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Dec 05, 2023 1:15 PM - Dec 07, 2023 7:00 PM

(Central Europe Standard Time)

DIA Global Clinical Trial Disclosure and Data Transparency Conference

This virtual live conference is a must-attend for anyone involved in clinical trials!

Session 9: Plain Language Protocol Synopses and Trial Results

Session Chair(s)

Scott  Feiner

Scott Feiner

Senior Manager, Trial Disclosure

AbbVie, United States

Robert  Paarlberg, MS

Robert Paarlberg, MS


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.


Thomas  Schindler, PhD


Thomas Schindler, PhD

BioNTech SE, Germany

Director Global Regulatory Affairs - Regulatory Operations

Julia Anna  Hild

Plain language Synopsis Protocol

Julia Anna Hild

Boehringer Ingelheim Pharma GmbH & Co.KG, Germany

Global Clinical Development & Operations

Mary Lynn  Mercado, PhD

Plain language Synopsis Protocol

Mary Lynn Mercado, PhD

Novartis Pharmaceuticals Corporation, United States

Senior Group Head Regulatory Writing

Ruediger  Pankow, DrSc

Clinical Trial Results in CTIS : A 360o View

Ruediger Pankow, DrSc


Regulatory Affairs Expert, CTIS SME and PO

Scott  Feiner

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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