Course description
EU & US Requirements for Pharmaceutical Labelling & Package Leaflets
This interactive three-day course will clarify the European and US regulatory requirements for developing labelling and package leaflets and clearly interpret the latest Directive. The course will also provide practical advice on designing and writing Patient Information Leaflets and Package Inserts to meet regulatory requirements and satisfy readability and compliance needs. 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.
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Suitability - Who should attend?
This course has been specifically designed to address the training needs of Managers and Executives in area such as:
- Regulatory Affairs
- Product Labeling
- Legal Counsel
- Drug Safety
- Medical Affairs
- Marketing
- Medical Information
The course will be beneficial to people new in their role, and more experienced professionals who need clarification on the new requirements.
Training Course Content
- Create SmPCs, PILs, and labels to meet EU and US requirements
- Review examples of PILs 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 non-prescription drugs or Failure Mode Effects Analysis
- Understand evaluation of container labels and carton labelling, as well as ‘human factors engineering’
- Recognise the differences between the EU SmPC (e.g. being conciseness and executive) and the US PI (e.g highlight opening section, detail)
Why choose PTI
On average, delegates of their online academies said:
Quality of content:
4/5
85% had applied content during the course to their role
Delivery rating:
4/5
Reviews
Average rating 5
Salma was very knowledgeable and provided lots of views from her experience. I really appreciated the Medical Devices insight too.
The practical examples, comparison between Medical Devices vs Drugs and the EU to US parts of the course were all excellent.
Very good and interesting course. A lot of hands on training!