Further your understanding of the latest requirements for labelling and packaging according to EU and FDA guidelines
Course Overview
本课程将欧美regul澄清atory 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.
Live Online Academies
Gain real-time access to a subject matter expert delivering online training in a structured virtual classroom environment. Live online academies are virtual versions of some of our most popular face-to-face courses.
Students will learn through:
- Live interactive sessions
- Direct interaction with the trainer during live sessions
- Participation in interactive features within sessions including polls, Q&A, break out rooms, tasks, case studies, and more
- Revisiting recorded sessions with unlimited access for 30 days
- Interaction with peers during live sessions and through the online forum
Timings and dates are subject to change - final confirmation will be provided with login details. Delegates will receive login instructions within a week of the course start date. If you have any questions please contactlifesciences-training@informa.com.
What will you learn?
SmPCc & PILs
SmPCc & PILs
Create SmPCs, PILs, and labels to meet EU and US requirements
How to avoid common errors
How to avoid common errors
Review examples of PILs to avoid common mistakes and deficiencies
EU PI
EU PI
Learn how to navigate the EU regulatory maze of EU PI
EU regulations
EU regulations
Clarify the regulations and practical implementation of EU legislation
Readability
Readability
Understand what readability really means without conducting user testing
User testing
User testing
Compare user testing with FDA testing methods such as ‘label comprehension studies’ of non-prescription drugs or Failure Mode Effects Analysis
Labelling
Labelling
Understand the evaluation of container labels and carton labelling, as well as ‘human factors engineering’
Compare EU & US regulations
Compare EU & US regulations
Recognise the differences between the EU SmPC (e.g. being conciseness and executive) and the US PI (e.g highlight opening section, detail)
Who is this course for?
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.
CPD Certified
Engaging in Continuing Professional Development ensures that both academic and practical qualifications do not become out-dated or obsolete; allowing individuals to continually ‘up skill’ or ‘re-skill’ themselves, regardless of occupation, age, or educational level. This course has been assessed and is CPD certified.
