InstructorRoyed Training
TypeOnline Course
Student Enrolled3
Price$790 / 55300 INR
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CMC Documentation and AI in Regulatory Affairs

Introduction

Features

Related Courses

Who should attend

About CMC Writing

CMC Writing Vs. CMC AI Course

The Post Graduate Certification in CMC Documentation & AI in Regulatory Affairs by Royed Training is a specialized online program designed to prepare future-ready regulatory professionals.

At the beginning, the course introduces participants to the fundamentals of regulatory affairs and the critical role of CMC (Chemistry, Manufacturing, and Controls) in global drug development. Next, learners progress step-by-step into authoring, reviewing, and managing CMC documentation across multiple markets. Importantly, the curriculum not only covers ICH guidelines, CTD/eCTD submissions, and Quality Overall Summaries, but also explains practical aspects of lifecycle management, variations, and regulatory queries.

Moreover, as the pharmaceutical industry continues to evolve, the course highlights how Artificial Intelligence is transforming regulatory affairs. Therefore, participants gain exposure to AI-driven dossier automation, labeling harmonization, risk prediction, and data integrity solutions. In addition, learners engage with real-world case studies, simulations, and capstone projects that bridge the gap between theory and industry application.

As a result, graduates of this program develop dual expertise:

  • Strong foundation in CMC authoring and global regulatory compliance
  • Practical ability to apply AI tools for faster, smarter, and more accurate regulatory submissions

Finally, the program concludes with a capstone project and mock regulatory defense, ensuring participants are fully prepared to face real-world regulatory challenges with confidence.

Equipping regulatory professionals with dual mastery: world-class CMC documentation skills and future-ready AI-powered regulatory expertise.

Course Snapshots:

  • Course Code: RYD-140
  • Title of the course: PG Certification in CMC Documentation and AI in Regulatory Affairs 
  • Duration: 1 Year
  • Nature of the course: Online learning course. So the course can be accessed online anywhere 24×7.
  • Eligibility : Graduation in any discipline. Even final year graduation students can apply.
  • Course Certificate: Certificate will be provided at the end of the successful completion of the course.

This online course utilizes interactive learning tools to guide each participant through the steps of CMC Writing process for different regulatory bodies and practical exposure in pre and post submission management. The course is designed to challenge students to apply what they have learned through the use of interactive exercises, reflection questions, expert live chat and a final assessment at the end of the course.

Features of the Course:

  • Comprehensive Curriculum – Covers CMC documentation for small molecules, biologics, and biosimilars along with AI applications in regulatory affairs.
  • Self-Paced Learning – 100% online, flexible access with 24×7 availability from anywhere.
  • Learn at Your Own Pace – Start, pause, and resume anytime, ensuring learning fits around professional schedules.
  • ‍ Interactive Learning – Includes lectures, case studies, real-world simulations, and practical assignments.
  • Global Regulatory Coverage – Insights on FDA, EMA, MHRA, PMDA, TGA, SFDA, GCC, and other international regulatory frameworks.
  • AI Integration – Hands-on training on AI-powered dossier preparation, labeling alignment, risk prediction, and regulatory intelligence tools.
  • Capstone Project – End-to-end CMC dossier preparation with AI assistance, plus mock regulatory defense.
  • Royed PG Certification – Globally recognized credential upon successful completion.
  • ‍ Industry-Oriented – Designed with practical focus, minimal theory, and application-driven content.
  • Career Advancement – Equips learners with dual expertise in traditional CMC authoring and future-ready AI regulatory skills.

Key Points to Note:

  • 100% Online & Self-Paced – 24×7 access, learn anytime, anywhere. This program is delivered as an online, self-paced training. Therefore, participants can access the course 24×7 from anywhere in the world. Moreover, the flexible design allows learners to progress at their own speed. Hence, the course can be completed at any pace, enabling participants to start, pause, and resume their learning journey at their convenience.
  • Focus on eCTD v4.0 – Gain practical skills in next-generation electronic submissions.
  • AI-Powered Training – Learn how AI transforms CMC documentation and regulatory affairs.

Some related courses

CMC Writing training content is also part of the International Drug Regulatory Affairs (EPGIDRA) and Drug Biologic Medical Device Regulatory Affairs (PGDBMRA) course. Therefore, a separate course is not required if you already taking EPGIDRA or PGDBMRA course. We also have dedicated Drug Dossier Preparation course which covers the CMC writing.

This program is ideal for professionals who want to advance their careers in regulatory affairs and CMC documentation while mastering AI-powered tools:

  • ‍Regulatory Affairs Professionals – seeking to enhance their dossier preparation and submission skills.
  • CMC Writers & Technical Authors – aiming to improve their expertise in Module 3 authoring and QOS preparation.
  • Pharma & Biopharma R&D Professionals – who need to understand regulatory documentation requirements.
  • Quality Assurance & Compliance Managers – focusing on data integrity, lifecycle management, and regulatory expectations.
  • AI & Digital Transformation Enthusiasts – interested in applying AI/ML, NLP, and automation tools in regulatory processes.
  • Graduates & Postgraduates in Life Sciences/Pharmacy – aspiring to build a career in global regulatory affairs.

Things about CMC Writing you must know.

At Royed Training platform we have two different CMC training course to Transform into a Next-Generation Regulatory Professional!

  • 1-Year PG Certification in CMC Documentation & AI in Regulatory Affairs – Comprehensive program covering global frameworks, AI integration, eCTD v4.0, case studies, simulations, and capstone projects.
  • ⏳ 1-Month Certification in Regulatory CMC Writing – Focused, fast-track course for professionals looking to strengthen skills in Module 3 authoring, QOS preparation, and global submission writing.

Here is the differences between deep dive with CMC+ AI career-defining expertise (1 Year) or a practical quick-skill boost (1 Month) cmc writing training.

CMC+AI Vs. CMC Writing Course Comparison


Feature
🎓 PG Certification in CMC Documentation & AI in Regulatory Affairs
⏳ Advanced Certification in Regulatory CMC Writing

Duration
12 Months
1 Month

Mode
100% Online, Self-Paced, 24×7 Access
100% Online, Self-Paced, 24×7 Access

Focus
Comprehensive training in CMC documentation (small molecules, biologics, biosimilars) + AI integration, global frameworks, lifecycle management, eCTD v4.0
Focused training on CMC writing – Module 3, QOS, analytical validation & global submission writing

Certification
Royed PG Certification (Globally Recognized)
Royed Certification in Regulatory CMC Writing

Best For
Regulatory affairs professionals seeking career-defining expertise and future-ready AI skills
Professionals needing a quick upskilling in CMC authoring and dossier preparation

Section 1Drug Discovery and Development Fundamental
Lecture 1R&D Process & Introduction to drug discovery
Lecture 2Investigational New Drug Application (INDA)
Lecture 3New Drug Application (NDA) 
Lecture 4Basic concept and understanding of the Generic Drug
Lecture 5Abbreviated New Drug Application (ANDA) Filing 
Lecture 6Exploratory IND Vs. Traditional IND
Lecture 7Patent & Exclusivity - Strategic Understanding | Patent Restoration| Orphan Drug Exclusivity (ODE) | NCE & NCI Exclusivity | GAIN Exclusivity | Pediatric Exclusivity | 180 days exclusivity
Lecture 8USFDA expedited programs
Lecture 9EMA and EMA Authorisation Process
Lecture 10EU MA Procedure - Centralised, Decentralised, Mutual Recognition, National Procedure 
Lecture 11IMPD | Significance | Format of IMPD | Differences with CTA, IB, IND
Lecture 12Investigator’s Brochure | Significance | Format of IB | Preparing different sections of IB
Lecture 13Data Exclusivity and Market Protection - Supplementary Patent Protection, Exclusivity, 6/10 Rule, 8+2+1 Formulae
Section 2Preformulation Studies
Lecture 14Preformulation Study in Drug Development 
Lecture 15Regulatory Requirements for Preformulation Study 
Lecture 16Logical Sequence of Preformulation Study | Case Insights | Strategies for preformulation studies  
Section 3Regulatory Requirements for Non-Clinical Studies
Lecture 17Regulatory Requirements for Non-clinical Studies | Types of Non-clinical studies 
Lecture 18Types and Timing of Non-clinical Studies 
Section 4Regulatory Requirements for Clinical Studies
Lecture 19Understanding on Clinical Trials  and Clinical Research 
Lecture 20Clinical Trial Protocol Writing
Lecture 21Ethics in Clinical Research
Lecture 22Informed Consent | Practical Training on preparing ICF | Ready Templates
Section 5ICH Guideline
Lecture 23Introduction to ICH | Members | Guidelines 
Lecture 24ICH Q1 : Stability Guideline | Matrixing | Bracketing
Lecture 25ICH Q2 : Analytical Validation 
Lecture 26ICH Q3 : Impurities
Lecture 27Rest of ICH Q Family Guidelines
Section 6Managing CMC requirements
Lecture 28Chemistry, Manufacturing & Controls 
Lecture 29Fundamental of CMC | Detailed understanding of CMC section writing | Important Points regarding CMC | Drug Product and Drug Substance | Excipient, FP, Analysis and Stability Study Requirements
Lecture 30505(j) ANDA, 505(b)(2) NDA, 505(b)(1) NDA
Lecture 31Advance Learning on 505B2 Pathway
Lecture 32EU MA Application Types and Strategic Planning
Section 7Dossier Preparation
Lecture 33Introduction to Common Technical Document (CTD)
Lecture 34CMC Dossier & Compliance Management
Lecture 35Key Consideration for Drug Master File Preparation and Submission 
Lecture 36Practical Understanding on Drug Master File Preparation and Submission
Lecture 37Associated Learning: Site Master File - Detailed Understanding 
Lecture 38Drug Master File - Fees
Lecture 39Drug Master File - Global Perspective [Across Different Regions]
Lecture 40Electronic Common Technical Document (ECTD)
Lecture 41Certificate of Analysis
Lecture 42Asean Common Technical Document (ACTD) 
Lecture 43Grouped Submission | Significance | Importance in Market Access and Regulatory point of view | Case Study
Section 8Dossier Submission and Management
Lecture 44FDA Forms and How to fill the resources
Lecture 45Strategic Discussion: PreIND, EOP1, EOP2 - What to expect !
Lecture 46Importance of effective dossier management
Lecture 47Discussion on 85 common deficiencies in CTD submission dossier
Lecture 48Detailed Understanding on ANDA Submission Dossier 
Lecture 49Prior Approval Submission 
Lecture 50Detailed Understanding on ANDA Fees
Lecture 51Detailed Understanding on 505(b)(2) VS. Suitability Petition : Case Based Learning
Lecture 52NCE Vs. 505b2 application - Case Based Learning 
Lecture 53FTF - 180 Days Exclusivity - Case Based Learning
Lecture 54Classic case study of the 505b2 filing : Case Based Learning
Lecture 55EU MA Strategic Planning: Full, Full-mixed, hybrid applications. Generic, Similar biologic application pathway, Well-established use application, Fixed combination application, Informed consent application
Lecture 56Supplemental New Drug Application (sNDA) | Filing and Submission Management | Requirements | Best Practices | Different Forms for sNDA submissions
Lecture 57OGD Table  - How to Prepare | Sample Tabular Summary Preparation
Section 9Stability Study
Lecture 58Modules on Stability Study : Stability Study - Fundamental Understanding | Interchangebility | Reports | API & FPP Stability Study
Lecture 59
Lecture 60Stability Zone Finder
Lecture 61Stability Studies : Case discussions
Lecture 62Stability Data for Zone IV countries
Lecture 63Accelerated and intermediate testing conditions
Lecture 64Long Term Stability Testing Requirements
Lecture 65Stability Study Protocol Development - Dosage form: Capsule
Lecture 66Stability Data Sheet
Lecture 67Dossier Stability Test
Lecture 68Testing Frequency
Lecture 69Bracketing
Lecture 70Matrixing
Section 10BA BE Study
Lecture 71PKPD in Drug Discovery | PK-PD trial | Understanding PKPD from regulatory perspective in drug approval process
Lecture 72Bioequivalence Study | Study design | Different types of BE Studies
Lecture 73Bioequivalence Study | Study design | Parallel Study | Crossover study design | Other alternative study designs | Blood Sampling Planning  | Analyte | Bioanalytical Methods Validation  | Statistical Model  | Ln Transformation  | Dose normalisation | Confidence interval acceptance criteria
Lecture 74Biopharmaceutical Classification System (BCS) | Types | Biowaivers | BCS tool for drug development and regulatory submission 
Lecture 75Bioequivalence Study - Discussion - Timeline of stability study and bioequivalence study 
Lecture 76Bioequivalence Study - Discussion - Dissolution Testing
Lecture 77Bioequivalence Study - Generic Approval and Additives Labeling Requirements 
Lecture 78BA BE Study Design  | Comparing different types of the study design 
Lecture 792wco Study Design  | Design Table | Importance  
Lecture 803wco Study Design  | Design Table | Importance  
Lecture 81FRCO Study Design  | Design Table | Importance  
Lecture 82OGD Table  - How to Prepare | Sample Tabular Summary Preparation
Section 11Post Approval Changes and Variation Management
Lecture 83Variation Management | Reasons for Variation | Working in Variation Department 
Lecture 84Variation Classification | Basis of Classification | US and EU Variation Classification | Other region variation guideline
Lecture 85EU variation -Types, Requirement & Planning - IA, IAIN, IB, II ; US FDA Variation AR, CBE-0, CBE-30, PAS - Strategic Discussion | Similarities & Differentiation
Lecture 86Impact Assessment in CMC Writing | Case Based Discussion| Scenario Decision Making 
Section 12Quality Issues | Post Filing Regulatory Queries | Response to Queries (RTQs) | Critical Issues in Submission Management
Lecture 87Data Integrity issues in Pharmaceutical Industry : Detailed Understanding 
Lecture 88Establishment Inspection Report | 483 Observations | USFDA Warning Letter | Handling of FDA inspection | Closing of Warning Letter 
Lecture 89Electronic Batch Record for effective compliance management | Key Understanding | Functionalities | Importance in managing data integrity
Lecture 90RTQs | Response to Queries | How to handle Regulatory Queries
Section 13Biologic CMC Requirements
Lecture 91Biosimilar Development Process
Lecture 92Strategic Consideration for Biosimilar Development 
Lecture 93Regulatory Requirements for Biosimilar | Stepwise evidence based development | Analytical Similarity | Clinical Study | PKPD study requirements | CMC expectation of Biosimilar
Lecture 94Studies required for approval of biosimilar
Lecture 95Comparability of Biologics | Different Categories of Comparability | General Principles
Section 14Differentiating CMC and Regulatory Writing with Medical and Scientific Writing
Lecture 96Introduction to Medical Writing | Objective | Significance | Medical Writing Vs. Scientific Writing | Key Notes 
Lecture 97Types of Medical Writing | Regulatory Writing | CMC Writing | Clinical Writing | Documents under each class of medical writing  
Lecture 98Ethical Consideration of  Medical Writing | Important Considerations | Effective strategies for each ethical consideration | Case studies 
Lecture 99Regulatory Documents | Classification of regulatory documents | Understanding of each class of documents | Ethical consideration for Regulatory Writing
Lecture 100Publication Writing and Regulatory Writing | Key Differences with Examples 
Lecture 101Regulatory Writing - Review Test 
Lecture 102Hands on Case Study Protocol Designing for Experimental Asthma Drug | Analysis of various aspect of protocol | Open File 
Lecture 103Drafting of Study Objective Methodology and Endpoint | Checklist
Section 15Reference | Discussions | CMC Case Studies
Lecture 104Comparison of Requirement of Various Regulatory Bodies
Lecture 105Comparison of Dossier Requirements of Europe and US
Lecture 106Comparison of DMF requirement of various regulatory bodies
Lecture 107ICH Guidelines - Comprehensive View
Lecture 108ICH CTD Top Level View with Notes and Explanation
Lecture 109Comparison of ICH US EU CTD
Lecture 110Regulatory Documents - At a glance
Lecture 111Structured CMC Writing Checklist
Lecture 112CMC Writing Case Study | Successful Documentation 
Lecture 113Structure for CMC Writing | Understanding 3.2.S and 3.2.P section | Documents requirements | Case Study  
Lecture 114Well written Vs. Poorly Written CMC Section | Practical Example  
Lecture 115Drug Substance Section in CMC | Documentations | Practical Examples | Do’s and Don’ts   
Lecture 116Example of Well-Written Drug Substance Characterization | Impurities and Degradation Products | Well-Written Impurities and Degradation Products | Synthesis and Manufacturing Processes | Control of Drug Substance (Specifications, Testing, and Acceptance Criteria)
Lecture 117Stability Studies and Data Presentation in CMC Writing | Case Based Analysis of Stability Study Data Presentation | Interpretation of stability data
Lecture 118Certificate of Suitability (CEP) | Significance | Importance | Understanding Regulatory Compliance and Submission Process | Walkthrough
Lecture 119CEP Dossier DMF - Differences
Lecture 120Developing Specifications for a New API
Lecture 121Example of Manufacturing Process and Controls
Lecture 122Interpretation of Stability Table
Lecture 123Critical Stability Scenarios | 8 Different Case Studies | Stability Study - Outcome based action plan creation
Lecture 124Critical Stability Issues - Database | Implication | Action Plan
Lecture 125Policy 0070 |  RPDP Submission and Management timeline | Anonymisation Report (AnR) - Significance | AnR in FRDP 
Lecture 126Common Pitfalls in CMC Writing and How to Avoid Them | Case Study
Lecture 127Process Validation Report (PVR) | Sample Process Validation Report Analysis | CPPs and CQAs identification
Lecture 128Case Study - Omissions of CPPs in PVR | Case insight, explanation, action plan | Correlations - CPPs - CQAs - IPCs 
Lecture 129Binding and Non-binding legal considerations - Module 3 Quality in CMC Section | Case Studies
Lecture 130Binding and Non-binding Scenarios with Examples
Section 16WHO Certification Scheme | Documentation
Lecture 131Introduction to Certificate of Pharmaceutical Product | Types of CoPP | List of Countries / Regulatory Authorities who requires CoPP | CoPP as a part of generic market expansion planning 
Lecture 132WHO-GMP Certification Scheme 
Lecture 133Template of Certificate of Pharmaceutical product | Key observations and points to note while working on CoPP
Lecture 134WHO Prequalification Status : Significance | Strategic Importance | Submission Process | WHO PQ Documentation | Case study on WHO PQ submission management
Lecture 135WHO EML Vs. WHO PQ | Significance | Importance in Market Access and Regulatory point of view
Section 17Fundamental of AI in CMC Documentation
Lecture 136Introduction to AI
Lecture 137Basics of AI ML DL | Key Differences | Application in industry
Lecture 138Types of AI
Lecture 139AI Project | Overview
Lecture 140Comprehensive Training on AI Project | Managing Stages | AI Iteration 
Lecture 141How machine learning
Lecture 142Understanding Regulatory Affairs – Traditional vs. Digital | 2 Case Study
Lecture 143Basics of AI for Regulatory Professionals | Understanding different models used in RA | Case Study | Simulation
Lecture 144AI Application across drug life cycle | Case Analysis | Model predictions
Lecture 145AI Terms with Regulatory Significance | Regulatory Applications
Lecture 146NLP in Regulatory Affairs | Conceptual understanding | Usage | NLP in Labeling
Lecture 147Data Grouping with Unsupervised Learning | Case Simulation | Hands on Exercise
Lecture 148Quality Data and Bias | Bias in datasets | Different Types of Bias in Pharma Datasets 
Lecture 149AI Data Quality Standard | Checklist
Lecture 150Download AI Data Quality Checklist
Lecture 151Case Study: Accelerated Approval Using Real-World Evidence AI
Lecture 152AI Model for Dossier Submission and Filing - Model Selection | Simulation
Lecture 153AI Technologies in RA
Lecture 154Structured Vs. Unstructured Data | Practical Understanding | Explore Patient Datasets
Lecture 155Sample Data Exercise | Data error | Data Refinement and Cleaning of the data 
Section 18AI in Regulatory Authoring and CMC Writing
Lecture 156AI-Powered Regulatory Document Authoring and CMC Writing
Lecture 157AI Tools Comparison - Authoring and CMC Writing (Module 2 & 3)
Lecture 158Tips for Selecting AI Tools (CMC Authoring)
Lecture 159CMC - AI Workflow Checklist | Simulation Based Cases
Lecture 160HITL Regulatory Document Authoring
Lecture 161Confidence Score in Regulatory Authoring | Case Simulation in CMC Authoring
Lecture 162Confidence Scores in Data Extract in Regulatory Writing [Case Simulation]
Section 19eCTD v4.0 Training
Lecture 163eCTDV4.0 Fundamental Understanding | Structures | Key Features
Lecture 164eCTDV4.0 Structure | Lifecycle Management 
Lecture 165eCTD Validation | Managing Validation | Tool Types | Types of Error | Validation Error Management
Lecture 166eCTD Validation Tools
Lecture 167eCTD Publishing Cycle
Lecture 168HL7 - Structure and Understanding in the context of eCTD V4.0
Lecture 169Tips and Submission Readiness Checklist
Lecture 170eCTD Submission Checklist Format
Lecture 171Regulatory Publishing Document Control Challenges
Lecture 172Document Control Checklist
Lecture 173Leaf Structure Analysis | Common Error in Leaf Structuring
Lecture 174Formatting Rules Templated and Agency Specification
Lecture 175Versioning for Regulatory Publishing
Lecture 176File Naming Standard
Lecture 177Text Recognition and Optical Character Recognition (OCR)
Lecture 178Versioning File Naming OCR - How they work together
Lecture 179Final Document Assembly
Lecture 180Visual Diagram : eCTD Structure and XML Hierarchy
Lecture 181TOC and CI Management
Lecture 182Initial Submission & Maintenance Submission
Lecture 183Managing Lifecycle Operators - NEW REPLACE DELETE APPEND
Lecture 184eCTD Dossier Lifecycle - Multi Sequence View
Lecture 18510 Year eCTD Lifecycle : Sequence Evolution Diagram
Lecture 186Global Decision Tree - Classifying Post Approval Changes
Lecture 187eCTD Technical Validation | Typical issues | Resolutions
Lecture 188eCTD Validation Readiness Checklist
Lecture 189QC Checklist Design and Pre Submission Review
Lecture 190Submission Gateway | FDA ESG • EMA CESP • Health Canada Portal • PMDA Gateway
Lecture 191Regulatory Publishing Simulation 
Lecture 192Pre-Gateway Submission Review Checklist | Post Submission Confirmation
Section 20Risk and Compliance Management
Lecture 193AI and Data Integrity | Regulatory Documentation | Case Based Learning | Understanding Data Integrity Principles | Application and Use Cases
Lecture 194Cases of data breaches with explanation
Lecture 195Case Based Discussion : Data Breach in AI-Assisted CMC Drafting 
Section 21CCDS Management | Global Labelling and Artwork Management
Lecture 196CCDS Management 
Lecture 197CCDS Management Tools - Native, AI Plus | Key Functionalities
Lecture 198AI Augmented Labelling Compliance System
Lecture 199Label Drift in CCDS Management | Simulation Case Study | AI Based Workflow in Label Drift detection and management
Lecture 200AI Review of Labels, PI and SMPC with help of the Case Based Simulation | 4 Case Simulations 
Lecture 201CCDS Management Case Study | Pregnancy Warning Upgrade Case Study
Lecture 202CCDS Management Case Study | Dosage Section Conflict | Case Based Analysis
Lecture 203Centralized Artwork Operation | Mechanism | Operation Step Planning 
Lecture 204Case Study on Centralized Artwork Operation  [Recall Management]
Lecture 205Artwork Management Terms | Key Understanding on Terminologies | Usage in Artwork Cases
Lecture 206Source Documents | Artwork Brief
Lecture 207Creating and Reviewing Label Content | Stakeholders of Labelling and Artwork Management | Case Studies 
Lecture 208Change control process for labels | Types of changes | Impact Assessment | Concept of Greyzone Changes 
Lecture 209Label Impact Assessment Checklist
Lecture 210Packaging Types & Their Impact on Artwork 
Lecture 211Design tool used in artwork | Esko Platform | Adobe Illustrator | CorelDRAW | File Format | Label Design Workflow and Tool Utilization 
Lecture 212Labelling Management System (LMS) | Understanding of Popular LMS Softwares | Workflow Management | Workflow Automation & Version Tracking | Best Practices
Lecture 213Concept of eLabel (Electronic Labeling) in Pharmaceuticals
Lecture 214Regulatory vs Commercial Perspective of Labelling | Labelling Compliance Function 
Lecture 215Types of Labels 
Lecture 216Artwork & Packaging Lifecycle | Artwork Management Lifecycle Workflow 
Lecture 217Global Artwork Labelling Framework | 5 Case Simulation
Lecture 218Country-Specific Labelling Requirements
Lecture 219Summary of Product Characteristics (SmPC) 
Lecture 220Patient Information Leaflet (PIL)
Lecture 221Summary of Product Characteristics (SmPC) – Review Checklist
Lecture 222Patient Information Leaflet (PIL) – Review Checklist
Lecture 223US Prescribing Information (PI) | Differences with EU SmPC 
Lecture 224US Prescribing Information (PI) - Review Checklist 
Lecture 225Fundamental Understanding on Medication Guide
Lecture 226Regulatory Decision Flow: When Is a Medication Guide Required? - Step Based Decision Making
Lecture 227Medication Guide - Review Checklist | Inspection Checklist 
Lecture 228PI Vs. Medication Guide Comparison 
Lecture 229Patient Information Leaflet (PIL) vs Medication Guide 
Lecture 230Label Components | Key considerations for effective designing of label 
Lecture 231Label Review Checklist 
Lecture 232Color Proofing, Dielines & Version Control"
Lecture 233CDR File - Monocarton | Outercarton | Keyline | Design Parameters
Lecture 234Injection Labels - Labels and Cartons
Lecture 235Various Design Component Placement Understanding (Injectables)
Lecture 236Concept of Logo File | Open and Curve File Importance
Lecture 237QC and Proof Reading in Labelling and Artwork
Lecture 238QC and Proofreading Checklist
Lecture 239Template Management and Creative Brief
Lecture 240Pre approval Labelling | ANDA Labelling | ANDA Labelling
Lecture 241Post approval Labelling | PAS | CBE-30 | Annual Reportable Changes
Lecture 242Decision Tree - PAS CBE-0 CBE-30 Annual Reportable Change Determination
Lecture 243Bulk Pack Labelling
Lecture 244Bulk Pack Labelling Checklist 
Lecture 245OTC vs Prescription Labelling | Claim Limitations & Consumer Safety Requirements
Lecture 246OTC vs Prescription (Rx) Label Checklist
Lecture 247OTC Approval Matrix 
Lecture 248OTC Claim Risk Scoring System
Section 22 Real World Evidence and Real World Data | Strategic Decision Making
Lecture 249Evidence Based Decision Making | Combine evidences for decision making | Do we need more evidence? 
Lecture 250RWD and RWE | Potential sources of RWE | Traditional RCTs vs. RWE | Case Study - RWE Programs | Influencing HCP decision-making
Lecture 251RWD and RWE in Product Lifecycle Management
Lecture 252RWD and RWE - Fit to use | Assessment 
Lecture 253RWD data sources | Different types | Detailed understanding of each class 
Lecture 254RWD Study Design
Lecture 255RWE Published Tool | Insights on commonly used tools
Lecture 256Healthcare Reimbursement Models : Value Based Care | Fee for Service (FFS) Model | Other Reimbursement Models
Lecture 257Consensus Narrative Review 
Lecture 258Electronic Patient Data | EMR | EHR | Differences | Software architecture and characteristics
Lecture 259Active Surveillance Schemes | Active Case Finding |Sentinel Surveillance | Cohort Studies | Vaccine Safety Surveillance | Pharmacovigilance Programs | Disease Registries |Event Monitoring
Lecture 260RWD Characteristics
Lecture 261RCT vs. RWE Comparison | Case Based Analysis
Lecture 262RCT and RWE Comparison
Section 23Working on Healthcare Datasets
Lecture 263Introduction to Healthcare Datasets
Lecture 264Dataset 1: Claims Data (Insurance)
Lecture 265Dataset 2: Retail Pharmacy Prescription Data
Lecture 266Dataset 3: Longitudinal Patient Data
Lecture 267Characteristics of Different Set of Healthcare Data
Lecture 268Reimbursement and Pricing Datasets
Lecture 269RWE Data Sources & Quality Considerations Checklist | Case Based Analysis
Lecture 270Triangulation and benchmarking | Enhancing Data Validation Through Cross-Referencing
Lecture 271RWD & RWE Case Database
Lecture 272RWE Large Dataset for Data Crunching Exercises |Data cleaning & preprocessing | Comparative Effectiveness Analysis 
Section 24AI Tools, Ethics and Future Landscape
Lecture 273AI Reg Tools - Review | Understanding Capabilities
Lecture 274Regulatory Authority View on AI Adoption
Section 25Course Certification
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