GVP Module VI - Collection, management and submission of reports of suspected ADR to Medicinal Products
The purpose of this training is to enable you to better understand the new obligations of Marketing Authorisation Holder's (MAH's) on collection, management and submission of reports of suspected Adverse Reactions to Medicinal Products as described in GVP Module VI rev. 2 effective since 22nd of November 2017.
MAH, Risk Management System, European GVP Module VI, Reporting of ADR, Emerging Safety Issue, Post-authorisation studies
Once completed, you will be able to:
Know all new definitions
Identify and notify an emerging safety issue
Comply strictly with the new requirements for collecting and reporting adverse reactions in the interim and final arrangements
Be aware of new changes including in the Revision 2, particularly for the ICSRs