Pharmacovigilance Quality Management Training
Day 1: 9.00 a.m. – 5.00 p.m.
Day 2: 9.00 a.m. – 5.00 p.m.
Day 3: 9.00 a.m. – 4.30 p.m.
Breaks will be arranged flexibly.
Content of the Course
Day 1
1. Introduction to Pharmacovigilance: Regulatory Requirements and Where They Come From
- Basics and general expectations in Good Vigilance Practice
- Pharmacovigilance (PV): Who is in charge of what?
o Organisational schemes
o Local PV contact person
o Qualification and training measures
o 24/7 availability
- What do NCAs (National Competent Authorities) expect?
o Experiences with Arab, other domestic and international authorities so far
- Examples for Do’s and Don’ts as a local PV contact
2. PV Requirements in MENA (Middle East and North Africa)
- Country specific requirements
- The registration process and legal requirements
- Contract specific requirements
- Typical contract templates
- Contract management: key elements and potential stumbling blocks
3. Partnerships with MAHs located in the EU
- What do EU based partners (MAHs, Marketing authorisation holders) expect from PV partners?
- Obligations: EU and Arab countries – commonalities and differences
- Local specific regulations in the regulatory context of the EU market
- The role of the EU QPPV (Qualified Person for Pharmacovigilance)
- Compliance challenges
o Key performance indicators
o Typical contracts
o Challenges with international partnerships
Following the official part of the conference, Chem-Academy invites you to a social evening reception. Benefit from the informal surrounding to intensify business contacts and extend your network.
Day 2
4. Partnerships with MAHs located in the US
- What do US based MAHs expect from PV partners?
- The US FDA (Food and Drug Administration): obligations
- Local specific regulations in the regulatory context of the US market
- Compliance challenges
o Key performance indicators
o Typical contracts
o Challenges with international partnerships
5. Monitoring of Medicine in the Market
- Monitoring in the target market
- Indicators for the maturity of a regulated healthcare market
- How to identify customer’s needs, and how to assess complaints
- How to trend customer satisfaction (ISO 9001)
- Typical adverse events (AEs) and experience in assessment of these
- How to serve PV expectations in the daily business
- Assessing patient’s feedback: behavior, typical complaints, and actual safety issues
- Processing PV relevant information
- PV’s role in case of a product recall
6. Safety Database
- Relevant applications
o EudraVigilance: the EMA’s (European Medical Agency) system for information on suspected adverse reactions
- Validation of digital systems
- The interface from principal to partner
- Reconciliation process
Day 3
7. Processes and the Toolbox for PV
- Defining processes for PV compliance
- Case intake and case report management
o What is the role of the QPPV?
o Follow-up
- Signal Management
- Literature searches
- Periodic Safety Update Report (PSUR)
- Risk Management Plans (RMPs)
- Business Continuity Plan in Pharmacovigilance
- Deviation Management
- Pharmacovigilance System Master File (PSMF)
8. Pharmacovigilance Documentation
- Good Documentation Practice
- Implementing a Quality Management System
o Key elements of ISO9001
- Electronic and paper-based documentation
- Data Management
o Data Protection Requirements
o European data requirements and expectations by partners and NCAs
o Retention of Safety relevant data
o Traceability and retrievability
o Source Data Verification
o How to exchange data with partners from different regulatory frameworks
9. PV Inspections
- What does “inspection readiness” mean?
- Preparing for inspections
- Typical questions during inspections
o Lessons learned from inspection by the US FDA and European authorities
- Dos and Don’ts before, during and after inspection
- Proper CAPA management (Corrective and Preventive Action)