OFFLINE REGULAR CLASSES

Fineness institute of clinical research

INTEGRATED DIPLOMA IN CLINICAL RESEARCH, PHARMACOVIGILANCE AND CLINICAL DATA MANAGEMENT, MEDICAL WRITING AND REGULATORY AFFAIRS AT WORKINGDOM OFFICE COMPLEX (FINENESS INSTITUTE OF CLINICAL RESEARCH) Block A, 2nd Floor, Palam Extension, Sector 7 Dwarka, New Delhi 110075

Syllabus

1) BASIC TERMINOLOGIES USED IN CLINICAL RESEARCH
2) OUTLINE OF CLINICAL RESEARCH
3) PHARMACOLOGY
4) DRUG DEVELOPMENT
5) OVERVIEW OF CLINICAL TRIAL
6) GUIDELINES AND REGULATIONS RELATED TO CLINICAL RESEARCH
7) ETHICS IN CLINICAL RESEARCH
8) PROJECT MANAGEMENT
9) QUALITY ASSURANCE AND QUALITY CONTROL
10) CAREER IN CLINICAL RESEARCH / TRIAL
11) INTRODUCTION TO PHARMACOVIGILANCE
12) HISTORICAL PERSPECTIVE OF PHARMACOVIGILANCE
13) TYPES OF PHARMACOVIGILANCE
14) GLOBAL SAFETY MONITORING SYSTEM
15) SETTING UP OF A PV CENTRE
16) MEDDRA
17) INTRODUCTION TO ADR AND ADR REPORTING
18) AGGREGATE REPORT
19) SIGNAL MANAGEMENT
20) RISK BENEFIT ASSESSMENT21) AUDIT AND INSPECTION
22) ROLE AND RESPONSIBILITIES IN PHARMACOVIGILANCE
23) INTRODUCTION TO CLINICAL DATA MANAGMEMENT
24) GUIDING PRINCIPLES AND REGULATIONS ASSOCIATED WITH CDM
25) STANDARD OPERATING PROCEDURE
26) DATA MANAGEMENT PLAN
27) CRF DESIGN
28) DATABASE VALIDATION,PROGRAMMING AND STANDARDS
29) ELECTRONIC DATA CAPTURE
30) DATA PRIVACY AND ENTRY
31) MANAGING LAB DATA AND COLLECTING ADVERSE EVENT DATA
32) MEDICAL CODING
33) SAE RECONCILIATION
34) CREATING REPORT AND TRANSFERING DATA
35) QUALITY MANAGEMENT OF CLINICAL DATA
36) LOCKING STUDIES
37) MIGRATING AND ARCHVING OF DATA
38) ROLE AND RESPONSIBILITIES IN CLINICAL DATA MANAGEMENT
39) INTRODUCTION TO MEDICAL WRITING
40) SCIENTIFIC WRITING
41) ICH GUIDELINES
42) MEDICAL WRITING FOR CLINICAL TRIAL
43) MEDICAL WRITING IN POST MARKET PHASE
44) CAREER IN MEDICAL WRITING
45) INTRODUCTION TO REGULATORY AFFAIRS
46) DOCUMENTATION OF DRUG ,MEDICAL DEVICE, BIOLOGICS AND REGULATORY FILING IN
US,EUROPE,INDIA, JAPAN, CANADA AND AUSTRALIA
47) E CTD SUBMISSION
48) INTELLECTUAL PROPERTY RIGHTS
49) PRIVACY AND CONFIDENTIALITY
50) CAREER IN REGULATORY AFFAIRS

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