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Brexit後のEUにおける臨床試験の実施方法

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Brexit後のEUにおいて日本企業が臨床試験を実施する場合、デンマークが最適な国の一つであることは、あまり知られていません。デンマークの保健省と日本の厚生労働省は、2017年に保健分野において戦略的―パートナーとなることで合意しており、それを受けて、本ウェビナーにご登壇いただくDKMA(デンマーク医薬品庁)と日本のPMDAは、薬事規制に関して連携と協力を強化しています。EUにおける臨床試験の最新動向をお届けするため、昨年11月に提携の覚書を締結したデンマーク大使館とLINK-Jは、この度初めてウェビナーを共催いたします。
最初に、EUでの臨床試験実施の窓口となっている、DKMALene Grejs Petersen先生より、臨床研究に関する規制当局からの支援についてご講演いただきます。
次に、デンマークの臨床試験のフィールドで、ライフサイエンス企業や患者団体、研究者を支援している政府系団体であるTrial NationCEOMarianne Pilgaard先生より現地の臨床研究エコシステムについてお話しいただき、最後にデンマークにおける具体的な臨床試験例について第一三共ノルディックスのMagnus Gisel氏Martin Ahlgren先生よりご講演いただきます。
臨床試験における国際協力や官民連携が、より効果的な医薬品開発につながることを願っております。

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日時

2021年5月20日(木)17:00-18:30

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時間 内容
17:00-17:05 開会挨拶
Joakim Steen Barron-Mikkelsen 
Minister Counsellor, Economic Diplomacy in Health, Royal Danish Embassy Tokyo Japan
17:05-17:10 LINK-J紹介
曽山明彦
LINK-J 常務理事
17:10-17:30 “Regulatory Authority Perspectives on Clinical Research for Decision-making ”
Lene Grejs Petersen
M.Sc.Pharm, Senior Advisor, Quality Assessment and Clinical Trials, Danish Medicines Agency (DKMA)
17:30-17:55 “The Danish Clinical Research Ecosystem ”
Marianne Pilgaard
Chief Executive Officer of Trial Nation
17:55-18:20 “Centre of Excellence in Oncology – a Clinical Research Case”
Magnus Gisel,
General Manager, Daiichi-Sankyo Nordics, Denmark
Martin Ahlgren
Medical Director Nordics, Daiichi-Sankyo Nordics, Denmark
18:20-18:30 Q&A・閉会挨拶
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)

登壇者略歴

photo_joakim.pngJoakim 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.

HP_DKMA-6.pngLene 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.

Photo_MariannePilgaard.jpgMarianne 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.jpgMagnus 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.

martinimage006.jpgMartin 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.

photo_Jakob_Larsen_23008.jpgJakob 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.

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【主催】デンマーク大使館
【共催】一般社団法人ライフサイエンス・イノベーション・ネットワーク・ジャパン(LINK-J)

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