'How to conduct clinical trials in EU after Brexit'

We are pleased to invite interested parties to the first multi-stakeholder Denmark-Japan Clinical Research & Trial Initiative - an online symposium joined by regulators, academics, pharma sponsors, service providers, technology companies, clinical site networks and patient organizations.
A new alliance between Trial Nation Denmark, Life Science Innovation Network Japan (LINK-J) and the Royal Danish Embassy Japan will promote clinical trials cooperation. With the aim of helping to accelerate accessibility to Danish, European and Japanese clinical research, we hope to offer access to clinical experts and networks; share regulatory and company perspectives; and provide cases on conducting clinical trials in support of regulatory decision-making, value demonstration and patient access to innovative medicines.
The online symposium is part of an expert series of symposia bringing awareness to public-private trial cooperation, the development good practices, and conduct of clinical trials. Supporting the new Danish Life Sciences Strategy and Japans Ministry of Health Pharma Industry Vision, international cooperation on clinical research will help demonstrate the value of global research and multi-national study data use for regulatory purposes.
We hope the symposium proves valuable and inspire more efficient medicines development practices through international cooperation and public-private partnerships.

*Language:English (English-Japanese simultaneous interpretation available)
*English captions are available (you can choose to turn them on or off).
*Please note that LINK-J and Royal Danish Embassy are not responsible for any errors or omissions in the captions.

How to use captions: Managing and viewing closed captioning

Date and Time:

Thurs, May 20, 2021 5:00-6:30 pm (JST) / 10:00-11:30 am (CEST)

Venue:

Online (Zoom Webinar)

Registration

(Opens an external site)

Registration Fee

Free
Click ”Registration” to open an external site, and click “GET TICKET” on the right bar to sign up for the webinar.

How to participate

This event will be broadcasted on Zoom webinar. Please make a registration through Peatix.
You can join the webinar from "Watch" in the Peatix page on the webinar day.

Program

- Please note that program and speaker may be changed for certain reasons.

TIME	Agenda
17:00-17:05(JST) 10:00-10:05(CEST)	Welcome Joakim Steen Barron-Mikkelsen　 Minister Counsellor, Economic Diplomacy in Health, Royal Danish Embassy Tokyo Japan
17:05-17:10(JST) 10:05-10:10(CEST)	Introduction of LINK-J Akihiko Soyama President and CEO, director, LINK-J
17:10-17:30(JST) 10:10-10:30(CEST)	“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(JST) 10:30-10:55(CEST)	“The Danish Clinical Research Ecosystem ” Marianne Pilgaard Chief Executive Officer of Trial Nation
17:55-18:20(JST) 10:55-11:20(CEST)	“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(JST) 11:20-11:30(CEST)	Q&A/Closing Remarks 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)

Biography

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.