Diploma in Clinical Research and Regulatory Affairs

QREC Clinical Research Institute
Distance

Rs 14,999
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Important information

  • Diploma
  • Distance learning
  • Duration:
    6 Months
  • Online campus
  • Delivery of study materials
  • Support service
  • Personal tutor
  • Virtual classes
Description

Diploma in clinical research will provide you with an in-depth understanding of the core areas of the clinical research and enhance your skills and knowledge to the level expected of a Clinical Research Associate / Professional.
In this Diploma we are providing you knowledge about Clinical Research and Regulatory Affairs.This Diploma course is 6 month program initiating with online teaching and enhance skills of Students and Professionals.

Important information
Venues

Where and when

Starts Location Timetable

Distance learning

Frequent Asked Questions

· What are the objectives of this course?

our success lies in the success of our students.We make every effort to equip and prepare our students to undertake successful career.

What you'll learn on the course

Clinical Research
Data Management

Teachers and trainers (3)

Dr. Deepak langade
Dr. Deepak langade
Biostats and Clinical Data Management

Mrs. Neha Ghondhale
Mrs. Neha Ghondhale
Regulatory affairs

Ritesh khandelwal
Ritesh khandelwal
Clinical operations and regulatory affairs

Course programme

Module.1- General Introduction to Clinical Research

Module.2 – Clinical Pharmacology

Module.3- Drug Discovery, Development & Phases of Clinical Trial

Module.4- Credentials of Clinical Trial

Module.5- CT Activities – Before, During & After

Module.6- Roles & Responsibilities of Clinical Research Professional

Module.7- Need of Ethics in Clinical Research

Module.8- Clinical Data Management

Module.9- Writing papers (Medical Writing)

Module.10 – Pharmacovigilance & Drug Reaction/Interaction

Module.11- Biopharmaceutical Indian Regulations & Guidelines (Drug & Cosmetic Act, Schedule-Y, ICH-GCP, overview of Schedule-T & M)

Module.12- Regulatory Regime in US (US-FDA)

Module.13- European Medicines Agency (EMEA)

Module.14- IND & NDA Requirements (Dossier Preparation)

Module. 15- Regulatory Processes For Medical Devices

Module.16- IPR & Patent Law


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