1. Drug development process:
Introduction
Various Approaches to drug discovery
1. Pharmacological
2. Toxicological
3. IND Application
4. Drug characterization
5. Dosage form
2. Clinical development of drug:
1. Introduction to Clinical trials
2. Various phases of clinical trial.
3. Methods of post marketing surveillance
4. Abbreviated New Drug Application submission.
3) 1. Good Clinical Practice- ICH,GCP, Central Drug Standard Control Organisation (CDSCO) guidelines
2. Challenges in implementation of guidelines.
3. Ethical guidelines in Clinical Research
4. Composition, responsibilities, procedures of IRB/IEC.
4. 1. Overview of regulatory environment in USA, Europe and India.
2. Role and responsibilities of clinical trial personnel as per ICH GCP
a. Sponsor
b. Investigators
c. Clinical Research Associate
d.Auditors
e. Clinical Research Coordinators
f. Regulatory Authority
5. 1. Designing of clinical study documents (protocol, CRF, ICF, PIC with assignment)
2. Informed Concent Process
3. Data management and its components
4. Safety monitoring in clinical trials.