Reasons to attend
The course will highlight the mandatory requirements for pharmacovigilance system compliance during medicines products life cycle indicating the main pillars for compliance effectiveness and the relevant key operational processes.
The course is composed of 2 parts: day one is providing the essential elements in pharmacovigilance, whereas day two consists of practical workshops for the attendees with pharmacovigilance functions. Day one can be attended as a standalone course.
What's included?
- Documents and materials related to this course are included
- Globally recognised certificates awarded after test completion
- This course has been granted PharmaTrain Recognition
Course schedule
Two Day face-to-face training: 09h00-17h00
Course Description
Day 1: Essentials for pharmacovigilance compliance
Morning session:
- Pharmacovigilance Systems and sponsors & MAHs responsibilities
- PV System Quality Management
Afternoon session:
- Regulatory Intelligence
- Business Continuity Plan
- Contractual Agreements
Day 2: “Advanced course” Pharmacovigilance Business Operations – Key operational Processes
Morning session:
- Essential / Basic Business Operation processes
- PV Tools - EMA go life plan
- Safety Monitoring
- Workshop
Afternoon session:
- Signal Management cycle and Risk minimisation strategy
- Inspection readiness
- Workshop
- Q&A - training Closure
No testimonial yet