The workshop took place on 7th November 2018. We organized the workshop with the scope to brainstorm the status of the regulatory and ethical scenario in the context of eHealth and expose the state of the art of three EU H2020 eHealth projects. These projects were the COUCH, the GOAL and the vCare. We discussed the process-to-market implications especially at the light of the Regulatory framework in the clinical research and uptake in the healthcare scenario.
Welcoming audience
The workshop opened Sofoklis Kyriazakos, the CEO of at Innovation Sprint. SK welcomed the audience and set the goals of the day.
The audience was consisting of speakers and attendees from many countries from diverse sectors. Among them were including medical industry, regulation, policy making, research, academia and SMEs. Following the welcome message, a keynote speech was given by Gianlugi Arialdi, CEO of the Brussels Life Sciences Incubator. GA presented BLSI structure and activities that embrace eHealth startups in Brussels.
Lectures
The first lecture gave Ingrid Klingmann, President at the European Forum for Good Clinical Practice in Brussels. Its title was “eHealth, Innovation and Patients’ Centredness”. Ingrid stressed the importance of patient centredness in clinical trials, however ensuring Goof Clinical Practice.
The following lecture gave Eric Klasen, Vice President Regulatory Affairs in Medtronic International Trading in Tolochenaz. EK talked about “Innovation and (EU) Regulation: the Medical Device case”. Eric has given a focus on the 2020 regulation about medical devices; the challenges and the status of play.
After the first 2 lectures, Emilio Vandelli – Managing Director of Arithmos Srl in Verona gave a speach. He talked about “eHealth Innovation and Clinical Research”. In his presentation he mentioned the trends in clinical research and how Arithmos is addressing them.
Following this presentation, Christina Kyriakopoulou – Directorate General for Research and Technological Development in the European Commission (Brussels) talked to audience. She presented in her talk “Horizon Europe” the current and future Health related priorities and calls.
Crash Test
Having completed the above lectures and presentations, the workshop attempted to “crash test” the 3 EC projects (workshop co-organizers). What we tested were their status and the possible barriers they will have to break with regards to regulations in their exploitation activities.
This was moderated by Alfredo Cesario, the Chief Scientific Officer in Innovation Sprint. In this context, Harm op den Akker, Senior Researcher in RRD in Enschede and coordinator of the COUCH project described the novelties. He also made a reference to the next steps that involve advanced technologies on argumentation framework to realize mutli-avatar approach for virtual coaching. Furhtermore, Aristodemos Pnevmatikatis, Associate Professor in Athens Information Technology and coordinator of the GOAL project, presented the status and the final activities of the project. The project is at the final stage and is executing commercialization activities in the area of gamification for behavioral change of elderlies.
Alfredo, briefly, presented vCare activities. vCare activities are focused on clinical pathways for virtual coaching in rehabilitation. Having concluded the 3 project presentations the morning speakers, Ingrid Klingmann, Eric Klasen & Emilio Vandelli, were raising questions to the presenters, in a constructive way for all to understand how critical is to address the regulatory challenges before the start of the exploitation, as this can even be a show stopper in R&D activities.
The last session
The last session included 3 speakers, one per project. Each speaker presented achievements, as well as best practices and lessons learned in EC projects. Lucia Pannese – CEO of IMAGINARY in Milan, talked about “Savings and better QoL: Gamifying Rehab“ . With her experience in R&D and commercialization activities in serious games audience heard plenty of interest things.
The second speaker was Andrew Pomazanskyi, Senior Project Manager in NUROGAMES in Köln. Andrew described us similar lessons learned with Lucia in his presentation “Problems of exploiting eHealth solutions from R&D projects“.
The third one was Marc Lange, Secretary General of EHTEL. Marc presented the expected transition of vCare from R&D into the practice in “Virtual Rehabilitation Coach: a journey from the proof of concept to routine care“, Marc Lange.
Conclusion
The workshop was concluded by Sofoklis Kyriazakos. Sofoklis, explained that the outcomes of the workshop will be summarized in a White Paper and all partners should contribute. The aim is to create impact for this critical point of regulation in R&D.
