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Practical Pharmacovigilance Auditing

RQA CPD Stamp

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

Tutors will be comprised from the list below:

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

Mark Parker
Director, CM Quality Ltd (Course Principal)

Lauren Ewen
Senior Manager, Allergan Ltd 

Kim Palmer
Janssen

Lindsay Watt
GlaxoSmithKline

Nazrul Khan
Global PV QA Consultancy Limited

Laura Trower
Allergan Ltd

Recent Feedback

"I am more confident about audit management after this course."

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)

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.

Course Programme

Please note timings may be subject to alteration

 

Day 1 

9.15  Registration
 9.30 Welcome and Introductions 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 information 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 (eg 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 

 9.00  Case Processing (from all sources)
Auditing the processes and systems designed for processing clinical trial and post marketing cases.
 9.45 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
     Archiving
     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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Recommended Products

Booklets

Management of the Training and Competency of Personnel in GxP and Research Environments
Pharmacovigilance Auditing Booklet

Courses

P08 The Auditing Course
P11 Systems Approach to Good Pharmacovigilance Practice
P42 Advanced Auditing Skills: Audit Analysis and Reporting

Webcasts

Webcast - Where Does Audit End?

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