On 25 November 2025 at 16:00 CET, our Regulatory Affairs Manager, Lara Šterbenc, led a comprehensive webinar titled “Essential Tools and Techniques for Preparing Product Information Using QRD Templates”, organised by TOPRA. The session attracted regulatory affairs professionals and newcomers alike, keen to deepen their understanding of harmonized documentation practices for medicinal products across the EU. 

What is QRD – and why it matters 

At the core of Lara’s presentation was the concept of QRD (Quality Review of Documents) templates – standardized document structures maintained by the European Medicines Agency (EMA) for regulatory submissions. These include templates for Summary of Product Characteristics (SmPC), the Patient Information Leaflet (PL/package leaflet), and product labelling. 

The use of QRD templates ensures that product information across different medicines and markets stays consistent, clear, and compliant with EU legislation — a foundation for regulatory alignment, patient safety, and transparent communication. 

What was the webinar agenda 

According to the shared presentation outline, these were the main topics Lara addressed: 

• What is QRD – definition and role of QRD/EMA templates. 

• Where to find QRD templates — How to access official templates (SmPC, PL, labelling) published by EMA. 

• General principles for using QRD templates — Overview of formatting rules, structure, and stylistic conventions required for regulatory compliance. 

• Practical tips for preparing national translations — Guidance on local/national adaptations, translation issues, language-specific considerations for multi-country submissions. 

• Annotated QRD — How to use the annotated QRD for additional guidelines while preparing product information. 

• New QRD template — Recent updates to the QRD template for centralised procedures (that has undergone public consultation which concluded in August 2025), implications for product information, specifically for the package leaflet. 

• Q & A session — Addressing participant questions, clarifying common pitfalls, and giving practical regulatory advice. 

This structure provided a clear, step-by-step walk-through of how to produce compliant, accurate, and user-friendly product information. 

What participants gained 

Attendees walked away with a solid foundation in regulatory best practices: 

• Understanding how to select and apply the correct QRD template depending on the medicinal product, procedure and target market. 

• Guidance on consistent formatting, standard terminology, and regulatory wording, as defined in the QRD conventions -ensuring clarity and avoiding regulatory delays or rejections. 

• Insight into translation of the PI – crucial for multinational submissions covering multiple EU member states. 

• Awareness of recent template updates (e.g. newer version of the QRD template) – helping to future-proof documentation processes and stay aligned with evolving EMA guidance. 

• Practical understanding of how to prepare SmPC, PL, labelling – all within the harmonized QRD framework. 

For many in attendance – especially those new to regulatory documentation — the webinar demystified the often-complex environment of EU submissions, transforming QRD compliance from a regulatory burden into a manageable, structured workflow. 

Our commitment – regulatory excellence & knowledge sharing 

By hosting and sponsoring this webinar, we reaffirm our commitment to high-quality regulatory documentation and continuous professional development. We firmly believe that mastering QRD-based product information is essential – not only for compliance and successful submissions, but also for transparently communicating medicinal product information to regulators, healthcare professionals, and ultimately, patients. 

We extend our sincere thanks to Lara for her expertise and time, and to all participants for their engagement and insightful questions. 

For those who could not attend – do not worry. We are planning to organise follow-up sessions, and will soon make available supporting materials and recorded summaries to help you master QRD-compliant documentation. Stay tuned!