Regulatory update for BioRiver members at MLM

On Thursday June 13^th MLM had the pleasure to host the „1^st BioRiver Member Forum“ „Current and prospective regulatory news in performing clinical trials“. in their facilities in Mönchengladbach.

Approx. 20 participants took the chance to participate in a guided lab tour through the impressive facilities of MLM before Dr. Frauke Hangen, Director of BioRiver, opened the forum.

BioRiver was happy to have gained Dr. Ingo Rath from CliPS – Clinical Project Services^® for the opening lecture as an expert on the new EU legislation 536/2014 (clinical trials regulation). The clinical trials regulation aims to harmonize the submission of clinical trials within the EU. Besides the change to an online electronical submission portal in 2020 the new legislation includes substantial changes in the procedure for submission and permission. Dr. Rath gave an excellent overview on the general aspects of the EU regulation 536/2014 and the current status of implementing it in national law. He explained in detail how member states, especially Germany, are preparing for the timepoint when the law comes into force. He also introduced the pilot project between sponsors and German authorities, like BfArm and PEI, in which both parties exercise the new processes for submitting clinical trials with the new and dramatically shortened timelines. It seems that authorities, ethics committees as well as sponsors in Germany are well prepared for the practical implementation of this clinical trials regulation.

The auditorium consisting of many representatives from CRO´s and sponsors used the chance to ask many questions, respectively shared their experiences in performing clinical trials e.g. in non-EU-countries.

The successful forum ended with a get-together with canapés and drinks and enabled the participants to network amongst each other and hopefully new business cooperation could be fostered by this event.

BioRiver e.V. as an independent industry organization aims to build a strong network for partners from industry, science and all life science stakeholders in North-Rhine-Westphalia. Amongst others some of the goals of BioRiver are to foster and fund Biotech companies, to promote technology transfer between research and industry. One of the highlight events over the year is the BioRiver Boost, a start-up competition for emerging companies.