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Join the U.S. Food and Drug Administration (FDA) and Health Canada for a regional ICH consultation to provide information and request input on guidelines recently reaching key ICH milestones. This virtual event is open to the public and will be held on May 11, 2022. It is intended for North American regulators as well as others in the industry and will discuss the following topics:
- E11A, Paediatric Clinical Trials Extrapolation
- Q9(R1), Quality Risk Management
- Q2/Q14, Analytical Validation
- E14/S7B, Clinical Evaluation of Qt/QTc Interval Prolongation and Proarrhythmic Potential QnA
- Q3D(R3), Revision for Cutaneous and Transdermal Products
