In a burgeoning EU regulatory environment setting ever-higher standards for the development and marketing of medicinal products and medical devices, the launch of a growing number of healthcare innovations such as medical e-records, tailored health apps and hardware solutions and big data sets, is facing challenges to adapt to the legislative landscape while raising new questions in terms of healthcare regulation, costs, census and monitoring among others.
Science|Business is organising a by-invitation roundtable with the aim of discussing these challenges and stressing the legal gaps paving the way to successful, patient-centred, health systems’ reforms in the digital era.
The proposed roundtable is scheduled in the afternoon of the 10 April 2018 and will be held in Brussels to discuss ways to build and achieve policies in this area.
The roundtable will gather high-level decision-makers, a wide range of opinion leaders including researchers, innovators, lawyers, healthcare professionals and patients, representatives of global companies, public organisations and universities, involved in the construction of health systems in the European Union.
Science|Business is an experienced convenor of high-level, cross-sector dialogues and intends to gather prominent stakeholders to open up the debate on digital health patient-centred reforms towards successful, outcomes-based health systems.
It is expected that the outcome of the proposed roundtable will serve the current EU-wide work on health reforms and interconnection.
Location: Renaissance Hotel (Rue du Parnasse 19) in Brussels, Belgium.
Duration and form: The date of the event is 10 April 2018. The event will span over 2 hours (16:00 to 18:00) and take the form of a high-level roundtable by invitation. Lunch will be provided to participants.
- Bart Vermeulen, Deputy Chief of Cabinet, Belgian Minister of Social Affairs and Health
- Political will in the conduct of a reform – pitfalls to avoid
- Signe Ratso, Deputy Director-General, DG Research and Innovation, European Commission
- Innovation principle
The introduction will be followed by the two following discussion topics.
1. Patients and electronic health records
- Eric Vertommen, Programme Manager, eHealth Actionplan, FPS, Federal Public Service Health, Food Chain Safety and Environment
- Concrete implementation in eHealth
- Marc-Henry Cornely, Secretary, OPHACO, Office of Cooperative Pharmacies of Belgium
- How pharmacies are concerned
- Frank Hulstaert, Senior Researcher, KCE, Belgian Health Care Knowledge Centre
- Two must-haves for adaptive pathways: patient records allowing real-time data analyses and pragmatic comparative effectiveness trials
- Hugues Malonne, Director General, Post Authorisation, Federal Agency for Medicines and Health Products (FAGG-AFMPS)
- Electronic health records as tools for safer medicines and healthcare products
2. Digital Health products and services in the EU legislative framework
- Sam Shah, Director, Digital Development, NHS England
- Case study: Delivering digital health technologies and services across EU borders
- Kevin Raymakers, Digitial Lead, Pfizer
- Digital Health products and services – how large companies do contribute
- Marnix Denys, Director, beMedTech
- The medical technology industry – powers and restrictions
- Annabelle Bruyndonckx, Lawyer, Simmons & Simmons LLP
- EU legislative framework – forces and limits
- Xavier Prats Monné, Director General DG Health and Food Safety, European Commission
- How the European Commission can push for and initiate adequate regulatory framework European-wide
Discussions during the roundtable will be moderated by Monica Dietl, Senior Advisor, Science|Business. The moderator will drive dynamic discussion with speakers and participants to the roundtable meeting, in order to lead a lively conference for the audience.
For more information, please contact Lysiane Pons (email@example.com).