September 13: Short Courses*
September 14-15: Conference
Short Course 1: Disclosures 101
Short Course 2: Preparing Documents for Disclosure and Public Sharing
*Short Courses require separate registration.
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 and the EU. With evolving requirements comes a host of new challenges, creating additional opportunities for knowledge-sharing and necessitating more interaction with peers. This conference will provide critical and timely information relating to clinical trial disclosure and data transparency from those on the front lines. It will highlight major recent regulatory changes and other related hot topics to clinical trial disclosure information transparency, including implementation of the US Final Rule, EMA Policy 0070, EMA policy 0043, data sharing, and lay language summaries. Engage with speakers who will provide expert insight into how study sponsors from industry, academia, and government are addressing these changes and putting them into practice.
Take a look at our Preliminary Schedule At-A-Glance.
Approved by the Regulatory Affairs Professionals Society for 12 RAC credits.
- Engage with the DIA CTD community
- Hear firsthand from colleagues from clinicaltrials.gov and the EMA on regulatory changes
- Patient-level data sharing of best practices, challenges, and data protection
- Exclusive short course to enhance your learning experience
Who should attend?
Professionals involved in:
- Clinical trial disclosure
- Transparency policies and compliance
- Clinical operations
- Medical writing, medical affairs, and medical communications
- Data management
- Data transparency/data sharing
At the conclusion of this conference, participants should be able to:
- Explain present and upcoming requirements for clinical trial disclosure and data transparency requirements globally
- Identify IT systems and tools that can facilitate clinical trial data disclosure compliance
- Describe best practices for operationalizing new provisions to be compliant with the new regulations for clinical trial disclosure and data transparency
Robert Paarlberg, MS • Principal
Paarlberg & Associates LLC, United States
Marla Jo Brickman, PhD • Senior Director - Clinical Data Transparency/Compassionate Access Lead
Pfizer Inc, United States
Merete Joergensen, MBA, MSc • Director, Global Clinical Registry
Novo Nordisk A/S, Denmark
Erik Lakes, MS, MSc • Associate Director, Global Clinical Study Disclosure
Takeda Development Center Americas, Inc., United States
Melanie North, PhD • Consultant
Melanie North Consulting, United States
Patricia A. Teden, MBA • President and Principal
Teden Consulting LLC, United States
Matthias Zerm, PhD • Sr. Expert Clininal Trial Disclosure and R&D Processes
Merz Pharmaceuticals GmbH, Germany