merger merger

Welcome to your new course portal!

On October 15th, moved to - which means you can now find all your favourite courses right here. Don't worry - you can still do all the things that you could do before.

All you need to do is search.

Show as: Mobile

EU & US Requirements for Pharmaceutical Labelling & Package Leaflets

Course summary
3 days
1,995 GBP excl. VAT
Professional Training
Next available date: 14/07/2020 - Online courses
Course Dates
Online courses
1,995 GBP
1,995 GBP

Course description

EU and US Requirements for Pharmaceutical Labelling

EU & US Requirements for Pharmaceutical Labelling & Package Leaflets - PTI

This comprehensive three-day training course explores the current European regulatory requirements for developing labelling and package leaflets and provides an in-depth explanation of the latest Directive. The course will also provide practical guidelines for designing and writing Patient Information Leaflets to meet regulatory requirements and satisfy readability and compliance needs.

The growing regulatory and consumer demand require accurate and complete product information more than ever before. This course will provide you with key practical information on devising successful labelling strategies to guarantee complete compliance.


In light of the uncertain times we’re facing at the moment, 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, delivered in bitesize sessions of 1.5-2 hours online.

All sessions will be recorded and uploaded to your virtual learning environment which you will get access to for a month. As part of this you will also be able to access a forum where you can communicate with your trainer and peers on the course.

Suitability - Who should attend?

This training programme is aimed at professionals specialising in Regulatory operations within the pharma industry.

Training Course Content

Training course content will cover:

  • Creating SmPCs, PLs, and labels to meet EU requirements
  • Product Information (PI) and US Package Insert (PI)
  • Examples of PLs to avoid common mistakes and deficiencies
  • How to navigate the EU regulatory maze of EU PI
  • The regulations and practical implementation EU legislation
  • Implementing the readability guideline of the PILs and QRD reference PI
  • What readability really means without conducting user testing
  • Comparing 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’
  • The merits of the EU SmPC (e.g. being conciseness and executive) vs the US PI (e.g highlight opening section, detail)

Why choose PTI

On average, delegates of their online academies said: 

Quality of content:


85% had applied content during the course to their role

Delivery rating:



In-house Training

PTI - Pharmaceutical Training International can also deliver this course as in-house training for your company. You can reduce costs, enhance accessibility to training resources and better address your company’s own business goals with a tailored PTI training package.

About provider

PTI - Pharmaceutical Training International

PTI - Pharmaceutical Training International - Training for the Pharma Industry

PTI is the global leader in professional education for the pharmaceutical industry, delivering a broad course portfolio that covers the industry spectrum: R&D, Clinical Development, Generics, Bio-pharmaceuticals, fine Chemicals, Agro-chemicals, Medical Devices, Animal Health, Manufacturing and Regulations. PTI's open courses,...

Read more and show all courses with this provider

Request info

Fill out your details to find out more about EU & US Requirements for Pharmaceutical Labelling & Package Leaflets.

  Contact the provider

  Get more information

  Register your interest

Contact info



 Show phone number


Average rating 5

Based on 5 reviews

Clinical Pharmacokineticist, Bayer Pharma
Very good and interesting course. A lot of hands on training!
Regulatory & Medical Affairs Manager, PAGB
Salma was very knowledgeable and provided lots of views from her experience. I really appreciated the Medical Devices insight too.
Regulatory Affairs Project Manager, LFB Biomedicaments
The practical examples, comparison between Medical Devices vs Drugs and the EU to US parts of the course were all excellent.
Request Information

Find out more about this EU & US Requirements for Pharmaceutical Labelling & Package Leaflets course - simply fill out your details:

Course rating
Based on 5 reviews
U.K. L&D Report: 2019 - Benchmark Your Workplace Learning Strategy

Are you curious about the L&D strategies of some of the U.K.'s top companies?

Find out what they're up to in's second annual U.K. L&D Report!


Learn more

Similar Courses