Priya Jambhekar is a consultant with EAS Consulting Group and has over twenty years of experience in the areas of product development, product safety, quality assurance, quality compliance, clinical operations, supply chain management and US and international regulatory affairs.
This 15 hour course will give participants the necessary overview of the US Food and Drug Administration's (FDA) current responsibilities, procedures, guidances and regulatory pathways that affect the review and approval of chemical drugs, biologicals, biopharmaceuticals, biosimilars and chemical generics. Using the ICH Common Technical Document (CTD) module format outline, significant Chemistry Manufacturing and Controls (CMC), Nonclinical and Clinical areas will be analyzed and discussed, as a basis for strategic planning for both submitting INDs, NDAs, BLAs, ANDAs, and post-approval supplements, as well as for holding key meetings with the FDA.
Understand the importance and underlying principles of the FDA regulatory review process for chemical drugs, biologics and biopharmaceuticals from Phase 1 IND through market approval
Learn how to prepare appropriate and necessary FDA regulatory submissions throughout the drug development process covering the CMC, Nonclinical and Clinical areas
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