Brexit後のEUにおける臨床試験の実施方法

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登壇者略歴

Joakim Steen Barron-Mikkelsen, MSc. Management of Technology
Minister Counsellor - Special Advisor, Economic Diplomacy in Health, Ministry of Foreign Affairs, Appointed liason to Japan Ministry of Health, Labour and Welfare (MHLW) and the Pharmaceuticals and Medical Devices Agency (PMDA)

Joakim Steen Barron-Mikkelsen has 20 years medical industry and public health experience, from both public and private sectors, emphasizing multi stakeholder participation in value and market access-oriented government, institutional and industry cooperation.
Achieved successful product launches and access, leading award winning preventive and health promotional programs, by executing internationally endorsed harm reduction, preventive and earlier intervention programs, encouraging clinical provider participation, promoting easier and better health choices for consumers.

Lene Grejs Petersen, M.Sc.Pharm, Senior Advisor, Quality Assessment and Clinical Trials, Danish Medicines Agency (DKMA)

Lene Grejs Petersen is Senior Adviser at the Danish Medicines Agency, Clinical Trial Unit. Lene has been member of the Clinical Trials Facilitation Group (CTFG) member since 2008 and the Danish representative of the EU Commission’s expert
group concerning clinical trials since 2001. Lene has been an employee at the Danish Medicines Agency since 2000 and she is involved in the implementation of the EU Clinical Trials Regulation into Danish legislation and works as a regulatory assessor and coordinator of clinical trial applications including VHP. Lene has a background as Master in Pharmacy.

Marianne Pilgaard, Chief Executive Officer of Trial Nation

Pilgaard has more than 25 years’ experience in life science clinical development, business and private-public partnerships. At Trial Nation our mission is to make Denmark the most attractive country for companies and other stakeholders to conduct clinical trials – for the benefit of patients, research and the economy.

Magnus Gisel, General Manager, Daiichi-Sankyo Nordics, Denmark

Magnus Gisel, General Manager, Daiichi Sankyo Nordics Magnus Gisel has an MSc in Business from Jönköping International Business School and DePaul University in Chicago. He has worked in the pharmaceutical industry for the past 20 years in various different roles. The past 15 years have been in leadership roles such as Business Unit Manager, Commercial Director and General Manager in companies including Roche, Novartis and since 2020 at Daiichi Sankyo. The majority of his experience lies with Oncology and Haematology where he has more than 15 years of experience.

Martin Ahlgren, Medical Director Nordics, Daiichi-Sankyo Nordics, Denmark

Martin Ahlgren MD PhD, Medical Director, Daiichi Sankyo Nordics Martin Ahlgren is an MD and PhD from University of Copenhagen. After finishing his internship and PhD in epidemiology research from Statens Serum Institut in Copenhagen, he joined the pharmaceutical industry 15 years ago. He has since worked in a number of medical specialist and leadership roles mainly in Immunology and Oncology. He has worked in Danish, UK and Nordic roles in in companies such as AbbVie, UCB and since 2019 in Daiichi Sankyo Nordics.

Jakob Bjerg Larsen, PhD (pharm), Head of Clinical Trials and Pharmaceutical Manufacturing Policy, Dept. of Politics & Analysis, The Danish Association of the Pharmaceutical Industry (LIF)

Jakob Bjerg Larsen is Head of Clinical Trials and Pharmaceutical Manufacturing Policy at the Danish Association of the Pharmaceutical Industry. Jakob has a background as a pharmacist and holds a PhD from the University of Copenhagen. He has more than 20 years of experience working with pharmaceutical policy and has in-depth knowledge of regulatory and legal issues related to clinical trials and pharmaceutical manufacturing.