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A Systems Approach to Good Pharmacovigilance Practice

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If you are wanting to book more than one person onto a course(s) please email courses@therqa.com

For Madingley Hall courses, if you wish to stay for additional nights or double occupancy, please contact the us - courses@therqa.com in the first instance

Course Information

Global, country and company specific events continue to challenge the ‘maturity’ of the PV system within each Marketing Authorisation Holder. There is a need to develop personnel to meet these challenges and improve how we provide information to support the safe use of medicinal products.

 We develop continuously how we think, communicate and plan globally and how to maintain the flexibility to act whether it is at a regional level, a specific country level, with a specific stakeholder including regulators or act on a person to person level. On top of this we need to assure that the PV system is functioning to plan.

 Many believe that the key to sustaining a mature PV system is the development of personnel to explore and appreciate the regulatory requirements and principles of design of the whole PV system with the purpose to operate effectively. An important part of this is how we share and deploy our experiences, how to manage risks and how to share issues.

 This course is an opportunity to explore the application of the European regulatory requirements to the global pharmacovigilance system and to share techniques for maintenance and improvement of the PV system in order to operate effectively, support improvement projects, and contribute to assurance of the operation of the global PV system.

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

Benefits

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

Course Objectives

Clarify what has to be done

  • Explore application of the legal requirements

Explore how to do what has to be done:

  • Adopt a systemic approach to systematically investigate or implement and maintain the PV system and quality system.
  • Examine how a compliant PV system and a compliant quality system interact to achieve compliance with regulatory requirements for PV.
  • Explore how to investigate the complexity of the PV system.

Discus how to identify what is missing or what needs to be improved

  • Discuss how to monitor and maintain the PV system and assure compliance

This course will assist delegates with:

  • An understanding of key system principles,
  • 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.

This course is structured to encourage delegates to:

  • Discuss and develop ideas -  Share knowledge and experiences -  Solve specific problems.

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

  • Understand better the pharmacovigilance system, its quality system and how the components interact to achieve the objectives of pharmacovigilance.
  • 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:

Jana Hyankova
Head of PV Department, iVigee (Course Principal)

Ron Ward
Consultant, Support in Pharmacovigilance Ltd.

Keith Wibley
Director of Pharmacovigilance, VigiReg Consulting Ltd

Susan Jardine
Head of QA, Pharmacovigilance and Regulatory Affairs in UK and Ireland, Ferring Pharmaceuticals

Gail Holland
Swansea Trial Unit Operations Lead, Swansea University

Recent Feedback

"Excellent course"
"Very knowledgable, able to deliver in a way that was engaging, invited question and helped understanding for those with little background in some areas."

CPD Points

23 Points

Course Programme

Please note timings may be subject to alteration

 

 

 

DAY 1

08:30

 

Welcome, Registration, course objectives and introduction to work groups.

09:30

 

Exploration of 'Real Life Situations' in the Pharmacovigilance System:
Exploration of how to organise what has to be done and spot what is missing?

10:00

 

Break

10:30

 

Workshop 1: Exploration of a few systems principles

11:30

 

The Regulatory Framework:
Identify the relevant regulations and directives. Explore GVP guidance, structure of the modules and standard format of each module.

12:00

 

The Pharmacovigilance Safety Master File:
Construction of the Pharmacovigilance System Master File and its purpose. 

13:00

 

Lunch

14:00

 

The Pharmacovigilance System:
Exploration of the structures and processes for pharmacovigilance.

14:45

 

Workshop 2 and feedback: The Pharmacovigilance System Puzzle:
Exploration of how it fits together

15:00

 

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.

15:30

 

Workshop 3 and feedback:
The quality system puzzle Explore the organisation of the PV quality system and how it interacts with the PV system.

15:45

 

Break

16:15

 

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.

16:30

 

Role of the QPPV:
Exploration of the legal responsibilities of the QPPV and the MAH.

17:15

 

Workshop 4 and Feedback:
To explore the challenges faced by the QPPV

18:00

 

End of day

 

 

DAY 2

08:30

 

Risk Management Plans:
A cornerstone of Pharmacovigilance

10:00

 

Processing of safety data:
Exploration of safety data processing, verification, validation, follow up, formatting and collation, reporting requirements, quality and data management

11:00

 

Break

11:30

 

Transmission to competent authorities part 1 and 2
Exploration of the use of EVPM, EVCTM  and XEVMPD to support PV.

12:30

 

Workshop 4:
Demonstration of how the QPPV for UK authorised products and UK Medicinal products are documented on the XEVMP Database.

12:45

 

Lunch

13:45

 

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

14:45

 

Pharmacovigilance in the Clinical Trial environment:
Information flow and responsibilities of the sponsor.

15:15

 

Break

15:45

 

Pharmacovigilance in the Clinical Trial environment:
Information flow and responsibilities of the sponsor.

16:15

 

The Pharmacovigilance Risk Assessment Committee (PRAC):
Exploration of how good practice is achieved. Composition, Role and Responsibilities. Examples of Referrals

17:45

 

End of Day 2

 

 

DAY 3

08:30

 

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.

10:00

 

Workshop 5–  To explore the compilation and submission of the PSUR

10:30

 

Break

11:00

 

Workshop 5–  continued

11:30

 

Safety Communications, Direct Healthcare Professional Communications
Exploration of the purpose of Safety Communications, who are involved and what are the Legal Requirements.

12:00

 

Exploration of the principles of risk based inspections and a review of common inspection findings.

13:00

 

Lunch

14:00

 

Development Safety Update Reports (DSURs):
Regulatory requirements, exploring good practice, Report Format, Reference Safety Information, schedule of submission, analysis evaluations and distribution.

14:40

 

Break

15:10

 

Recap of the course:

16:00

 

End 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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