Virginia Acha, PhD, MSc
AVP, Global Regulatory Policy, Merck Sharp & Dohme LLC, United Kingdom
Virginia (Ginny) has worked in industry and academia throughout her career, combining interests in science policy research and innovation performance within and across organizations. She joined MSD in 2017 and since January 2020 she leads the talented and experienced Global Regulatory Policy and Intelligence team for MSD. Ginny spearheaded regulatory policy initiatives within industry and in MSD to address the COVID-19 imperatives, and to explore how this experience may prove a watershed for development and regulation of medicines for the future. She also Chairs the Advanced Therapeutics working group at IFPMA, and her work has resulted in a number of peer-reviewed publications and invited presentations globally.
Niklas Hedberg, MPharm
HTACG Co-Chair & Chief Pharmacist, Dental and Pharmaceutical Benefits Agency, TLV, Sweden
Niklas Hedberg is the Chief Pharmacist at the Swedish national governmental authority, the Dental and Pharmaceuticals Benefits Agency (TLV). He is the Chair of the EUnetHTA Executive Board and the TLV lead partner in EUnetHTA WP 3 Evaluation. Niklas has been working with pricing and reimbursement since 2001. Niklas started as a medical assessor and project leader in the agency, he was the Head of the Department for New Submissions between 2009 and 2014 and is since in his current position. Niklas has a broad experience of different aspects of value based evaluation and over time has seen the increasing importance for health technology assessment (HTA) both across health care systems and on local level to prepare accurate decision making.
Tony Humphreys, MPharm
Head of the Regulatory Science and Innovation Task Force, European Medicines Agency, Netherlands
Tony is the Head of the Regulatory Science and Innovation Task Force (TRS) responsible for providing leadership in the Task Force and the Agency to enable its continuous future proofing through operation of a regulatory science observatory, addressing key scientific and technological trends and their translation through the development of regulatory science strategy, planning and governance. He also provides leadership for supply and availability of medicines under the extended mandate of the Agency.
Head Regulatory Affairs Region Europe , Novartis Pharma AG, Switzerland
Current role is Regulatory Affairs Head US, Early development and Business Development and Licensing in Novartis Pharmaceuticals Corporation. Prior experience includes global and European regulatory affairs roles in Novartis and GSK in areas including Metabolism, Cardiovascular, Oncology & Vaccines.
Elena Popa, MPharm
Regulatory Policy and Innovation Lead, Bayer, Switzerland
Elena is a pharmacist by training with a master in drug safety and pharmacovigilance. She joined Bayer as a Regulatory Policy & Intelligence Lead and provides direction and development of Regulatory Policy & Intelligence activities supporting Bayer’s pipeline and strategies, with a particular emphasis on the regulatory use and acceptance of RWD/RWE in drug development. Before joining Bayer, Elena was a Senior Manager, Scientific Programmes at Drug Information Association and engaged annually with over 500 stakeholders and volunteers from the entire healthcare ecosystem. In her free time, Elena is passionate about traveling, visiting art museums, painting and watching Formula 1 (#essereFerrari).
Michael Berntgen, PhD
Head of Scientific Evidence Generation, European Medicines Agency, Netherlands
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.
Shahid Hanif, PhD, MSc
Managing Director, GetReal Institute, Netherlands
Shahid Hanif is the Managing Director of the GetReal Institute, a not-for-profit multi-stakeholder association based in the Netherlands, which aims to facilitate the adoption and implementation of real-world evidence in regulatory, HTA and clinical decision-making in Europe. He leads the GetReal Institute, which follows two Innovative Medicines Initiative (IMI) funded programmes, to establish it as a leading independent and sustainable European forum for stakeholder dialogue, consensus development and co-creation of solutions to advance the use of real-world evidence.
Ansgar Hebborn, PhD, MBA
Head - Access Policy Affairs Europe, F. Hoffmann-La Roche AG, Switzerland
Ansgar Hebborn is Roche Pharma's Head of Access Policy Affairs Europe. He represents Roche in relevant industry associations e.g. in Brussels as the chair of EFPIA’s European HTA Working Group. During the past few years, he has taken an active role as advisor and stakeholder representative in various HTA collaboration networks e.g. EU HTA Network, EUnetHTA and the HTAi Policy Forum Committee, and also has been involved in the foundation of other initiatives in this field e.g. the Green Park Collaborative, the HTAi Asia Policy Forum and SwissHTA. In an earlier role as health economist and outcomes research specialist for Roche in the US, he has gathered extensive experience with real world data research.
Xavier Kurz, MD, PhD, MSc
Head of Data Analytics Workstream, European Medicines Agency, Netherlands
Xavier Kurz graduated in 1982 as a Medical Doctor at the University of Liege, Belgium. He specialised in Tropical Medicine and worked for several years in public health projects in Africa and Asia. He obtained a MSc (1991) and a PhD (1997) in Epidemiology and Biostatistics at McGill University, Montreal, Canada. He then joined the Department of Pharmacology of the University of Liege and the Belgian Centre for Pharmacovigilance (Ministry of Health) as scientific expert. He joined the European Medicines Agency (EMA) on 1st September 2005. He is currently leading the Data Analytics team within the Data Analysis and Methods Task Force.
Anne Willemsen, MSc
Senior Project Manager, Joint Production Co-Lead Partner - Pharmaceuticals, ZIN - National Health Care Institute, Netherlands
Anne holds double Masters Degrees in Health Sciences, specialising in both Health Technology Assessment and Health Policy. This led her through research and project management roles within the Dutch National Healthcare Institute (Zorginstituut Nederland) since 2016 and she lead the EUnetHTA 21 Joint Clinical Assessment (JCA) Secretariat. Since April 2023, she is the co-chair of the HTA Coordination Group Subgroup on JCA under the HTA Regulation.
Juan Garcia-Burgos, MD, PhD
Head of Public and Stakeholders Engagement Department, European Medicines Agency, Netherlands
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.
Hubert Leufkens, PharmD, PhD
Professor, Pharmaceutical Policy and Regulatory Science, Utrecht University, Netherlands
Hubert (Bert) G. Leufkens is professor of Pharmaceutical Policy and Regulatory Science at Utrecht University. He is research and policy-wise active at several (inter)national platforms on innovation, drug safety, pharmaceutical policy and regulatory science (e.g. past-member EMA Pharmacovigilance Working Party 2005-2009, chair of Dutch Medicines Evaluation Board (MEB) 2007-2017, past-member of the EMA CHMP 2009-2015, past-President of ISPE, since 2008 Scientific Director of the Utrecht WHO Collaborating Centre for Pharmaceutical Policy and Regulation. Bert is member of the Scientific Leadership Team of Lygature since 2018. He is (co) author of >500 papers in peer reviewed journals, book chapters and research reports.
Karin Van Baelen, PharmD
Head, Global Regulatory Affairs, Janssen, Belgium
Karin is leading the Global Regulatory Affairs organization at Janssen. She facilitates the relationship between the Janssen pharmaceutical companies and global health authorities, influencing and interpreting global regulatory requirements and enabling our companies to meet those guidelines. In addition, she oversees the development of regulatory strategy for products from all therapeutic areas. Karin engages in policy development at national and international levels.
Jesper Kjær, MS
Co-Chair, EMA/HMA Big Data Steering Group; Director of 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.
Evert Jan van Lente, MS
Director EU-Affairs, AOK Bundesverband (Federal Insurer), Germany
Mr. van Lente is a health economist and director EU-Affairs of the AOK-Bundesverband, Germany. He is involved in developments in the health sector on European level, especially in pharmaceuticals, medical devices, e- and mHealth. He is based in Brussels and Berlin. The AOK-Group is the leading statutory health insurance with 26 Million insured persons in all states of Germany. Mr. van Lente is lecturer at the University Ulm and the University of Applied Science Bonn-Rhein-Sieg, Germany
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