Diploma in Clinical Research and Regulatory Affairs
Diploma
Distance
Description
-
Type
Diploma
-
Methodology
Distance learning
-
Duration
6 Months
-
Online campus
Yes
-
Delivery of study materials
Yes
-
Support service
Yes
-
Personal tutor
Yes
-
Virtual classes
Yes
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.
About 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.
Reviews
Subjects
- Clinical Research
- Data Management
Teachers and trainers (3)
Dr. Deepak langade
Biostats and Clinical Data Management
Mrs. Neha Ghondhale
Regulatory affairs
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
Diploma in Clinical Research and Regulatory Affairs