8th Nordic-Baltic Clinical Trials Conference – How to boost clinical research in the Nordic and Baltic Region?
Day 1: 30.10.2024
12.15-13.00 Registration, networking and coffee & sandwich
13.00-13.10 Welcome and practicalities
Mia Bengtström
Chair: Jutta Lindborg, Head of Clinical Project Management, Bayer Oy
EU actions to boost the competitiveness of EU in clinical trials
13.10-13.40 Accelerating Clinical Trials in the EU (ACT EU) with focus on Priority Action 8 that aims to facilitate the development of aligned clinical trial guidance across the EU
Monique Al Vice Chair, Clinical Trials Coordination Group (CTCG) and Special Advisor, Central Committee on Research Involving Human Subjects (CCMO), the Netherlands
13.40-14.15 Decentralised clinical trials and ICH GCP for the future of clinical trials
Tiina Holmberg, Seconded National Expert (Fimea) at European Medicines Agency, Inspections Office
What is needed to get more clinical trials to EU and the Nordic / Baltic Region?
14.15-14.40 What are Pharma companies looking for when placing clinical trials? What does it take to become an attractive country?
Eva Adås, Nordic head clinical operation at Johnson&Johnson Innovative Medicine
14.40-15.05 What is needed for Academic clinical trials to flourish?
Raija Silvennoinen, Senior Hematologist, Helsinki University Hospital Comprehensive Cancer Center
15.05-15.35 Coffee Break
Attracting clinical trials by Ethics Committee collaboration to achieve harmonized requirements
15.35-16.00 MedEthicsEU
Monique AlSpecial Advisor, Central Committee on Research Involving Human Subjects (CCMO), the Netherlands
16.00-16.20 Reflections on how the Nordic and Baltic Region can promote harmonization
Outi Konttinen, General secretary, National Committee on Medical Research Ethics (Tukija)
Cross Border Clinical trials – why are they so important?
16.20-16.45 Cross Border clinical trials, what is it and why is it a problem? The EU-X-CT initiative
Susan Bhatti, EU Global Regulatory and Scientific Policy, Merck B.V.
16.45-17.10 Overcoming issues related to cross border participation will benefit patients and make Europe a more attractive place for clinical trials
Bettina Ryll, Stockholm School of Economics Institute for Research, Melanoma Patients Network Europe
17.10-17.20 Q&A
Topic is also included in the panel discussion on day 2: How to enable patients in EU to participate in a clinical trial in another EU country – how to facilitate this in our region and could the Nordic-Baltic Region be in the forefront piloting the concept?
17.20-17.25 Thank you for today and practicalities
18.00-19.00 Networking Event hosted by the City of Helsinki at the Old City Hall
Day 2: 31.10.2024
Actions to boost the competitiveness of the Nordic and Baltic region in clinical trials and trends in clinical trials
9.00- 9.10 Introduction to day 2
Chair: Catharina Östberg, Clinical Operations Head of Site Management Hub EMEA 1, Bayer
National strategies and best practices
9.10-9.25 Actions in Finland
Päivi Sillanaukee, Special Envoy for Health and Well-being, Ministry of Social Affairs and Health
9.25-9.40 Trial Nation – Denmark
Kirsten Bødker, Head of Business Relations
9.40-9.55 NorTrials – Norway
Signe Øien Fretland, Head of NorTrials coordinating unit, Oslo University Hospital
9.55-10.10 Clinical Studies Sweden
Anna Ramnemark, Chairman of Clinical Studies Sweden, Head of Clinical Research Center, Umeå
10.10-10.30 Fimea database for clinical trials – for patients and treating physicians
Kaisa Sunela, Head of section, Clinical assessor/chief physician on Fimea
10.30-10.45 Topic to be confirmed
10.45-11.15 Discussions on Nordic-Baltic collaboration and some examples
moderator: Catarina Östberg
Panelists: Päivi Sillanaukee, Kirsten Bødker, Signe Øien Fretland, Anna Ramnemark
11.15-12.15 Lunch
Medicines-Device combination trials
12.15-12.40 EU commission initiative COMBINE
Janica Juvonen, Senior officer, National Committee on Medical Research Ethics
12.40-13.10 Medicines-Device combination trials, pharmaceutical industry expectations for competitive Europe
Lucia D’Apote, Executive Director ELMAC & JAPAC, Global Regulatory and R&D Policy, Amgen
Boosting clinical research
13.10-13.45 Panel discussion: How to boost clinical research in the Nordic and Baltic Region?
Any national initiative to be converted into Nordic initiatives? Perspectives from National, Nordic and European initiatives.
13.45-14.15 Networking Coffee
14.15-14.45 Drug Rediscovery Protocol (DRUP) study FINPROVE and collaboration in Personalized cancer care in EU
Katriina Jalkanen, Head Physician, HUS Comprehensive Cancer Center, Clinical Trial Unit
14.45-15.10 Value from Nordic Health Data VALO - Better research, development and innovations within Nordics
Saara Malkamäki, Specialist, Sitra
15.10-15.30 National clinical trials awards 2024
The researcher of the year
The research nurse of the year
The CRA of the year
15.30 Thank you for participating in the Nordic and Baltic collaborative conference!
