,
Medical assessor
MHRA, United Kingdom
Ricarda Meincke,
Regulatory Manager
Swiss Agency for Therapeutic Products (Swissmedic), Switzerland
Lubos Michalov, User Advisory Group Member; Finance Manager
Gravitate Health; Slovak Environmental Agency, Slovakia
Nobumasa Nakashima,
Associate Executive Director for International Programs
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Dr. Nakashima joined Ministry of Health, Labour and Welfare (MHLW) in 1992. He spent his career in the international field such as WHO and OECD, not only in the domestic field. He worked as International Planning Director at MHLW since 2014, Director of Office of International Regulatory Affairs at MHLW since 2016, and Senior Director for International Programs and Associate Center Director for Asia Training Center (ATC) at PMDA since 2018. Since 2020, he has been Associate Executive Director (International Programs) and is responsible for enhancing PMDA’s international affairs including cooperation with foreign counterparts and organizations, to advance Agency’s mission of promoting health and safety in Japan.
Georg Neuwirther,
IT Director
Austrian Medicines & Medical Devices Agency (AGES), Austria
Georg Neuwirther joined the Agency for Food and Health Safety (AGES) in 2003 where he held several management positions in IT and infrastructure. In 2014 he was appointed Head of IT of the division “Austrian Medicines and Medical Devices Agency” after successfully modernizing the IT landscape. He is member of the EU Telematics Management Board (EUTMB), Telematics Architecture Board (TEAB), SPOR Taskforce and chairs the Electronic Application (eAF) Maintenance Group.
Lorraine Nolan,
Chief Executive
Health Products Regulatory Authority (HPRA), Ireland
Ms Nolan joined the HPRA in 2001 and since that time has held a number of different roles at senior level within the organisation across a range of areas including inspection and authorisation of human medicines, medical devices, cosmetics and controlled substances. Prior to assuming the role of Chief Executive she was Director of Human Products Authorisation & Registration. Ms Nolan is a member of the Management Board of the European Medicines Agency (EMA), and is also it’s vice chair. Ms Nolan is also a member of the EU HMA Management Group.
Janet Nooney,
Expert Scientific Assessor, VRMM- Benefit Risk Management
Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
Dr Janet Nooney is an expert scientific assessor in pharmacovigilance at the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK. Dr Nooney divides her time between co-ordinating the MHRA’s strategy on improving information for use of medicines during pregnancy and breastfeeding and assessing safety issues for new and established medicines. Her work includes assessing risk management plans for new medicines and applications to maintain or vary marketed medicines, especially in the fields of lipid regulation and women’s health, and monitoring safety of medicines use during pregnancy. She is Principal Assessor to the Medicines for Women’s Health Expert Advisory Group to the Commission on Human Medicines (CHM).
Frederik Grell Nørgaard, Special Adviser, Clinical Trials,
Danish Medicines Agency
Handan Öztunca, Head of Marketing Authorization Department
Turkish Medicines and Medical Devices Agency (TITCK), Turkey
Ilona Reischl,
Biologics Quality Assessor
Federal Office for Safety in Health Care(BASG), Austria
Ilona Reischl joined the Austrian Agency in March 2006 and is currently an assessor within the clinical trials unit that is responsible for the evaluation of clinical trials with medicinal products and medical devices as well as GCP inspections. Her background is that of a quality assessor of biologics including Advanced Therapy Medicinal products and she is the Austrian member of the European Medicines Agency Biologics Working Party and the Committee for Advanced Therapies. Her regulatory expertise in Clinical Trials, Non-interventional studies, scientific advice and compassionate use procedures reflect a strong interest in the development of biological medicinal products.
Anja Schiel,
Senior Adviser/Statistician,
Unit for HTA and Reimbursement
Norwegian Medicines Agency (NoMA), Norway
Anja Schiel is working as Senior Advisor and Statistician for Norwegian Medicines Agency (NoMA). She has studied Biology at the Johannes Gutenberg-University Mainz, holds a PhD from the Free University Amsterdam and has many years of experience in medical research. Since 2017, she is also the Chair for the Biostatistics Working Party at EMA. Her role within NoMA involves working at the intersection of regulatory and HTA work, a unique perspective due to the structure of the Norwegian Agency.
Hiiti Sillo,
Group Lead, Country Regulatory Strengthening
WHO, Switzerland
Hiiti Sillo is a Pharmacist and the current Team Lead, Regulatory Systems Strengthening (RSS), within the Regulation and Safety Unit under the Department of Regulation and Prequalification, WHO. In this role, he is responsible for coordinating WHO efforts to support Member States build strong regulatory capacities to ensure access to safe, effective and quality assured medical products. Before joining WHO in January 2018, he was the Director General of the Tanzania Food and Drugs Authority (TFDA) since 2010.
Eva-Maria Stegemann, Health Ministry of Saxony , Germany
Violeta Stoyanova-Beninska,
Chair COMP EMA, Chair Scientific and Regulatory Advice MEB
Medicines Evaluation Board, Netherlands
Dr. Violeta Stoyanova-Beninska is Chair of the Committee for Orphan Medicinal Products at the European Medicines Agency since 2018. Before that she was a member of the COMP and Chair of the National Scientific and Regulatory Advice at the Medicines Evaluation Board. Violeta is supervisor of PhD students and guest lecturer at several universities. She is also member of scientific and advisory boards of international projects related to rare diseases, personalized medicine and orphan drug development.
Kenichi Tamiya,
Associate Executive Director
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Mr. Kenichi Tamiya is the Associate Executive Director for New Drug Evaluation at PMDA and is in charge of supervising the review of new drugs except for vaccines and regenerative medical products. Before assuming his current position in 2020, Mr. Tamiya was the Pharmaceutical Management Director, Medical Economics Division at MHLW and was responsible for Reform of Drug Pricing System. Mr. Tamiya has over 25 years' experience in MHLW, including new drug review at the Pharmaceuticals and Medical Devices Evaluation Center, National Institute of Health Sciences, post-marketing safety measures and promotion of R&D for innovative medical products. Mr. Tamiya holds a Master's degree in Pharmaceutical Sciences form the University of Tokyo.
Paul Tanui, Senior Program Officer
AUDA-NEPAD, South Africa
Shannon Thor,
International Policy Analyst, Office of Global Policy & Strategy, Europe Office
FDA, United States
Lieutenant Commander Shannon Thor is a pharmacist and officer in the United States Public Health Service. She serves as an International Policy Analyst in FDA’s Europe Office where she is responsible for providing leadership and technical expertise on international public health initiatives and US-European Union relations. Her previous experience at FDA includes policy advisor roles in the Office of Health and Constituent Affairs and the Office of New Drugs. Prior to FDA, LCDR Thor served as an officer in the US Navy, where she supervised pharmacy operations and directed medication safety programs at military medical centers around the world.
Phil Tregunno,
Group Manager, Vigilance, Intelligence and Research Group
Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Phil is the Group Manager of the MHRA's Vigilance Intelligence and Research Group (VIRG) and has over seventeen years of experience working in pharmacovigilance. Prior to his current role Phil spent nine years leading and developing the Signal Management function, including systems, processes, and relevant aspects of Pharmacovigilance Legislation. He is responsible for the operational delivery of the Vigilance, Intelligence and Research Group, including delivery of relevant aspects of the Agency’s digital transformation programme.
Paula Walker,
Head of Compliance (GCP, GPvP, GLP & GxP Expert Circle)
Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
Paula Walker has been with the MHRA since 2009, joining as a GCP inspector, and subsequently moving to the role of Operations Manager for the GCP team in 2013. Paula is currently the Head of Compliance (1) responsible for the GCP, GPvP, GLP inspections teams and GxP Expert Circle. She has a BSc in Biomedical Science, MA in Biotechnological Law & Ethics, and a Post-Graduate Diploma in Clinical Trials. In 2020/21 Paula chaired the International Coalition of Medicines Regulatory Authorities (ICMRA) working group on Remote GCP & GMP inspections during the pandemic, resulting in the publication of an international reflection paper on changing approaches to inspections published at the end of 2021.
Mats Welin,
Senior Expert
Medical Products Agency (MPA), Sweden
Senior expert at the Medical Products Agency in Sweden, working with quality assessment of human and veterinary biologics and normative work within this field. Since 1996 I am the Swedish delegate of the Biologics working party (BWP) and have been a member of the EMA group involved in classification of variations for many years. I am a member of EMEA PAT team and was also a delegate of the Q-IWG of the ICH during its existence to work with introduction of the Q8-Q10 concepts.
Naoyuki Yasuda,
Director, Office of International Regulatory Affairs
Ministry of Health, Labour and Welfare (MHLW), Japan
Mr. Naoyuki Yasuda graduated from Osaka University in 1991. He careered industrial policy, industrial chemicals assessment, medical devices revaluation, international cooperation on narcotics and psychotropics, blood/blood product safety and vaccine supply and overall pharmaceuticals and medical devices international issues. He has taken his current position from Jul., 2018. He is one of Assembly and Management Committee Members of ICH from Japan.
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