Cobert's Manual Of Drug Safety And Pharmacovigilance (Third Edition). William Gregory
Chapter 25Post-marketing Spontaneous ICSR/SAE Reporting
Post-marketing ICSRs versus Clinical Trial ICSRs
Notes on United States Requirements for Post-marketing NDA Reporting of SAEs
MedWatch to Manufacturer Program
Reports from the FDA via the Freedom of Information Act
Instructions on Filling Out the MedWatch Form
Post-marketing Periodic Reports
Section 1: Narrative Summary and Analysis
Section 2: Narrative Discussion of Actions Taken
Periodic Safety Update Reports
PSUR in ICH E2C(R2) Format: The Periodic Benefit–Risk Evaluation Report
Chapter 27Signals and Signaling in the Context of Risk Management
The Conclusions and Next Steps
Computerized Tools for Signal Detection and Workup
Key Documents on Signaling and Good PV Practices
FDA Guidance on Good Pharmacovigilance Practices of 3/2005
EU GVP Module IX — Signal Management (2012: Revision 1, Delivered Nov 2017)