Session Highlights for March 6 and 7
09:00-12:30 - Graduates Session
With Speakers from the DIA and National Health Authorities to discuss:
Key Note Speakers:Georgette Lalis,European Commission,
DG Enterprise and Industry, Belgium Jean-Franois Dehecq,sanofi-aventis, France
18:00-21:00
Buffet Reception
13:00-13:45
Special Session:
An Assessment of the Community System of Pharmacovigilance
Session Moderator: Marie A. Dray
Speaker: Peter Arlett, MD, European Commission, Europe
The European Commission-sponsored study An Assessment of the Community System of Pharmacovigilance was made public in February 2006 and the Commission has launched a public consultation on its results including an invitation to comment on the strengths and weaknesses of the Community System. As part of this consultation, Dr. Arlett will present the study report and attendees will be invited to make comments and pose questions on the Community System of Pharmacovigilance.
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.
FDA-Approved Gene Therapy Beqvez Shows Sustained Efficacy, Safety in Long-Term Hemophilia B Trial
April 17th 2025Beqvez (fidanacogene elaparvovec), an FDA-approved one-time gene therapy for hemophilia B, demonstrated sustained factor IX expression, low bleeding rates, and a favorable safety profile over long-term follow-up.