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Practical Pharmacovigilance Auditing

RQA CPD Stamp

If you are wanting to book more than one person onto a course(s) please email courses@therqa.com

For Madingley Hall courses, if you wish to stay for additional nights or double occupancy, please contact the us - courses@therqa.com in the first instance

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:

Mark Parker
Director, CM Quality Ltd (Course Principal)

Lauren Ewen
Senior Manager, Allergan Ltd 

Mijal Chavda
Director, GVP Quality, Kyowa Kirin International

Nazrul Khan
Global PV QA Consultancy Limited

Bhagti Khera
Norgine

Jonathan Rowell
Johnson & Johnson

Recent Feedback

"The course was well organized, and spread over 3 days with much needed breaks. It was really good to do this course face to face where I met other professionals from the industry and shared our experiences with one another."
"He had great knowledge and experience and I liked the examples and stories which was presented with humor."
I would like to thank you for the interesting and clear information. It's always nice to learn from people with a lot of experience."

CPD Points

19 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 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 Case Processing (from all sources)
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 Third Parties
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

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"

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 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.

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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
RP09 The Remote Auditing Course REMOTE LEARNING
RP35 Practical Pharmacovigilance Auditing REMOTE LEARNING

Webcasts

Webcast - Where Does Audit End?

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