SponsoredWebinar-Product Information prep with QRD Templates

SponsoredWebinar-Product Information prep with QRD Templates
FREE SPONSORED WEBINAR - This webinar will explore the QRD templates and provide practical guidance on how to use them while preparing product information.   .

25 February - 15:00 - 16:00 GMT / 16:00 – 17:00 CET
Essential Tools and Techniques for Preparing Product Information Using QRD Templates  

QRD stands for Quality Review of Documents. It is a set of standard templates and guidelines developed by the European Medicines Agency (EMA) to ensure that product information for medicines is always presented in a consistent, structured, and compliant format.

This means that key documents — the summary of product characteristics (SmPC), the package leaflet (PIL), and labelling — all follow a clearly defined structure. Understanding how to find and apply the correct QRD templates for your country is therefore essential.
In this course, we will explore the QRD templates and provide practical guidance on how to use them while preparing product information.

Learning outcomes
Participants will learn how to identify the right template and prepare product information in line with QRD requirements.

Target audience
This course is especially designed for beginners, including:
• Professionals who are new to preparing product information for human medicines
• Individuals just starting their career in regulatory affairs
• Regulatory professionals with limited experience who want to learn the basics of preparing product information

Speaker details

Lara Šterbenc, Regulatory Affairs Manager, Billev Pharma East

Lara holds a Master’s degree in Pharmacy and began her career as a Regulatory Affairs Manager at Krka d.d. Novo mesto, overseeing compliance and regulatory processes for various EU and non-EU markets. She transitioned to Billev Pharma East, where she continues her work as a Regulatory Affairs Manager. Her work covers all aspects of regulatory affairs with a current focus on EU markets.


This webinar is sponsored by Billev Pharma East



Disclaimer: Whilst TOPRA is running this webinar for Billev Pharma East, this is not an endorsement of Billev Pharma East, Billev Pharma East's affiliates, employees or its products and services. TOPRA is also not responsible for the content or views expressed during the webinar.

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Pricing

  • Members: free
  • Non-members: free

Terms and Conditions

By purchasing this webinar, you are agreeing to TOPRA's training terms and conditions.


 
When
25/11/2025 15:00 - 16:00
Where
ONLINE
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