Diploma in Clinical Research and Regulatory Affairs

Diploma

Distance

₹ 14,999 VAT incl.

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.

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Reviews

Subjects

  • 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

Diploma in Clinical Research and Regulatory Affairs

₹ 14,999 VAT incl.