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?
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
Course Objectives
Clarify what has to be done
Explore how to do what has to be done:
Discus how to identify what is missing or what needs to be improved
This course will assist delegates with:
This course is structured to encourage delegates to:
By the end of the course delegates will be able to:
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
"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."
"Fabulous presenter who engaged with the participants encouraging participation and lively open discussions. Very knowledgeable and helpful."
23 Points
Please note timings may be subject to alteration
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DAY 1 |
08:30 |
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Welcome, Registration, course objectives and introduction to work groups. |
09:30 |
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Exploration of 'Real Life Situations' in the Pharmacovigilance System: |
10:00 |
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Break |
10:30 |
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Workshop 1: Exploration of a few systems principles |
11:30 |
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The Regulatory Framework: |
12:00 |
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The Pharmacovigilance Safety Master File: |
13:00 |
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Lunch |
14:00 |
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The Pharmacovigilance System: |
14:45 |
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Workshop 2 and feedback: The Pharmacovigilance System Puzzle: |
15:00 |
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The Quality System for Pharmacovigilance: |
15:30 |
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Workshop 3 and feedback: |
15:45 |
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Break |
16:15 |
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The Quality System for Pharmacovigilance: |
16:30 |
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Role of the QPPV: |
17:15 |
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Workshop 4 and Feedback: |
18:00 |
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End of day |
|
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DAY 2 |
08:30 |
|
Risk Management Plans: |
10:00 |
|
Processing of safety data: |
11:00 |
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Break |
11:30 |
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Transmission to competent authorities part 1 and 2 |
12:30 |
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Workshop 4: |
12:45 |
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Lunch |
13:45 |
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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 |
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Pharmacovigilance in the Clinical Trial environment: |
15:15 |
|
Break |
15:45 |
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Pharmacovigilance in the Clinical Trial environment: |
16:15 |
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The Pharmacovigilance Risk Assessment Committee (PRAC): |
17:45 |
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End of Day 2 |
|
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DAY 3 |
08:30 |
|
Periodic Safety Update Reports (PSURs)/Periodic Benefit Risk Evaluation Reports (PBRERs): |
10:00 |
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Workshop 5– To explore the compilation and submission of the PSUR |
10:30 |
|
Break |
11:00 |
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Workshop 5– continued |
11:30 |
|
Safety Communications, Direct Healthcare Professional Communications |
12:00 |
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Exploration of the principles of risk based inspections and a review of common inspection findings. |
13:00 |
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Lunch |
14:00 |
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Development Safety Update Reports (DSURs): |
14:40 |
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Break |
15:10 |
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Recap of the course: |
16:00 |
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End of course |
This course is running in our paper format. Access to the course material will not be given to delegates in advance of the course.
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.
Management of the Training and Competency of Personnel in GxP and Research Environments
Pharmacovigilance Auditing
P08 The Auditing Course
P35 Practical Pharmacovigilance Auditing
P36 Practical Approach to Good Pharmacovigilance Regulatory Inspections
RP09 The Remote Auditing Course REMOTE LEARNING
RP35 Practical Pharmacovigilance Auditing REMOTE LEARNING