Description
The Advanced Diploma in Regulatory Affairs & Medical Writing (ADRA-MW) is an e-learning program designed to provide students a complete understanding of clinical trial regulations, regulatory documents created during the clinical trial process and tasks of performing medical writing for these documents. It equips you to start a career in Regulatory Affairs specialist or as a Medical writer. The course is aligned to the requirements of the industry.
Curriculum
Course Stats – 29 Modules, 111 Chapters, 110 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 – 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 3 – 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 4 – Schedule Y
- Introduction, Amendments to Schedule Y
- Clinical Trials
- Studies in Special Population, Post Marketing Surveillance and Special Studies
- Appendices
Module 5 – Indian Regulations Governing Clinical Trials
- Regulatory Authorities in India
- Guidelines and important provisions
- Indian Regulatory Approval Process and approval timelines
Module 6 – Regulatory Regime in US
- Responsibilities of US FDA
- FDA Centers
- Code of Federal Regulations
- FDA guidelines for industry
Module 7 – European Medicines Agency (EMEA)
- Introduction, Roles and Responsibilities of EMEA
- Committees of EMEA
- EU Clinical Directives
- EUDRA CT
Module 8 – Regulations in Japan
- Organization and Function of MHLW (JAPAN)
- Pharmaceutical Laws and Regulations in Japan
- Drug Development in Japan
Module 9 – 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 10 – Efficacy Topics related to Clinical Studies
- Clinical Safety
- Dose Response Studies
- Clinical Evaluation
Module 11 – Common Technical Document (CTD)
- General principles of CTD
- Modules with Diagrammatic representation
- eCTD
Module 12 – IND and NDA Requirements
- IND and NDA applications in U.S
- IND and NDA Applications in India
Module 13 – CMC Information
- CMC for Phase I
- CMC for Phase II and III
Module 14 – Overview of GHTF
- Organization
- Study Groups and Documents
Module 15 – Regulatory Processes for Medical Devices and Veterinary Products
- U.S Scenario
- Indian Scenario
Module 16 – Biosimilars EMEA Guidance and Regulations
- Guidelines and Applications of Biosimilars
- Specific Guidelines
Module 17 – Biopharmaceutical Indian Regulations and Guidelines
- Regulatory Bodies
- Guidelines for Pre-Clinical and Clinical studies
Module 18 – Regulatory Strategic Planning, Interfacing and Corporate Communications
- Regulatory Strategic Planning
- Corporate Communications
Module 19 – Basics of Good Medical Writing
- Introduction & Scope of Medical Writing
- Good Versus Poor Scientific Writing – An Orientation
- Statistics in Medical Writing
Module 20 – Computer Skills
- MS Word, Excel & Other Open Source Software
- Effective Internet Literature Search
Module 21 – Overview of the Regulatory, Marketing and Drug Promotion Process
- Introduction to Regulatory Medical Writing
- Investigation New Drug & Investigational Device Exemption Application
- Protocols, Amendments & Study Reports
- Investigator Brochure & Product Labels
- NDA’s, BLA’s & PMA’s
- Annual Reports
- Product Labeling
- Abstracts & Posters for Scientific Meetings
- Manuscripts for Publication in Scientific Journals
- Legal-Copyright-IP Issues in Medical writing
Module 22 – Common Technical Document
- Introduction and overview of CTD and eCTD
- Putting it all together – CTD Module 1
- Putting it all together – Producing the CTD Modules
- Multi-region submissions & submission standards
- Interfacing with regulatory agencies and answering queries
- Aggregate safety reports
Module 23 – Protocol, Investigator’s Brochure and Case Report Forms
- Writing clinical study protocols
- Introduction to writing Investigator Brochure’s
- Writing case report forms
- Writing regulatory compliant informed consent forms
- ICSR – Patient Narratives
Module 24 – Clinical Study Report
- Parts of a Clinical Study Report
- Templates & Boilerplate Text
- Tips on writing each section of the CSR
Module 25 – Sentence Control
- Fundamentals of Sentence Construction
- Controlling Voice of Sentence for Readability
- Correct Punctuation
- Consistency in Tense Use
- Imprecise Words and Phrases
- Word Order and Pronouns
- Subject – Verb Agreement
Module 26 – Writing Flow and Cohesiveness
- Writing Effective Paragraphs
- Using Effective Data Displays
- Using Style Guides for Consistent Medical Writing
- Overcoming Writers Block
Module 27 – Publication Writing
- Structure of a Scientific Paper
- Electronic Submissions
- Abstract for Scientific Meeting
- Case Report
- Review
- Ethics of Publication
- Guidelines of Publication (e.g. CONSORT, ICMJE, GPP)
- Referencing Guidelines & Taking Software’s Help
Module 28 – Documents in Medico-Marketing
- Leave behind literature (LBL), Visual Aids and Brochure’s
- Continuing Medical Education (CME) for Doctors
- Evidence Based Medicine
- MR Training Manual
- Web Content, Audio-Visual Aids, CDs
Module 29 – Managing the Review Process
- Effective Review Practices
- Managing Incongruous Comments from Reviewers & Reaching Concurrence
- Process Flow and Metrics for Managing Regulatory Submissions
Course Completion
- Final Assessment
- Course Certification
Certification
At the end of the course, students will be awarded a certificate of completion.
Duration
The duration of this program is 6 months.
You will have access to the course on the learning portal, for the duration of the program.
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