Advanced Veterinary Pharmacovigilance – the purpose of this course is to provide a comprehensive, yet practical assessment of the main requirements to ensure a compliant reporting Company.
13-14 Mar 2019
& 1-2 Oct 2019
Volume IXb is the new key document on Pharmacovigilance guidelines used by the Veterinary regulatory authorities. The purpose of this course is to provide a comprehensive, yet practical assessment of the main requirements to ensure a compliant reporting Company. It will also consider the implications of the proposed EU Regulation for Veterinary Medicinal Products and its impact on pharmacovigilance.
PROGRAMME TO INCLUDE
This course 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 course run by Management Forum. Adverse event monitoring and drug safety offices together with regulatory affairs and personnel from registration departments will find this seminar useful.
09.00 Registration and Coffee
09.30 Welcome and Introductions
The DDPS and the PV Master File
Product Safety Reviews
Company Core Safety Information
Compliance and PV
17.00 End of Day One
09.00 PV Reporting in Licensing/Distribution Agreements
Signal Detection/Benefit Risk & Risk Management
Audits & Inspections: Are you Ready?
What are inspectors looking for?
Discussion will take place throughout the two days
16.30 End of Day Two
Declan O'Rourke (13-14 Mar 2019)
Declan O’Rourke has over 20 years’ experience in industry where he has held technical, marketing, product development, clinical development, production and pharmacovigilance roles.
Declan 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 Consultancy specialising in EU pharmacovigilance and represented IFAH-EU in the VICH Working Group on pharmacovigilance.
Declan is also an Associate Professor in Veterinary Pharmaceutical Development at Nottingham Veterinary School, Past President of British Cattle Veterinary Association and a member of the Veterinary Products Committee (VPC).