Regulatory Open Forum

Dear All , 

Kindly attain this ICH meeting ( Joint US FDA – Health Canada ICH Public Meeting webinar on February 24, 2023)  which could be helpful 

https://www.fda.gov/drugs/development-approval-process-drugs/cder-small-business-industry-assistance-sbia?utm_medium=email&utm_source=govdelivery

INTENDED AUDIENCE : North American regulators, industry, and other stakeholders interested in learning more about current efforts conducted under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) to develop and harmonize scientifically driven, global standards for safe, effective, and high-quality pharmaceuticals.

TOPICS COVERED : 

• ICH Background

• ICH Guidelines Reaching Key Milestones

  • Clinical Electronic Structured Harmonized Protocol

  • Drug Interaction Studies

  • Bioequivalence for Immediate-Release Solid Oral Dosage Forms

  • A Selective Approach to Safety Data Collection in Specific Late-Stage Pre-Approval or Post-Approval Clinical Trials

  • Rodent Carcinogenicity Studies for Human Pharmaceuticals

  • Assessment and Control of DNA Reactive (mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk

  • Biodistribution Studies for Gene Therapy Products

  • Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin

  • Continuous Manufacturing

  • Bioanalytical Method Validation

------------------------------
[SANKET] [SHAH] [ REGIONAL MANAGER]
[QA AUDITOR]
[ABBOTT]
[MUMBAI] [MAHARASHTRA]
[INDIA]
------------------------------