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An Essential Overview of Pharmacovigilance Training Course

A practical guide to understanding the role of pharmacovigilance.

19 Oct 2021

& 8 Apr 2022 , 10 Oct 2022

Book now

Details

Course overview

Pharmacovigilance has undergone rapid regulatory change in recent years and become one of the most demanding aspects of the pharmaceutical industry to both understand and comply with. There are many requirements and duties for companies to perform regarding the safety of their products to satisfy regulatory demands, and sanctions for non-compliance can be severe.

EU pharmacovigilance legislation requires companies to train all staff, including those not working directly in pharmacovigilance, and this invaluable one-day course will help you meet that requirement with a concise overview of the pharmacovigilance function and current regulatory requirements.

Benefits of attending:

  • Gain an overview of EU pharmacovigilance
  • Understand the documentation required by regulatory authorities
  • Clarify the roles and responsibilities of a licence holder
  • Understand the role of the Qualified Person for Pharmacovigilance (QPPV)
  • Review the standard operating procedures (SOPs) in relation to pharmacovigilance

Who should attend?

This course will be relevant for anyone requiring an overview of pharmacovigilance or wishing to consolidate existing knowledge. It will also benefit those working in pharmacovigilance, as well as those who support or interact with pharmacovigilance from areas including medical information, regulatory affairs, clinical, sales and marketing, legal, commercial and quality.

Programme

An introduction to EU pharmacovigilance

  • Safety report sources
  • Safety reporting requirements
  • Follow-up of safety reports
  • Electronic safety reporting
  • Safety file retention

Documentation to be supplied to regulatory authorities

  • Individual case safety reports – special situations – EU
  • Periodic safety update reports (PBRERs, DSURs, RMPs)
  • Answering queries from regulatory authorities
  • Updating product labelling – emphasis on safety changes

Department links in the company to pharmacovigilance

  • Product quality and pharmacovigilance
  • Sales and marketing and pharmacovigilance
  • Legal, commercial and pharmacovigilance
  • Regulatory and pharmacovigilance
  • Medical information and pharmacovigilance

The roles and responsibilities of a licence holder

  • Obtaining a licence for a product – the PSMF
  • Supporting the licence approval
  • Quality management requirements
  • Submissions and licence approvals
  • Regulatory inspections

The role of the QPPV

  • Essential attributes of the QPPV
  • The duties of the QPPV and what the QPPV must do
  • Internal audits of the company pharmacovigilance activities

SOPs in relation to pharmacovigilance

  • Why the need for SOPs?
  • Critical SOPs
  • SOP maintenance
  • SOP training
  • Who should be trained and in what?

Pharmacovigilance inspections

  • Purpose of a regulatory inspection
  • Scope of the pharmacovigilance inspection
  • Conduct of the pharmacovigilance inspection
  • The pharmacovigilance inspection report
  • Corrective actions following a pharmacovigilance inspection

Presenter

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 now

19 Oct 2021
Live webinar
19 Oct 2021
Live webinar
GBP 599.00
EUR 859.00
USD 970.00
+ VAT @ 20.00%
Enrol now
to attend
Live webinar
8 Apr 2022
Live webinar
8 Apr 2022
Live webinar
GBP 599 499
EUR 859 719
USD 970 814
Until 4 Mar 22*
Enrol now
to attend
Live webinar
10 Oct 2022
Live webinar
10 Oct 2022
Live webinar
GBP 599 499
EUR 859 719
USD 970 814
Until 5 Sep 22*
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

Continuing professional development

This course qualifies for 6 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

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Previous customers include...

  • Abbott Laboratories GmbH
  • AbbVie
  • Actelion Pharmaceuticals Ltd
  • Chemidex Pharma
  • CHEPLAPHARM Arzneimittel GmbH
  • Chiesi UK Ltd
  • Delorbis Pharmaceuticals Ltd
  • Emdoka bvba
  • Ewopharma AG
  • Fresenius Kabi Ltd.
  • GlaxoSmithKline
  • GW Pharmaceuticals
  • Impatients N.V. tradename myTomorrows
  • Jazz Pharmaceuticals
  • MAP Medical Technologies Oy
  • Meda Pharmaceuticals Limited
  • Mundipharma Research GmbH & Co. KG
  • Mundipharma Research Ltd.
  • Nelsons
  • Novo Nordisk A/S
  • Pharma Nord ApS
  • Pharmacosmos
  • Porton Biopharma Limited
  • RB Corporate Services Ltd
  • Research and Markets
  • Roche Moscow Ltd.
  • Teva
  • Warner Chilcott UK Ltd
  • Weleda
  • Wortley Byers Law

[The speaker was] very professional and knowledgeable.

Priyanka Parasher, Global Pharmacovigilance and Product Information officer, Nelsons, Apr 21

It was brill for an overview! Questions were answered by the speaker and the atmosphere made me feel really comfortable and allowed me to ask the questions in a confident way.

Shelley Browning, Regulatory and PV Manager, Weleda, Apr 21

Graeme was knowledgeable on all the material. [Overall] very good and informative.

Nicholas Gurreri, Safety scientist, GSK, Apr 21

Very informative. Good content.

Anna-Faye Halls, Pharmacovigilance Coordinator, GW Pharmaceuticals, Apr 21

A clear and informative presentation. The speaker was very knowledgeable and delivered the course at a good pace. I particularly liked that [he] gave examples for each section of the topic.

Sio M Leong, Senior Associate Pharmacovigilance , GW Pharmaceuticals, Oct 19

The course provided a good overview of pharmacovigilance. Graeme made the course very interesting with lots of useful examples and I would definitely recommend this to other colleagues.

Sue Harper, PV Team Coordinator, GW Pharmaceuticals, Oct 19

All round, a thoroughly enjoyable course which gave a broad overview of PV. The speaker was absolutely amazing and I particularly enjoyed the anecdotes he added from his previous experience.

Alice Brown, Pharmacovigilance Trainee, GW Pharmaceuticals, Oct 19

Overall, I was glad I could attend this course. A lot of practical examples were shared and all my questions were resolved.

Elena Ojeda, Sr. RA Officer, Patheon Softgels, B.V., Oct 19

The content and Graeme's knowledge and examples were very good - his slides could have been updated to be more watchable. Great course, will recommend.

Sarah Freeman, Compliance Manager, Ceuta Healthcare, Oct 18

Brilliant course for beginner to understanding the world of PV.

Josephine Wong, Pharmacovigilance Coordinator, Chemidex Pharma Ltd., Oct 18

Content was clear and informative, the slides were interesting and provided clear information, and the speaker was brilliant

Sophie Burden , Regulatory Affairs officer , Porton Biopharma Limited , Oct 17

Very informative, liked that there were notes to take away for future reference. The speaker was great and went through the content in a way which engaged us.

Bonnie Allen, Vigilance Risk Management Student Placement, Mundipharma Research Ltd, Oct 17

Content was clear and simple to understand. Presentation was consistent and easy to follow + Graeme was cheerful and informative with the correct level of professionalism

Sophie Burden , Regulatory Affairs officer , Porton Biopharma Limited , Oct 17

Particularly enjoyed the examples which the speaker gave, it really aids understanding. Interesting content.

Bonnie Allen, Vigilance Risk Management Student Placement, Mundipharma Research Ltd, Oct 17

Very useful, comprehensive training and experienced speaker

Marion Autour, Pharmacovigilance Manager, Servier Research & Development Ltd, Apr 17