2-Day Course: Advanced Veterinary Pharmacovigilance (London, United Kingdom - October 1-2, 2019) - ResearchAndMarkets.com

January 28, 2019

DUBLIN--(BUSINESS WIRE)--Jan 28, 2019--The “Advanced Veterinary Pharmacovigilance” conference has been added to ResearchAndMarkets.com’s offering.

The purpose of this seminar is to provide a comprehensive, yet practical, assessment of the main requirements of Volume IXb, the new key document on pharmacovigilance guidelines used by the veterinary regulatory authorities to ensure a compliant reporting company.

This course will also consider the implications of the proposed EU Regulation for Veterinary Medicinal Products as well as Brexit and their impact on pharmacovigilance.


Programme Day One

09.00 Registration and Coffee

09.30 Welcome and Introductions

The DDPS and the PV Master File

The DDPS The DDPS - What happens now The PV Master File - purpose and maintenance Transition from DDPS to PV Master File

PV Training

Requirements for PV training Who trains whom and when? Training records, maintenance and updates Role of QA and HR in training

Product Safety Reviews

The Safety Review Committee Timings for Safety Review Record keeping for Safety Review meetings

Company Core Safety Information

Core Safety Information How to determine what to include, what to exclude in CSDS Maintenance & development of CSDS

Compliance and PV

Basic principles Measuring compliance Quality versus quantity in safety reports

17.00 End of Day One

Programme Day Two

09.00 PV Reporting in Licensing/Distribution Agreements

What types of Agreements exist? Audits of pharmacovigilance capabilities in partners What agreements need to be in place for PV reporting? PV reporting agreements - what needs to be covered? Monitoring PV agreements - what happens if it goes wrong?

Signal Detection/Benefit Risk & Risk Management

The pharmacovigilance system - Signal Detection and Analysis: What is required? Benefit-Risk assessments Risk management/minimisation Crisis Management Communication with the Public

Audits & Inspections: Are you Ready?

What are inspectors looking for? Inspection findings and outcomes

Discussion will take place throughout the two days

16.30 End of Day Two

For more information about this conference visit https://www.researchandmarkets.com/research/88vr23/2day_course?w=4

View source version on businesswire.com:https://www.businesswire.com/news/home/20190128005317/en/

CONTACT: ResearchAndMarkets.com

Laura Wood, Senior Press Manager


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Related Topics:Animal Healthcare/Veterinary



SOURCE: Research and Markets

Copyright Business Wire 2019.

PUB: 01/28/2019 07:37 AM/DISC: 01/28/2019 07:37 AM


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