Overview of Webinar

The revision of ICHQ2(R1): Validation of Analytical Procedures and the development of ICHQ14: Analytical Procedure Development reached the key ICH milestone of Step 2 publication for public consultation in March 2022. The combined topic Q2(R2)/Q14 represents an opportunity to provide guidance on how to apply enhanced development approaches (‘Quality by Design’) to analytical procedures and how to use the knowledge obtained to support routine use of procedures. Q2(R2)/Q14 will also have the potential to facilitate the selection or identification of development approaches that will reduce the risk incurred by post-approval changes to analytical procedures discussed in ICHQ12: Pharmaceutical product Lifecycle Management. This webinar will explain why these guidelines are being developed as well as highlighting the implications and opportunities.

Learning Outcomes

By the end of this webinar, you will be able to understand: 

  • How Quality by Design can be applied to Analytical Procedures (“Analytical Quality by Design” or AQbD) and learn about key concepts such as the Analytical Target Profile (ATP)
  • What has changed in the revision of ICHQ2(R1) and what opportunities this may provide
  • The purpose of ICHQ14 and what this new guideline means for the pharmaceutical industry.

About the Speaker

Philip Borman, director and senior fellow at GSK. Over many years, Phil has pioneered the adaptation of Quality by Design principles to analytical procedures and currently co-leads the EFPIA ICH Q2(R2) and ICH Q14 guidance on Quality by Design.  

For further information including registration link, see event flyer EIPG webinar 'Analytical Procedures ICH Q2(R2) and Q14'_15 June 2022

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