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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
BioNTech SE, Germany
Director Global Regulatory Affairs - Regulatory Operations
Plain language Synopsis Protocol
Julia Anna Hild
Boehringer Ingelheim Pharma GmbH & Co.KG, Germany
Global Clinical Development & Operations
Plain language Synopsis Protocol
Mary Lynn Mercado, PhD
Novartis Pharmaceuticals Corporation, United States
Senior Group Head Regulatory Writing
Clinical Trial Results in CTIS : A 360o View
Ruediger Pankow, DrSc
Germany
Regulatory Affairs Expert, CTIS SME and PO
Clinical Study Reports (CSR) & The Difference Between Policy 0070 and EU CTR
Scott Feiner
AbbVie, United States
Senior Manager, Trial Disclosure
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