The purpose of this In-house course is to provide a comprehensive, yet practical assessment of the main requirements to ensure a compliant reporting Company.
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.
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The DDPS and the PV Master File
Product Safety Reviews
Company Core Safety Information
Compliance and PV
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
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 Consultancy specialising in EU pharmacovigilance and represented IFAH-EU in the VICH Working Group on pharmacovigilance.
He 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).