During the 2024 Avoca Quality Consortium Summit, an ICH E6 (R3) quality panel discussion led by Karen Harvey, Senior Director of the AQC, delved into how the ICH E6 (R3) guidelines will impact clinical trial execution. Key topics included the need for comprehensive early planning, adopting flexible and fit-for-purpose trial designs, and the crucial role […]
WCG’s Avoca Quality Consortium (AQC) provided comments to the FDA as part of the ICH E6(R3) Draft Guidance public consultation on behalf of our 200+ members. By leveraging the power of the consortium, we united cross-functional feedback, representative of all key stakeholders (Sponsors, CROs, Service Providers, and Sites). The revision to ICH GCP E6(R3) highlights […]
1996 – A year on the calendar which was punctuated with a number of firsts – DVDs were launched, the first mammal was cloned, eBay debuted as one of the hottest companies and closer to our space, the adoption of ICH E6 GCP became a reality. Oh and may I add that Google did not […]
Every time I hear this term being used, there is a part of me that freezes. The word “inspection” brings back the same sense of dread I used to have as a kid when I needed to prepare for an exam.
Brexit has been the talk of town following Britain’s recent decision to leave the European Union. Headlines are flying and the conversation is only strengthening around the impact this decision will have on industries of all kinds – including the pharma industry.