2 Day Advanced Veterinary Pharmacovigilance Online Training Course, November 24th-25th, 2021 – ResearchAndMarkets.com

DUBLIN–(BUSINESS WIRE)–The “Advanced Veterinary Pharmacovigilance Training Course” 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.

The programme will also consider the potential impact of Brexit on pharmacovigilance and the implications of the proposed EU Regulation (2019/6) on Veterinary Medicinal Products.

Interactive sessions throughout the two days will give delegates the opportunity to discuss key issues of current concern with our experienced trainer.

Programme to include:

• Overview of European regulatory framework
• The key requirements of Volume IXB
• The detailed description of the pharmacovigilance system (DDPS) and the pharmacovigilance system master file (PSMF)
• 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

The course can be used as part of the training to become a QPPV or deputy QPPV

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 event useful.

Key Topics Covered:

The DDPS and the PSMF

• The DDPS
• The DDPS – what happens now?
• The PSMF – purpose and maintenance
• Transition from DDPS to PSMF

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 and what to exclude in a company core data sheet (CCDS)
• Maintenance and development of a CCDS

Compliance and PV

• Basic principles
• Measuring compliance
• Quality versus quantity in safety reports

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 and 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 and inspections: are you ready?

• What are inspectors looking for?
• Inspection findings and outcomes
• Implications of the proposed EU pharmacovigilance legislation

Risk Management Dealing with an Alert

For more information about this conference visit https://www.researchandmarkets.com/r/7vul2l

Contacts

ResearchAndMarkets.com

Laura Wood, Senior Press Manager

[email protected]
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