Further to the ICH Management Committee’s endorsement of the Q2(R2)/Q14 IWG Concept Paper in October 2023, the Q2(R2)/Q14 IWG was established to prepare and deliver training materials which will facilitate an aligned interpretation and a harmonised implementation of Q2(R2) “Validation of Analytical Procedures” and Q14 “Analytical Procedure Development” Guidelines in ICH and non-ICH regions by:

• Illustrating the general concepts of ICH Q2(R2) and Q14;
• Providing more depth to the discussion of the Annexes in ICH Q2(R2) and Q14 to address some specific implementation aspects relevant for different cases.

Further information can be found in the Q2(R2)/Q14 IWG Concept Paper.