The VPH Institute and the Avicenna Alliance bring together research institutions and companies focused on in silico medicine to collaborate on a number of activities, from policy to engagement and research with the common goal to facilitate the adoption of in silico medicine. This year we have a number of new working groups open to all VPHi members, sign up to give your contribute!
All this working groups are open for participation to VPHi and AA members. The working groups normally meet remotely (via teleconference) every 3 months. If you're interested in any of the topics and you would like to contribute with your expertise, please contact: email@example.com
1. The Policy Development Working Group, led by Emmanuelle Voisin (Voisin Consulting Life Sciences- VCLS) works on delivering policy recommendations to include in silico modeling in all health care related policies, focusing on those policies where the legislative opportunities present themselves at EU level. In the near future, this WG will focus on pediatrics and orphan medicines.
2. The International Development Working Group, led by Markus Reiterer (Medtronic). Its activities focus on the active engagement (especially on the regulatory level) with priority countries (China, Japan, South Korea), and on the follow-up with additional countries (India, Israel, Canada, Singapore, Australia, Brazil, Russia and Switzerland).
3. The Research and Technology Working Group, led by our Executive Director Lies Geris, seeks to bridge the missing mile between basic research and the commercialization of products. In this space, the group focuses on the following activities:
4. (NEW) EMA Working Group, led by our Executive Director Lies Geris in collaboration with Flora Musuamba Tshinanu, Belgian regulator and vice-chair of the modeling and simulation working party of EMA. This working group focuses on drafting a white paper, similar to US V&V40, to give guidance on how to validate models in the context of drug development in order to speed up the adoption process of in silico models.
5. (NEW) Tissue Characterisation Working Group, led by (Venkat)eswaran Perumal (Strker), focuses on implementing a set of guidelines and a library on soft tissues to be used as a birth certificate of the data in the regulatory submission process.
6. (NEW) Good simulation practices (GSP) Woking Group, led by Luca Emili (insilicotrials) aims at creating Good Simulation Practices as a tool to support the regulatory acceptance of M&S. As the clinical trials are defined by GCP Good Clinical Practices the groups goals is to start the discussion of the definition of the practices for the in silico trials. If you are not following the GCP what you are not doing cannot be defined as a clinical trial. At the moment is very hard to say how to do, review, evaluate, an in silico trials. GSP will fill this gap.