MARACA International was at the RAPS EU MDR/IVDR Brussels Workshop 4–5 July 2017.
Dr. Van Hove participated in the discussions on the implementation of the new European Medical Device Regulation (MDR) and the new In vitro Diagnostic Device Regulation (IVDR).
MARACA International was at the MedTech Summit Meeting in Amsterdam, The Netherlands, on 19-23 June 2017.
Dr. Van Hove participated in the discussions on the implementation of the new European Medical Device Regulation and the new In vitro Diagnostic Device Regulation.
Dr. Van Hove presented on Companion Diagnostics at the DIA 29th Annual Euromeeting , 29-31 March 2017 in Glasgow, UK
Dr. Van Hove was asked to share his experience with setting up companion diagnostics projects with pharmaceutical companies and in vitro diagnostic device manufacturer as partners. He highlighted the opportunities and the difficulties with such partnerships. Dr. Van Hove summarized how a successful companion diagnostics partnership could be setup and lead to the successful registrations of the drug and the companion diagnostic device.
On 4 May 2016, the official text of the GDPR Regulation has been published in the EU Official Journal. While the Regulation entered into force on 24 May 2016, it shall apply from 25 May 2018.
Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation).
The Regulation is an essential step to strengthen citizens’ fundamental rights in the digital age and facilitate business by simplifying rules for companies in the Digital Single Market. Violations can cost a company up to 4% of worldwide revenue. More details can be found here.
