CTIS, EMA Policy 70, global registry requirements: Master data disclosure, transparency and lay summaries best practice with guidance from the experts Thomas Wicks and Jaclyn Spedaliere.
Examine emerging country-specific registry requirements and gain a comprehensive understanding of global regulatory updates and impact on clinical data transparency functions.
Examine emerging country-specific registry requirements and gain a comprehensive understanding of global regulatory updates and impact on clinical data transparency functions.
Thomas Wicks
Head of Transparency Operations, Citeline
ライフサイエンス分野で20年以上の経験を持つ戦略リーダーであり、現在はCitelineの透明性業務責任者を務めています。業界をリードするTrialScopeの情報開示ソリューションの戦略を指揮し、透明性に関する深い知識と実績を持っています。
トーマスは、情報開示要件や透明性のトレンドについてのオピニオンリーダーとしても高く評価されており、これまでに60以上のカンファレンスで講演し、40以上の出版物を執筆しています。また、裁判の透明性を尊重するソリューションを加速させることを使命とし、チームに力を与えることに情熱を注いでいます。
Jaclyn Spedaliere
Senior Director, Commercial Strategy & Delivery, Citeline
Jaclyn is an accomplished director with over 15 years of experience driving growth and customer success with leading technology companies. She currently serves as Senior Director, Commercial Strategy & Delivery at Citeline, where she supports pharmaceutical companies in navigating the clinical environment with Citeline’s Regulatory portfolio suite of products.
Clinical Data Disclosure Europe focuses on advancing practices and regulations related to the transparency of clinical trial data. It addresses the latest developments in clinical data disclosure, including the EU’s requirements for data sharing and transparency. The event covers best practices for creating plain language summaries that make clinical trial results accessible to the public and stakeholders, ensuring compliance with regulatory standards. Discussions often include strategies for improving data transparency, enhancing public trust, and addressing challenges in data disclosure. The conference brings together experts from the industry, regulatory bodies, and advocacy groups to share insights and foster collaboration on these crucial issues.
Register for the event by visiting the event site.
