Clinical Research - Udemy

EduCBA Learning Solutions, Udemy

Learn all the nuts and bolts of Clinical research and learn the important concepts associated with it as well.

Clinical Research is one of the most knowledge-intensive industries. It is complete biography of drug from its inception in the lab to its introduction to the consumer market and beyond. Any molecule is identified is subjected to pre-clinical and clinical trials before entering in to market. Though post marketing surveillance is also part of the same. Pre-clinical studies are associated with effect of drug on animals. All the toxicological studies, tests for teratogenicity, carcinogenicity are carried out. After this, the data obtained from the studies are submitted as an IND (Investigational Drug Application) to take permission for human studies. Then, it is enter in to clinical trials. There are 4 phases in it.

SCOPE-
It is very clear that India has become a very preferred destination for clinical research. The industry is growing exponentially and is expected to reach Rs. 7000 Cr by 2010. Statics shows that if India's clinical trial business grows to 10% of that in US by 2015, the industry will need approximately 50,000 clinical research professionals.

Any professionals from CRO (Clinical Research Organisation), Pharmaceutical, biotech, practising doctors and fresh graduates can apply for it. Salary states are high. As around 700 Cr. expenditure is there for single research.

Any branch on your own interest has greater opportunity. Right now Pharmaceutics and pharmacology has greater scope. Also pharmacognosy people as Herbal Industries are booming in India. But choosing branch or subject on your interest is more beneficial as one can give free flow of thoughts and also new innovations. So, demand is there for all branches but only on one condition that you have basic to the latest knowledge.

We will be covering the following modules in this course:

    ·Introduction to Clinical research

    ·Basics in Pharmacology and pharmacy

    ·New Drug Discovery

    ·Guideline for Clinical Trail

    ·Ethics in clinical research

    ·Regulations in clinical research

    ·Biostats

    ·Special clinical trail

    ·Clinical Trail Document

    ·Quality in clinical Trail

    ·CDM

    ·Clinical trial Management

    ·Pharmacovigilance

    ·soft skill for cr professionals

Target Customers for this course:

    ·Students

    ·Professionals

Pre-Requisites for this course:

    ·Basic Computer Knowledge

    ·Passion to learn

    ·Any Science Graduates/ postgraduates / doctors


  • What are the requirements?
    • Basic Computer Knowledge
    • Inclination towards clinical research
    • A science, medical background would be an added advantage
  • What am I going to get from this course?
    • Over 6 lectures and 37 mins of content!
    • Learn Basics in Pharmacology and pharmacy and New Drug Discovery
    • Learn Guidelines for Clinical Trial, Ethics in clinical research and Regulations in clinical research
    • Learn Clinical trial Management and Pharmacovigilance
  • What is the target audience?
    • Students
    • Professionals
    • Any Science Graduates/ postgraduates / doctors

SECTION 1: Introduction
  • Introduction
  • SECTION 2: Regulation, Act and Amendment
  • Evolution of Ethics and Regulation in Clinical Trials
  • US Food, Drug and Cosmetic Act
  • Kefauver-Harris drug Amendment (1962)
  • SECTION 3: Drug Development Processes
  • Steps in New Drug Development
  • Drug Development Stages
  • Dates:
    • Free schedule
    Course properties:
    • Free:
    • Paid:
    • Certificate:
    • MOOC:
    • Video:
    • Audio:
    • Email-course:
    • Language: English Gb

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