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SESSION 9: EMA Policy 0070: Challenges and Techniques for Sponsors
Session Chair(s)
Merete Joergensen, MBA, MSC
Clinical Disclosure and Transparency Expert
Merete-J Consulting, Denmark
With increasing regulations for transparency, how are patients and Ethics Committees impacted and do the regulations meet their needs?
Speaker(s)
Industry Experience with Preparing Documents for Submission
Nicole Hinton
Ultragenyx Pharmaceutical, United States
Executive Director, Clinical Trial Transparency
Mats Ericson, PHD
Amgen, France
Director Regulatory Affairs
Technical Solutions to Ease the Process of Redaction/ Anonymisation/Justification
Janice Branson, MSC
Novartis Pharma AG, Switzerland
VP Head of Statistics, Immunology & Dermatology Unit