Given the COVID-19 pandemic, we want to make sure that our programmes can be followed in a safe environment for you. Therefore, we will switch this course to a series of live online sessions (webinars) until further notice. You can register for the course here, as we will ensure that your registration will be transferred to the online format. If there is a price difference you will be invoiced the lower amount.
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 standalone course.
Day 1: Essentials for pharmacovigilance compliance
- Pharmacovigilance Systems and sponsors & MAHs responsibilities
- PV System Quality Management
Day 2: “Advanced course” Pharmacovigilance Business Operations – Key operational Processes
- Regulatory Intelligence
- Business Continuity Plan
- Contractual Agreements
- Essential / Basic Business Operation processes
- PV Tools - EMA go life plan
- Safety Monitoring
- Signal Management cycle and Risk minimisation strategy
- Inspection readiness
- Q&A - training Closure