The Center for Professional Advancement, Amsterdam
5-7 November 2007
Who Should Attend:
This course is specifically designed for personnel in the pharmaceutical and biotechnology industries who need a detailed understanding of what comprises an IND, NDA, BLA, ANDA, SNDA, and CTD. This includes but is not limited to those involved in:Pre-Clinical Research
Regulatory Affairs
Clinical Research
Product Development
CMC Components
Management
Quality Assurance Participants should have a basic understanding of new product development and/or regulatory affairs in order to best comprehend the lectures presented in this course.
Description:
The content of this course is designed to present the intricate parts of INDs, NDAs, BLAs, ANDAs, SNDAs and CTDs. These regulatory submissions for drug and biologic products will be based on the requirements of the US Code of Federal Regulations, the ICH Guidelines for global submissions and the EU Directives. Specifics of the IND, NDA, BLA, ANDA, SNDA and CTD will be detailed for safety, quality, and efficacy. Non and pre-clinical data, clinical data and CMC data to achieve product approvals globally will be enumerated for expediting new product approvals. Other subject areas include: FDAs internal structure, policies, and procedures
GCP, GLP and GMP regulation requirements for INDs, NDAs, BLAs, ANDAs, SNDAs, CTDs and Drug Master Files
The FDA review process for new product approvals, including FDA/Industry Meetings and Liaison
Acceptance of foreign data for new product approvals, EU Directives on global submissions.
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