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A 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.
Delegates 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 investigate systematically the Pharmacovigilance system and its quality system. PV practitioners and Quality Assurance Personnel 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 application of 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
  • Systematically investigate the Pharmacovigilance system and quality system
  • Examine how the Pharmacovigilance system and quality system interact to achieve compliance.
  • The risk based approach to auditing the PV system and quality system
  • The maintenance of 'inspection readiness'
  • Explore how to investigate the complexity of the PV system.
  • Discuss how to monitor and maintain the PV system and assure compliance

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

  • An enhanced understanding of key system principles
  • Application of the legal requirements and key processes to meet the objectives for pharmacovigilance
  • A practical approach  to implementing, maintaining and monitoring the PV system and its quality system
  • A procedure to share expertise to increase efficiency and confidence.
  • 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

This course is structured to encourage delegates to

  • Discuss and develop ideas
  • Share knowledge and experiences
  • Solve specific problem

By the end of the course delegates will be better able to:

  • Understand the pharmacovigilance system, its quality system and how these interact
  • Investigate, and analyse the pharmacovigilance system and to identify what is missing and what needs to be improved.

Course Tutors

Tutors will be comprised from the list below:

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

Jose Alberto Ayala Ortiz

Recent Feedback

"All presenters were clear and easy to understand."
"Different presentations from lots of different presenters was good."

CPD Points

23 Points

Course Programme

Please note timings may be subject to alteration


 Day 1

 8.30 Welcome, Registration and Course Objectives
Explore the marketing environment, burden of side effects.  Clarify the definition and objectives of Pharmacovigilance.  Illustration of the expanse of knowledge to implement and maintain a Pharmacovigilance system. 
 9.45 Explore the Regulatory Framework for Pharmacovigilance
Explore who is involved in the EU Regulatory Network.  Explore the reasons for changes to the EU Legislation.  Identify the relevant regulations and directives and when to apply them.  Explore the purpose of the GVP guidance, structure of modules and standard format of each module.  Identify a few other related requirements and where to find them.  List the sanctions for non-compliance. 
 10.15  Break
 10.45 The Pharmacovigilance Safety Master File
Construction of the Pharmacovigilance System Master File and its purpose.
 12.00 The Pharmacovigilance System
Exploration of the structures processes for pharmacovigilance. 
12.45 Workshop 1 and Feedback
The Pharmacovigilance System Puzzle: Exploration of how it fits together.
13.00 Lunch 
 14.00 The Quality System for Pharmacovigilance
Exploration of the structures and 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.
15.00 Workshop 2 and Feedback
The quality system puzzle.  Explore the organisation of the PV system quality system and how it interacts with the PV system. 
 15.15 Break 
 15.45 Understanding and Investigating 'Real Life Situations' in the Pharmacovigilance System
Exploration of how to organise what has to be done and spot what is missing.
 16.45 Role of the QPPV
Exploration of the role of the QPPV in real situations.  Visualise QPPV office as a whole. 
17.15 Workshop 3 and Feedback
Explore the role of the QPPV and the QPPV Office in real situations.  Understand connections with other departments/groups
Establish how the QPPV determines:
     - What needs to be done and how this is organised?
     - What are the MAHs responsibilities and how is this organised?
     - What specific interactions would you expect with QA and others?
     - Are you able to spot when something is missing quickly?
 18.00 Close of day 

Day 2 

8.30 Pharmacovigilance in the Clinical Trial Environment
Information flow and responsibilities of the sponsor. 
 9.30 Risk Management Plans
A cornerstone of Pharmacovigilance.
10.30 Break 
 11.00 Processing of Safety Data
Exploration of safety data processing, verification, validation, follow up, formatting and collation, reporting requirements, quality and data management. 
12.30 Lunch 
 13.15 Workshop 4 and Feedback
14.15 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.
 15.15 Break 
 15.30 Communication with Competent Authorities 
Description of EVPM, EVCTM and xEVMPD
 17.00 The Pharmacovigilance Risk Assessment Committee (PRAC)
Exploration of how good practice is achieved.  Composition, Role and Responsibility. 
17.30 Workshop 5 - To Explore Good Practice Within the PRAC
 18.00 Close of day 

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 6 - PSUR
10.00 Break 
 10.30 Workshop 6 PSUR continued and Feedback
 11.30 Safety Communications, Direct Healthcare Professional Communication
What does Safety Communication refer to?
What is Emerging Safety Information and its importance?
Who are involved in producing and distributing Safety Communications?
What are the Legal Requirements?
Set up and Maintenance of Safety Communications, Direct Healthcare Professional Communications.
12.00 Workshop 7
Develop a strategy, and identify structures and processes to implement the revision 1 to safety communications.
How would you go about identifying what is missing or needs to be improved?
12.30 Lunch 
 13.30 Development of Safety Update Reports (DSURs)
Regulatory requirements, exploring good practice, Report Format, Reference Safety Information, schedule of submission, analysis evaluations and distribution. 
14.10 Risk Based Inspections and Common Findings
Exploration of the principles of risk based inspections and a review of common inspection findings.
14.50 Break
15.20 Recap of the course 
15.50 Close of course

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)

Where the venue is Madingley Hall, accommodation and dinner are available for the dates of the course (we recommend you take this as the location has few nearby facilities). 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.
Bed and Breakfast is £77*, dinner is £35*  (* per night per person) - these can be selected during the booking process.

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