EMA Moves Ahead on Relocation; Postpones Portal Launch
The European Medicines Agency (EMA) is moving ahead to relocate to one of the remaining 27 European Union member states. The Europen Council is expected to make a decision on the new location in October of this year. The agency has begun impact assessment studies to help prepare for the move and retain as many staff as possible, according to the EMA.
The EMA has started on the re-distribution of the workload relating to the evaluation and monitoring of medicines to ensure the quality of EMAs scientific assessments and compliance with legal timelines. There is a group for human medicines and one for veterinary medicines to allocate the workload.
The agency is also working on the provision of guidance and information to pharma companies.
Additionally, the EMA announced that the EU clinical trial portal and database’s go-live date has been postponed, due to technical issues with the IT systems. EMA said it is working closely with its IT service provider to ensure that corrective measures are implemented and will closely monitor progress.
The agency will provide an update at the next meeting of the Management Board in October 2017. Due to these delays, the EU Clinical Trial Regulation will now come into application in 2019 instead of October 2018, as previously scheduled.
Improving Relationships and Diversifying the Site Selection Process
April 17th 2025In this episode of the Applied Clinical Trials Podcast, Liz Beatty, co-founder and chief strategy officer, Inato, discusses a number of topics around site engagement including community-based sites, the role of technology in improving site/sponsor relationships, how increased operational costs are impacting the industry, and more.
Behind the Buzz: Why Clinical Research Leaders Flock to SCOPE Summit
February 7th 2025In this episode, we meet with Micah Lieberman, Executive Conference Director for SCOPE Summit (Summit for Clinical Ops Executives) at Cambridge Innovation Institute. We will dive deep into the critical role of collaboration within the clinical research ecosystem. How do we bring together diverse stakeholders—sponsors, CROs, clinical trial tech innovators, suppliers, patients, sites, advocacy organizations, investors, and non-profits—to share best practices in trial design, program planning, innovation, and clinical operations? We’ll explore why it’s vital for thought leaders to step beyond their own organizations and learn from others, exchanging ideas that drive advancements in clinical research. Additionally, we’ll discuss the pivotal role of scientific conferences like SCOPE Summit in fostering these essential connections and collaborations, helping shape the future of clinical trials. Join us as we uncover how collective wisdom and cross-industry partnerships are transforming the landscape of clinical research.
Landmark Phase III Trial Shows Keytruda Significantly Improves Event-Free Survival in LA-HNSCC
April 28th 2025Interim KEYNOTE-689 trial data show that perioperative Keytruda significantly lowers the risk of disease progression or recurrence in resectable, locally advanced head and neck squamous cell carcinoma, marking the first major clinical advance for this patient population in more than two decades.
