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Systems Approach to Good Pharmacovigilance Practice

Course Information

The purpose of this course is to facilitate how delegates visualise, monitor and provide assurance of how elements of the pharmacovigilance system fit together, interact and change over time to achieve the objectives of pharmacovigilance. 
Auditors and Pharmacovigilance (PV) practitioners will explore application of the legal requirements in the GVP modules. They will examine how the PV system and its quality system interact to achieve compliance with regulatory requirements to enable safe use of medicines. PV auditors will develop an approach to define the scope of the PV audit and conduct PV audits. PV practitioners will develop an approach to implementing, monitoring and maintaining the PV system. The course uses presentations and workshops.

Who should attend

  • Auditors
  • Pharmacovigilance Quality System Managers
  • Pharmacovigilance scientists
  • The QPPV


Throughout the course delegates will explore how to apply the legal requirements for the PV system and quality system and how to assure these systems.
They will demonstrate their ability to contribute to 

  • The compilation and maintenance of the Pharmacovigilance Safety Master File
  • The audit and maintenance of an effective and efficient PV system and quality system
  • The risk based approach to auditing the PV system and quality system
  • The maintenance of 'inspection readiness'
  • Oversight of the PV system

The course is structured to encourage delegates to explore GVP through the

  • Application of the legal requirements and key processes to meet the objectives for pharmacovigilance
  • Analysis of how the PV quality system integrates with the PV system to deliver the objectives of the system
  • Development of a Pharmacovigilance System Master File
  • Exploration of the principles of risk based auditing and the Competent Authority's approach to risk based inspections
  • Exploration of how to audit and monitor processes with the PV system and quality system.

Course Tutors

Ron Ward
Consultant, Support in Pharmacovigilance Ltd (Course Principal)

Jana Hyankova
Director, EU QPPV, PrimeVigilance s.r.o.

Keith Wibley
Director of Pharmacovigilance, VigiReg Consulting Ltd

Sophie Radicke

Recent Feedback

"A very complete course. Very clear and very well managed bearing in mind the large extent of the matter.
Workshops have been very useful."

Course Material

This course is running in our paper format. Access to the course material will not be given to delegates in advance of the course.

Additional Requirements
(not included in course fees)

Accommodation is available at Madingley Hall for the dates of the course. If you wish to book alternative dates please specify in the ‘accommodation requirements’ box when making your booking and we will check availability with Madingley Hall.

Course Programme

Day 1

8.30 Registration
8.45 Welcome and Course Objectives
Illustration of what we need to know in order to success. Explanation of what is meant by Risk Benefit Assessment and safe use of medicines.
9.25 The Regulatory Framework and the role of the QPPV
Description of the regulatory framework in the EU and how it is applied.
10.40 Break
11.10 Introduction to Workshops
11.20 The Pharmacovigilance System
Exploration of the structures processes for pharmacovigilance and how these interact.
12.00 Workshop 1 and feedback
The Pharmacovigilance System Puzzle: Exploration of how it fits together
12.30 Lunch
13.15 The Quality System for Pharmacovigilance
Exploration of the structures processes for the PV quality system and discussion of how it interacts with the pharmacovigilance system to meet the objectives of pharmacovigilance effectively and efficiently.
14.00 Workshop 2: The Quality System Puzzle
Explore the organisation of the PV quality system and how it interacts with the PV system
14.15 Workshop 2 feedback
14.30 Risk Management Plans: A Cornerstone of Pharmacovigilance
15.30 Break
16.00 Understanding and Investigating 'Real Life Situations' in the Pharmacovigilance System
17.00 Workshop 3: Exploration of the PV system in real situations
18.00 Close of day 1

Day 2

8.30 Pharmacovigilance in the Clinical Trial environment
Information flow and responsibilities of the sponsor.
9.30 The Pharmacovigilance Safety Master File: Construction of the Pharmacovigilance System Master File and its purpose
11.00 Break
11.30 Processing of safety data
Exploration of safety data processing, verification, validation, follow up, formatting and collation, reporting requirements, quality and data management
13.00 Lunch
13.45 Workshop 4
14.15 Workshop 4 feedback
14.45 Signal detection and evaluation / Risk Benefit Assessment
What is a signal? What are the regulatory requirements?. How is signal detection and evaluation conducted? Qualitative and quantitative methods of signal detection. Risk Benefit Assessment
15.45 Break
16.00 Safety Communications, Direct Healthcare Professional Communications
17.00 The Pharmacovigilance Risk Assessment Committee (PRAC)
Exploration of how good practice is achieved. Composition, Role and Responsibilities.
17.30 Workshop 5: To explore good practice within the PRAC
18.00 Close of day 2

Day 3

8.30 Periodic Safety Update Reports (PSURs)/Periodic Benefit Risk Evaluation Reports (PBRERs)
Regulatory requirements, exploring good practice, Report Format, Reference Safety Information, schedule of submission, analysis evaluations and distribution.
9.30 Workshop 5: To explore the compilation and submission of the PSUR
10.00 Break
10.30 Workshop 5 Continued: To examine the compilation of the PSUR, source of information and presentation
10.50 Workshop 5 feedback
11.30 Transmission to competent authorities
Description of EudraVigilance, xEVMPD
12.30 Lunch
13.30 Exploration of the principles of risk based inspections and a review of common inspection findings
14.10 Break
14.40 Development Safety Update Reports (DSURs)
Regulatory requirements, exploring good practice, Report Format, Reference Safety Information, schedule of submission, analysis evaluations and distribution.
15.20 Recap of course with questions and answers
15.50 End of course

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