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Session 9: Plain Language Protocol Synopses and Trial Results
Session Chair(s)
Scott Feiner
Senior Manager, Trial Disclosure, AbbVie, United States
Robert Paarlberg, MS
Principal, Paarlberg & Associates LLC, United States
This session will provide general experience with protocol plain language synopses as well as reporting clinical trial results and recent efforts with AI. Areas to be addressed include Annex IV (Summary Results of the Clinical Trial), interim results, intermediate results as well as highlighting the differences with what is reported from the clinical study report between Policy 0070 and the EU Clinical Trials Regulation.
Speaker(s)
Introduction
Thomas Schindler, PhD
Director Global Regulatory Affairs - Regulatory Operations, BioNTech SE, Germany
Plain language Synopsis Protocol
Julia Anna Hild
Global Clinical Development & Operations, Boehringer Ingelheim Pharma GmbH & Co.KG, Germany
Plain language Synopsis Protocol
Mary Lynn Mercado, PhD
Senior Group Head Regulatory Writing, Novartis Pharmaceuticals Corporation, United States
Clinical Trial Results in CTIS : A 360o View
Ruediger Pankow, DRSc
Clinical Trial Regulatory Consultant | CTIS SME, Independent Consultant, Germany
Clinical Study Reports (CSR) & The Difference Between Policy 0070 and EU CTR
Scott Feiner
Senior Manager, Trial Disclosure, AbbVie, United States