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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)
Document Disclosure: Approach and Experience in the EEA
Vilmantas Navickas, MBA
Boehringer Ingelheim, Germany
Principal Operations Manager
Increasing Document Disclosure Requirements: Novo Nordisk’s Approach
Sandeep Undavalli, MS
Novo Nordisk Service Centre India Private Ltd, India
Lead Clinical Disclosure Professional
Harmonizing Organizational Disclosure Practices in the Current Disclosure Landscape
Lora Killian, MBA
Pfizer Inc, United States
Clinical Trial Transparency and Disclosure Lead
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