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Virtual Event

Jun 10, 2020 8:30 AM - Jun 10, 2020 4:10 PM

(W. Europe Standard Time)

4051 Basel, Switzerland

Regulatory Science Strategies Information Day


Virginia  Acha, PhD, MSc

Virginia Acha, PhD, MSc

AVP, Global Regulatory Policy, Merck Sharpe & Dohme LLC , United States

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 to lead regulatory policy efforts ex-US for innovation that leads to better treatment for patients globally. Since 2020 this scope has expanded, as Ginny now leads the talented and experienced Global Regulatory Policy and Intelligence team for MSD. Her work has regularly focused on policy shocks that challenge innovation and access to novel therapies for patients, including global and industry-wide policy work on BREXIT, COVID-19 and now the R&D impacts of the Inflation Reduction Act.

Niklas  Hedberg, MPharm

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

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.

Susan  Longman

Susan Longman

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

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

Michael Berntgen, PhD

Head of Scientific Evidence Generation, European Medicines Agency, Netherlands

Michael Berntgen, Head of Scientific Evidence Generation at the EMA, Amsterdam, oversees robust medicine development. Collaborating with stakeholders, the department provides scientific advice, supports pediatric and orphan diseases, and manages the PRIME scheme. Michael, a pharmacist with a PhD, worked in pharmaceutical regulatory affairs in Germany and the UK from 1999 to 2006. Joining BfArM in 2006, he moved to EMA in 2007, holding various positions until becoming Head of the department in March 2020.

Shahid  Hanif, PhD, MSc

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

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

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

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

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

Hubert Leufkens, PharmD, PhD

Emeritus Professor of Pharmaceutical Policy and Regulatory Science, Utrecht University, Netherlands

Hubert (Bert) G. Leufkens is emeritus professor of Pharmaceutical Policy and Regulatory Science at Utrecht University, the Netherlands. He is research and policy-wise active at several (inter)national platforms on regulatory science, innovation, drug safety, and pharmaceutical policy (e.g., past-member EMA Pharmacovigilance Working Party, chair of Dutch Medicines Evaluation Board (MEB), past-member of the EMA CHMP, past-President of ISPE, former Scientific Director of the Utrecht WHO Collaborating Centre for Pharmaceutical Policy and Regulation. He is vice-president of the European Federation for Pharmaceutical Sciences (EUFEPS), and (co) author of >600 papers in peer reviewed journals, book chapters and research reports.

Karin  Van Baelen, PharmD

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

Jesper Kjær, MS

Global Director for Public, Private Partnerships, Strat Ops, Global Med Affairs, Novo Nordisk, Denmark

Global Director for Public, Private Partnerships at Novo Nordisk, Global Medical Affaris. Former 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

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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