Description
BENEFITS IN ATTENDING
Ensure your company s pharmacovigilance strategy is compliant.
As truly pan-European requirements for product development and registration have become a reality, there is an accompanying need for a consistent, homogenous and harmonised approach for the monitoring of adverse drug reactions and the sharing of safety information across the EU. The various EU Pharmacovigilance guidelines intend to achieve this. This seminar will provide an interpretation of the new regulations and detailed guidance on how SARs should be handled, the requirements of PSURs and Pharmacovigilance Inspections. This will be reinforced by interactive case-based discussions and workshops. In addition, an overview of some of the future issues in respect of global harmonisation and electronic communication will be considered.
There will be an option to discuss individual cases for review by the group. Please bring case details with you.
