Overview
Clinical trial sponsors and academia are facing a host of new registration requirements worldwide. With evolving requirements come new challenges, which call for benefits that create additional opportunities for knowledge-sharing and interaction with peers offer.
The 2022 Global Clinical Trial Disclosure and Data Transparency Conference builds on prior successful conferences to leverage learnings from regulators and international experts in the field. This event will provide essential, timely information about global clinical trial disclosure, data transparency, data sharing for secondary research, and the EU Clinical Trial Information System (CTIS) with the focus on transparency in relation to the protection of personal data and commercially confidential information. 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.
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
- Statisticians and biometrics
- Medical writing, medical affairs, and medical communications
- Clinical operations
- Compliance/Legal
- Clinical Data Protection responsible
- Regulatory
- Publications
- Data management
- Clinical/Medical Research
- Patient Advocacy
Learning objectives
Objectives
- 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.
- Spotlight focus on disclosure requirements in the US, Canada, the EU, the UK, China, and Japan.
- Use a unique opportunity for networking and asking questions to your own specific situation and area of responsibility.
Attendees will:
- Learn about current and upcoming disclosure requirements, with spotlight on the US, Canada, the EU, the UK, China, and Japan
- 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
- Explore the impact of data protection for personal data and options and functionality of protection of commercially confidential information
- Obtain practical suggestions for preparing disclosure-ready study documents, including redaction options
- Review the requirements for lay language summaries and options for producing these documents
- Network with regulators, industry, patients, academia and other stakeholders to ask questions and leverage best practices for your own specific situation and area of responsibility
Program Committee
-
Merete Joergensen, MBA, MSc • Clinical Disclosure and Transparency Expert, Former EFPIA, CREG Clinical Trials
Independent, Denmark -
Scott Feiner • Senior Manager, Clinical Records Management, Strategic Clinical Operations
AbbVie, United States -
Robert Paarlberg, MS • Principal
Paarlberg & Associates LLC, United States -
Matthias Zerm, PhD • Lead Expert, Clinical Trial Disclosure and R&D Processes
Merz Therapeutics, Germany -
Thomas Schindler, PhD • Director Medical Writing
BioNTech, Germany -
Joyce Swart • Clinical Disclosure Lead
Alcon Research, LLC, United States
