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A Masterclass in Practical Pharmacovigilance Auditing

Please note for dates 4th-5th November only a 10% discount is available for this course when booked with a two-day or full 3rd EUQA Conference delegate package.  To take advantage of this discount, please add ALL items to your basket and enter PRECON in the discount code box.  
This course may also be booked as a stand-alone course.

 

RQA CPD Stamp

Course Information

This two-day masterclass, based on RQAs well established three-day Practical Pharmacovigilance Auditing 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 provides a wealth of information which will provide delegates with

  • An enhanced understanding of key pharmacovigilance audit principles, preparation, design and conduct
  • The opportunity to explore ideas and fresh approaches through workshops
  • Increased expertise, efficiency and confidence

Course Tutors

Tutors will be comprised from the list below:

Pam Bones
Consultant, Rigg UK Consulting Ltd 

Kim Palmer (Course Principal)
Janssen

 

CPD Points

11 Points

 

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. 
10.45
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. 
11.30 Break
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 Case Processing (from all sources)
Auditing the processes and systems designed for processing clinical trial and post-marketing cases.
 

Day 2 

 9.00 Auditing the Roles and Responsibilities of the QPPV
Auditing the roles and responsibilities of the Qualified Person responsible for Pharmacovigilance. 
 9.45 Elements of Risk Management System (Part 1).
10.45 Break
 11.00 Elements of Risk Management System (Part 2). 
12.00 Lunch
 13.00  Auditing Licensing/Marketing Partners
Contracts, safety data exchange agreements and oversight by the Marketing Authorisation Holder.
 13.45 Workshop 3 - Speed Auditing 
 14.15 Workshop 3 - Feedback 
14.45
Break   
 15.00
  • Hot Topics
  • Auditing Device Vigilance
  • PSP and Market Research
  • Auditing 'facilities'
         Computerised system
         Archiving
         Business continuity. 
 15.45 Regulatory Inspection and Audit of Quality Assurance
Are your audit programme and quality assurance function inspection ready?
Hints and tips on being the interviewee. 
 16.30 Close of day 

 

    

 

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.

You will also receive a copy of our booklet - "Pharmacovigilance Auditing"

Accommodation (not included in course fees)

Please see here for accommodation link - for course date 4th-5th November 2019.

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Recommended Products

Booklets

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

Webcasts

Webcast - Where Does Audit End?

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