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ICH has recently formed two new working groups: Q2 (R2)/Q14: Analytical Procedure Development and Revision of Q2(R1) Analytical Validation. These proposed guidelines are intended to complement ICH Q8 to Q12. We want to hear the voice of industry and feed back comments/concerns to the new ICH working groups.

Starts

Feb 05, 2019, 18:00

Ends

Feb 05, 2019, 21:00

Location

Toronto, Canada

PMcG SGS Collaboration

Spaces are limited, so please register!

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Details

  • February 5, 2019
  • 6:00pm - 9:00pm
  • Radisson Suite Hotel Toronto Airport

 ICH has recently formed two new working groups: Q2 (R2)/Q14: Analytical Procedure Development and Revision of Q2(R1) Analytical Validation. These proposed guidelines are intended to complement ICH Q8 to Q12.

Q14 is proposed to harmonise the scientific approaches of Analytical Procedure Development, and to provide the principles relating to the description of Analytical Procedure Development process. This new guideline is intended to improve regulatory communication between industry and regulators and facilitate more efficient, sound scientific and risk-based approval as well as post-approval change management of analytical procedures.

We want to hear the voice of industry and feed back comments/concerns to the new ICH working groups.

Your evening will include:

  • Light finger buffet
  • Non alcoholic beverages
  • Brief overview of the enhanced approach for analytical procedures, what it means for you and the intent of the new working groups for ICHQ2 and ICHQ14.- Pauline McGregor, Ph.D.

  • A contract testing lab perspective - Houri Simonian Ph.D

  • Discussion and information sharing

 

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