Diploma in Clinical Research & Regulatory Affairs

Curriculum

The program combines comprehensive clinical research training with specialized learning in pharmaceutical regulatory affairs and structured software training in Oracle Siebel Clinical.

The curriculum progresses from clinical research foundations through clinical trial operations and management before moving into pharmaceutical regulations, regulatory submissions, product-development requirements and regulatory strategy.

Oracle Siebel Clinical training provides practical exposure to clinical trial management software as part of the Clinical Research component of the program.

 

Module 1 – General Introduction

• Pharmaceutical & CR – Industry Overview
• Introduction to Clinical Research
• Stakeholders and Roles in Clinical Research
• History and Milestones in Clinical Research
• Principles of Good Clinical Practice
• Technologies in Clinical Trial Management
• Overview of Clinical Research Regulatory Bodies

Module 2 – Epedemiology and Evidence Based Medicine (EBM)

• Epidemiology 1 – Introduction
• Epidemiology 2 – Concept of Causation
• Epidemiology 3 – Epedemiological Study Designs
• Epidemiology 4 – Statistics
• Evidence Based Medicine

Module 3 – Pharmaceutical Medicine

• Introduction to Pharmaceutical Medicine
• Pre-clinical Development of Drugs and Biologics
• Clinical Phases of Drug development
• General Pharmacology
• BA-BE Studies
• Pharmacogenetics-Pharmacogenomics
• Toxicology
• Systemic Pharmacology
• Clinical Trial Design
• Intellectual Property Rights
• Personalized Medicine
• Clinical Trials in Pediatrics
• Drug Safety in Pregnancy
• Research Methods for Genetics Studies
• Stem Cell Research and its Applications
• Endpoints in Clinical Trials
• Clinical Trial Registries

Module 4 – Therapeutic Areas

• Introduction to Health and Disease
• Endocrinology 1
• Endocrinology 2 (Diabetes)
• Cancer Biology
• Cardiovascular Medicine
• Respiratory Medicine
• Psychiatry
• Neurology
• Women’s Health
• Infectious Diseases
• Dermatology

Module 5 – Ethics in Clinical Research

• Ethics in Clinical Research
• Informed Consent Process
• International Conference for Harmonization
• Schedule-Y
• ICMR Guidelines

Module 6 – Roles and Responsibilities

• Investigator Responsibilities
• Sponsor-Vendor Responsibilities
• IRB Responsibilities
• Role of Clinical Research Personnel

Module 7 – Clinical Trial Preparation

• Clinical Study Protocol – Protocol Writing
• CRF Design

Module 8 – Essential Documents and Regulatory Submission

• Essential Documents
• IND Submission
• Clinical Study Report (CSR)
• NDA Submission

Module 9 – Study Start-up

• Study Feasibility and Site Selection
• Pre-Study Visit
• Site Initiation
• Informed Consent Process
• Subject Recruitment and Retention
• Trial Master File

Module 10 – Clinical Trials Monitoring

• Routine Site Monitoring
• CRF Review and Source Data Verification
• Drug Accountability
• Safety Reporting and Pharmacovigilance
• Site Close-out

Module 11 – Compliance and Audits

• Site Audit and Overview
• Sponsor Compliance and Audit
• Standard Operating Procedures (SOP) in Clinical Research
• Electronic Records and Signatures
• Conflict of Interest

Module 12 – Data Management and Biostatistics

• Data Management Overview
• Introduction to Biostatistics
• Data Analysis and Reporting

Module 13 – Regulatory Affairs in Clinical Research

• Regulatory Enviroment in the US
• Regulatory Environment in Europe
• Regulatory Environment in India

Module 14 – Medical Device Trials

• Medical Devices – Definition and Lifecycle
• Global Regulatory Strategy for Medical Devices
• Medical Device- Trial Design Considerations

Module 15 – Project and Vendor Management

• Fundamentals of Project Management
• Integrated Project Management
• Clinical Research Outsourcing – Vendor Selection
• Clinical Research Outsourcing – Vendor Management
• Clinical Trial Supplies

Module 16 – Financial Management of Clinical Trials

• Accounting for Managers
• Clinical Trial Budgeting
• Clinical Trials Marketing
• Indemnity and Compensation

Module 17 – Personality Development and Communication Skills

• Understanding Self
• Self-esteem
• Emotional Intelligence
• Attitude
• Leadership
• Interpersonal Relationships
• Group Dynamics and Team building
• Stress Management
• Performance Appraisal
• Time Management
• Conflict Management

Module 18 – Oracle Siebel Clinical CTMS

• Siebel Clinical – Application Overview
• Siebel Clinical – Business Solution Footprint
• Siebel Clinical for Clinical Trial Management
• Siebel Clinical Fundamentals
• Siebel Clinical Fundamentals – Session 1

Module 19 – Introduction to the Judicial System in India

• Introduction to Medical Ethics, Medical Malpractice
• Overview of Judicial System in India
• Legitimacy and Paternity
• Privileged Communication and Professional Secrets

Module 20 – Drugs and Cosmetic Act and Rules

• Introduction, Aims and Objectives, Definitions
• Schedules to Drug Rules
• Import, Manufacture and Sale of Drugs
• Labeling and Packaging of Drugs

Module 21 – Schedule Y

• Introduction, Amendments to Schedule Y
• Clinical Trials
• Studies in Special Population, Post Marketing Surveillance and Special Studies
• Appendices

Module 22 – Indian Regulations Governing Clinical Trials

• Regulatory Authorities in India
• Guidelines and important provisions
• Indian Regulatory Approval Process and approval timelines

Module 23 – Regulatory Regime in US

• Responsibilities of US FDA
• FDA Centers
• Code of Federal Regulations
• FDA guidelines for industry

Module 24 – European Medicines Agency (EMEA)

• Introduction, Roles and Responsibilities of EMEA
• Committees of EMEA
• EU Clinical Directives
• EUDRA CT

Module 25 – Regulations in Japan

• Organization and Function of MHLW (JAPAN)
• Pharmaceutical Laws and Regulations in Japan
• Drug Development in Japan

Module 26 – In-Vitro and In-Vivo Pre-clinical studies

• ICH Safety Guidelines related to Carcinogenicity, Genotoxicity, Reprotoxicity
• ICH safety guidelines related to pharmacology and immunotoxicology studies

Module 27 – Efficacy Topics related to Clinical Studies

• Clinical Safety
• Dose Response Studies
• Clinical Evaluation

Module 28 – Common Technical Document (CTD)

• General principles of CTD
• Modules with Diagrammatic representation
• eCTD

Module 29 – IND and NDA Requirements

• IND and NDA applications in U.S
• IND and NDA Applications in India

Module 30 – CMC Information

• CMC for Phase I
• CMC for Phase II and III

Module 31 – Overview of GHTF

• Organization
• Study Groups and Documents

Module 32 – Regulatory Processes for Medical Devices and Veterinary Products

• U.S Scenario
• Indian Scenario

Module 33 – Biosimilars EMEA Guidance and Regulations

• Guidelines and Applications of Biosimilars
• Specific Guidelines

Module 34 – Biopharmaceutical Indian Regulations and Guidelines

• Regulatory Bodies
• Guidelines for Pre-Clinical and Clinical studies

Module 35 – Regulatory Strategic Planning, Interfacing and Corporate Communications

• Regulatory Strategic Planning
• Corporate Communications

Course Completion

• Final Assessment
• Course Certification