On April 21, 2022, the online seminar From Research & Product Development to Market Uptake within the Diagnostics Sector took place as part of the Interreg NWE Codex4SMEs project. Diagnostics developers from a wide range of SMEs across Europe were presented an overview of fundamental aspects of protecting and funding their inventions, as well as regulatory requirements of the IVDR for the market uptake of diagnostics in the EU. Read More
The European Medicines Agency has pre-published a draft guidance document for public consultation Guidance on the procedural aspects for the consultation to the European Medicines Agency by a notified body on companion diagnostics. Relevant parties such as notified bodies and manufacturers of companion diagnostics can submit suggestions for improvement until 20 February 2022. Read More
(Stuttgart) – The advisory committee of the Codex4SMEs project met in Septem-ber 2021. Due to the pandemic, the participants from Ireland, France, the Nether-lands, Luxembourg, Belgium, Austria, Switzerland and Germany held the meet-ing remotely. As the German consortium leader, BioRegio STERN Management GmbH had invited to the session to present the results and opportunities deliv-ered by the project, which has been promoting the building of a transnational network since 2017. The aim is to accelerate the development of companion di-agnostics along the entire value chain of small and medium-sized enterprises. Read More
An appealing framework programme was created with subject matter expects ranging from regulatory affairs to market access by the Enterprise Europe Network (EEN) and the Interreg NWE project Codex4SMEs, with special thanks to project partner Daniela Onofri from Medicen as event coordinator. Participants learned about opportunities to work with global medtech companies in programmes such as Horizon Europe Health and the Innovative Health Initiative. Read More
The BIC In Vitro Diagnostics Regulatory Roadmap is written from the manufacturer's perspective and is a map that provides guidance not only on what to do, but also on how to do it. The regulatory activities are aligned with the standards that provide the solution to achieving regulatory compliance. Read More
On July 6th 2021 the online event „Biomarkers from Research to Market“ took place as part of the Interreg NWE project Codex4SMEs. Find here a recording of the session as well as the slides of the speakers Read More
To give small and medium-sized companies the chance to quickly launch new products on the market, the Interreg NWE project Codex4SMEs supports SMEs to pitch to investors through the online event MeetMyInvestor. Read More
An online seminar on the European In-Vitro Diagnostics Regulation (IVDR) took place on May 11, 2021. Almost 50 participants received an introduction to the most important points of the IVDR. There were also instructions for the Biomarker Commercialization Guide (BIC Guide) and the IVDR Regulatory Guide. With this IVDR online seminar, the two networks Interreg North-West Europe Codex4SMEs and Interreg Baltic Sea BiC offered extensive tips and tools for getting started on the current topic. Read More
