Advanced Veterinary Pharmacovigilance Seminar: Assessment of the Main Requirements of Volume IXb - London, United Kingdom - October 1-2, 2019

DUBLIN, May 31, 2019 /PRNewswire/ -- 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 to include:

• Overview of European regulatory framework n The DDPS and the PV Master File
• PV training
• Product safety reviews
• Company core safety information
• Compliance and PV
• PV reporting in licensing/distribution agreements
• Signal detection
• Benefit-risk assessments
• Risk management
• Crisis management
• Implications of the proposed EU pharmacovigilance legislation

Who Should Attend:

This seminar will be beneficial to those who have some experience of veterinary pharmacovigilance and is a good follow-on course from the Introduction to Veterinary Pharmacovigilance, which is also run by Management Forum. Adverse event monitoring and drug safety officers, including QPPVs and Deputy QPPVs, together with personnel from regulatory affairs and registration departments will find this seminar useful.

Agenda:

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/r/pbq5hs

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