概要
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.
Highlights
- 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
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プログラム委員会
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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 Clinical Disclosure and Transparency Expert
Merete-J Consulting, Denmark -
Erik Lakes, MS, MSc Senior Director and Head, Data Disclosure & Transparency
Beigene, United States -
Melanie North, PhD Manager, Clinical Trial Transparency and Disclosure
United States -
Patricia 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
