Short Courses: September 18
Conference: September 19-20
Clinical trial information transparency is taking on new dimensions. Clinical trial sponsors and academia are facing a host of new registration requirements in the US, EU, and elsewhere. With evolving requirements comes new challenges, creating additional opportunities for knowledge-sharing and necessitating more interaction with peers. This conference will provide critical and timely information relating to global clinical trial disclosure and data transparency from those on the front lines.
NEW! This year's conference will have an even greater global presence than ever!
Check out our 2019 Program!
On-Demand WebinarEU Device Regulations – The European Database on Medical Devices (Eudamed)
The EU’s 2017 passage of new medical device regulations presents substantial changes in how clinical trials of medical devices are disclosed in the EU, from protocol approval to the reporting of summary results. In 2020, Eudamed will provide the public with a comprehensive view of medical device research and approvals throughout the EU. This webinar will look at the new EU requirements and discuss how sponsors can approach meeting them.
Who should attend?
- Clinical trial disclosure
- Transparency policies and compliance
- Clinical operations
- Medical writing, medical affairs, and medical communications
- Data management
- Data transparency/data sharing
- Clinical/Medical Research
- Patient Advocacy
- Discuss best practices to achieve good compliance
- Assess the operational challenges and considerations in executing Innovative Trial Designs
- Describe the changes in EudraCT and the practical implications
- Describe the current status of Clinical Data Summary Pilot Program and any findings related to the program implementation to date
Robert Paarlberg, MS • Principal
Paarlberg & Associates LLC, United States
Suzanne Carlson, MA • Consultant
ABSD Associates, LLC, United States
Kelly Coulbourne, MS • Director, Clinical Trial Disclosure and Data Transparency
Arena Pharmaceuticals, United States
Patrick Fawcett • Information Disclosure Administrator, Office of Research Protections
University of Pittsburgh, United States
Merete Joergensen, MBA, MSc • Senior Director, Clinical Transparency
Novo Nordisk A/S, Denmark
Francine Lane, MBA • Vice President, Global Transparency
Informa, United States
Nate Root, MSc • Associate Director, Disclosure and Transparency
Ionis Pharmaceuticals, United States