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Pharmacovigilance QMS & Inspection Preparation Training Course

This course is designed to help understand pharmacovigilance quality management systems (QMS) and risk-based audits.

16-17 Nov 2022

& 23-26 Jan 2023 , 22-23 May 2023 , 28-29 Sep 2023

Book or reserve now


Course overview

Since the introduction of the new pharmacovigilance legislation in the EU, QMS and self-audits have become an increasingly important topic. Companies have been challenged by regulators to implement risk-based audits where continual improvement of processes, systems and compliance to regulations needs to be demonstrated. This is required from the top of the company organisation in all areas of regulatory activity including clinical, pharmacovigilance, sales and marketing, IT and medical services.

This must-attend course will explain principles, approaches and regulatory expectations for the pharmacovigilance QMS and risk-based audits and has been designed to help in both the assessments of risk and the whole CAPA process. The highly participative programme will include a mix of presentations from our expert trainer, reallife case studies and practical workshop sessions which will help consolidate learning.

Benefits of attending:

  • Explore pharmacovigilance quality management systems (QMS) and risk-based audits
  • Learn the importance of key performance indicators (KPIs) in your QMS
  • Ensure compliance with assessments of risk and your CAPA plans
  • Discuss pharmacovigilance inspections and QMS activities

Who should attend?

QA representatives, EU QPPVs and all working in pharmacovigilance, regulatory, clinical and administrators responsible for the management of the CAPA systems.


The audit basics

  • The purpose of an audit
  • Qualifications of the auditor
  • The audit SOP and design
  • The difference between audits and inspections
  • Audit planning and risk assessments

The legislation and audits

  • The requirements to perform company audits
  • In-house versus external audits
  • What needs to be audited
  • Which departments need auditing for safety?


  • QMS design
  • Quality cycles – expectations and deviations
  • Quality risk assessments
  • KPIs
  • Quality failings and corrections

QMS and the audit report

  • The audit scope and conduct
  • The audit report content
  • The grading of audit reports
  • Corrective action plans (root cause analysis)
  • Re-audits

Workshop session

You will be asked to design the QMS for a safety department that has recently been audited. You will need to devise a plan based on any risk elements and audit findings identified and look at designing a QMS approach with KPIs.

Introduction to PV inspections

  • Background
  • Purpose – design
  • Roles and responsibilities of the licence holder
  • Conduct of regulatory inspections

Risk-based inspections

  • Defining risk
  • Routine and for-cause inspections
  • Triggers for an inspection
  • Who should attend the inspection?

The pharmacovigilance inspection cycle

  • Pre-inspection questionnaires
  • Site visits and telephone audits
  • Results and CAPAs
  • Inspection follow-up questionnaires
  • Follow-up inspections

Workshop session

You will be presented with a series of findings from a regulatory inspection. You will have to look at the findings and work out priorities, devise root cause analyses and provide detailed CAPA plans which will include QMS activities.

Common findings from regulatory inspections

  • Grades of findings (and how to grade findings)
  • How to grade findings in the same PV area
  • Allied findings in other departments
  • KPIs versus legislation
  • Variations in major authority inspections


Graeme Ladds (More...)

Graeme Ladds, Director of PharSafer, has over 30 years’ experience working in the pharmaceutical industry. Having started his career at Ashbourne Pharmaceuticals in 1989 as Head of Drug Safety & Medical Information, he went on to become Head of Global Pharmacovigilance at Shire Pharmaceuticals. He then set up his consultancy and specialist CRO company, PharSafer Associates Ltd, where he has been involved in establishing pharmacovigilance in companies, performing audits across Europe and the USA, SOP writing, acting as QP for companies, and helping with regulatory inspections.

Book now

Book or reserve now

NEW higher discounts for booking multiple places - bring your colleagues to make your training budget go further:
30% off the 2nd delegate; 40% off the 3rd delegate; 50% off the 4th delegate

Choose your date below - or reserve your place with no obligation for 7 days at Reserve now
16-17 Nov 2022
Live webinar
UK (London)
16-17 Nov 2022
Live webinar
UK (London)
GBP 1,299 1,099
EUR 1,859 1,579
USD 2,098 1,786
Until 12 Oct*
Enrol now
to attend Live webinar
23-26 Jan 2023
Live webinar
UK (London)
23-26 Jan 2023
Live webinar
UK (London)
GBP 1,299 1,099
EUR 1,869 1,589
USD 2,129 1,817
Until 19 Dec*
Enrol now
to attend Live webinar
22-23 May 2023
Live webinar
UK (London)
22-23 May 2023
Live webinar
UK (London)
GBP 1,299 1,099
EUR 1,869 1,589
USD 2,129 1,817
Until 17 Apr 23*
Enrol now
to attend Live webinar
28-29 Sep 2023
Live webinar
28-29 Sep 2023
Live webinar
GBP 1,299 1,099
EUR 1,869 1,589
USD 2,129 1,817
Until 24 Aug 23*
Enrol now
to attend Live webinar

Learn more about our face-to-face and webinar training formats.

* Note the early booking discount cannot be combined with any other offers or promotional code. As such, discounts for the 2nd/3rd/4th attendees are based on the full price of the course. Please contact us for pricing if you wish to send more than 4 delegates.

Continuing professional development

This course qualifies for 12 hours for your CPD records.
More about CPD

Customised in-house training

We can customise this course to meet the requirements of your organisation and deliver it at your location and/or online.

Contact us

Previous customers include...

  • Abbott Healthcare Products B.V
  • Agency for Medicinal Products and Medical Devices of Croatia (HALMED)
  • Allergan
  • Amicus Therapeutics
  • Arriello sro
  • Astellas Pharma Europe Ltd
  • Celltrion
  • Chanelle Pharmaceuticals Manufacturing Ltd
  • Creo Pharma Ltd
  • CSL Behring GmbH
  • Cycle Pharmaceuticals Ltd.
  • Ewopharma International
  • Fresenius Kabi Deutschland GmbH
  • Grunenthal Ltd
  • Institut de Recherches Internationales Servier
  • Insud Pharma
  • L. MOLTENI & C.
  • MEI Pharma
  • Nelsons
  • NorthStar Healthcare
  • Novimmune SA
  • Piramal Critical Care B.V.
  • Research and Markets
  • Union pharmaceutique d’orient sal
  • Xellia d.o.o.

The speaker was excellent and gave very practical examples of what is looked for in an Audit

Kathleen Dunphy, Senior Administrator , NorthStar Healthcare, Nov 20

The speaker was very knowledgeable and easy to approach and I would definitely attend another course that had him as trainer. The practical examples were very useful and the course was interesting, well organised, and had a good balance in terms of content and difficulty.

Claudia Percivalle, Head of Global Regulatory Affairs, Cycle Pharmaceuticals Ltd. , Nov 19

Excellent presentation by a very experienced speaker. The examples provided and the exercises were greatly appreciated.

Anne-Elisabeth Collignon, Pharmacovigilance Head of PV Quality Assurance, Institut de Recherches Internationales Servier, Nov 19

The course actually exceeded my expectations and gave me an inside view of flaws in my PhV system. Great speaker with a lot of knowledge, good pace and experiences/stories from real life.

Hrvoje Sarec, Pharmacovigilance Specialist, Xellia d.o.o., Nov 19

I wanted to reinforce my knowledge and I definitely accomplished this. Graeme Ladds was great as usual. His pharmacovigilance knowledge is extensive, any question was answered confidently and debate was encouraged.

Christopher Harper, Senior Medical Information Manager, Astellas Pharma Europe Ltd, Nov 19

The speaker was very very good and I particularly liked the opportunity to exchange experiences and examples.

Evangelia Tsakiraki, EU QPPV, Piramal Critical Care B.V., Nov 19

A very well knowledgeable presenter in QA and particularly in PV. The content was rich and touched all areas in great detail. The course is very well balanced and anyone (junior to experienced) in QA could understand and learn from the training.

Netsanet Desta-Evers, Clinical Safety Compliance Specialist, Novimmune SA, Nov 18

[The speaker] was good :) Overall, it was a good class!

Jiwan Park, QA Associate, Celltrion, Nov 18

Very interactive and interesting the speaker has a great knowledge of the subject and respond to all our queries.

Tracy Salamoun, Regulatory affairs Associate , Union pharmaceutique d’orient sal, Nov 18