In-Depth Clinical Trial Design and Drug Development
This course provides a comprehensive understanding of clinical research and trial management, covering fundamental principles, stages of drug development, and key regulatory frameworks. Participants will gain insights into ethical guidelines, essential trial documents, and recent regulatory updates, preparing them for effective and compliant clinical trial conduct.
Module 1 : Introduction to Clinical Research and Fundamentals of Clinical Trials
- Overview of the clinical research industry
- Basics of clinical trials, including phases (Phase I, II, III, IV)
- Role of stakeholders (sponsors, investigators, CROs, etc.)
- Importance of ethical considerations
Module 3 : Ethics and Good Clinical Practices
- Understanding ethical principles (autonomy, beneficence, justice)
- ICH Good Clinical Practice (GCP) guidelines (E6 R2)
- Informed consent process
- Monitoring and safety reporting
Module 5 : Regulatory Frameworks in Clinical Research
- Historical context of clinical research regulations
- International bodies (FDA, EMA, WHO)
- National regulatory bodies (FDA India, EMA, etc.)
Module 7 : Recent Developments in Clinical Trials
- Recent changes in clinical trial regulations (India)
- Impact of New Drugs and Clinical Trials Rules, 2019
- Emerging trends in clinical research
Module 2 : Stages of Drug Development
- Stages of drug development (discovery, preclinical, clinical)
- Investigational New Drug (IND) application
- Clinical trial design and objectives
Module 4 :Indian Clinical Trial Guidelines
- Specific guidelines for clinical trials in India
- Schedule Y requirements (Indian regulatory framework)
- Local regulatory authorities (CDSCO, DCGI)
Module 6 : Key Clinical Trial Documents
- Protocol development and content
- Case Report Form (CRF) design
- Informed consent form
- Investigator’s Brochure
- Study Progress Report
Duration : 4hrs / week ( 2 days/week )
Schedule : Session of 2 hours twice a week
Batches Starting From
August 2024
Enroll Now For Early Bird Offers
Duration : 4hrs / week ( 2 days/week )
Schedule : Session of 2 hours twice a week
Perks Of Offline Course
Role Play
Get to work on live projects
Face-to-face guidance by PM (Project Manager)
Clinical on-site exposure