The 2021 Conference builds on prior very successful conference series and leverages learnings from Regulators and international experts in the field. Clinical trial sponsors and academia are facing a host of new registration requirements in Europe in comparison with other regions. With evolving requirements comes new challenges, creating additional opportunities for knowledge-sharing and necessitating more interaction with peers. This event will provide essentials and timely information about global clinical trial disclosure, data transparency, data sharing for secondary research and updates on the EU Clinical Trial Information System (CTIS) and how Brexit is impacting the disclosure ecosystem. It brings leading study sponsors from Industry and Academia together with regulators and other players to exchange knowledge and share their experiences with the implementation of Clinical Trial Disclosure and Data Transparency from various viewpoints.
- Strategic Aspects of Disclosure and Transparency Beyond Compliance
- UK Disclosure Requirements Updates’
- Patients’ Perspectives around Disclosure
- Considerations on Increased Transparency, Data Privacy and Data Sharing
- Disclosure Requirements in Medical Device Studies
- Non-Interventional studies
- Academia’s Challenges in Clinical Trial Disclosure – Bridging the Gap
- Global Collaboration Initiatives and the Benefits for Transparency & Disclosure
- Lay Summaries are coming!
- Public Demonstration of EU CTIS
- EU Clinical Trial Regulation: Joint Collaboration within Industry Organisation
Who should attend?
Professionals from Industry, Academia, Regulatory Authorities and other domain involved in:
- Clinical trial disclosure
- Data transparency/data sharing
- Transparency policies and compliance
- Medical writing, medical affairs, and medical communications
- Clinical operations
- Clinical Data Protection responsible
- Data management
- Clinical/Medical Research
- Patient Advocacy
- Benefit from the various perspectives on regulatory, legal aspects and practical challenges from large to smaller sponsor organisations.
- Leverage best practices on the practical implementation through case studies by the exchanging of views between regulators, industry, patients, academia and other stakeholders.
- Gain insights into how the transparency provisions in the EU Clinical Trial Regulation are implemented in the Clinical Trial Information System (CTIS) and how the latter works.
- Gain insights on the impact of Brexit pertaining to the clinical trial registration and results reporting requirements.
- Use a unique opportunity for networking and asking questions to your own specific situation and area of responsibility.
Merete Joergensen, MBA, MSc • Clinical Disclosure and Transparency Expert, Former EFPIA, CREG Clinical Trials
Scott Feiner • Senior Manager, Clinical Records Management, Strategic Clinical Operations
AbbVie, United States
Robert Paarlberg, MS • Principal
Paarlberg & Associates LLC, United States
Nate Root, MSc • Associate Director, Disclosure and Transparency
Ionis Pharmaceuticals, United States
Matthias Zerm, PhD • Lead Expert, Clinical Trial Disclosure and R&D Processes
Merz Therapeutics, Germany
Thomas Schindler, PhD • Director Medical Writing
Sameer Sharma, MPharm • Manager, Clinical Trial Transparency
Merck KGaA, Germany