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:<ul><li>
FDAs internal structure, policies, and procedures</li>
<li>GCP, GLP and GMP regulation requirements for INDs, NDAs, BLAs, ANDAs, SNDAs, CTDs and Drug Master Files</li>
<li>The FDA review process for new product approvals, including FDA/Industry Meetings and Liaison</li>
<li>Acceptance of foreign data for new product approvals, EU Directives on global submissions.</li></ul>
