Current regulatory requirements for conducting clinical trials in India for investigational new drugs/new drug (Version 3.0)
Week 1 : Lecture 0: Course overview
Lecture 1: Overview of Indian drug regulatory system Lecture 2: Overview of drugs & cosmetics Act and Rules thereunder Lecture 3: Overview of New Drug and Clinical Trials Rules Rules, 2019
Week 2 : Lecture 4: Pre-clinical data requirements Lecture 5: Rules governing clinical trials Lecture 6A: Phases of clinical trial, forms, and fees Lecture 6B: Regulatory pathway and data requirements for NDCT, 2019
Week 3 : Lecture 7: BA/BE study and study centres: Legal provisions Lecture 8: Guidelines to conduct BA/BE studies Lecture 9: Ethics Committee registration and re-registration
Week 4 : Lecture 10: Ethical considerations Lecture 11: Good Clinical Practice Lecture 12A: Requirements for import/manufacture of new drug/IND for conducting clinical trials in India Lecture 12B: Requirements for import/manufacture of new drug/IND for sale/distribution and unapproved new drug for patients
Week 5 :Lecture 13: Important issues Lecture 14: Special concerns Lecture 15: Clinical trial related guidelines (NDCT Rules)
Week 6 :Lecture 16: Content of proposed clinical trial protocol Lecture 17: Content of a clinical trial report Lecture 18: Post marketing assessment and clinical trial compensation
Week 7 : Lecture 19: Common observations during submission of CT/BA/BE protocol Lecture 20: Common observations during CT/BA/BE centre inspections Lecture 21: Drug development process: Overview
Week 8 : Lecture 22: Salient feature of NDCT 2019 (What's new in NDCT?) Lecture 23A: Online submission (SUGAM) Lecture 23B: Online submission (CTRI) Lecture 24: Tables given in NDCT 2019 and its content
Lecture 1: Overview of Indian drug regulatory system Lecture 2: Overview of drugs & cosmetics Act and Rules thereunder Lecture 3: Overview of New Drug and Clinical Trials Rules Rules, 2019
Week 2 : Lecture 4: Pre-clinical data requirements Lecture 5: Rules governing clinical trials Lecture 6A: Phases of clinical trial, forms, and fees Lecture 6B: Regulatory pathway and data requirements for NDCT, 2019
Week 3 : Lecture 7: BA/BE study and study centres: Legal provisions Lecture 8: Guidelines to conduct BA/BE studies Lecture 9: Ethics Committee registration and re-registration
Week 4 : Lecture 10: Ethical considerations Lecture 11: Good Clinical Practice Lecture 12A: Requirements for import/manufacture of new drug/IND for conducting clinical trials in India Lecture 12B: Requirements for import/manufacture of new drug/IND for sale/distribution and unapproved new drug for patients
Week 5 :Lecture 13: Important issues Lecture 14: Special concerns Lecture 15: Clinical trial related guidelines (NDCT Rules)
Week 6 :Lecture 16: Content of proposed clinical trial protocol Lecture 17: Content of a clinical trial report Lecture 18: Post marketing assessment and clinical trial compensation
Week 7 : Lecture 19: Common observations during submission of CT/BA/BE protocol Lecture 20: Common observations during CT/BA/BE centre inspections Lecture 21: Drug development process: Overview
Week 8 : Lecture 22: Salient feature of NDCT 2019 (What's new in NDCT?) Lecture 23A: Online submission (SUGAM) Lecture 23B: Online submission (CTRI) Lecture 24: Tables given in NDCT 2019 and its content
