PG DIPLOMA IN CLINICAL RESEARCH MANAGEMENT
Comprehensive modules covering 4 Phases of Clinical Trials, Pharmacovigilance, Regulatory Affairs, Clinical Data Management, Audit & Quality Management with SAS.
| Duration | 7 Months | ||||||
| Fees | Rs.1 Lac | ||||||
| Highlights | Laptop complementary for each student | ||||||
Eligibility |
|
||||||
| Classes | 5 days per week | ||||||
| Faculty | Industry Professionals and Experts | ||||||
| Job Opportunities | Clinical Research Coordinators / Clinical Research Associates / Clinical Data Analyst / Regulatory Affairs / Regulatory Affairs Associate / Clinical Scientist / Safety Reporter / Medical Editor /Clinical Reporting / Clinical Research Manager / Global Regional project Managers/Medical Reviewer/Drug Safety Physician/Business Developer/Clinical Research Analyst/ Medical Writer | ||||||
| Job Openings | Pharmaceutical Companies Intas, Apotex, Strides, Avasthagen / Biocon / Dr. Reddy’s, AstraZeneca CRO Suven Life Science /Clinigene/ Icon clinical / Symphony / MMS Holdings & SMO / Metropolis / Quintiles Life Science Division Indegene/ Accenture / Tata Consultancy Service/ Cognizant Technology Hospitals St. Johns / VIMS / MSR |
PGDCRM – COURSE MODULES
1. Basics
- Anatomy
- Physiology
- Basics in Pharmacology
2. Trial Process
- New Drug Development
- Preclinical Trials
- The 4 phases of Clinical Research
3. Pharmacology
- Bioequivalence Study ( BE )
- Bioavailability ( BA )
- Pharmacokinetics - ADME
- Pharmacodynamics
4. Regulatory Affairs & Documentation
- Evolution of Drug Regulation.
- Protocol
- Informed Consent Form and Process
- Investigator Brochure
- IRB ( IEC )
- Schedule Y
5. Clinical Trial Operations
- Site and Investigator Selection
- Recruitment
- Clinical Trial Study Design
- Adverse Events
- IRB
6. CDM
- Biostatistics
- SAS in clinical trials
- Data Management
7. ICH – GCP
8. Quality
- Audit
- Errors - Misconduct and Fraud
- Quality Control
9. Pharmacovigilance
- Introduction to Pharmacovigilance
- ADR Definition; Classification; Identification
- ADR Assessment – Causality scales
- Importance of PV National & International Scenario
- Regulatory Aspect of PV
- Establishment of PV Program
- ADR Reporting
- MEDRA / Drug Dictionary
10. Mock Interview
- Inter Personal Skills
- Group Discussions
- Soft Skills
- Personality Development
11. Seminar & Final Examination
COURSE MODULES
ADVANCED DIPLOMA
ENQUIRY