September 14-15: Conference
Short Course 1: Disclosures 101
This preconference training is designed for professionals new to clinical trial disclosure operations.
Short Course 2: Preparing Documents for Disclosure and Public Sharing
This preconference training is appropriate for medical writers who will be preparing documents for disclosure.
*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.
- NEW - Engage with the DIA CTD community at the open meeting
- NEW- Poster session and oral abstract presentations
- Keynote Address from Michael S. Lauer, MD, FACC
- 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 courses to enhance your learning experience
- Exhibits to learn about the latest solutions and services
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 • Senior Trial Disclosure Director, Global Clinical Registry
Novo Nordisk A/S, Denmark
Erik Lakes, MS, MSc • Director, Clinical Study Disclosure
PRA HEALTH SCIENCES, 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 • Lead Expert, Clinical Trial Disclosure and R&D Processes
Merz Pharmaceuticals GmbH, Germany