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Practical Pharmacovigilance Auditing REMOTE LEARNING

RQA CPD Stamp

REMOTE LEARNING - this course will be delivered to you live online from the UK. 

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

Nazrul Khan
Global PV QA Consultancy Limited

Laura Trower
Allergan Ltd

Recent Feedback

"As I work for a Japanese pharmaceutical company and live in Japan, I was not able to participate in F to F training class due to its high cost (transportation fee is almost the same as the training fee). Although the time difference was a little bit tight for me, it was tolerance and there was much more effectiveness to participating your online training class. I hope you would continue providing online courses after the coronavirus pandemic."
"I liked his presentations and explanations. Easy to understand and to ask questions. He resolved the questions very well."
"All tutors had had a good knowledge and experience. So, it was good presentation."

 

CPD Points

14 Points

Course Programme 

 

 

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 Pharmacovigilance Audit - Requirements and Expectations
EU PV legislation (relevant Regulations and Directives) and key highlights from Module I, II, IV relating to PV auditing. 
10.45 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
 15.30 Workshop 1 - Feedback
 16.00 Close of day 
 

Day 2 

 9.00 Auditing Case Management Activities
Auditing the processes and systems designed for processing clinical trial and post marketing cases.
 10.00 Auditing the QPPV and the PSMF
Auditing the roles and responsibilities of the Qualified Person responsible for Pharmacovigilance and the Pharmacovigilance System Master File. 
 11.00 Break 
11.15 Workshop 2 - Planning a System Audit 
12.00 Workshop 2 - Feedback 
 12.30 Lunch
13.30 Auditing External Business Partners
Contracts, safety data exchange agreements, outsourcing and oversight by the Marketing Authorisation Holder.
 14.30 Risk Management Systems Part 1, including:
   - Signal management
   - Labeling
   - Risk management plans and risk minimisation
 15.45 Break
 16.00 Workshop 3 - Speed Auditing
16.45 Close of day 
 

Day 3 

9.00 Risk Management Systems Part 2, including:
   - PASS
   - PSUR (PBER) and DSUR
   - Safety communications (DHPC)
10.15 Break
10.30 Audit Report Writing and CAPA management
 11.15 Hot Topics
   - PV QMS
   - Market Research/PSP
   - 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 

 

    

 

Course Material

This course will be run completely online. You will receive an email with a link to our online system, which will house your licensed course materials and access to the remote event. 

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
  • Access to an online course group to enhance networking

You will need a stable internet connection, a microphone and a webcam. 

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

 

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Recommended Products

Booklets

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

Courses

P08 The Auditing Course
P11 A Systems Approach to Good Pharmacovigilance Practice
P35 Practical Pharmacovigilance Auditing
P41 Advanced Auditing Skills: Audit Planning and Performance
P42 Advanced Auditing Skills: Audit Analysis and Reporting

Webcasts

Webcast - Where Does Audit End?

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