2-Day Course: Advanced Veterinary Pharmacovigilance (London, United Kingdom - October 1-2, 2019) - ResearchAndMarkets.com
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 FileThe DDPS The DDPS - What happens now The PV Master File - purpose and maintenance Transition from DDPS to PV Master File
PV TrainingRequirements for PV training Who trains whom and when? Training records, maintenance and updates Role of QA and HR in training
Product Safety ReviewsThe Safety Review Committee Timings for Safety Review Record keeping for Safety Review meetings
Company Core Safety InformationCore Safety Information How to determine what to include, what to exclude in CSDS Maintenance & development of CSDS
Compliance and PVBasic 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 AgreementsWhat 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 ManagementThe 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/
Laura Wood, Senior Press Manager
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Related Topics:Animal Healthcare/Veterinary
INDUSTRY KEYWORD: EDUCATION OTHER EDUCATION HEALTH VETERINARY
SOURCE: Research and Markets
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PUB: 01/28/2019 07:37 AM/DISC: 01/28/2019 07:37 AM