An Essential Overview of Pharmacovigilance

An Essential Overview of Pharmacovigilance is dedicated to the evolving regulatory landscape of pharmacovigilance and how to ensure compliance with EU safety legislation in the pharmaceutical industry.

Topics

• Documentation to be Supplied to Regulatory Authorities
• An Introduction to EU Pharmacovigilance
• The Roles and Responsibilities of a Licence Holder
• Department Links in the Company to Pharmacovigilance
• Standard Operating Procedures (SOPs) in Relation to Pharmacovigilance
• The Role of the Qualified Person (QP) for Pharmacovigilance
• Pharmacovigilance Inspections

Who should Attend

Attendees involved or interested in:

• Regulatory Affairs
• Pharmacovigilance
• Sales & Marketing
• Clinical
• Commercial
• Legal
• Quality