Scribd
Upload
10 views3 pages

Hands on CTD Preparation and Submission Program

The Hands-On CTD Preparation & Submission Training spans approximately 3 months with online lectures twice a week and a doubt session. The program covers various sections including CTD fundamentals, ICH guidelines, global drug registration, and eCTD submission, culminating in certification for participants who achieve at least 80% in the exam. Participants will produce module-wise documents, eCTD publications, and receive additional support such as resume audits and mock interviews.

Uploaded by

prakash deshmukh
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
10 views3 pages

Hands on CTD Preparation and Submission Program

The Hands-On CTD Preparation & Submission Training spans approximately 3 months with online lectures twice a week and a doubt session. The program covers various sections including CTD fundamentals, ICH guidelines, global drug registration, and eCTD submission, culminating in certification for participants who achieve at least 80% in the exam. Participants will produce module-wise documents, eCTD publications, and receive additional support such as resume audits and mock interviews.

Uploaded by

prakash deshmukh
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
You are on page 1/ 3

Hands-On CTD Preparation & Submission Training

Duration: Approx. 3 Months

Online Lectures: Weekly Twice (Saturday & Sunday) Time: (7:00 pm to 9:00 pm IST)

Doubt Session: Thursday: 8:00 pm to 9:00pm IST

Note: Schedule is subject to change as per speaker’s availability

Certification: Upon completion of program and obtaining at least 80% marks in exam

Tentative syllabus:
Section 1 — Foundation
1. CTD Fundamentals
2. CTD Triangle
3. Submission-Ready PDF
4. Granularity
5. Node & Leaf
6. Bookmarks, links, pagination, figure/tables, file naming, metadata
7. STF basics
8. Regional nuances
9. Common rejections

Section 2 — ICH Guidelines


10. M-Series (M4, M4Q/M4S/M4E, M8)
11. Q-Series for CMC (Q1, Q2, Q3A/B/C/D, Q6A/B)
12. E-Series for Clinical (E3, E6, E9)
13. For non-clinical (M3)

Section 3 — Generic Drugs


14. Generic Pathway Overview
15. RLD & RS
16. Bioequivalence Strategy & Waivers
17. Comparative dissolution
18. Patent, Exclusivity & Orange Book Tactics
19. ANDA vs 505(b)(2) (Case Study)
20. Sameness Q1/Q2/Q3
21. Paragraph certifications
22. Authorized generics
23. Stability study
24. Analytical Method Validation
25. Process Validation
26. Qualification (IQ, OQ, PQ)

Section 4 — Global Drug Registration (US, EU, Japan, UK, China)


27. United States (FDA/CDER/CBER)
28. European Union (EMA/NCA)
29. Japan (PMDA/MHLW)
30. United Kingdom (MHRA)
31. China (NMPA/CDE)
32. IND/NDA/BLA/ANDA
33. Orange Book & exclusivities
34. DMF/ASMF
35. Centralized/Decentralized/MRP/National
36. eSubmission Gateway
37. Variations

Section 5 — Drug Discovery


38. Target identification
39. Hit identification
40. Lead identification
41. Lead optimization
42. From Target to Candidate (Case study)
43. Tox study (Case study)

Section 6 — Nonclinical & Clinical Trials


44. IND/CTA
45. Nonclinical Trials
46. Clinical Trials
47. Pharmacovigilance

Section 7 — Preparation of Module 1–5 Documents


48. Module 1 (Regional) — Hands-On
49. Module 2 (Summaries: QOS/Overviews) — Hands-On
50. Module 3 (CMC: API & DP) — Hands-On
51. Module 4 (Nonclinical) — Hands-On
52. Module 5 (Clinical/CSR/BE) — Hands-On
Section 8 — eCTD Submission
53. Introduction to the application platforms (SaaS)
54. Training on application platform— Hands-On
55. Publisher Orientation & Project Setup — Hands-On
56. Sequence Creation— Hands-On
57. Lifecycle Change (labeling/spec updates) — Hands-On

Section 9 — XML Validation


58. Validator Rules & Typical Failures — Hands-On
59. Full Validation— Hands-On

Section 10 — SPL Preparation & Validation


60. SPL Concepts & Building Blocks — Hands-On
61. Highlights of Prescribing Information — Hands-On
62. Full Prescribing Information — Hands-On
63. SPL Validation — Hands-On

Participant Deliverables
 Module-wise authored documents (M1–M5, case studies).
 eCTD publication
 Validation reports
 SPL (labeling) and validation
 Resume audit
 LinkedIn profile audit
 Mock interview
 Certification
 Placement assistance

You might also like