2024 - Safety-focused from Start to Submission: A Story of Target Safety Assessment and ICH S1B (R1) Guidelines
Date2024-10-23
Deadline2024-10-23
VenueONLINE-VIRTUAL, USA - United States
KeywordsLife Sciences; Pharmaceutical Regulation; Drug Discovery & Development
Topics/Call fo Papers
Discover an informative webinar that focuses on how the KnowledgeScan™ solution is advancing drug safety applications, including Target Safety and Weight of Evidence Assessments in accordance with the addendum to the International Council for Harmonisation (ICH) S1B (R1) guideline on testing for carcinogenicity of pharmaceuticals.
The solution rapidly generates TSAs to identify potential adverse effects of target modulation, while the WoE assessment can potentially avoid the need for the two-year rat carcinogenicity study. This approach not only enhances ethical standards but also offers considerable financial savings by minimizing reliance on long-term animal testing.
Read more...
Register for this webinar today to understand what is required to make robust, evidence-based documentation for effective safety assessment submissions.
Keywords: Drug Development, Drug Discovery, Clinical Research, Drug Safety, Pharmacovigilance, Regulatory, ICH, Safety Assessment, Toxicology/Safety
The solution rapidly generates TSAs to identify potential adverse effects of target modulation, while the WoE assessment can potentially avoid the need for the two-year rat carcinogenicity study. This approach not only enhances ethical standards but also offers considerable financial savings by minimizing reliance on long-term animal testing.
Read more...
Register for this webinar today to understand what is required to make robust, evidence-based documentation for effective safety assessment submissions.
Keywords: Drug Development, Drug Discovery, Clinical Research, Drug Safety, Pharmacovigilance, Regulatory, ICH, Safety Assessment, Toxicology/Safety
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Last modified: 2024-09-17 05:17:37