Course Overview

An interactive pharmaceutical 'refresher' workshop on the variations process requirements and categorisation in EU and US that is specifically designed for QA Professionals.


This workshop includes real examples of regulatory procedures and data requirements for variations to EU MAs/and post-approval changes to US NDA/ANDA/BLA submissions. 

This workshop will explore:

  • Regulatory agency expectations on the data that should be included in variation
  • The categorization of post-approval changes; e.g. 1A, 1B, Type 2 in EU and CBE0, CBE30 or prior approval in USA
  • The need for the QP/QA to be kept informed regarding post-approval changes via an effective change control process
  • New/emerging expectations arising from ICH Q12

By the End of This Workshop, You Will Improve/Expand…

  • Your awareness and knowledge of the latest regulatory procedures for post-approval changes
  • Your knowledge on how EU and USA regulatory procedures work
  • Your ability to communicate with your regulatory support functions

Facilitated By…

Helen Erwood

Helen has been working in pharmaceutical regulatory affairs/regulatory compliance for many years; she has wide experience in the regulation of medicines, medical devices and borderline/OTC/ nanotechnology products and enjoys the challenge of dealing with something that doesn’t quite fit the current regulations. Helen is also eligible to act as a nonclinical expert for EU submissions. In addition, Helen also regularly presents at The Organisation for Professionals in Regulatory Affairs (TOPRA) meetings and provides training within the industry on regulatory affairs.

Workshop Fees

Workshop cost (excluding VAT)  £710.00


Early bird and multiple delegate booking discounts available. Discounts also offered to NHS staff, regulators and charities - contact us for details.

Have a question or want to book a place? Contact - you can also register online by clicking below.

You may also be interested in the Regulatory Affairs for QA: Marketing Authorisations workshop which is taking place the day before.