An Essential Overview of Pharmacovigilance (London, United Kingdom - April 30, 2018)

  • ID: 4435770
  • Conference
  • Location: London, United Kingdom
  • 1 Day
  • Management Forum
  • Conference Dates: April 30, 2018
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A Practical Guide to Understanding the Role of Pharmacovigilance

Pharmacovigilance has become one of the most demanding aspects to both understand and comply with. This course will provide a concise overview of the pharmacovigilance function and the regulatory requirements.

Course Overview

Pharmacovigilance has become one of the most demanding aspects to both understand and comply with. There are many requirements 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.

Why you should attend

The new Pharmacovigilance Legislation requires companies to train all staff, including those not working directly with Pharmacovigilance and this course will meet that requirement.

TOPICS TO BE COVERED INCLUDE:

  • An Introduction to EU Pharmcovigilance
  • Documentation to be supplied to Regulatory Authorities
  • Department links in the company to Pharmacovigilance
  • Licensing partners and Pharmacovigilance
  • The role of the Qualified Person for Pharmacovigilance
  • Standard Operating Procedures (SOPs) in Relation to Pharmcovigilance
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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
  • Supporting the license approval
  • Submissions and license approvals
  • Regulatory Inspections

The Role of the Qualified Person (QP) for Pharmacovigilance

  • Contract versus Permanent
  • Essential attributes of the QP
  • The duties of the QP
  • What the QP must do
  • Internal audits of the Company Pharmacovigilance activities

Standard Operating Procedures (SOPs) in Relation to Pharmacovigilance

  • Types of SOPs required
  • Production and sign off of SOPs
  • SOP maintenance
  • SOP training
  • Who should be trained and in what

Pharmacovigilance Inspections

  • Preparation for 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

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  • Graeme Ladds Mr Graeme Ladds,
    Director ,
    PharSafer Associates Ltd.


    Graeme Ladds, Director of PharSafer, has over 22 years’ experience working in the pharmaceutical industry. Having started his career at Ashbourne Pharmaceuticals in 1989 as Head of Drug Safety & Medical Information, Graeme went on to become Head of Global Pharmacovigilance at Shire Pharmaceuticals.

    The last 11 years have been spent in his consultancy company, PharSafer Associates Ltd. During this time, Graeme 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.

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This course will be relevant for anyone requiring an overview of Pharmacovigilance. It may be of particular interest to those new to Pharmacovigilance or in a support staff role. It will also be relevant to anyone who works with Pharmacovigilance – eg Regulatory Affairs, Clinical, Sales & Marketing, Legal, Commercial and Quality.

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ADDRESS

Rembrandt Hotel
11 Thurloe Pl,
Kensington
London
SW7 2RS
United Kingdom


DIRECTIONS

The Rembrandt Hotel is located at 11 Thurloe Place, London, SW7 2RS. The hotel’s location in central London couldn’t be better, whether you’re travelling for business or leisure. You’ll be right between two of London’s most fashionable areas – South Kensington and Knightsbridge – within walking distance of museums, theatres, Harrods and Hyde Park.

You can hop on the Tube at South Kensington and take the District, Circle or Piccadilly lines direct to the City of London, Heathrow Airport and all other areas of the city. Look out of your window and you may well see the Victoria and Albert Museum – it’s right across the street.

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