- Name: Shabnam Mansuri
- Course: Drug Dossier Preparation
- Certificate Id: sM2RYD-024298
- % Secured: 74%
- Date of completion of the course: 12th of April, 2021
Course Performance - Shabnam Mansuri
SL | Topic | Score | Max. Score | % Secured |
---|---|---|---|---|
1 | CTD - Dossier | 28.40 | 32 | 88.80 |
2 | CMC Test 1 | 30.00 | 36 | 83.30 |
3 | CMC Dossier and Regulatory Compliance | 46.00 | 50 | 92.00 |
4 | ECTD | 37.05 | 53 | 69.90 |
5 | Stability Study - Fundamental Training Self Assessment Test 1 | 48.83 | 60 | 81.40 |
6 | Effective Management of Drug Dossier | 25.50 | 30 | 85.00 |
7 | ANDA Submission Filing | 18.00 | 24 | 75.00 |
8 | 505b2 Pathway | 14.00 | 32 | 43.80 |
9 | PAS in ANDA Submission | 7.33 | 10 | 73.30 |
10 | ANDA Fees | 15.67 | 22 | 71.20 |
11 | 505(B)(2) Vs. ANDA Suitability Petition | 13.16 | 18 | 73.10 |
12 | FTF-180 DAYS EXCLUSIVITY | 15.00 | 20 | 75.00 |
13 | 505(b)(2) Filing Case Study FDC | 20.00 | 20 | 100.00 |
14 | 505(b)(2) - Avoiding 30-month stay of ANDA litigation | 2.00 | 16 | 12.50 |
15 | ACTD | 17.33 | 30 | 57.80 |
16 | Deficiencies and Mistakes in Dossier | 9.83 | 20 | 49.10 |
17 | DMF Test 1 | 20.00 | 40 | 50.00 |
18 | SMF | 19.00 | 20 | 95.00 |
19 | DMF Fees (US) | 8.00 | 10 | 80.00 |
20 | DMF in Global Perspective | 24.00 | 26 | 92.30 |
21 | Data integrity | 13.33 | 14 | 95.20 |
22 | 483 observation and Warning Letter | 33.50 | 40 | 83.80 |
SL | Topic | Score | Max. Score | % Secured |
∑ = 465.93 | ∑ = 623 | |||
Avg= 21.18 | Avg= 28.32 | Avg= 73.98 |