+91 92711 17886 | biopharma@mitconindia.com
Shivajinagar, Pune — 411005

Our Courses

Advanced PG Diploma in Clinical Research — 6-in-1 Course

Duration: 6 Months  |  Regular & Weekend Batches  |  95% Placement Ratio

Clinical Research Program

PG Diploma in Clinical Research

Ideal job-oriented course for Life Science, Pharmacy & Medical graduates

MODULE 01
Clinical Research Operations
  • ICH-GCP Guidelines
  • New Drug & Clinical Trials Rules
  • TMF / eTMF Management
  • Site Management & Monitoring
  • Protocol Deviations & AE Reporting
MODULE 02
Clinical Data Management
  • Introduction to CDM & Process Flow
  • Data Entry & Database Design
  • Data Review & Validation
  • Essential Documents in CDM
  • CDISC Standards Overview
MODULE 03
Pharmacovigilance
  • Introduction to Pharmacovigilance
  • Eudravigilance System
  • Signal Detection & Management
  • PSUR Writing
  • CIOMS / MedWatch Forms
MODULE 04
Medical Writing
  • Introduction to Medical Writing
  • Protocol Writing
  • Investigator Brochure (IB)
  • Informed Consent Document (ICD)
  • Manuscript & Publication Writing
MODULE 05
Regulatory Affairs
  • Global Regulatory Agencies
  • Common Technical Document (CTD)
  • CTD for API & Formulation
  • Introduction to eCTD
  • Drug Approval Processes
MODULE 06
Interpersonal Skills
  • Soft Skill Development
  • Presentation Skills
  • CV Preparation & Writing
  • LinkedIn Profile Creation
  • Interview Preparation
Eligibility Criteria
MBBS BDS BAMS BHMS B.Pharm M.Pharm B.Sc (Life Sciences) M.Sc (Life Sciences) Biotechnology Nursing
Duration
6 Months
Batch Type
Regular & Weekend Batches
Enrol Now

All Available Courses

Clinical Research Courses
Advanced PG Diploma in Clinical Research
Advanced PG Diploma in Clinical Research

6-in-1 ideal job oriented clinical research course for life science, pharmacy and medical graduates.

6 Months Regular & Weekend Batches
View Details
Biotechnology Courses
Research Project Based Training
Research Project Based Training

Dissertation Projects, Internships, Final Year Projects, On-Job Training

View Details

Ready to Enrol? Get Free Counselling Today!

Talk to our experts and find the right course for your career goals.