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Session 8 Track 2: Transparency and Public Disclosure Requirements for Medical Writing Submission Documents
Session Chair(s)
Ruggero Galici, PhD
Director, Nonclinical and Clinical Pharmacology Writing
Alexion Pharmaceuticals, AstraZeneca Rare Disease, United States
The EU is launching two electronic systems that will facilitate clinical data transparency and public disclosure. The Clinical Trial Information System (CTIS) and the European Database for Medical Devices (Eudamed) are expected to be functional in 2022. This presentation will discuss the changes in transparency and disclosure requirements in the EU, and the global impact of these new requirements on global submission documents. Early experiences with these systems will be shared, including the documents impacted, how they are impacted, and the timelines involved.
Learning Objective : At the conclusion of this session, participants should be able to:
- Describe the new requirements in transparency and public disclosure in the EU in connection with the new systems CTIS and Eudamed
- Identify the medical writing documents impacted and how they are impacted
- Describe the role that medical writers in complying with the requirements of CTIS and Eudamed
Speaker(s)
Speaker
Raquel Billiones, DrSc
Alexion Pharmaceuticals (AstraZeneca Rare Disease), Switzerland
Director, Medical Writing