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Practical Pharmacovigilance Auditing


Course Information

This well established course will explore key phases of pharmacovigilance auditing. It will address the impact of the EU pharmacovigilance legislation on auditing and provide guidance on auditing pharmacovigilance systems at both the global and local organisational level. This course is designed for pharmacovigilance auditors, auditors new to pharmacovigilance and pharmacovigilance professionals to provide them with insight into developing and/or optimising a pharmacovigilance audit programme. In order to gain maximum benefit from the course, an understanding of pharmacovigilance is advantageous.

This course will assist delegates with

  • A practical approach for the development and conduct of pharmacovigilance audits
  • An enhanced understanding of key pharmacovigilance audit principles, preparation, design and conduct
  • Increased expertise, efficiency and confidence

Course Tutors

Pam Bones
Consultant, Rigg UK Consulting Ltd (Course Principal)

Lauren Ewen
Senior Manager, Allergan Ltd 

Kim Palmer

Recent Feedback

"The real examples and the workshops given by the tutors and delegates were really valuable for me and hence for my professional development."

CPD Points

19 Points

Course Material

Following requests from attendees of previous RQA events we are pleased to offer course material in PDF format for delegates attending this course. 

The advantages of this include

  • Ability for delegates to keep material on a mobile device
  • Ability to review material at any time pre and post course
  • Environmental benefits – less paper being used per course

The material will be emailed in advance of the course and RQA will not be providing any printed copies of the course notes during the training itself. Delegates wishing to have a hard copy of the notes should print these in advance to bring with them. Alternatively delegates are welcome to bring along their own portable devices to view the material during the training sessions.

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

9.15 Registration
9.30 Welcome and Introduction and Introduction to the Workshops
The objectives of the workshops are defined and process and outputs described
10:00 Introduction to the EU PV Legislation relating to PV auditing and GVP modules that impact PV auditing 
EU PV legislation (relevant Regulations and Directives) and key highlights from Module I, II, IV relating to PV auditing
10:30 Break
11:00 Audit Planning and Scheduling
Understanding and defining the PV Audit universe, applying risk-based audit strategy, using risk assessment and risk criteria, identifying an audit schedule and resourcing audits
11:45 Audit Types, Processes and Preparation
Types of PV audits, QA audit process requirements and tools necessary to execute audit programmes
Detailed info on how to prepare for audits (by audit type), common features in audit preparation, and perhaps a table to show differences on preparation by audit types and planning individual audits (e.g. preparation, audit planning, audit conduct, audit reporting, CAPA management)
12:30 Lunch
13:30  Auditing Affiliates/Local Operating Companies
Auditing the processes and systems in place at local affiliate offices including post-marketing surveillance. clinical trials, medical information, regulatory, sales/marketing, etc
14:30 Workshop 1 – Audit Schedule
15:00 Workshop 1 – Feedback
16:00  Close of day

Day 2

09:00 Case Processing (from all sources)
Auditing the processes and systems designed for processing clinical trial and post-marketing cases
09:45 Auditing the Roles and Responsibilities of the QPPV
Auditing the roles and responsibilities of the Qualified Person responsible for Pharmacovigilance
10.30 Break
10.45 Workshop 2 - Planning System Audit 
11:45 Workshop 2 – Feedback
12:15 Auditing Licensing/Marketing Partners
Contracts, safety data exchange agreements and oversight by the Marketing Authorisation Holder.
13:00 Lunch
13:45 Aggregate Reports
The development, review, approval, distribution of PSUR and PBER/DSUR
14:30 Workshop 3 – Speed Auditing
15:30 Break
16:00 Workshop 3 - Feedback
16.30 Close of day

Day 3

9.00 Auditing Signal Detection
Auditing the processes and systems designed for conducting safety signal detection
10:00 Auditing Risk Management Plans and Post-Authorisation Safety Studies
10.45 Break 
11.00 Hot Topics
Auditing Device Vigilance
PSP and Market Research
Auditing 'facilities'
     Computerised systems
     Business continuity
12:00  Lunch
13:00  Regulatory Inspection and Audit of Quality Assurance
Are your audit programme and quality assurance function inspection ready?  Hints and tips on being the interviewee
14:00  Final Wrap Up
An opportunity for open discussion on topics raised during the course or relevant to it.
15:00  Close of course

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