Veterinary Medicines Regulation Update: Product Information

Veterinary Medicines Regulation Update: Product Information
This workshop will cover the legislative requirements and practicalities imposed by the new regulation on packaging and labelling, and will offer an opportunity for discussion with industry professionals and regulators.


When:
 16 May 2022
Time: 9.00-12.30 GMT

 


Overview 

Webinars photoThe Veterinary Medicines Regulation requires a number of changes to the SPC, labelling and package leaflet (product information) for veterinary medicines. This workshop will cover the legislative requirements and practicalities, as well as offering an opportunity for discussion with both industry professionals and regulators.

Learning objectives

During this workshop, we will cover:

  • What is changing?
    o QRD template v.9
  • Timelines for change (transitional arrangements)
  • What is still in development for labelling requirements?

     

Target Audience

Professionals working in European veterinary medicines regulatory affairs or placing products on the European market:
  • At all levels of experience
  • Involved with originator or generic products

Speaker

Emily Drury
Veterinary Regulatory Affairs Team Leader
European Medicines Agency

In 2001, Emily began her career in veterinary regulatory affairs within the consultancy Cyton Biosciences, eventually heading up their regulatory projects team.

She joined the European Medicines Agency in 2009 to take up the role of CMDv Secretary and project manager for post-authorisation procedures, including variations, renewals and referrals. In 2017, Emily took over as Head of the Veterinary Regulatory and Organisational Support Service until 2020, managing post-authorisation activities, CVMP & CMDv secretariats, validation of incoming product applications and provision of regulatory advice.

Having gained experience in managing that multi-disciplinary Service, Emily has now formed a specialised regulatory affairs team within the EMA’s Veterinary Division and is enjoying this expert role during the implementation of the Veterinary Medicines Regulation.

Alongside her regulatory expertise, Emily has specialist knowledge of product information and labelling and has led on the 2021 revision of the QRD template.
 

Rhona McHugh
HPRA (The Health Product Regulatory Authority)

Rhona McHugh graduated with a BSc and PhD in Pharmacology from University College Dublin before working, for a number of years, as a product development scientist in the immunodiagnostics industry. 

Rhona has over 11 years’ experience as a pharmaceutical assessor of veterinary medicinal products (including immunological, pharmaceutical and homeopathic assessment) serving as a national and European expert in the review of pharmaceutical regulatory submissions and policy for the HPRA and EMA.

She has served as the Irish representative for the Co-Ordination group for mutual recognition and decentralised procedures - veterinary (CMDv) since February 2018.
 


CPD

This course offers 2.5 CPD hours for successful completion. To learn why CPD is important visit our Lifelong Learning page.

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Prices

Type Member  Non-member 
Standard    £70 + VAT £95 + VAT 
 

Discounted Places

A limited number of discounted places are available at the rates below for those:

Please email meetings@topra.org for a discount code before making your booking.

Type Member  Non-member 
Discount  £35 + VAT*  £47.50 + VAT* 


* VAT, if applicable, is charged at a rate of 20%.

Terms and conditions

By purchasing this webinar, you are agreeing to the terms and conditions.

When
16/05/2022
Where
ONLINE
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