Controversial and debated topics in Clinical Trials
A well thought out clinical strategy is critical for a clinical study, our experts of clinical study talk about the…
Interplay between ICH and Data Privacy – GDPR
As professionals in the life sciences industry, we work in a regulated environment and we are a key element in…
FDA Advisory Committee Meeting on Toxicity Risks of AAV Vector-Based Gene Therapy Products: a CMC…
The FDA’s Cellular, Tissue, and Gene Therapies Advisory Committee (CTGTAC) held a meeting on September 2nd and 3rd, 2021, to…
COVID-19 – THE LEARNINGS AND LONG-TERM IMPACT IN CLINICAL STUDY MANAGEMENT IN THE EU/UK
Introduction At the beginning of 2020, COVID-19 pandemic hit the whole world and led to unprecedented measures, including general lockdown…
Possible Contexts of Use for In Silico trials methodologies: a consensus-based review
The term “In Silico Trial” indicates the use of computer modelling and simulation to evaluate the safety and efficacy of…
The implementation of the Clinical Trial Regulation (Regulation (EU) No 536/2014): where do we stand?
While the Regulation (EU) No 536/2014 was adopted back in 2014, its application in the European Union depends on the…
How to Secure Early Stage Development and First-In-Human Studies
We co-organized this digital event with Biopôle Lausanne. On this Webinar: Biopôle presentation (Olivier Philippe) …
General Data Protection Regulation and Patients Enrolled in EU Clinical Trials
Processing and cross-border flows of personal data significantly increased over the past decades in the EU, and it became necessary…