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New ICF templates available

New ICF templates available for clinical experimentes and trials.

Templates clinical studies

Recorded infosessions: Medical devices

  • 14 June 2022: European regulation of medical devices – introduction
    This session will focus on general concepts of medical devices according to the European Regulation (EU) 2017/745 on Medical Devices (MDR). The definition of a medical device, the process to obtain CE mark, the main applicable standards and the regulatory stakeholders will be discussed. The session will not go in detail on clinical studies with medical devices.

  • 21 June 2022: Clinical studies with medical devices
    This session will focus on the regulatory framework of clinical studies with medical devices according to the European Regulation (EU) 2017/745 on Medical Devices (MDR).  The application process for EC/FAMHP approval, content of the submission dossier and the principles of good clinical practice (ISO14155) during a clinical study with medical devices will be discussed.

Read here how to view the recorded sessions

Partner in de kijker: Chloë De Witte

BlueHealth Innovation Center stelt partner UZ Gent voor “Er zit veel ondernemend talent binnen UZ Gent en dat ondersteunen we maar al te graag”, aldus Chloë De Witte, Innovatie en Valorisatie Officer UZ Gent.

Innovatie loket en valorisatie loket

Ben je op zoek naar funding voor je onderzoek maar weet je niet wat de meest geschikte funding is? Heb je een innovatief idee maar weet je niet direct hoe er mee verder te gaan? Wil je klinisch onderzoek doen en is de regelgeving of procedure niet helemaal duidelijk?

Voor al deze vragen kun je binnenlopen op het innovatie en valorisatie loket. Elke maand wordt er een walk-in moment voorzien waarop HIRUZ adviseurs beschikbaar zijn voor al jullie vragen, en dit zonder een afspraak te maken. Dit initiatief start vanaf mei 2022.

INNOVATIELOKET
Doel: Het uitwerken en ondersteunen van innovatieve projecten zoals het toepassen van nieuwe technologieën in producten, diensten en processen
Adviseurs: Een team adviseurs met gemengde expertise
Wanneer: elke 1ste dinsdag van de maand, van 13:00-14:30 in de vergaderzaal van HIRUZ, ingang 81, route 810

VALORISATIE LOKET
Doel: bent U op zoek naar funding voor onderzoek
Adviseurs: HIRUZ-Innovatie en Valorisatie team
Wanneer: elke 3de dinsdag van de maand, van 13:00-14:30 in de vergaderzaal van HIRUZ, ingang 81, route 810

KCE Trials 2022 investigator-led call

KCE Trials 2022 investigator-led call (deadline for submission 13th September 2022)
For more information: KCE Trials 2022 investigator-led call | KCE (fgov.be)

What and for who?
The KCE Trials programme focuses on pragmatic and practice-oriented clinical studies which show comparative effectiveness and clear value for money by a potential return on investment. Those studies compare two treatment options (with ‘no treatment’ being one of the possible treatment options) that are already in use in clinical practice in a given indication, but are not yet sufficiently directly compared (i.e. which of the two treatment options work best in daily practice). Accepted study interventions are not limited to drugs or medical devices but also include a broad range of interventions, such as psychotherapy, diet, diagnostic tests, surgery or ways to deliver health care.

Info sessions
KCE is organizing online info sessions for interested applicants:

  • Info session 1: on 7th June 2022, 2 pm to 4 pm, with focus on the scope of the call, the methodology of pragmatic trials and patient involvement.  
  • Info session 1on 9th June 2022, 2 pm to 4 pm, with focus on selection process, budget and legal aspects.

You can access the agenda here. Registration is free but mandatory by sending an email to trials@kce.fgov.be (before Wednesday 1st June 2022).

Support of HIRUZ
Investigators with a research proposal will have the support of the Clinical Trial Unit (CTU) of Health, Innovation and Research Institute (HIRUZ) to submit and perform the proposed clinical trial. For more information and support, please contact HIRUZ CTU via Hélène De Naeyer (Helene.denaeyer@uzgent.be or 09/332.05.05).