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Disclosure of Clinical Regulatory Documentation - The Company Perspective (How do we disclose documentation?)

Level:
Area:
Code:
Sym5.7
Duration:
00:45:00
Workshop profile:
Objective:
Content:
EMA Policy 0070 and the challenges facing the pharmaceutical industry This session will provide insights into sponsor-internal processes to ensure compliance with EMA Policy 70. For a sponsor, the challenge is to satisfy the regulatory needs whilst protecting both personal data and commercially confidential information in addition to maintaining fast and efficient processes. During the talk, we will address the key processes for provision of transparency-ready clinical documents. Other topics are the information and training of the relevant departments and the need to consider the general public as a secondary audience.