1-Day Course: An Essential Overview of Pharmacovigilance (London, United Kingdom - October 11, 2019) - ResearchAndMarkets.com

The "An Essential Overview of Pharmacovigilance" conference has been added to ResearchAndMarkets.com's offering.

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 help you meet that requirement.

Benefits of attending:

• Gain an overview of EU pharmacovigilance and 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
• Learn about all aspects of 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 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.

Agenda

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 Qualified Person for Pharmacovigilance (QPPV)

• Essential attributes of the QPPV
• The duties of the QPPV and what the QPPV 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

For more information about this conference visit https://www.researchandmarkets.com/r/fbjo0j

View source version on businesswire.com: https://www.businesswire.com/news/home/20190917005969/en/