AN ESSENTIAL GUIDE
TO PHARMACOVIGILANCE

Conference Date: 04 Oct 2010
Conference Ref: A10-4510
Fee: £575 + VAT
Venue: The Rembrandt Hotel, London

WHY YOU SHOULD ATTEND

Pharmacovigilance has become one of the most demanding aspects for licence holders to both understand and comply with. There are many requirements for Companies to perform various duties regarding the safety of their products to satisfy regulatory demands.  Regulatory Authorities are visiting all licence holders to perform inspections on a Companies compliance to Pharmacovigilance and the visits can also include visiting marketing partners as well (even outside the EU) and the sanctions that exist for those Companies who do not look after the safety of their products are severe and could result in licence withdrawal.

This course has been designed to simply explain what Companies need to be aware of in terms of their responsibilities and what they need to do to avoid regulatory action. Can you afford not to know?

WHO SHOULD ATTEND

This course will be relevant for anyone requiring a concise overview of the Pharmacovigiliance function. It may also be of particular interest to those who are new to Pharmacovigilance or who work with pharmacovigilance, eg Regulatory Affairs, Sales & Marketing, Legal, Commercial and Quality.

Topics to be covered will include:

• An Introduction to EU Pharmacovigilance
• 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
• Pharmacovigilance Inspections

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