Essentials of Preclinical Research (2:0)

Dr. Ramachandra S G

Central Animal Facility, IISc

Syllabus

The syllabus includes History and OECD Principles of GLP, GLP Consensus Documents, Guidance Documents for Compliance Monitoring Authorities, Advisory Documents of the Working Group on GLP, Position Papers, Regulatory authorities, Introduction to Toxicology, Toxicology studies, Ecotoxicology studies, Genetic Toxicology studies, Developmental & Reproductive Toxicology studies, OECD test guidelines and Biocompatibility studies.

What we will learn?

1 Introduction: Preclinical research
2 History and OECD Principles of GLP
3 GLP Consensus Documents
4 GLP Guidance Documents
5 GLP Advisory Documents
6 GLP Advisory Documents
7 GLP Position papers
8 Data Integrity
9 Quality Assurance and GLP
10 Introduction to Toxicology
11 Toxicology studies
12 Medical devices
13 OECD Guidelines : Physical and Chemical properties-Section 1
14 OECD Guidelines : Effects on Biotic Systems-Section 2
15 OECD Guidelines : Environmental Fate and Behaviour-Section 3
16 OECD Guidelines : Health Effects -Section 4
17 OECD Guidelines : Other Test Guidelines -Section 5
18 Regulatory authorities

Minimum Qualification

B.Sc.,/B.Pharma/BVSc.

Pre-requisites

NIL

Who can apply?

1. Biomedical Research Institutes,  2. R&D units,  3. Pharmaceutical industries,  4. Contract Research Organizations. Students , professionals and faculties from life sciences domains.