QRD Template Seminar

Our teams are specialised in adapting SmPC/PL and label texts to the current language-specific QRD templates. They not only take into account the linguistic and country-specific requirements of the national authorities, but also give consideration to the individual exceptions and formatting rules.

Our specialist trainers will speak about which regulatory requirements exist, where interpretations are needed and which specific requirements exist.

The seminars are particularly aimed at responsible persons in regulatory departments and translators wishing to specialise in the translation of SmPCs, PLs and labels.

During the seminars, the following topics are treated in detail:

  • QRD templates
    - Legal background
    - Recommendations for readability
    - Requirements of authorisation procedures

  • MRP/DCP - Specific characteristics of the procedure

  • CP and EMA - Specific characteristics of the central procedure

  • Blue Box - Requirements and implementation within the CP

  • Structure - Navigation in SmPC, labels, PL

  • Abbreviations – “Tables of non-standard abbreviations“

  • Linguistic style - Requirements and recommendations with respect to “Stylistic Matters“

  • EU designation - country-specific spellings

  • “Besonderheitenliste” - Contents of the “Excipients Guideline“

  • Standard translations - in accordance with Appendices I-IV

  • Lay Terms - patient-friendly terms and recommendations for use

  • Discussion on details - e.g. the English/German MRP/DCP QRD templates

  • EDQM terminology - Standard Terms

  • MedDRA terminology - requirements for adverse effect frequency, system organ classes

  • Standard sentences and headings - national specifics

  • Formatting and file names - in accordance with “EMA/524020/2007 “User guide on how to generate PDF versions of the product information – human” andEMA/62470/2007 “QRD convention to be followed for the EMA-QRD templates”, e.g. for SI units, non-breaking spaces and hyphens

Place

Our seminars are tailored individually to your needs and take place directly within your department. Alternatively, you and your team members can also attend one of our general seminars in Neu-Ulm. Ask about possible dates.

Content for regulatory affairs department

Personal conversation is at the forefront of our training for responsible persons from regulatory affairs departments. We define, together with you, the topics on which you wish your seminar to focus. We would also be happy to extend the theoretical training by means of a workshop, in which we would work personally in the team to edit one of your product information documents.

Content for translators

The contents of our training courses for translators focus specifically on the requirements with respect to translation. The courses take place at our premises in Ulm or optionally can be booked as an online seminar. We also offer the possibility of using the specialist knowledge acquired in a practical workshop.

Contact us. We look forward to meeting you.

Dr Gunnar Box
E-Mail: gunnar.box@langcor.de
Tel.: 0731/9858800