Individual
location
Flexible
date

A 1-day practical & interactive training:

Labelling & packaging in the EU

Equip your professionals with a complete technical understanding of the regulatory framework of labelling in the EU. Delegates will gain a complete insight into important guidelines, legislation, the summary of product characteristics, the patient information leaflet and variations submissions.

Agenda

Important guidelines and legislation
  • Regulatory requirements in the EU
  • Identify each of the labelling elements
  • Examples of different products and labelling changes
  • Risk based approach
  • Product and process understanding
  • Critical attributes and parameters
  • Continuous improvement

Product characteristics (SmPC)
  • Unique insights into and the importance of writing the SmPC
  • Communicate proper use and risk of a medicine by both the SmPC

Patient information leaflet (PIL) and labels
  • The requirements for labels and leaflets
  • The therapeutic indications and listing contraindications
  • Warnings and precautions for use
  • Potential drug interactions
  • Adverse reactions
  • Instructions for storage, shelf life and in use stability claims

Readability guidelines
  • Fullfil regulatory and best medical practice
  • Customize the information to meet the needs of physicians and patients
  • Give good quality information

Variations submissions / deficiency letters
  • When should variations be submitted
  • The variability of the requirements for different product types
  • Timelines
  • The variation approval process
  • Influencing cost and number of variations, as well as user fees
After every session a case study will show how theory works in practice.
Contact us for further information