FULL TIME - APGDCR with SKILL INDIA (GOI) Certification
(Full Time)
Course objective: It focuses on the essential principles of Clinical Research and standard regulatory controls necessary to study the safety and efficacy of a drug. The course content has been reviewed and approved by Clinical research experts and academicians where more emphasis is laid on Planning, conducting, monitoring and generating information as per global standards and regulatory requirements. Students are not only trained in Clinical Research but there is a special focus given to Management & Soft Skill learning.
Duration of the course: Comprehensive 6 months regular program. This includes 3 months class-room teaching+ 3 months training in Industry, research writing and seminar presentation.
Course Timings and Schedule: 3 hours classroom training, scheduled on Mon- Fri
Eligibility
- M.B.B.S, M.D, M.S, D.N.B, D.M (Interns are also eligible)
- B.D.S, M.D.S, B.P.T, B.Tech (Biotechnology)
- B.A.M.S, B.H.M.S, B.U.M.S
- B.Pharm, M.Pharm, Ph.D
- B.Sc, M.Sc, Ph.D (Final year students are also eligible)
- Working Professionals
Module 1
Introduction to Clinical Research. Drug discovery & Development
Basics of Pharmacology and pharmacy, Preclinical Research- GLP & GMP
Module 2
Regulatory Affairs/ Regulations in Clinical Research
Introduction to Intellectual property rights
Module 3
Clinical Research Operations
Ethics in clinical research
Module 4
Clinical Data Management-Designing of Clinical Trials and Biostatistics
Basics of Pharmacology and pharmacy, Preclinical Research- GLP & GMP
Module 5
CRO, SMO, Clinical trial documents
QA and QC – Audits and Inspections
Module 6
Pharmacovigilance & Drug Safety Monitoring
Module 7
Soft skills training, Business communication and IT applications
Module 8
Research writing and presentation
Classroom teaching by eminent faculty involving Lectures and Power Point Presentations.
Assignments are given to students, which include preparation of CRF’s (Case Record Forms), IC (Informed Consent Forms), PIs (Patient Information Sheets), Protocol Designing, PMS (Post Marketing Surveillance Studies) plan designing.
Exercises are given to students wherein data on Toxicology, Bioavailability and Bio-equivalence is made available to the students and inferences, graphs and calculations are drawn from the same. Exercises are also in the form of MCQs (Multiple choice questions), Q&A (questions and answers) and Report writing.
Workshops are conducted for students emphasizing on problem-solving through interaction and exchange of information.
Note: “Fees (Registration & program fees) once paid will not be refundable”