Pharmaceutical Labelling & Package

This interactive three-day course will clarify the European regulatory requirements for developing labelling.

Medical & Health Care, Pharmaceuticals/Drug Discovery

Pharmaceutical Labelling & Package 4-6 Jun 2014 Radisson Blu Edwardian Grafton Hotel, United Kingdom
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In the face of increasing regulatory and consumer demand, the need for accurate and complete product information has never been stronger. This course will provide you with key practical information on devising successful labelling strategies to guarantee complete compliance.

- Create SmPCs, PLs, and labels to meet EU requirements Product Information (PI) and align with US Package Insert (PI)
- Review examples of PLs to avoid common mistakes and deficiencies
- Learn how to navigate the EU regulatory maze of EU PI
- Clarify the regulations and practical implementation EU legislation
- Implement the readability guideline of the PILs and QRD reference PI
- Understand what readability really means without conducting user testing
- Compare user testing with FDA testing methods such as label comprehension studies of nonprescription drugs or Failure Mode Effects Analysis
- (FMEA) for evaluation of container labels and carton labeling, as well as human factors engineering
- Recognise the merits of the EU SmPC (e.g. being conciseness and executive) vs the US PI (e.g highlight opening section, detail)

Book before the 7th May 2014: £1,795.00 + (VAT @ 20.00%) = £2,154.00
Book after the 7th May 2014: £1,895.00 + (VAT @ 20.00%) = £2,274.00