Pharmacovigilance System Compliance During Medical Product Life Cycle
Book a session
| Date | Product | Location | Price | |
|---|---|---|---|---|
| 17/11/2025 | Pharmacovigilance System compliance during medical product life cycle | Brussels | EUR 1850 | Book |
| If you would like to have this course as an in-house session click here | ||||
About this course
Reasons to attend
The Pharmacovigilance training 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 Pharmacovigilance training 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
Course schedule
- Two Day face-to-face training: 09h00-17h00
Course Description
Day 1: Essentials for pharmacovigilance complianceMorning session:- Pharmacovigilance Systems and sponsors & MAHs responsibilities
- PV System Quality Management
- Regulatory Intelligence
- Business Continuity Plan
- Contractual Agreements
- Essential / Basic Business Operation processes
- PV Tools - EMA go life plan
- Safety Monitoring
- Workshop
- Signal Management cycle and Risk minimisation strategy
- Inspection readiness
- Workshop
- Q&A - training Closure
Programme highlight
- The mandatory requirements for pharmacovigilance system compliance during medicines products life cycle.
Learning objectives
- Understand the essential requirements for PV system compliance
- Be able to identify the key success factors for Authority Inspections readiness
- Be able to self-evaluate PV tasks and management – Risk based approach / gap analysis
- Become familiar with mandatory pharmacovigilance system compliance including Contractual agreements, expedited and periodic safety reporting in clinical trials and post-marketing
- Be familiar with the requirements for Pharmacovigilance system compliance
- Be acquainted with recent EMA changes that impact Marketing Authorities Holders (MAHs) for 2017 – 2018.
- Know the elements for pharmacovigilance audits and inspections readiness
- Understand the principles of signal and Risk management cycles and Risk minimisation strategy
- Be able to describe the pharmacovigilance quality management – tools for compliance
Who should attend
- Professionals involved in pharmacovigilance mainly Qualified Persons for Pharmacovigilance (QPPV)
- Pharmacovigilance Quality Managers
- PV compliance collaborators
- Pharmacovigilance auditors
- Other stakeholders:
- CEO, COO of medium to small size companies, as they need to understand the implications and need for compliance in pharmacovigilance
Competencies
This course covers competencies that are part of the ECCRT Competency Framework
- Scientific Concepts & Research Design (1)
- Ethical & Participants Safety Considerations (0)
- Investigational Product Development and Regulation (7)
- Clinical Studies Operations (GCPs or ISO 14155) (7)
- Study and Site Management (1)
- Data Management and Informatics (4)
- Leadership and Professionalism (0)
- Communication (0)
- Teamwork (0)
- Business acumen (0)
Trainers
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