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Press release content from Business Wire. The AP news staff was not involved in its creation.

Two Day Pharmacovigilance QMS & Inspection Preparation Course (London, United Kingdom - May 14-15, 2020) - ResearchAndMarkets.com

December 2, 2019 GMT

DUBLIN--(BUSINESS WIRE)--Dec 2, 2019--

The “Pharmacovigilance QMS & Inspection Preparation” conference has been added to ResearchAndMarkets.com’s offering.

This course is designed to help understand pharmacovigilance Quality Management Systems (QMS) and risk based audits

Since the introduction of the new pharmacovigilance legislation in the EU, QMS and self-audits have become an increasingly important topic.

Companies have been challenged by regulators to implement risk-based audits where continual improvement of processes, systems and compliance to regulations needs to be demonstrated. This is required from the top of the company organisation in all areas of regulatory activity including clinical, pharmacovigilance, sales and marketing, IT and medical services.

This course is designed to help in both the assessments of risk and the whole CAPA and preventative action elements.

Benefits of attending:

Who Should Attend:

QA representatives, EU QPPVs and all working in pharmacovigilance, regulatory, clinical and administrators responsible for the management of the CAPA systems.


Programme day one

The audit basics

The legislation and audits


QMS and the audit report

Workshop session

You will be asked to design the QMS for a safety department that has recently been audited. You will need to devise a plan based on any risk elements and audit findings identified and look at designing a QMS approach with KPIs.

Programme day two

Introduction to PV inspections

Risk-based inspections

The pharmacovigilance inspection cycle

Workshop session

You will be presented with a series of findings from a regulatory inspection. You will have to look

at the findings and work out priorities, devise root cause analyses and provide detailed corrective and preventative

action plans which will include QMS activities.

Common findings from regulatory inspections

Final discussion session

For more information about this conference visit https://www.researchandmarkets.com/r/m66hsw

View source version on businesswire.com:https://www.businesswire.com/news/home/20191202005493/en/

CONTACT: ResearchAndMarkets.com

Laura Wood, Senior Press Manager


For E.S.T Office Hours Call 1-917-300-0470

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For GMT Office Hours Call +353-1-416-8900



SOURCE: Research and Markets

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PUB: 12/02/2019 08:02 AM/DISC: 12/02/2019 08:03 AM