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Session 8: Information (CCI) in Clinical Trial Applications and Documents
Session Chair(s)
Scott Feiner
Senior Manager, Trial Disclosure
AbbVie, United States
While the EMA has provided updated guidance on the protection of CCI in CTIS, it is Member States that assess applications and raise RFIs on redactions and sponsor justifications to protect CCI. This session will cover both sponsor approaches to protecting CCI and Member States assessment of these approaches. Special considerations for protecting CCI in Complex Clinical Trials, Pre-CTA advice from Member States, and Interim CSRs will be discussed. Note: Marianne Lunzer and Silvia Garrido-Lestache will be participating virtually
Learning Objective : At the conclusion of this session, participants should be able to:- Prepare applications that protect CCI
- Explain the publication of dosing information in the EU
- Anticipate the special considerations of Complete Clinical Trials and Interim CSRs
- Plan CCI protection approaches in line with Member State expectations
Speaker(s)
Speaker
Marianne Lunzer, DrMed
AGES, Austria
Assessor, Dept of Clinical Trials, Federal Office for Safety in Health Care
Speaker
Silvia Angela Garrido-Lestache, MSc
EMA, Netherlands
Clinical Data Publication Manager, Transparency Department
Accelerating Clinical Trials Publication by Proactively Protecting CCI: Adapting to EU-CTIS Revised Transparency Rules
Raina Agarwal, MPharm
MMS Holdings Pvt Ltd., India
Associate Director, Clinical Trial Disclosure and Transparency