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Session 5: Transparency as the new normal - Practical Aspects of Document Disclosure: What, When and Where
Session Chair(s)
Matthias Zerm, PHD
Lead Expert, Clinical Trial Disclosure and R&D Processes, Germany
Taking it to the document level: From the WHO Trial Registration Data Set and basic results entries, via protocols and SAPs, to (almost) entire clinical trial applications and clinical reports from market application dossiers. This session will explore:
1) What (clinical) documents are published where and when,
2) Practical approaches and implications in sponsor organizations,
3) What roles will clinical trial disclosure expert functions have in it.
Speaker(s)
Vilmantas Navickas, MBA
Principal Operations Manager, Boehringer Ingelheim Pharma Gmbh & Co. KG, Germany
Document Disclosure: Approach and Experience in the EEA
Sandeep Undavalli, MS
Clinical Transparency Specialist, Novo Nordisk Service Centre India Private Ltd, India
Increasing Document Disclosure Requirements: Novo Nordisk’s Approach
Lora Killian, MBA
Clinical Trial Transparency and Disclosure Lead, Pfizer, United States
Harmonizing Organizational Disclosure Practices in the Current Disclosure Landscape
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