Diploma in Clinical Research, Clinical Data Management and Pharmacovigilance

  • Introduction to CR
  • Drug development, IND
  • History of clinical research
  • Clinical research industry and opportunities in India
  • Regulatory aspects of CR
  • ICH GCP
  • Schedule Y
  • Belmont report, Declaration of Helsinki
  • Monitoring of Clinical Trails
  • Auditing
  • Pharmacovigilance
  • Bioavailability bioequivalence studies
  • Overview of clinical data management
  • Overview of biostatics
  • Medical writing

Clinical Trail Design

  • Protocol
  • Informed Consent
  • IRB/EC
  • Regulatory Affairs Profession in India
  • ICH Quality Guidelines
  • Regulatory system for Europe, US, Australia, New Zealand, Semi Regulated Markets
  • Introduction to Intellectual Property & Guidelines.
 Diploma in Clinical Research, Clinical Data Management and Pharmacovigilance

Diploma in Clinical Research, Clinical Data Management and Pharmacovigilance

Fees:- 55,000/- INR
Duration:- 6 months
Contact No:- 020-66289451/52
Email:- biopharma@mitconindia.com

Molecular Biology Incubation Laboratory & Instruments

Course Enrollment