An Essential Overview of Pharmacovigilance

This course will provide a concise overview of the pharmacovigilance function and the regulatory requirements.

12 Oct 2018

& 11 Oct 2019

GBP 699
EUR 979
USD 1,090

Book now

Course Overview

Pharmacovigilance has become one of the most demanding aspects 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. This course will provide a concise overview of the pharmacovigilance function and the regulatory requirements. EU pharmacovigilance legislation requires companies to train all staff, including those not working directly in pharmacovigilance and this course will meet that requirement.

Key topics to be covered:

  • Gain an overview of EU pharmacovigilance
  • Understand the documentation required to be supplied to regulatory authorities
  • Clarify the roles and responsibilities of a licence holder
  • Understand the role of the Qualified Person for Pharmacovigilanc (QPPV)
  • What are the Standard Operating Procedures (SOPs) in relation to pharmacovigilance
  • Discuss pharmacovigilance inspections

Who should attend

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

Programme

09.00 Registration and Coffee

09.30 Meeting starts

An Introduction to EU Pharmacovigilance

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

Documentation to be Supplied to Regulatory Authorities

  • Individual Case Safety Reports
  • 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 license for a product – PSMF
  • Supporting the license approval
  • Quality management requirements
  • Submissions and license approvals
  • Regulatory inspections

The role of the Qualified Person Pharmacovigilance (QPPV)

  • Essential attributes of the QP
  • The duties of the QP
  • The duties of the QP and what the QP must do
  • Internal audits of the Company Pharmacovigilance activities

Standard Operating Procedures (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

17.00 Meeting ends

Presenter

Graeme Ladds

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

12 Oct 2018
12 Oct 2018 Rembrandt Hotel, London GBP 699.00
EUR 979.00
USD 1,090.00
+ VAT @ 20.00%
Enrol now
11 Oct 2019
11 Oct 2019 Venue not yet confirmed
+ VAT @ 20.00%
Enrol now

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Previous customers include...

  • Abbott Laboratories GmbH
  • Acino Estonia OÜ
  • Actavis UK Ltd
  • Actelion Pharmaceuticals Ltd
  • Besins Healthcare
  • Central medical stores
  • Chemidex Pharma
  • Chiesi UK Ltd
  • Delorbis Pharmaceuticals Ltd
  • Emdoka bvba
  • Ewopharma AG
  • Fresenius Kabi Ltd.
  • Holland & Barrett International Limited
  • Jazz Pharmaceuticals
  • Meda Pharmaceuticals Limited
  • Merial
  • Mundipharma Research GmbH & Co. KG
  • Mundipharma Research Ltd.
  • Nutrition Group Plc
  • Porton Biopharma Limited
  • Reckitt Benckiser Brands Ltd
  • Servier Research & Development Ltd
  • Teva
  • Warner Chilcott UK Ltd
  • Wortley Byers Law

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

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

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

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

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

The course was a very good overview of PV, it's responsibilities and how it fits into industry.

Chloe Harper-Ahston, Pharmacovigilance, Quality & Safety and Global Regulatory Affairs Coordinator, Jazz Pharmaceuticals

Very useful, comprehensive training and experienced speaker

Marion Autour, Pharmacovigilance Manager, Servier Research & Development Ltd

Deep and comprehensive content. Engaging and prepared speaker. Clear presentation.

Francesca Guarino, , Besins Healthcare

No negatives what so ever - it is exactly as described - an essential overview - without being too information heavy.

Emma Ryan, PV Administrator, Chiesi UK Ltd

The speaker was nice, friendly, approachable

Zakiya Rahman, Regulatory Affairs & Deputy national safety officer, Fresenius Kabi Ltd.

The course was good enough for 1 day. Content was condensed and informative. Good presentation .

Ghadir Alqallaf, Pharmacist, Central medical stores

I was very pleased that I choose to do this course. The content was very in-depth without being overwhelming. I found it useful to have the slides printed off as well as going through on screen as made it a lot easier to make notes and comments on. The speaker was very clear and helpful and made things easy to understand.

Kayleigh Sexon, Regulatory specialist, clinical operations, Actavis UK Ltd