Dear Industry Stakeholders, The EMA’s Human Medicines Committee (CHMP) has published a statement urging the EU research community to prioritise large randomised controlled studies because they are most likely to generate the conclusive evidence needed to enable rapid development and approval of potential treatments of CIVID-19. The statement promotes a harmonised approach to data collection […]Read More "EMA/CHMP statement on Call to pool research resources into large multi-centre, multi-arm clinical trials to generate sound evidence on COVID-19 treatments"
On the 15th October 2019, the European Commission (EC) published a set of documents applicable to clinical trials that will be authorised under Regulation EU No 536/2014, once it becomes applicable. Please see under the following link EudraLex – Volume 10 – Clinical trials guidelines : https://ec.europa.eu/health/documents/eudralex/vol-10_en#fragment1Read More "Clinical trials guidelines"
A dedicated working group has prepared a new template for the Informed Consent Form (ICF) for interventional clinical trials with an investigational medicinal product on adult patients. The working group consisted of representatives of BAREC (Belgian Association of Research Ethics Committees), pharma.be (the Belgian association of the innovative (bio)pharmaceutical industry) and patient organizations, and was […]Read More "PUBLICATION of ICF templates for interventional trials on adult patients"
GDPR, all CROs and entreprises are getting compliant The new EU regulation on General Data Protection is to be applied as of May 25, 2018. Read more here and make sure your CRO is compliant : GDPR regulationRead More "GDPR, all CROs and entreprises are getting compliant"
Surfing the innovation wave, an interview with the Director General EFPIA Influential industry body, EFPIA, has for years helped pharma improve transparency and repair its long-tainted reputation. Tackling key issues such as innovation, patient access and collaborative R&D, Eyeforpharma caught up with the new Director General, Nathalie Moll, to discover where their focus is for […]Read More "Surfing the innovation wave, an interview with the Director General EFPIA"