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A Systems Approach to Good Pharmacovigilance Practice


Course Information

The purpose of this course is to explore the complexity of the pharmacovigilance (PV) system, the purpose of activities within the PV system, what has to be done, how to monitor activities within the PV system, how to maintain the PV system and how to ensure compliance with regulatory requirements.

Delegates will explore the European Regulatory Requirements for PV. 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 benefit from exploration of a systems approach to investigate systematically the Pharmacovigilance system and its quality system. Other Quality Assurance Personnel and PV practitioners will benefit from a ‘systems 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 

  • A systematic investigation of the Pharmacovigilance System and its Quality System
  • Examination of 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 complex PV system
  • Discussions about how to monitor and maintain the PV system and assure compliance

The course is structured to encourage delegates to explore Good Pharmacovigilance Practice through:

  • Discussion and development of ideas
  • Sharing of knowledge and experiences
  • Solving specific problems

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

  • Understand the legal requirements to support key processes to meet the objectives for pharmacovigilance
  • Understand how the PV quality system interacts with the PV system to deliver the objectives of the system
  • Adopt a practical and systematic approach to monitoring and maintaining the PV system and its quality system
  • Systematically investigate, and analyse the pharmacovigilance system and its quality system to identify what is missing and what needs to be improved to meet the objectives of pharmacovigilance system in order to effectively audit and monitor these systems
  • Appreciate the scope of the pharmacovigilance system / audit universe
  • Apply procedures to share expertise in order to increase effectiveness, efficiency and confidence
  • Understand Competent Authorities’ approach to risk-based inspections

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

"Great job! Really engaged presenter, passionate and responsive. Appreciate his ability to think big picture and decomplicate a complex process."
"I very much liked the small group setting and easy interaction with the course faculty."
"The tutors were very knowledgeable about the regulations and how to best put them to practice."

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 additional 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 (three courses with drinks, in the main dining room with other course participants) is £35* (* per night per person) - these can be selected during the booking process.  As part of the booking process we ask for dietary requirements and these will be taken in to consideration by Madingley Hall.  Alternatively bar snacks are available on a pay as you go basis, not bookable through RQA.

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