PHARMASRI CLINICAL RESEARCH
1. Clinical Research Associate
A. Fundamentals of clinical research
B. Drug Discovery and Development
C. Clinical Research Process
D. Bioavailability and Bioequivalence
E. Clinical Research- Ethics
F. Regulatory bodies
G. Computers in Clinical research
H. Clinical trial process and management of clinical trials
I. Audits in Clinical trial
J. Documentation –Clinical Research
K. Essential documents in Clinical Research
L. Cold chain management
M. Six sigma-Clinical trials
N. Clinical Research- Outsourcing
O. Statistics in Clinical Research
P. Quality Control and assurance
Q. Clinical Research-Finance
PHARMASRI
Clinical Research
Associate
Clinical Data
Management
Pharmacovigilence
R. Design of protocol and SAP
2. Clinical Data Management
A. Introduction
B. CRF design
C. Data base design
D. Data validation Specifications
E. Self evident corrections (SEC) , Data handling convention
F. Types of data entry
G. Discrepancy Management,
H. Creation and Resolution of Data Clarification Forms
I. Data acquisition, Data validation procedures
J. 21 CFR part 11
K. SOP,s
L. Data protection
M. Paper vs EDC
N. QC process/QA process
O. Medical coding
P. Statistical analysis and reporting
3. Regulatory Affairs
Introduction
Types of regulatory affairs, DCGI, CDSCO, FDA, ENVISA
Ethics Review
Informed consent process
Integrity, misconduct and conflicts in Clinical research
Identification of new drugs
Invitro studies
In vivo studies in animal models
Application to CDSCO
Approval requirements
Biologics
Regulatory Requirements
DCGI guidelines
Data analysis and reporting
Difference between ANDAs and NDAs, Orphan drugs
Role of Drug regulatory authority, audits, notices, warning letters
Legal implications, requirements in other countries
MeGuide, Kefauver-harris amendments, Waxman-hatch Amendments
4. PHARMACOVIGILENCE
5. CLINICAL SAS PROGRAMMING
6. PATENT ANALYSIS
7. QULAITY ASSURANCE IN CLINICAL TRIALS
Duration : 2 MONTHS