HPRA information day on implementation of Regulation 2019/6 in Ireland – virtual event

Event Date: 28/10/2021 10:00 - 28/10/2021 15:30

The HPRA will host a webinar for marketing authorisation holders and manufacturers of veterinary medicines on implementing the new requirements that will come into effect as part of Regulation 2019/6, the new veterinary regulation.

Date and time

10.00 am to 3.30 pm, Thursday 28 October 2021

Aim of the event 

This event is focussed on the implementation of the new veterinary regulation as it affects stakeholders in the animal health sector in Ireland. Speakers from the HPRA, the Department of Agriculture, Food and the Marine (DAFM) and the Animal and Plant Health Association (APHA) Ireland will deliver the event. The aim is to update stakeholders on changes that affect them, as they relate to the regulation and monitoring of veterinary medicinal products in Ireland.

The event will be divided into four sessions to facilitate stakeholder participation. Significant time will be given to a question and answer period after presentations in each session. Registrants are invited to submit questions at the time of registration so that they can be addressed in presentations or in the Q&A session. It will also be possible to raise questions in a chat function during the event.

Programme and conduct

For information on the topics covered during the event, please see the draft programme. The webinar is organised into four sessions as follows:

  • Session 1, 10.00 am – 11.00 am: Update on new legislative framework for veterinary medicines 

  • Session 2, 11.15 am – 12.15 pm: Changes to marketing authorisation procedures 

  • Session 3, 1.30 pm – 2.20 pm: Changes to pharmacovigilance monitoring of veterinary medicines

  • Session 4, 2.30 pm - 3.30 pm: Changes to GMP, manufacturing and distribution requirements

Each session will address the specific topic in the title and will be conducted as a separate webinar in order to make each session available as a separate recording to stakeholders following the event. The HPRA will provide four links - one for each session - to registrants by email before the event. If you wish to join a particular session, click on the relevant joining link. Disregard links for sessions you do not wish to attend. A break of at least 10 minutes between sessions will facilitate delegates moving between sessions. The welcome address will be included in the Session 1 link. The HPRA will use Microsoft Teams as the event platform.

Who should attend                             

This webinar is intended for animal health companies and veterinary manufacturers that manufacture or supply the medicines concerned in Ireland. It may also be relevant to relevant contract research organisations, trade organisations as well as personnel from DAFM, APHA as well as to other regulatory bodies.

Registration

If you would like to attend, please register by emailing events@hpra.ie and include your name, company name and any questions that you would like to see covered during the course of the event.

Please register by 26 October. The HPRA will send the links for joining the webinar to registrants by 27 October.

Fee

The event is free of charge. However, please ensure to register in advance using the link above.

Recordings

If you are unable to attend the event, you can access the information in a recording of each separate session on the HPRA website after the event.

Queries

If you have queries regarding this event, please email events@hpra.ie



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