webinar
Patient Engagement Explained: Insights from a Patient, a Patient Association and a Pharmaceutical Company
Have you wondered about the role of patient engagement in healthcare product development? Currently, there is a huge emphasis on…
webinar
Ask the Experts: EU CTR/CTIS: Adoption and Early Experience
The EU Clinical Trials Regulation no. 536/2014 became effective on 31 January 2022 and the first approved trials are now…
webinar
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…
webinar
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…
blog
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…
blog
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…
publication
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…
blog
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…
