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.
• 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)
Sumaiya Patel is a director of a regulatory consultancy with over 11 years’ experience in both pre and post-approvals for generic, CRO and big pharma organisations. Sumaiya has experience in regulatory implementation and training, focusing on CMC, clinical development, strategy and manufacturing. She has extensive experience in writing Module 3 of CTD, Module 2 of the CTD and also Quality Expert statements to support dossiers and Type II Quality variations. She has a track record of providing regulatory inputs related to CMC aspects during the development product lifecycle.
This course has been specifically designed to address the training
needs of Managers and Executives in area such as:
The course will be beneficial to people new in their role, and more
experienced professionals who need clarification on the new
2017 Course Reviews
"Salma was very knowledgeable and provided lots of views from her experience. I really appreciated the Medical Devices insight too."
Regulatory & Medical Affairs Manager, PAGB
"The practical examples, comparison between Medical Devices vs Drugs and the EU to US parts of the course were all excellent."
Regulatory Affairs Project Manager, LFB Biomedicaments
"The comparison between EU & US Requirements aspect was very in-depth."
Regulatory Affairs Senior Team Leader, Perrigo Israel
"The case studies were very good. We received a lot of information regarding the EU & EU abpit drugs and Medical Devices."
Product Information Specialist, ORION
Very good and interesting course. A lot of hands on training!