Medical Governance and Compliance in the Pharmaceutical and MedTech Industries
The objective of this White Paper is to guide Medical Affairs personnel on the key components of the legal, regulatory, and industry codes of practice requirements which are applicable to Medical Affairs in Pharma and Medical Devices industries, and how to identify and mitigate risks. This paper also includes company control frameworks for compliance with the requirements through policies, processes (usually captured in Standard Operating Procedures [SOPs]), systems, training, monitoring, and audit.