For healthcare products that require clinical studies to support licensing or regulatory clearance the execution of the clinical plan is the most critical stage in the product development process of a company. For young companies the success of a clinical study is very crucial and determines if the company is able to continue its product development program and eventually get market approval by the regulatory organisations such as the FDA and EMA.
In this Expert Class the design and preparation of the clinical trials will be discussed from the perspective of biotech products and medical devices. What are the requirements of the different clinical studies, the time lines, required partners and costs. Is it possible to speed up clinical studies by applying other strategies?
The Expert Class program is set up in an interactive way such that the participants have also the possibility to bring their own questions and discuss issues they encounter in their own (start-up) company and/or business case. The Expert Class will also give the possibility to broaden the participants network.
Date and Time:
Friday October 25, 2024
13.00 – 18.00 hrs.
Venue:
Rotterdam (venue t.b.a.)
Program:
13.00 hrs. Welcome
13.30 hrs. Start Expert Class by Leon Mur (moderator) and introduction Life Sciences@Work by Chrétien Herben
13:45 hrs. Presentations by
Frank Ruwe, Sr Consultant Clinical Operations at 3D-PharmXchange and Clinical Operations Lead at Treeway
Smart clinical strategy, innovative clinical trial designs, patient recruitment, clinical endpoints, data collection & trial management.
Bridget Peterson, Consultant Clinical Operations at 3D-PharmXchange
Multidisciplinary team work, roles & responsibilities, CROs, vendors`, risk management, real-world data, innovative randomization and data collection systems core documentation, site manuals and project plans.
Willem Mees van der Bijl, Founder & CEO at Spatium Medical
Medical device clinical trials: a company’s perspective.
16:00 hrs. Experts feedback on questions from the participants
17.00 hrs. Drinks and bites
18.00 hrs. End of Expert Class
LifeSciences@Work Expert Classes are a series of targeted (virtual) workshops organized in close collaboration with industry and academic experts
- The small-scale and personalized Expert Classes welcome Venture Challenge Alumni, Value Centre Alumni and NWO Take off Alumni.
- New early startups not (yet) part of our LS@W community but interested to join are also very welcome, provided there is a match with the LS@W community profile.
- Participation is free-of-charge for startup teams.
Registration is needed to attend!
Please send an e-mail to miranda.de.regt@iventus.nl to receive your confirmation and additional final information.
Please note: limited number of places available! Availability on first-come, first-served basis.
This meeting is powered by Health~Holland