wdt_ID | Learning Code | Topic | Major Class | Duration in minutes |
---|---|---|---|---|
1 | PCDL0001 | Introduction to R&D Process & drug discovery | Drug Discovery Development to Commercialization | 35 |
2 | PCDL0002 | Investigational New Drug Application | Drug Discovery Development to Commercialization | 45 |
3 | PCDL0003 | New Drug Application (NDA) | Drug Discovery Development to Commercialization | 60 |
4 | PCDL0004 | Basic concept and understanding of the Generic Drug | Drug Discovery Development to Commercialization | 60 |
5 | PCDL0005 | Abbreviated New Drug Application (ANDA) | Drug Discovery Development to Commercialization | 60 |
6 | PCDL0006 | Complete Response Letter (CRL) and Action plan for effective management of CRL | Drug Discovery Development to Commercialization | 30 |
7 | PCDL0007 | Handling of orange book | Drug Discovery Development to Commercialization | 30 |
8 | PCDL0008 | USFDA Expedited Programs (Detailed Understanding) | Drug Discovery Development to Commercialization | 30 |
9 | PCDL0009 | 505(j) ANDA, 505(b)(2) NDA, 505(b)(1) NDA | Drug Discovery Development to Commercialization | 30 |
10 | PCDL0010 | Concept of Authorized Generics: Key Understanding | Drug Discovery Development to Commercialization | 30 |
Learning Code | Topic | Major Class | Duration in minutes |