Diploma in Clinical Research & Regulatory Affairs

Curriculum

Course Stats – 35 Modules, 192 Chapters, 146 Quizzes

 

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