GXP Solutions | Good Pharmacovigilance Practices (GVP) Training

Good Pharmacovigilance Practices (GVP) Training

These GVP training courses focus on the activities relating to the detection and prevention of adverse effects and problems associated with medicines. The course is a complete training solution or may serve as a refresher course for those working in Pharmacovigilance.

Note

Course content can be tailored to your business needs.
All courses are live group training events.

Course 1 - Good Pharmacovigilance Practices (GVP) Regulations

Good Pharmacovigilance Practices (GVP) course covers key topics in Pharmacovigilance including:

The Pharmacovigilance System and Its Quality Systems
Pharmacovigilance System Master File (PSMF)
Pharmacovigilance Inspections
Risk Management Systems
Management And Reporting of Adverse Reactions.
Periodic Safety Update Report (PSUR)
Post Authorization Safety Studies

Course 2 - Pharmacovigilance and Drug Safety Auditing Course

Pharmacovigilance and Drug Safety Auditing Course will include the following topics. With a focus on how to verify compliance with GVP regulations.

Pharmacovigilance (PV) Roles and Responsibilities
PV Quality Management Systems
Training
Product Quality Complaints (PQC)
Product Recall Management
Medical Information Enquiries
Vendor Management
Regulatory Affairs
Case Processing
Aggregate Reporting (e.g., PSUR/PBRERs)
Risk Management
Archiving
Computer System Validation for PV Systems