An Essential Overview of Pharmacovigilance

Course

In The Rembrandt Hotel, London

£ 699 + VAT

Description

  • Type

    Practical seminar

  • Level

    Intermediate

  • Location

    The rembrandt hotel, london

  • Class hours

    8h

  • Duration

    1 Day

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.

Facilities

Location

Start date

The Rembrandt Hotel, London (London)
See map

Start date

On request

About this course

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 Pharmacovigilance

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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Reviews

Subjects

  • Pharmacovigilance
  • Qualified Person
  • Pharam
  • Pharma
  • Pharmaceutical Regulations
  • License holder
  • Management
  • Medical Devices
  • Training
  • SOP's

Teachers and trainers (1)

Graeme Ladds

Graeme Ladds

Director, PharSafer

Course 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
  • 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

Additional information

Please note we are also running: This meeting runs back-to-back with Essential Guide to Medical Information on 28 April and there is a £100/€140 discount off this event. To find out more call Customer Services on +44 (0)20 7749 4730 or e-mail info@management-forum.co.uk

An Essential Overview of Pharmacovigilance

£ 699 + VAT