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Presented by
Management Forum

Advanced Veterinary Pharmacovigilance Training Course

Including the main requirements of Volume IXB, an update on the proposed EU Regulation (2019/6) on Veterinary Medicinal Products and the impact of Brexit

2-3 July 2024
+ 9-10 October 2024 »
from £1099

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Format: Live online
CPD: 12 hours for your records
Certificate of completion

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Course overview

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

This course forms part of our selection of Animal Health training courses, designed to keep you up to date with the latest regulations surrounding veterinary medicines, animal feeds, and industry best practices.

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.

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

Enrol or reserve

The Advanced Veterinary Pharmacovigilance course will cover:

Day 1
Day 2

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

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Declan O'Rourke
ORTEC PV Consultancy Ireland Ltd

Declan O’Rourke has over 20 years’ experience in industry where he has held technical, marketing, product development, clinical development, production and pharmacovigilance roles.

He is a veterinary surgeon, holds a Diploma in Marketing, a Master of Business Administration and a Fellowship of the Royal College of Veterinary Surgeons. He now directs Ortec PV Consultancy Ireland specialising in pharmacovigilance and represented IFAH-EU in the VICH Working Group on pharmacovigilance.

He is Honorary Associate Professor in Veterinary Pharmaceutical Development at Nottingham Veterinary School and Past President of British Cattle Veterinary Association.

More details

NEW higher discounts for multiple bookings - bring your colleagues to make your training budget go further:

30% off the 2nd delegate*
40% off the 3rd delegate*
50% off the 4th delegate*

Please contact us for pricing if you are interested in booking 5 or more delegates

2-3 July 2024

Live online

09:30-17:00 UK (London) (UTC+01)
10:30-18:00 Paris (UTC+02)
04:30-12:00 New York (UTC-04)
Course code 13792

GBP 1,099 1,299
EUR 1,589 1,869
USD 1,817 2,129

Until 28 May

2 days live online training
Browser-based, no download usually required
See presenters and interact with fellow attendees
Download documentation and certification of completion
Fair transfer and cancellation policy

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Not ready to book yet?

for 7 days, no obligation

9-10 October 2024

Live online

09:30-17:00 UK (London) (UTC+01)
10:30-18:00 Paris (UTC+02)
04:30-12:00 New York (UTC-04)
Course code 13952

GBP 1,099 1,299
EUR 1,589 1,869
USD 1,817 2,129

Until 04 Sep

2 days live online training
Browser-based, no download usually required
See presenters and interact with fellow attendees
Download documentation and certification of completion
Fair transfer and cancellation policy

View basket

Not ready to book yet?

for 7 days, no obligation

* Early booking discounts may not be combined with other discounts or offers. As such, the discounts for 2nd/3rd/4th delegates are based on the full price; and apply only when booking multiple delegates on the same date.