Course No 20306
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The conference will present and highlight the current developments in the field of method validation and life cycle management. Experts from industry and laboratories will present the current status of the revision and the contents of the guidelines on the one hand, and their own experiences in the establishment and validation of methods and procedures on the other hand.
The previous harmonised guideline Q2(R1) has been in force in its current form since 2005. At that time, it combined the two guidelines Q2A, which contained analytical methods for required validation parameters, and Q2B, the methodology guideline. In 2018, it was decided to develop a new ICH quality guideline on analytical method development (ICH Q14) and to revise the ICH Q2(R1) guideline on analytical method validation to potentially combine both documents into one document for simplification and clarity. In parallel, the USP also developed the <1220> Analytical Procedure Life Cycle chapter, which was published in October 2021. On 14 November 2018, a Final Concept Paper “ICH Q14: Analytical Procedure Development and Revision of Q2(R1) Analytical Validation was published. It was proposed to develop a new quality guideline on Analytical Procedure Development and to revise the ICH Q2(R1) Guideline on Validation of Analytical Procedures: Text and Methodology.
After an extended processing time, the two documents on ICH Q14 and ICH Q2(R2) were published on the 24 March for consultation by the ICH regulatory members. The goal is to finalize by Step 4 by May 2023. Together, ICH Q14 and ICH Q2(R2) describe the development and validation activities proposed during the life cycle of an analytical method to assess the quality of medicinal products and medical devices.
In summary, ICH Q14 and ICH Q2(R2) represent the harmonised scientific and technical principles for analytical methods throughout the lifecycle of analytical methods. ICH Q14, through the principles described, is intended to improve communication between industry and regulatory authorities and achieve more efficient, science-based and risk-based approval, as well as to facilitate post-approval change management of analytical methods. The revised form of ICH Q2(R2 continues to provide the general framework for validation of analytical methods, now expanded to include new technologies (e.g., for biological products or multivariate analytical methods).
09.15 - 10.00 h
Congress Keynote: Biological Manufacturing – Demanding Quality and Compliance Requirements
Dr Tilman Rock, SVP, Site Head Vienna (Austria), Boehringer Ingelheim Biopharma
ICH Q2(R2)/Q14: Mission accomplished?
Dr Joachim Ermer, Ermer Quality Consulting
Lifecycle Management of Analytical Procedures, Instruments and Systems in the USP
Dr Chris Burgess, ECA Analytical Quality Control Interest Group
Next Steps of Practical Life Cycle Management in Laboratories
Ulla Bondegaard, NovoNordisk
Insights into ICH Q14: Analytical Procedure Development
Dr Mario Ramos, Valicare
Impact of New ICH Q14 and Q2(R2) Draft Guidelines on Potency Assays – Focus on SPR
Simon Gaderer, VelaLabs
Method Validation for Anti-Drug Antibodies (ADA) and Neutralizing Antibdies (NAbs)
Dr Ralf Hess, Entourage
From Vision to Validation: The Method Live Cycle explained by the Example of a HPLC Method
Sarah Herzog, Reference Analytics
Development and Validation of a Customized Amplex UltraRed Assay for Sensitive Hydrogen Peroxide Detection in Pharmaceutical Water
Dr Alexandra Heussner, Vetter
A Full Spin on Analytical Lifecycle Management: Proof of Concept
Fábio Brito, Infosaúde - LEF