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EU & US Requirements for Pharmaceutical Labelling & Package Leaflets

25 August - 4 September 2020

New LIVE Online Academy

LIVE ONLINE ACADEMIES


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.

Delegates will receive login instructions within a week of the course start date. If you have any questions please contact [email protected].

For more information and a comparison with other digital study modes, download the digital training guide

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


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:

  • 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.

We're looking forward to welcoming our attendees and expert course leaders at EU & US Requirements for Pharmaceutical Labelling & Package Leaflets in London in June.

Our number one priority is the safety of our delegates and colleagues, and there are always measures in place at our venues to safeguard your health and safety. There are extra measures in place for 2020 in light of developments with COVID-19.

Book with total confidence – click here to be fully assured on how your booking rights are protected.

                                                                       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!


Clinical Pharmacokineticist, Bayer Pharma

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