International Council for Harmonisation (IHC) Guidelines are recommendations on the information needed in a clinical study report. IHC Guidelines are used for reports on studies investigating therapeutics, prophylactic, and diagnostic agents tested on human subjects.
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In June 2022, the ICH released the first draft of its harmonized global Drug Interaction Studies Guideline (M12). The guideline is the result of several meetings of the Expert Working Group...
Learning Objectives: 1. Explain what is gene therapy is. 2. Explain what steps are involved for getting a gene therapy product to the clinic. 3. Discuss development and manufacturing process...
Analytical Method Validation work is based on a variety of guidelines and requirements hence being time-consuming and stressful. Reducing this work and improving efficiency while ensuring th...
Analytical Method Validation work is based on a variety of guidelines and requirements hence being time-consuming and stressful. Reducing this work and improving efficiency while ensuring th...
DATE: November 28th, 2017TIME: 6:00AM PT, 9:00AM ETThe work of ICH has significance for pharmaceutical manufacturers globally. This webinar discusses the key validation ch...
DATE: May 25, 2016
TIME: 8am Pacific time, 11am Eastern time, 4pm UK time, 5pm European time, 11pm Beijing time
In this two-part webinar, we will be presenting the following t...