European Directorate for the Quality of Medicines & HealthCare

Moderator at the EDQM’s 60th anniversary conference

Dr Sarah-Taïssir Bencharif is a physician and health journalist. She practices emergency medicine in rural and remote parts of Canada as well as in Brussels, Belgium. Some of the topics she has covered as a journalist include public health policy, the health workforce and mental health, and her work has appeared in Politico, The Globe and Mail, The Toronto Star, The Walrus and via the Canadian Broadcasting Corporation (CBC).

She is a graduate of Toronto Metropolitan University’s Master of Journalism and completed her medical training at Queen’s University, McGill University and the University of Ottawa (Canada).

Sarah-Taïssir is based in Brussels, Belgium.

Participant in the Townhall session: Navigating public health challenges in 2024 (Today)

Florence Baron-Papillon has a doctorate in Pharmacy and a post-graduate degree in health economics and business from emlyon business school (France). She is Head of Corporate Public Affairs Europe for Sanofi, leading a team that drives Sanofi’s engagement across Europe – EU institutions and EU/country stakeholders - on policy and legislative topics related to healthcare including health innovation, healthcare system sustainability, access and procurement, pandemic response and preparedness, healthcare, supply and industrial strategy, digital health/AI, climate and health and pharmaceutical regulations.

She has been the President of the Vaccines Europe Board since September 2022 and co-chair of the Vaccines Europe/European Federation of Pharmaceutical Industries and Associations (EFPIA) biopreparedness taskforce leading industry interactions with the EU Commission’s Health Emergency Preparedness and Response (HERA) department. She has been active in trade associations for more than 10 years, in particular by contributing to COVID-19 vaccine access, the European Joint Action on Vaccination (EU-JAV), influenza and adult immunisation, sustainable supply and Health Technology Assessment (HTA) topics.

Over her 20+ year career, she has held various positions in various sectors, ranging from health economics and outcome research to market access/HTA and policy affairs in Europe, in consulting companies and Sanofi Pasteur-MSD, before joining Sanofi in 2017. She has extensive knowledge of the vaccine business and European policies.

Participant in the Townhall session: Navigating public health challenges in 2024 (Today)

Danielle Brady is a Policy Analyst at the European Policy Centre in Brussels (Belgium). She holds a Bachelor of Arts in Philosophy, Politics from Maynooth University (Ireland) and a Master of Arts in Politics from Queen’s University Belfast (Northern Ireland). She joined the European Policy Centre in 2021 and her work focuses on EU health and social policy. She has written on and published in the areas of the European health union, planetary health, AI in health, the European Pillar of Social Rights and gender equality.

Participant in the Townhall session: Navigating public health challenges in 2024 (Today)

Participant in the Townhall session: Navigating public health transformation (Today)

Presenter: GEON 30th anniversary presentation (Together)

Dr Katerina Brezovska is a full professor at the Institute of Applied Chemistry and Pharmaceutical Analysis at the Faculty of Pharmacy of Ss Cyril and Methodius University, Skopje (Republic of North Macedonia). She is also the responsible person for quality assurance of laboratory activities at the Center for Drug Quality Control, OMCL of the Republic of North Macedonia. She holds a PhD in pharmaceutical science (2012) from the Faculty of Pharmacy, Ss. Cyril and Methodius University and completed a six-month research internship at the Department of Molecular Biosciences, Wenner-Gren Institute, Stockholm University, Stockholm (Sweden) as part of her doctoral studies.

Katerina also has a specialist qualification in Drug Quality Control (2008) obtained from the Faculty of Pharmacy, Ss. Cyril and Methodius University. She co-ordinates a national project entitled “Building a national strategy to combat falsified medicines” and actively participates in the work of the OMCL network, in the working groups for the elaboration/revision of quality management documents, in training sessions organised by the network and in mutual joint audits as a technical auditor. She is an active member of the OMCL Falsified Medicines Working Group and of European Pharmacopoeia Group of Experts 10C. Since 2023, she has been a member of the GEON Advisory Group.

Katerina is the author/co-author of five books and more than 70 scientific papers published in international scientific journals and conference proceedings.

Participant in the Townhall session: Navigating public health challenges in 2024 (Today)

Co-presenter of the European Pharmacopoeia – Celebrating 60 years of thriving collaboration (Together)

Dr Salvador Cañigueral is Professor of Pharmacognosy and Phytotherapy at the Faculty of Pharmacy and Health Sciences of the University of Barcelona (Spain). He holds a PhD in Pharmacy from the University of Barcelona (1986), and he completed part of his training in Switzerland (University of Lausanne) and Germany (University of Regensburg). His research deals with the chemistry, biological activity and quality control of medicinal and aromatic plants, herbal drugs and herbal preparations.

Salvador is the author of more than 150 papers, mainly in international scientific journals, and over 300 contributions to congresses (most of them international), as well as the author or editor of seven books and 15 book chapters on medicinal plants, phytotherapy and the history of science. In addition, he is the founder and scientific editor of the Spanish Revista de Fitoterapia, and associate editor of the journal Frontiers in Pharmacology. He is also co-editor of the web site www.Fitoterapia.net.

He is a full member of the Royal Academy of Pharmacy of Catalonia, President of the Spanish Society of Phytotherapy (SEFIT), member of the board of the HPTLC Association and past member of the Board of the European Scientific Cooperative on Phytotherapy (ESCOP) and other international associations. He has been the Chair of the Phytotherapy Group of the Spanish National Formulary, the Phytochemistry Group of the Spanish Pharmacopoeia, and of the Spanish Pharmacopoeia Commission. He is a member of two European Pharmacopoeia groups of experts on herbal drugs and herbal drug preparations: 13A (2005-), which he also chaired from 2011 to 2019, and 13B (1999-), of which he is currently the Chair. He was also first Vice-Chair of the European Pharmacopoeia Commission from 2019 to 2022 and is the current Chair.

Participant in the Townhall session: Navigating public health challenges in 2024 (Today)

Co-presenter: Joining forces in the field of substances of human origin (Together)

Dr Johanna Castrén is the Director of Blood Donation Operations at the Finnish Red Cross Blood Service. She is a medical doctor with almost 15 years of experience as a general practitioner. She has worked for the Finnish Red Cross Blood Service since 2008, before her current position as a medical officer, and as the Chief Medical Officer in Blood Donation Operations. In 2023, she was appointed Director of Blood Donation and joined the management team. Since 2014, she has acted as Finland's representative in the European Committee on Blood Transfusion (CD-P-TS). She was elected Vice-Chair of the Committee in 2021 and Chair in 2023. She is a member of the CD-P-TS Blood Guide Working Group and chaired the Plasma Supply Management Working Group from 2017 to 2019.

Her expertise in the field of blood services covers a wide range of medical and administrative matters. It is strongest in donor selection, donor adverse events, donor communication and web-based donor services. She is the author of more than 40 scientific papers and conference publications.

Ass. Prof. JUDr. Tomáš Doležal, PhD., LL.M., is a leading legal scholar in medical and civil law. He is Head of the Department of Civil Law and Head of the Research Unit for Medical Law and Bioethics at the Institute of State and Law, Academy of Sciences of the Czech Republic, and lecturer at the Institute of Medical Law and Public Health, Faculty of Medicine. He is Vice-Chair of the Council of Europe Steering Committee for Human Rights in the fields of Biomedicine and Health (CDBIO) and Head of the Czech Unit of UNESCO International Network in Bioethics. He collaborates with the Association of General Practitioners, especially during public consultations on medical legislation.

He is the author of many publications, including the monographs The Doctor-Patient Relationship in Private Law, Protection of patients' rights, and Causation the Civil Law.

Opening Session

Participant in the Townhall session: Navigating public health challenges in 2024 (Today)

Presenter: What does the EDQM do for me and my health? (Today)

Presenter: The EDQM and the future: our contribution to the evolution of public health (Tomorrow)

Dr Petra Doerr has been the Director of the European Directorate for the Quality of Medicines & HealthCare (EDQM) since 1 October 2021.

As a pharmacist and PhD, Petra spent the first ten years of her professional career in the medical products industry, working in international regulatory affairs. Before joining Swissmedic, the Swiss Agency for Therapeutic Products, she held the position of Vice President Regulatory Affairs Europe, Africa and Asia at Valeant Pharmaceuticals, Inc.

She joined Swissmedic in October 2004 as Head of International Affairs. In July 2007, she was promoted to Head of Management Services & Networking and became a member of the Management Board. In this capacity, she assumed responsibility for quality management systems, planning and controlling in addition to steering the national and international collaboration and communications activities. From January 2014 until June 2019, she then held the position of Head of Communication & Networking and Deputy Executive Director.

Among other responsibilities in external relations, she oversaw the international activities of Swissmedic with other agencies and international organisations. She was a member of the ICH Management Committee and the IPRP Management Committee as well of the Scientific Advisory Council of the Centre for Innovation in Regulatory represented Swissmedic at the Heads of Agencies Summits/ICMRA meetings and the DIA’s Council of Regulators. Between 2013 and 2016, she served as the Chair of the International Pharmaceutical Regulators Forum (IPRF; now IPRP). In November 2018, she was elected Vice-Chair of the ICH Assembly.

From July 2019 to October 2020, Petra was also Director and owner of Petra Doerr Consulting Ltd., providing consultancy services to the World Health Organizsation (WHO) and other not-for profit organisations.

She joined WHO as Head of the Regulation and Safety Unit, Regulation and Prequalification (RPQ) Department of the Access to Medicines and Health Products (MHP) Division from November 2020 until August 2021.

Dr Beatriz Domínguez-Gil has a PhD in internal medicine and specialises in nephrology. She joined the National Transplant Organization (ONT) in November 2006 and became its Director General in May 2017. ONT is the Spanish national authority responsible for the oversight, co-ordination and organisation of the donation and clinical use of organs, tissues and cells.

She is also Chair of the European Committee on Transplantation (CD-P-TO), President of the Iberoamerican Network/Council on Donation and Transplantation (RCIDT) and a member of the WHO Task Force to promote ethical practices in the donation and transplantation of organs, tissues and cells.

Beatriz is a former Co-Chair of the Declaration of Istanbul Custodian Group on Organ Trafficking and Transplant Tourism and was also President of the European Donation and Transplant Coordination Organisation (EDTCO), Chair of the Ethics Committee of the Transplantation Society (TTS) and a Councillor for Europe at the TTS.

She has authored more than 245 publications in scientific journals and book chapters, and presented more than 550 communications and papers at national and international conferences.

Participant in the Townhall session: Navigating public health challenges in 2024 (Today)

Dr Markus Goese is Head of EU CMC Regulatory Policy at F. Hoffmann-La Roche Ltd in Basel, Switzerland. He holds a PhD in biochemistry/organic chemistry from the Technische Universität München, Munich (Germany). Markus has more than 20 years of industry experience in various companies (Roche, DSM and Novartis) in pharmaceuticals and fine chemicals research, development, manufacturing and commercialisation. For the last 17 years, he has worked in CMC Regulatory Affairs, initially on Biopharmaceutical Products in early- and late-stage development, and later as EU Lead CMC Regulatory Policy for Roche Pharma Global Technical Operations. Dr Goese is currently Chair of EFPIA's Manufacturing and Quality Expert Group (MQEG) and one of the substitute (industry) members of Swissmedic's delegation to the European Pharmacopoeia Commission.

Dr John Kinsman is an infectious disease social scientist, with extensive experience in sub-Saharan Africa and the EU. Since 2019, he has worked with the European Centre for Disease Prevention and Control (ECDC), supporting EU Member States on a range of social and behavioural issues related to the prevention and control of communicable diseases. During the COVID-19 pandemic, this involved countering online vaccination misinformation, promoting acceptance and uptake of COVID-19 vaccination, and addressing pandemic fatigue in the population. Since then, his focus has turned to the development of an EU-wide community of practice for colleagues working on the prevention of communicable diseases through use of social and behavioural sciences. He also supports capacity-building initiatives in this area in a number of EU neighbourhood countries, including the promotion of vaccination acceptance and uptake in Ukraine. His publications cover a wide range of topics, including AIDS, Ebola, antimicrobial resistance, COVID-19, Zika, polio, MERS, vaccination acceptance and uptake, public health emergency preparedness planning, and health systems.

Participant in Townhall session: Navigating public health challenges in 2024 (Today)

Dr Volker Oeppling holds a PhD (1990) in veterinary medicine and qualified as a specialist in veterinary microbiology in 1993. He joined the Paul-Ehrlich-Institut (German Federal Agency for Vaccines and Biomedicinal Products) in 1991. After being involved in several research-related activities, he was appointed Head of the section responsible for polysaccharide-based human bacterial vaccines in 1998. Since 2007, he has been Head of the Microbiological Vaccines section which is responsible for the assessment of marketing authorisation applications (quality, preclinical and clinical data), batch release and assessment of clinical trial applications in the area of human bacterial vaccines. At present, he is a member of several committees including: European Pharmacopoeia Expert Group 15 (Human vaccines and sera), the Biological Standardisation Programme Steering Committee (EDQM) and the drafting group responsible for producing a batch release guideline for human vaccines (EDQM).

Participant in Townhall session: Navigating public health challenges in 2024 (Today)

Co-presenter: Consumer health-cosmetics: joining forces for the benefit of consumers (Together)

Durk Schakel holds a BSc (1991) from the University for Analytical Chemistry of Leeuwarden (The Netherlands) and a BSc (2000) in Food Science. From 1992 to 1998 he was a chemical engineer in the Food Laboratory of the Netherlands Food and Consumer Product Safety Authority (NVWA) in Leeuwarden and from 1998 to the present he has been a researcher in the Chemical and Microbiological Laboratory of the NVWA in Groningen. He gives technical research and development advice in the field of toys, cosmetics, tattoo inks, food contact materials, textiles, biocides and household chemicals. He is a member of European groups for market surveillance and for quality aspects of analytical methods in the field of cosmetics, is an expert for the REACH Analytical Working Group and an active participant in ISO and CEN for cosmetics and toys.

Dr Olivier Thaunat is Professor of Nephrology and Clinical Immunology in Lyon University Hospital (France). He obtained his MD in renal medicine from the University of Pierre et Marie Curie (Paris, France) in 2004. He specialised in transplant immunology and obtained a PhD in Immunology in 2008 for his work elucidating the role of lymphoid neogenesis in chronic rejection. Between 2009 and 2011, he was a postdoctoral fellow in the Lymphocyte Interaction Lab directed by Dr Facundo Batista in the London Research Institute (UK). Since 2012, he has had tenure in the Department of Nephrology, Transplantation and Clinical Immunology of the Edouard Herriot University Hospital in Lyon and he heads the research group at INSERM Unit 1111, aiming at establishing new strategies to prevent and cure rejection.

Olivier has published more than 190 peer-reviewed articles and given over 180 invited lectures all over the world. He is currently the president of the Scientific Committee of the Société Francophone de Transplantation and the president-elect of the European Society for Organ Transplantation.

Participant in the Townhall session: Navigating public health challenges in 2024 (Today)

Dr Pierre Tiberghien holds an MD and a PhD and was clinical haematologist at the Besançon University Hospital (France) until 2009. He headed the Bourgogne Franche-Comté Etablissement Français du Sang (EFS, French transfusion public service) and a university INSERM research laboratory on host-graft immune interactions and, between 2009 and 2017, was national Head for medicine and research at the EFS. In addition to his work as Professor of Medicine (immunology) at the Franche-Comté University, he is currently senior advisor for European and international medical and scientific affairs at the EFS, president of the European Blood Alliance (EBA) and president-elect of the International Society of Blood Transfusion (ISBT).

Hilde Vanneste holds an MSc in Bioscience Engineering (1995) with a specialisation in chemistry from the University of Leuven (Belgium).Hilde is Director of CMC Regulatory Affairs at Johnson & Johnson Innovative Medicines (formerly known as Janssen Pharmaceutica NV). She started her career at Janssen Pharmaceutica NV in 1996 in process technology transfer and supported the development and subsequent marketing application for a medicine treating mild Alzheimer’s disease to the market. After 6 years she joined the chemical production department, where she qualified a production scale chromatographic separation unit for selectively separating stereoisomers.

In 2005 she joined the CMC regulatory department and since then has worked on different types of medicines ranging from chemical APIs for tablets, capsules and long-acting formulations to monoclonal antibodies and vaccines. She is now exploring the world of cell and gene therapies.

In 2005 Hilde also joined the API industry association, APIC, and immediately took on an active role, for example, leading the API suggestions for improvement of the 2008 variation system revision by the EU Commission. In November 2023 she ended her 4-year presidency role at APIC, preparing the association for the rapidly changing future.

Participant in Townhall session: Navigating public health challenges in 2024 (Today)

Dr Pavle Zelić, MSc, Pharm, is a Serbian public health official, certified diplomat, international health expert and lecturer and accomplished writer/scriptwriter. After completing his master’s degree in Pharmacy at the University of Belgrade (Serbia), he worked in the pharmaceutical industry for three years. Since 2009, he has been a manager in International Cooperation, European Integration and Public Relations at the Medicines and Medical Devices Agency of Serbia. His other academic achievements include recognition as best student/valedictorian for the class of 2010/11 at the prestigious Diplomatic Academy of the Ministry of Foreign Affairs of Serbia and being awarded the US State Department Hubert H. Humphrey Fellowship for 2021/22 at Emory University, Atlanta, Georgia, USA, and Centers for Disease Control and Prevention – US CDC. He has initiated, negotiated and put into practice many agreements with regulatory authorities worldwide. He is Serbia’s representative but also an expert and elected official in WHO at European and global level in the areas of risk communication, community engagement and infodemic management, preparedness, and substandard and falsified medicinal products.

He represents Serbia in the EU and European bodies on topics such as public health communications, counterfeit medicinal products, pharmaceuticals and pharmaceutical practices. He is the current Vice-Chair and former Chair of the European Committee on Pharmaceuticals and Pharmaceutical Care (CD-P-PH) and former Chair of the Committee of Experts on Minimising Public Health Risks Posed by Falsification of Medical Products and Similar Crimes (CD-P-PH/CMED) of the EDQM.

He has also managed many broad-scale international projects, and organised major professional events in Serbia and abroad. He is a prolific author, with several thousand reports to his name, who lectures at several faculties in Serbia, and often speaks at international events. He has received several awards for his work in both the health sector and the arts.

Sustainability in Health (Tomorrow)

Dr Fiona Adshead, chairs the Sustainable Healthcare Coalition that inspires partnerships and action on sustainable healthcare. She also works as an independent expert advisor and board member for national and global organisations on wellbeing and sustainability.

She is a high-profile wellbeing and public health leader with a track record of reframing thinking and developing innovative strategy and programmes at the heart of business and government. Her previous roles include Deputy Chief Medical Officer and Director General in the UK Government, Director of Chronic Disease and Health Promotion at the World Health Organisation and Bupa’s Chief Wellbeing Officer.

Fiona is a visiting Professor at UCL and is a Senior Associate at Cambridge Institute for Sustainability Leadership. Fiona’s recent board roles include Fresenius ESG Advisory Board, British Land’s Sustainability Advisory Panel, Marks and Spencer’s Sustainable Retail Advisory Board, and Business in the Community’s Wellbeing Leadership Team. Fiona is a member of the Health System Taskforce of the Sustainable Markets Initiative.

Opening Session

Participant in the Townhall session: Navigating public health challenges in 2024 (Today)

Presenter: What does the EDQM do for me and my health? (Today)

Presenter: The EDQM and the future: our contribution to the evolution of public health (Tomorrow)

Dr Petra Doerr has been the Director of the European Directorate for the Quality of Medicines & HealthCare (EDQM) since 1 October 2021.

As a pharmacist and PhD, Petra spent the first ten years of her professional career in the medical products industry, working in international regulatory affairs. Before joining Swissmedic, the Swiss Agency for Therapeutic Products, she held the position of Vice President Regulatory Affairs Europe, Africa and Asia at Valeant Pharmaceuticals, Inc.

She joined Swissmedic in October 2004 as Head of International Affairs. In July 2007, she was promoted to Head of Management Services & Networking and became a Member of the Management Board. In this capacity, she assumed responsibility for quality management systems, planning and controlling in addition to steering the national and international collaboration and communications activities. From January 2014 until June 2019, she then held the position of Head of Communication & Networking and Deputy Executive Director.

Amongst other responsibilities in external relations, she oversaw the international activities of Swissmedic with other agencies and international organisations. She was a member of the ICH Management Committee and the IPRP Management Committee as well of the Scientific Advisory Council of the Centre for Innovation in Regulatory Science, and represented Swissmedic at the Heads of Agencies Summits/ICMRA meetings and the DIA’s Council of Regulators. Between 2013 and 2016, she served as the Chair of the International Pharmaceutical Regulators Forum (IPRF; now IPRP). In November 2018, she was elected Vice-Chair of the ICH Assembly.

From July 2019 to October 2020, Petra was also Director and owner of Petra Doerr Consulting Ltd., providing consultancy services to WHO and other not-for profit organizations.

She joined WHO as Head of the Regulation and Safety Unit, Regulation and Prequalification (RPQ) Department of the Access to Medicines and Health Products (MHP) Division at the World Health Organization from November 2020 until August 2021.

Dr Alexandre Méjat, who is personally affected by Bethlem muscular dystrophy, now represents the patient voice within consortia such as the European NeuroMuscular Centre (ENMC) and EURORDIS (of which he is a member of the executive committee), as well as ERN-EuroNMD, the European Joint Program on Rare Diseases (EJP-RD) and the International Rare Disease Research Consortium (IRDiRC), actively promoting both scientific collaboration and patient involvement at all steps of research.

After obtaining his PhD in molecular and cellular biology, Alexandre worked on neuromuscular junction defects and Emery-Dreifuss muscular dystrophy in France and the USA. He led a research group in Lyon (France) for eight years and was a member of the board of directors of I-Stem (Evry, France; 2005-2017) and AFM-Téléthon (Evry; 2010-2017) before joining the International Scientific Networks Department, becoming its Head in 2023.

David Novillo-Ortiz is currently unit Head and regional advisor at the World Health Organization (WHO), co-ordinating the digital health flagship initiative and the data, metrics and analytics portfolio. Prior to joining WHO/Europe, he served as co-ordinator of the eHealth programme at the Pan American Health Organization from 2010-2018. Furthermore, David served from 2006 to 2010 as a Technical Officer for the Ministry of Health of Spain, where he was appointed Executive Advisor to the Minister.

David obtained his Master’s and PhD in Information Sciences from the University Carlos III of Madrid (UC3M) (Spain). He also received a Master’s in Public Health from the University of Bordeaux (France) and the Public University of Navarre (UPNA) (Spain). He serves pro bono as an Honorary Senior Research Fellow at University College London (UK) and as an Adjunct Professor on biomedical informatics at the University of Utah (USA).  

Presenter: Environment / Sustainability in Health: drivers for change by the pharmaceutical industry (Tomorrow)

Dr Kirsty Reid is Director of Science Policy at the European Federation of Pharmaceutical Industries and Associations (EFPIA). She holds a PhD in Ethnopharmacognosy (2003) from the University of KwaZulu-Natal, South Africa. For the past 18 years she has worked extensively on research and on EU public and regulatory affairs. She leads work on alternatives to animal testing, environment, health, safety and sustainability issues. She sits on the advisory boards of the European Horizon Europe Project Transpharm and the PharGTrans project, funded through the Research Council of Finland. She is the EFPIA representative in the European Partnership for Alternative Approaches to animal testing (EPAA), EFPIA representative as the accredited stakeholder to the ECHA and the EFPIA liaison on environment and chemical dossiers to the European Medicines Agency. She has a number of published papers across these topics.

Presenter: 3D Bio-printing: from the petri dish towards whole organ manufacturing (Tomorrow)

Prof. Mark Skylar-Scott is an Assistant Professor of Bioengineering at Stanford (USA), a member of the Basic Science and Engineering Initiative at the Children’s Heart Center in Stanford and an Investigator at the Chan-Zuckerberg Biohub in San Francisco. Mark received his BA and MEng degrees in Engineering at the University of Cambridge (UK) in 2007. For his doctoral thesis under the guidance of Prof. M. Fatih Yanik at MIT, he developed multiphoton photopatterning techniques to print full-length proteins on 2D surfaces and in 3D scaffolds to probe and direct neural and vascular growth. After his PhD, he briefly worked at Formlabs as a materials engineer where he helped to develop their first commercial printer resin. For his postdoctoral research at Harvard and the Wyss Institute with Prof. Jennifer Lewis, he performed 3D bioprinting of thick and vascularised tissues, and created new high-throughput multimaterial multinozzle 3D printing systems. Now at Stanford, he has received the NIH Director’s New Innovator Award and an ARPA-H Award to support the development of new 3D printing hardware, wetware, and software to accelerate cardiovascular tissue engineering towards thick, vascularised and functionally therapeutic organs.

Presenter: The rise of artificial intelligence in health: hopes and risks (Tomorrow)

Eric Sutherland is a Senior Health Economist leading the work of the Organisation for Economic Co-operation and Development (OECD) in Digital Health, bringing together policy guidance for digital tools, integrated data and responsible analytics including artificial intelligence. In that role, he is accountable for measuring and evolving the OECD’s Recommendation on Health Data Governance (2016) and supporting digital health policy that provides data protection (e.g. security and privacy) and timely access to quality data to optimise the use of data for information, insights and impact among individuals, health workers, policy makers, researchers and innovators. Eric’s work has led to publications on the use of artificial intelligence in health, the state of digital security in health across the OECD, and a thematic chapter on digital health in the OECD’s flagship Health-at-a-Glance 2023 report.

Co-presenter: The benefits of sharing knowledge (Together)

Dr Gerrit Borchard, PharmD, is a licensed pharmacist who obtained his PhD in pharmaceutical technology from the University of Frankfurt (Germany). After holding several academic positions at Saarland University (Germany) and Leiden University (The Netherlands), he joined Enzon Pharmaceuticals, Inc. (USA) as Vice President of Research. In 2005, he was appointed Full Professor of Biopharmaceutics at the University of Geneva (Switzerland) and in 2015 he was an invited professor at Graz University (Austria). He was President of the Swiss Academy of Pharmaceutical Sciences (SAPhS) from 2014 to 2022 and has served as President of the School of Pharmaceutical Sciences at the University of Geneva since 2022.

Prof. Borchard's research interests lie in the fields of biopharmaceutical sciences, nanomedicine and vaccine development. He has (co-)authored more than 180 scientific papers (13 802 citations, h-factor 60) and 23 book chapters, edited two books, is named as inventor on ten patents, and has given over 250 invited lectures.

In 2012, he joined the Non-Biological Complex Drugs (NBCD) Working Group hosted at Lygature, Utrecht (The Netherlands), joining its steering committee in 2015. He joined the External Advisory board of the EU-Nanotechnology Characterization Laboratory (EU-NCL) in 2016 and was Chair of the NBC Working Party at the European Directorate for the Quality of Medicines & HealthCare (EDQM) from 2016 to 2023. In November 2022 he was appointed Chair of the mRNA Vaccine working party at the EDQM by Swissmedic.

Having been exposed to a variety of different work environments, he is fluent in Dutch, English, French and German. He is also an enthusiastic long-distance runner and loves to roam the trails and by-roads of the Swiss mountains.

Dr João Breda has a PhD in Food Consumption & Nutritional Sciences from Porto University (Portugal), a Master of Business Administration from the EU Business School in Barcelona (Spain), a Master’s in Public Health and initially graduated in Nutritional Sciences. He is Head of the World Health Organization (WHO) Office on Quality of Care and Patient Safety in Athens (Greece) and Special Adviser to the WHO Regional Director. Before moving to Greece, João held Senior Positions in WHO Copenhagen (Denmark) for seven years and WHO Moscow (Russian Federation) for four years.

The WHO Office on Quality of Care and Patient Safety is tasked with improving quality of care and patient safety at country level, focussing on reducing inequalities while promoting health innovation and leadership. João has led the team in Athens since 2021, while supporting the Regional Director in setting-up new projects, particularly in Southern European countries. These initiatives are mainly focused on quality of care and patient safety as well as public health leadership.

The WHO Office on Quality of Care and Patient Safety engages in a wide range of activities to promote and develop high-performing health systems across the region. It has supported missions to various countries, enabled knowledge-sharing and created networks to increase learning and good practice in quality of care and patient safety. In the last 24 months, it has actively collaborated with Albania, Armenia, France, Greece, Italy, Kazakhstan, Kyrgyz Republic, Latvia, Malta, Montenegro, North Macedonia, Portugal, Romania, Serbia, Slovenia and Tajikistan, notably on the development of national strategies or action plans, training and capacity-building of health leaders and practitioners and the development of quality of care and patient safety frameworks. The Office has also reached out to a wider audience through 11 published reports, 21 draft studies, two evaluation tools, and 34 scientific publications to promote knowledge-sharing.

In March 2023, the WHO Office on Quality of Care and Patient Safety held the first ever meeting of the WHO European Focal Points Network on Quality of Care and Patient Safety with the goal of building networks for change while making quality of care and patient safety integral to national health policy agendas. The meeting was attended by experts, policymakers, health professionals and civil society organisations from across the region. Overall, only in the last year, the Office has supported 28 technical meetings, 27 local and high-level meetings and four training sessions and webinars, launched five new WHO Collaborating Centres, integrated six regional and worldwide collaborations and reached out to a total of 5000 participants in meetings and workshops, including 2000 remote participants.

João was the Director of the first and second editions of the WHO European Public Health Leadership Course in collaboration with partners from the national institute of health (ISS) in Italy (November 2022) and the University of Bordeaux (France) (November 2023), involving contributors from around the world and the use of dynamic modern teaching methodologies. João also led the team that designed and implemented the first WHO European Autumn School on Quality of Care in Lisbon (Portugal), October 2023.

Until 2021, he headed the WHO European Office for the Prevention and Control of Noncommunicable Diseases (NCD Office), which is an integral part of the WHO Regional Office for Europe. Launched in 2014, the NCD Office marked an important milestone in the commitment made to combatting NCDs in the WHO European region. Led by João, the NCD Office provided support to 53 Member States in the WHO European region based on population-level, targeted approaches to ensure a reduction in NCD risk and an overall decline in premature mortality.

In 2019, the team he led was given an Award of Excellence announced by Dr Tedros Adhanom Ghebreyesus, WHO Director-General, which acknowledged both their exceptional contribution to the Organization and the tangible gains and achievements of their work.

For eleven years, João was Programme Manager for Nutrition, Physical Activity & Obesity at the WHO Regional Office for Europe, responsible for the development, implementation and evaluation of the European Food and Nutrition Action Plan 2015-2020 and the Physical Activity Strategy for the WHO European Region 2016-2025.

João was also the recipient of the Gold Medal for outstanding services in the field of Health, granted by the Portuguese Ministry of Health in 2018. In addition, he has received more than 20 scientific and academic awards and/or distinctions, notably an Honorary Professorship from the Medical Academy of Kazakhstan 2018, the Gerlev Award 2016 (Denmark) and gold medals for his work in obesity (particularly in children) from the Polish Institute of Maternal and Child Health (2021) and the Nutritionists Professional Order 2021 (Portugal). João has published more than 250 original academic articles and reports, as well as more than 20 original books (including the best seller on infant nutrition in Portugal) and has more than 10000 citations. He is also considered to be among the top 1% researchers on obesity, globally.

Before joining WHO, João was the Portuguese WHO/Europe focal point for alcohol, nutrition, and physical activity, and a member of the High Level Group on Nutrition and Physical Activity and the EU Platform for Action on Diet, Nutrition and Physical Activity for more than 10 years. He was the first co-ordinator of the national platform against obesity under the Portuguese Ministry of Health. He worked as a public health official at the General Health Directorate for many years. He was the Head of the Nutrition Department at Atlantic University in Lisbon as well as lecturer and researcher at the Agrarian School of Coimbra (ESAC) (Portugal), the University of the Algarve (Portugal) and the School of Hospitality and Culinary Arts in Coimbra. João is guest Professor at the National School of Public Health (NOVA) in Lisbon and at the Faculty of Nutritional Sciences – Porto University.

He is proficient in English, Spanish and Portuguese (mother tongue) and has intermediate knowledge of French and basic knowledge of Russian.

Participant in the Townhall session: Navigating public health challenges in 2024 (Today)

Presenter: GEON 30th anniversary presentation (Together)

Dr Katerina Brezovska is a full professor at the Institute of Applied Chemistry and Pharmaceutical Analysis at the Faculty of Pharmacy of Ss Cyril and Methodius University, Skopje (Republic of North Macedonia). She is also the responsible person for quality assurance of laboratory activities at the Center for Drug Quality Control, OMCL of the Republic of North Macedonia. She holds a PhD in pharmaceutical science (2012) from the Faculty of Pharmacy, Ss. Cyril and Methodius University and completed a six-month research internship at the Department of Molecular Biosciences, Wenner-Gren Institute, Stockholm University, Stockholm (Sweden) as part of her doctoral studies.

Katerina also has a specialist qualification in Drug Quality Control (2008) obtained from the Faculty of Pharmacy, Ss. Cyril and Methodius University. She co-ordinates a national project entitled “Building a national strategy to combat falsified medicines” and actively participates in the work of the OMCL network, in the working groups for the elaboration/revision of quality management documents, in training sessions organised by the network and in mutual joint audits as a technical auditor. She is an active member of the OMCL Falsified Medicines Working Group and of European Pharmacopoeia Group of Experts 10C. Since 2023, she has been a member of the GEON Advisory Group.

Katerina is the author/co-author of five books and more than 70 scientific papers published in international scientific journals and conference proceedings.

Co-presenter: 30th anniversary of the Certification of suitability procedure (Together)

Hélène Bruguera graduated in Biochemistry from the University of Nancy (France) and obtained a master’s degree in industrial pharmacy from the University of Strasbourg (France). She joined the pharmaceutical industry where she worked in analytical development for ten years and on the preparation of the quality part of marketing authorisation applications.

She joined the EDQM in 2000, and is currently the Head of the Certification Department. She deals with the management of the CEP procedure, which includes assessment of dossiers, as well as the EDQM inspection programme for active substances manufacturers. She is also involved in international platforms related to the quality of medicines and active pharmaceutical ingredients (ICH and IPRP Quality Working Group).

Participant in the Townhall session: Navigating public health challenges in 2024 (Today)

Co-presenter of the European Pharmacopoeia – Celebrating 60 years of thriving collaboration (Together)

Dr Salvador Cañigueral is Professor of Pharmacognosy and Phytotherapy at the Faculty of Pharmacy and Health Sciences of the University of Barcelona (Spain). He holds a PhD in Pharmacy from the University of Barcelona (1986), and he completed part of his training in Switzerland (University of Lausanne) and Germany (University of Regensburg). His research deals with the chemistry, biological activity and quality control of medicinal and aromatic plants, herbal drugs and herbal preparations.

Salvador is the author of more than 150 papers, mainly in international scientific journals, and over 300 contributions to congresses (most of them international), as well as the author or editor of seven books and 15 book chapters on medicinal plants, phytotherapy and the history of science. In addition, he is the founder and scientific editor of the Spanish Revista de Fitoterapia, and associate editor of the journal Frontiers in Pharmacology. He is also co-editor of the web site www.Fitoterapia.net.

He is a full member of the Royal Academy of Pharmacy of Catalonia, President of the Spanish Society of Phytotherapy (SEFIT), member of the board of the HPTLC Association and past member of the Board of the European Scientific Cooperative on Phytotherapy (ESCOP) and other international associations. He has been the Chair of the Phytotherapy Group of the Spanish National Formulary, the Phytochemistry Group of the Spanish Pharmacopoeia, and of the Spanish Pharmacopoeia Commission. He is a member of two European Pharmacopoeia groups of experts on herbal drugs and herbal drug preparations: 13A (2005-), which he also chaired from 2011 to 2019, and 13B (1999-), of which he is currently the Chair. He was also first Vice-Chair of the European Pharmacopoeia Commission from 2019 to 2022 and is the current Chair.

Participant in the Townhall session: Navigating public health challenges in 2024 (Today)

Co-presenter: Joining forces in the field of substances of human origin (Together)

Dr Johanna Castren is the Director of Blood Donation Operations at the Finnish Red Cross Blood Service. She is a medical doctor with almost 15 years of experience as a general practitioner. She has worked for the Finnish Red Cross Blood Service since 2008, before her current position as a medical officer, and as the Chief Medical Officer in Blood Donation Operations. In 2023, she was appointed Director of Blood Donation and joined the management team. Since 2014, she has acted as Finland's representative in the European Committee (Partial Agreement) on Blood Transfusion (CD-P-TS). She was elected Vice-Chair of the Committee in 2021 and Chair in 2023. She is a member of the CD-P-TS Blood Guide Working Group and chaired the Plasma Supply Management Working Group from 2017 to 2019.

Her expertise in the field of blood services covers a wide range of medical and administrative matters. It is strongest in donor selection, donor adverse events, donor communication and web-based donor services. She is the author of more than 40 scientific papers and conference publications.

Dr Beatriz Domínguez-Gil has a PhD in internal medicine and specialises in nephrology. She joined the National Transplant Organization (ONT) in November 2006 and became its Director General in May 2017. ONT is the Spanish national authority responsible for the oversight, co-ordination and organisation of the donation and clinical use of organs, tissues and cells.

She is also Chair of the Committee on Transplantation of the Council of Europe (CD-P-TO), President of the Iberoamerican Network/Council on Donation and Transplantation (RCIDT) and a member of the WHO Task Force to promote ethical practices in the donation and transplantation of organs, tissues and cells.

Beatriz is a former Co-Chair of the Declaration of Istanbul Custodian Group on Organ Trafficking and Transplant Tourism and was also President of the European Donor Transplant Coordination Organization (EDTCO), Chair of the Ethics Committee of the Transplantation Society (TTS) and a Councillor for Europe at the TTS.

She has authored more than 245 publications in scientific journals and book chapters, and presented more than 550 communications and papers at national and international conferences.

Dr Adam Hacker is the Director and Head of Global Regulatory Affairs and Quality, Coalition of Epidemic Preparedness Innovations (CEPI). At CEPI, Adam co-chairs the Regulatory Advisory Group, consisting of 14 regulatory authorities, where regulatory issues related to pandemic preparedness are discussed. Adam also leads CEPI’s regulatory activities around the 100-days initiative, collaborating extensively with regulatory authorities worldwide. He has more than 20 years of pharmaceutical industry experience in leadership roles in both vaccine and haematology/oncology development, and expertise in regulatory affairs, quality and medical affairs. Adam was also recently appointed as the Chair of the MHRA’s Review Panel.

Martin Harvey has been Head of International Affairs at the European Medicines Agency (EMA) since October 2021. He joined the EMA legal team in 1995 after several years as a European affairs consultant in Brussels (Belgium). He headed the Office of the Executive Director and served as Head of Communication, before later moving to the Agency's International Affairs team. He took an 18-month career break with UNITAID, the World Health Organization-hosted partnership dedicated to innovation in global health from 2019-2020. Martin holds law degrees from the University of Dundee (UK) and the Vrije Universiteit Brussels (Belgium).

Marie-Laure Hecquet is Policy Advisor in the office of the EDQM Director, where she provides policy and strategy advice and is responsible for relations with European partners.

She started her career in the public sector as a medical and research scientist. In 2007, she joined the Council of Europe/EDQM as Scientific Assistant within the European Pharmacopoeia Department, moving on to become Scientific Programme Manager in the Biological Standardisation, OMCL Network and HealthCare Department where she was responsible for establishing quality management and capacity building activities for European blood establishments. In 2019, she was appointed Head of the Healthcare Section and then Head of the Substances of Human Origin Section. In 2022, she joined the office of the EDQM Director as Policy Advisor.

Marie-Laure holds a trinational MSc/Eng.D in Biotechnology Engineering and a certification in policy-making from the London School of Economics. She has also lectured in Public Health, European Health legislation and Management of Organisations at the University of Strasbourg (France).

Co-presenter: 30th anniversary of the Certification of suitability procedure (Together)

Dr Susanne Keitel is a former Director of the EDQM. She holds a PhD (1987) in pharmaceutics from Berlin Free University (Germany) and is a licensed pharmacist (1982). After having spent ten years in pharmaceutical development in the research-based pharmaceutical industry, she held a number of senior positions at the German Federal Institute for Drugs and Medical Devices (BfArM), including the responsibility for quality assessment and European licensing procedures, before joining the Council of Europe as the Director of the EDQM in 2007, a post she held until her retirement in October 2021. Susanne was elected corresponding foreign member of the French Académie Nationale de Pharmacie in 2009. After serving as a co-opted expert in the EDQM’s Certification Steering Committee since October 2023, she was appointed its Chair from January 2024.

Co-presenter: Consumer health-cosmetics: joining forces for the benefit of consumers (Together)

François-Xavier Lery is the Head of the EDQM’s Pharmaceutical and Consumer Care Section, Department of Biological Standardisation, OMCL Network and HealthCare (DBO). He obtained his degree in pharmacy from the University of Paris. He specialised in medicinal chemistry and obtained his PhD in January 1999 from the same university, working on his thesis in a laboratory that was part of the French National Centre for Scientific Research (CNRS). In 1999 and 2000 he worked at the French Health Products Safety Agency in Saint Denis (Paris) as a pharmaceutical assessor for chemical products and in 2001 he joined the EDQM in Strasbourg (France) as a Scientific Programme Manager dealing with Certificates of Suitability. His responsibilities there included overall processing of applications, dossier assessment and organisation and co-ordination of the EDQM inspection programme, participating as an auditor for numerous Good Manufacturing Practice (GMP) inspections of Chinese and Indian active substance manufacturers. In 2005, François-Xavier moved to the DBO Department where he co-ordinated the sampling and testing programme under the responsibility of the European Medicines Agency (EMA). From June 2006 to June 2009, he was seconded from the EDQM to the EMA in London as a scientific administrator in charge of the co-ordination of GMP inspections and quality defects related to centrally authorised products. Between 2008 and 2009, he also ran an international project focusing on collaborating with the US FDA and Australian TGA on GMP inspection activities.

In June 2009, he returned to the EDQM where he took on responsibility for anti-falsification projects, i.e. eTACT (EDQM anti-falsification traceability service for medicines) and API fingerprinting. Since June 2012, he has been Head of the Pharmaceutical and Consumer Care Section within DBO.

Jaime Marco is a Scientific Programme Manager in the EDQM’s Substances of Human Origin (SoHO) Division, Biological Standardisation, OMCL Network and HealthCare Department, at the EDQM. He holds a master’s in Pharmacy (2013) from the Complutense University of Madrid (Spain). Prior to joining the EDQM, Jaime worked at the Spanish National Transplant Organisation (ONT), where he was involved in several projects, notably the Spanish Liver Transplant Registry, the Global Observatory on Donation and Transplantation and Biovigilance programmes. He joined the EDQM as a Principal Scientific Assistant in 2019, where he has taken charge of the Guide to the quality and safety of organs for transplantation and the Network of National Focal Points on Travel for Transplantation, among others.

Co-presenter “General European OMCL Network - 30th Anniversary” (Together)

Dr Laurent Mallet is Head of the Biological Standardisation, OMCL Network and HealthCare Department at the EDQM. He obtained his Master of Science in Biochemistry from Claude Bernard University, Lyon (France) and completed his PhD work in Virology and Molecular Biology under the co-direction of Professor Michèle Aymard (National Reference Center for Enterovirus, Lyon) and Dr François Pelloquin (Sanofi Pasteur, formerly Pasteur Mérieux-Connaught). He obtained his PhD in 1996. After several positions within Sanofi Pasteur in France and in Canada, he was appointed Global Head of Analytical Sciences at Sanofi Pasteur, where he remained until November 2019. He joined the EDQM in December 2019. He was a member of several expert committees, including European Pharmacopoeia Group of Experts 15 (Human vaccines and sera), and a stakeholder in the French Pharmacopoeia Committee for Biological Products and Innovative Therapies”. He was also involved in several WHO working groups on vaccines, including the WHO Study Group on Cell Substrates.

He currently represents the EDQM on the WHO Expert Committee on Biological Standardization (ECBS), and in the NC3Rs Steering Committee reviewing animal testing requirements in WHO biologicals guidelines, the COVAX Regulatory Advisory Group and the implementation working group ICH Q5A and of the IABS Board.

Dr Vanja Nikolac-Markic is Head of the EDQM’s Substances of Human Origin (SoHO) Division in the Biological Standardisation, OMCL Network and HealthCare Department. She started her career in the SoHO field in 2001 as a transplant co-ordinator then headed the SoHO inspection service at the Ministry of Health in Croatia from 2009 to 2021. From 2021 to 2023, she held the position of Principal Expert for Microbial Safety at the European Centre for Disease Prevention and Control in Sweden. She led and participated in numerous EU projects in the SoHO field and served as a country representative in international bodies and institutions such as the Council of Europe’s Steering Committee for Human Rights in the fields of Biomedicine and Health (CD-BIO), the assembly of the EU DG SANTE national competent authorities, etc. She was also involved in various technical assistance programmes and projects in countries outside the EU, as a project leader, field expert and consultant.

Co-presenter: Joining forces in the field of substances of human origin

Jean-Philippe Plançon is the president and co-founder of the European Patient Organisation for Dysimmune and Inflammatory Neuropathies (EPODIN) and has been living with a rare disease for 25 years. In 2006, he founded the Association française contre les neuropathies périphériques (AFNP), an organisation supporting people affected by rare neurological disorders such as Guillain-Barré syndrome, CIDP and painful neuropathies.

Jean-Philippe is also Vice-President of the French Rare Diseases Alliance, a patient organisation composed of 240 associations.

After having been a member of several expert committees of the French National Agency for Medicines and Health Products Safety (ANSM), Jean-Philippe is currently Vice-Chairman of the Board of Directors of this agency, where he represents users/patients of the French national healthcare system.

At the European level, beyond EPODIN, Jean-Philippe is involved in the European reference network, EURO-NMD, where he chairs the Educational Advisory Board.

Participant in Townhall session: Navigating public health challenges in 2024 (Today)

Co-presenter: Consumer health-cosmetics: joining forces for the benefit of consumers (Together)

Durk Schakel holds a BSc (1991) from the University for Analytical Chemistry of Leeuwarden (The Netherlands) and a BSc (2000) in Food Science. From 1992 to 1998 he was a chemical engineer in the Food Laboratory of the Netherlands Food and Consumer Product Safety Authority (NVWA) in Leeuwarden and from 1998 to the present he has been a researcher in the Chemical and Microbiological Laboratory of the NVWA in Groningen. He gives technical research and development advice in the field of toys, cosmetics, tattoo inks, food contact materials, textiles, biocides and household chemicals. He is a member of European groups for market surveillance and for quality aspects of analytical methods in the field of cosmetics, is an expert for the REACH Analytical Working Group and an active participant in ISO and CEN for cosmetics and toys.

Co-presenter: Fit for life: how a transplant saved my life (Together)

Liz Schick is the President of the World Transplant Games Federation (WTGF). Born in London, UK, Liz Schick started a career in dress design, but changed direction in the early 1980s when she moved to Switzerland where she began working in sport as a fitness instructor and where she and her husband bought a sports shop specialising in winter sports.

In 1997 at the age of 35, Liz was diagnosed with epithelioid hemangioendothelioma (EHE), a rare vascular liver tumour. She had always had a keen interest in medicine and communication and decided to make the most of her medical contacts and do as much research as possible to help her make the right choices for treatment and to help her on the road ahead. A liver transplant seemed the best treatment. Their children were 5 and 8 at the time.

During her time on the transplant waiting list, Liz featured in a documentary on waiting for a transplant and volunteered for Swisstransplant, the Swiss Foundation for Organ Donation, where she now works part time. She started competing at the World Transplant Games in 2001 at the Winter Games in Nendaz in Switzerland where she not only competed but also organised the first Nicholas Cup, an event for transplant recipient children.

She subsequently started TACKERS - Transplant Adventure Camps for Kids and continued competing at the Summer and Winter World Games.

In 2011, Liz was elected to the WTGF Board and subsequently became part of the WTGF Executive Committee as Honorary Secretary. In April 2023, she was elected President of the WTGF. The WTGF not only stages the Summer and Winter World Transplant Games in collaboration with their member country organisations, but also promotes physical activity and research into improving the quality of life for transplant recipients, living donors and donor families as well as promoting organ donation globally.

Co-presenter: Together for better health (Together)

Cathie Vielle is the Head of the European Pharmacopoeia Department and the Secretary to the European Pharmacopoeia Commission. She graduated in Pharmacy in 1996 from the University of Strasbourg (France). Since then, she has held several positions in QA compliance and in supply chain departments in an international pharmaceutical company and in September 2005 became Head of the Quality Department at a manufacturing site for worldwide markets (e.g. Europe, USA, Japan). Cathie joined the EDQM in May 2009.