Advanced PG Diploma in Clinical Research & Regulatory Affairs

Key Facts

Duration

12 Months

Max. Duration

24 Months

Mode

Online

CREDITS

60 ECTS

Overview

Clinical research is a rapidly progressing, essential field of medical science that deals with the evaluation of new medicines and therapies with an ethical approach. Developing these new medicines is very challenging considering the inter-individual, inter-racial and cultural diversities that we possess as human beings.
Advancement towards the idea of developing personalized treatments is giving a new dimension to the research and development efforts of the global drug development industry.
Fundamental to clinical research is the domain of regulatory affairs which forms a network of standardized laws, regulations and guidelines creating an equilibrium between facilitation of innovation and safety of subjects enrolled in clinical trials.

In the present global clinical research landscape, regulatory affairs professionals lead multinational assignments and make sure that clinical trials are performed in compliance to the applicable regulatory requirements of the sponsor’s nation as well as the international locations where the clinical trial is being conducted.

Overview

At JLI we strive to develop clinical research and regulatory affairs professionals who are equipped with the most relevant and up-to-date knowledge and skills. This Advanced Clinical Research and Regulatory Affairs training program is practically driven and centered on the tasks expected of a regulatory affairs professional in the clinical research industry. In this Regulatory Affairs training you are provided with the understanding of the global regulatory structure and acquire skills needed for regulatory strategic planning throughout the product lifecycle.

In this training course you will understand the techniques of critical evaluation for risk/benefit analysis by assessing the economic, societal, regulatory and corporate requirements. You will also attain the expertise essential for performing in an advisory role as a regulatory affairs specialist for pre and post marketing projects. Additionally, you will learn how to interface with the regulatory agencies and other key stakeholders for accomplishing regulatory compliance.

PROGRAM STRUCTURE

The program is comprised of 26 modules that can be completed in about 12 months. For a detailed list of modules covered in this program, please refer to the curriculum.

See Curriculum

MODULE 01: GENERAL INTRODUCTION
MODULE 02: EPIDEMIOLOGY & EVIDENCE BASED MEDICINE
MODULE 03: PHARMACEUTICAL MEDICINE
MODULE 04: THERAPEUTIC AREAS
MODULE 05: ETHICS IN CLINICAL RESEARCH
MODULE 06: ROLES AND RESPONSIBILITIES
MODULE 07: CLINICAL TRIAL PREPARATION
MODULE 08: ESSENTIAL DOCUMENTS AND REGULATORY SUBMISSION
MODULE 09: STUDY START-UP
MODULE 10: CLINICAL TRIALS MONITORING
MODULE 11: COMPLIANCE AND AUDITS
MODULE 12: DATA MANAGEMENT AND BIOSTATISTICS
MODULE 13: REGULATORY AFFAIRS IN CLINICAL RESEARCH
MODULE 14: MEDICAL DEVICE TRIALS
MODULE 15: PROJECT AND VENDOR MANAGEMENT
MODULE 16: FINANCIAL MANAGEMENT OF CLINICAL TRIALS
MODULE 17: PERSONALITY DEVELOPMENT AND COMMUNICATION SKILLS
MODULE 18: INTRODUCTION TO JUDICIAL SYSTEM
MODULE 19: SCHEDULE Y
MODULE 20: REGULATIONS GOVERNING CLINICAL TRIALS
MODULE 21: REGULATORY REGIME – FDA, EMA, JAPAN, SINGAPORE
MODULE 22: SAFETY TOPICS RELATED TO PRE-CLINICAL & CLINICAL STUDIES
MODULE 23: COMMON TECHNICAL DOCUMENT, IND & NDA REQUIREMENTS
MODULE 24: CMC INFORMATION & GHTF OVERVIEW
MODULE 25: MEDICAL DEVICES, VETERINARY PRODUCTS & BIOSIMILARS
MODULE 26: BIOPHARMACEUTICAL REGULATIONS AND REGULATORY STRATEGIC PLANNING

TOTAL CREDITS: 60

What is a credit?

A credit represents the amount of effort that is required to complete the program. Each module credit is equal to approximately 20 hours of study including lecture, tutorial, projects, assignment, field work etc. as may be applicable.

The curriculum for the program – Advanced Post Graduate Diploma in Clinical Research & Regulatory Affairs (APGDCR-RA) is comprehensive, has been developed and evaluated by experienced pharmaceutical regulatory affairs professionals and is fully endorsed by the clinical research industry. Not only is this online training course suitable for new graduates but also for working professionals who either wish to grow further in their clinical research and/or regulatory affairs career, or those who wish to make a move to the clinical research or pharmaceutical regulatory affairs domain from any other related industry.

How You Will Study

Assessments

Multiple Choice Questions
Each lesson that you study online will be followed by a multiple choice question test. These usually comprise of 15 to 20 questions and can be attempted multiple times if needed. Pass percentage is 60%. The next unit in the sequence only unlocks once you have passed the test.
Project Work
Each module is followed by a project or an assignment. This is like writing an essay in 1000 to 1500 words. The project topic and the guidelines to be followed will be available in your account.

How much does it cost?

Career Opportunities

This unique program will prepare you to explore clinical research job opportunities such as clinical research coordinator, clinical research associate, clinical trial manager as well as jobs that are specific to regulatory affairs such as Regulatory Affairs Executive / Associate / Manager etc.

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