Advanced Veterinary Pharmacovigilance

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.

In-house Training and Consultancy Services

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.

Your next step is to call us now on +44 (0)20 7749 4730 or email us at or use our contact form and find out how we can help. There are no commitments, and if we cannot help our advice and recommendations are free of charge.

Sample programme - Day one

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

Sample programme - Day two

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

Recommended trainer

Declan O’Rourke

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).

Bespoke training

We can customise this course to meet the requirements of your organisation. Contact us to discuss your training requirements.

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