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Periodic Safety Update Reports for Veterinary Medicinal Products Training Course: face to face & live webinar

Including requirements for regions including the EEA, USA, Canada and Australia and an update on the implications of Brexit

*NEW EVENT!*

4-5 Nov 2020

& 11-12 May 2021 , 19-20 Oct 2021

Book now

Course overview

Periodic safety update reports (PSURs) are pharmacovigilance documents intended to provide a comprehensive and critical evaluation of the riskbenefit balance of a veterinary medicinal product at defined time points after its authorisation, taking into account new or emerging safety information in the context of cumulative information on risk and benefits. Regulatory authorities assess information in PSURs to determine if there are new risks identified for a veterinary medicine and/or if its risk-benefit balance has changed. A PSUR assessment can determine if further investigations on a specific issue are needed, or if an action is necessary to protect animal health (eg an update of the information provided to animal healthcare professionals).

This interactive two-day seminar will provide a comprehensive, yet practical, assessment of the main requirements for PSURs in the European Economic Area (EEA), USA and other geographic regions. Content and format of the PSUR will be covered in depth, and key legislation and guidelines will be reviewed in order to ensure a compliant reporting company. The programme will also include workshops on PSURs for the EEA, USA and Australia. This is an excellent opportunity to gain essential information for your company to ensure compliance with the PSUR requirements.

Benefits of attending:
  • Understand the requirements of periodic safety update reports (PSURs)
  • Know the format and content of PSURs
  • Establish who is responsible
  • Plan your management and assessment of PSURs
  • Be updated on the implications of Brexit
  • Understand the requirements of periodic drug experience reports (PDERs) in the USA
  • Compare the differences between PSURs and PDERs
  • Discover the requirements of other countries
  • Consolidate learning with practical workshop sessions

Who should attend?

The event will be beneficial to all those with some experience of veterinary pharmacovigilance who require essential training on PSURs including:

  • Adverse event monitoring officers
  • Drug safety officers
  • QPPVs and deputy QPPVs
  • Personnel from regulatory affairs and registration departments

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

Programme - day 1

PSURs

  • What are they?
  • Why are they so important?
  • History of VICH
  • Implementation of VICH GL 29

PSURs in the EEA

  • Guidance
  • Preparation
  • Format and content
  • Analysis of data
  • Incidence calculation
  • Submission
  • Risk-benefit information
  • Addendum reports
  • Bridging reports
  • Writing the report

Implications of Brexit

  • Impact
  • Preparation

Workshop: Preparing and writing a PSUR

USA: Center for Veterinary Medicine (CVM) – PDERs

  • Guidance
  • Format and content
  • Analysis of data
  • Submission
  • Writing the report

Workshop: Preparing and writing a PDER

Programme - day 2

Biologicals: United States Department of Agriculture (USDA)

  • When will reporting start?
  • Requirements
  • Format and content
  • Analysis of data

Canada: Annual summary reports and case reports

  • PSURs and other reports
  • Guidance
  • Format and content
  • Analysis of data

Australia: PSURs

  • Guidance
  • Format and content
  • Analysis of data

Workshop: Preparing and writing a PSUR (Australia)

Other region/country requirements

  • Japan
  • South America

Presenter

Declan O'Rourke (More...)

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 Honarary 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).

Book now

  attend Face to face attend Live webinar
4-5 Nov 2020, Rembrandt Hotel, London
4-5 Nov 2020 Rembrandt Hotel, London GBP 1,199.00
EUR 1,679.00
USD 1,870.00
Until 23 Sep*
Enrol now
to attend
Face to face
GBP 999.00
EUR 1,439.00
USD 1,630.00
Until 23 Sep*
Enrol now
to attend
Live webinar
11-12 May 2021, Venue not yet confirmed
11-12 May 2021 Venue not yet confirmed GBP 1,199.00
EUR 1,679.00
USD 1,870.00
Until 30 Mar 21*
Enrol now
to attend
Face to face
GBP 999.00
EUR 1,439.00
USD 1,630.00
Until 30 Mar 21*
Enrol now
to attend
Live webinar
19-20 Oct 2021, Venue not yet confirmed
19-20 Oct 2021 Venue not yet confirmed GBP 1,199.00
EUR 1,679.00
USD 1,870.00
Until 7 Sep 21*
Enrol now
to attend
Face to face
GBP 999.00
EUR 1,439.00
USD 1,630.00
Until 7 Sep 21*
Enrol now
to attend
Live webinar

Learn more about our different training formats.

* Note the early booking discount cannot be combined with any other offers or promotional code