1. Clinical Data Management (CDM)
2. Pharmacovigilance (PV)
The Program would cover the following areas:
Drug Discovery and Development-Overview
- Drug Discovery Process including stages of Basic Research, Drug Development which involves Pre-Clinical Testing, Clinical Research, Registration with the Drug Regulatory Agencies and finally introduction of the Drug to the public after the due Approvals, etc.
- Data Management Plan
- Clinical Data Management System
- Clinical data repositories
- Loading of external data into CDM system
- Query management
- Data Clarification form
- Remote data entry
- Clinical data entry-single, double entry, SAE reconciliation, Coding of adverse events
- Data cleaning and Data validation (using SAS Software) (working with missing values, outliers start and end dates, system validation).
- E-CRF designing, data tracking
- Data base locking
- Clinical data archiving
- CDM SLA
- General Overview
- Key terms & Terminologies
- Gen. & Sys. Prin. Of PV
- SOPs in PV
- Regulatory guidelines & laws in PV
- Med. Dic. for drug regulatory activities - MedDRA
- Diag. & Mang. of Adverse drug Reactions
- AE/ADR reporting sys. & forms
- Causality Assessment
- Narrative writing
- Expedited Reporting requirements
- PSURs for marketed drugs
- Signal Detection Tools
- Risk assessment, evaluation & Management
- Quality sys. In PV
- PvPI (National Pharmacovigilance Protocol)
- PV Database and other PVG software
- Additionally IT skill development, Periodic Communication and Personality Development sessions will be conducted.
M. Sc in Chemical / Biological Sciences.
B. Tech / M. Tech Biotechnology.
M.B.B.S. / B.D.S.
B. V. Sc
B. Sc. Allied Health Sciences.
Degrees in Alternate Systems of Medicine
Graduates in Para Medical Branches
Other equivalent Qualifications as approved by the authority.
Candidates are instructed to bring all final year copy of their UG/PG Certificates.
If any candidate is found not to meet the required eligibility criterion, or indulge in any form of malpractice, he/she will not be permitted to proceed further with the admission process.
Course Coordinator, AU-KBC Research Centre,
MIT Campus,Anna University Chennai,Chromepet,
Chennai - 600 044.
Tel: 91-44-22232711 Extn.133,