Including requirements for regions including the EEA, USA, Canada and Australia and an update on the implications of Brexit
4-5 Nov 2020
& 11-12 May 2021 , 19-20 Oct 2021
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:
The event will be beneficial to all those with some experience of veterinary pharmacovigilance who require essential training on PSURs including:
The course can be used as part of the training to become a QPPV or Deputy QPPV.
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).