Introduction
Who should attend
Features
Related Courses
About RA
This online life Science Regulatory Affair course provides understanding of regulation, registration process and strategic planning. This PG Certification trains Regulatory Affairs professionals for drug, biologic, medical devices, fmcg, food, dietary supplement / nutraceutical, cosmetic Industry. This comprehensive regulatory affairs training involves the real life job simulations. Hence, the course provides practical knowledge. Moreover, this course focuses on how regulatory professionals work in the life science company. Therefore, it helps users to understand the key responsibilities and job functions.
In these comprehensive self-paced modules, participants gain a deep understanding of the entire development-to-commercialization journey of drugs, biologics, and medical devices. Step by step, you’ll explore how innovative products progress from discovery and development to investigational applications, clinical trials, and marketing authorization.
Moreover, the course goes beyond traditional learning—it dives into generic drug approval processes, abbreviated pathways, and accelerated approvals for drugs and medical devices, ensuring you grasp every critical regulatory milestone.
Transitioning from fundamentals to advanced concepts, the program covers diverse regulated sectors including pharmaceuticals, biologics, medical devices, cosmetics, food, and nutraceuticals. You’ll not only master the regulatory, registration, and strategic management frameworks, but also understand how these domains interconnect in today’s global life-science ecosystem.
Most importantly, the course features a dedicated focus on Artificial Intelligence (AI) in Regulatory Affairs—a revolutionary area shaping the future of compliance, dossier preparation, and regulatory submissions. With AI now driving efficiency, accuracy, and decision-making across the regulatory lifecycle, this module empowers professionals to stay ahead in an increasingly digital regulatory environment.
In short, this training helps you transform from a traditional regulatory professional into an AI-empowered expert, ready to navigate evolving global regulations with confidence and strategic insight.
One of the standout features of Royed Training’s course is its expansive reach. This program doesn’t limit itself to just one segment of the life sciences industry. Instead, it encompasses a wide range of sectors, including:
- Pharmaceuticals: Understanding drug regulations and compliance.
- Biologics: Navigating complex biological product approvals.
- Medical Devices: Meeting safety standards and regulatory requirements for medical equipment.
- Food and FMCG: Comprehending food safety regulations and compliance for fast-moving consumer goods.
- Cosmetics: Ensuring adherence to cosmetic regulatory guidelines.
- Dietary Supplements/Nutraceuticals: Mastering rules governing nutritional products.
Hence, this comprehensive course in life science Regulatory Affairs provides an in-depth understanding of the regulatory framework governing the development, approval, and post-market compliance. This dynamic field plays a pivotal role in ensuring the safety and efficacy of healthcare products, as well as their timely market access. In fact, participants will gain the knowledge and skills necessary to navigate the complex regulatory landscape, making them valuable assets to pharmaceutical and medical device companies, regulatory agencies, and related organizations.
Course Snapshots
- Course Code: RYD-119
- Title of the course: Executive PG Certification in Life Science Regulatory Affairs (EPLsRA)
- Nature of the course : Online distance learning course. Hence, this course can be accessed online across anywhere 24×7. Moreover, you can attend the course at your convenience in your flexible time. For example, you want to attend the session at your 11 pm at night, you can do that.
- Duration of the course : 1 Year
- Eligibility: Graduation in any discipline.
- Course Certification : Certificate will be provided at the end of the successful completion of the course
Who should attend this course?
- Those who are in the regulatory affairs and related department.
- Professionals from drugs, biologics and medical devices industry.
- Anyone requiring an overview and detail understanding on working of regulatory affairs.
- Fresher or beginners, Those who want to make a career in the regulatory department.
- Healthcare professionals and researchers.
- Quality assurance and quality control personnel.
- FDA professionals and Government regulatory agency staff.
- Those seeking a career in regulatory affairs.
Objective of the course
- Understand the regulatory requirements and processes for drugs, biologics, medical devices, food, dietary supplement, cosmetics in various global markets.
- Gain insights into the lifecycle of these products, from development and clinical trials to post-market surveillance.
- Learn to interpret and apply relevant regulations, guidelines, and standards from regulatory authorities, including the FDA, EMA, and other agencies.
- Develop proficiency in preparing regulatory submissions and ensuring compliance with regulatory requirements.
- Appreciate the ethical and safety considerations integral to regulatory affairs, including pharmacovigilance and quality management.
- Acquire the skills to assess, mitigate, and manage risks associated with regulatory compliance.
Features of Drugs, Biologics and Medical Devices Regulatory Affairs Course
- This course covers all aspects of the drug, biologics and medical devices regulatory affairs in a single course. Hence, user need not to purchase the drugs, medical devices and biologics training separately.
- The course provides orientation to job related practical aspects of the regulatory managers. Therefore, on completion of the course, the participants will develop the hands on understanding on the regulatory affairs working.
- One of the important feature of the course is real life simulation on critical decision making process. Hence, these simulations help to enhance the regulatory strategic decision making.
Case Based Learning
- Advance training on drug registration requirements for various regulatory bodies.
- Access to Case Studies to learn about the drug and medical device registration steps. Hence, participants will develop advanced competency on drugs, biologics and medical devices strategic planning.
We also have 1 year Executive PG certification in Life Science Regulatory Affairs course. This course covers comprehensive regulatory training on pharmaceutical and biopharmaceuticals regulatory affairs.
Life Science Training Courses
Course Code |
Course |
Duration |
RYD-118 |
Life Science Global Management |
1 Year |
RYD-112 |
Life Science Business Consulting |
1 Year |
RYD-119 |
Life Science Regulatory Affairs |
1 Year |
Regulatory Affairs Training Courses
Career in Life Science Regulatory Affairs
Life Science Regulatory Affairs is a field within the life sciences industry that deals with the regulatory requirements and processes necessary for the development, approval, and marketing of pharmaceuticals, medical devices, biologics, food, dietary supplment / nutraceutical. cosmetic and other healthcare products. It involves ensuring that these products meet the standards and regulations set by governmental agencies such as the Food and Drug Administration (FDA) in the United States, the European Medicines Agency (EMA) in Europe, and similar regulatory bodies worldwide.
Professionals in this field are responsible for interpreting and implementing regulations, preparing and submitting regulatory documents for approval, communicating with regulatory agencies on behalf of their companies, and ensuring compliance throughout the product lifecycle. They play a critical role in helping companies navigate the complex regulatory landscape to bring safe and effective products to market while meeting legal requirements.
Section 1Fundamental of Drug Discovery and Development
Lecture 1Introduction to R&D Process & drug discovery
Lecture 2Investigational New Drug Application
Lecture 3New Drug Application (NDA)
Lecture 4Basic concept and understanding of the Generic Drug
Lecture 5Abbreviated New Drug Application (ANDA)
Lecture 6Preformulation Study in Drug Development
Lecture 7Regulatory Requirements for Preformulation Study
Lecture 8Logical Sequence of Preformulation Study | Case Insights | Strategies for preformulation studies
Lecture 9Regulatory Requirements for Non-clinical Studies | Types of Non-clinical studies
Lecture 10Types and Timing of Non-clinical Studies
Lecture 11Exploratory IND Vs. Traditional IND
Lecture 12Patent & Exclusivity - Strategic Understanding | Patent Restoration| Orphan Drug Exclusivity (ODE) | NCE & NCI Exclusivity | GAIN Exclusivity | Pediatric Exclusivity | 180 days exclusivity
Lecture 13Orphan Drug Designation
Lecture 14Review on Drug Discovery and Development
Lecture 15Understanding on Clinical Trials and Clinical Research
Lecture 16Clinical Trial Protocol Writing
Lecture 17Ethics in Clinical Research
Lecture 18Informed Consent | Practical Training on preparing ICF | Ready Templates
Lecture 19FDA Forms and How to fill the resources
Lecture 20Strategic Discussion: PreIND, EOP1, EOP2 - What to expect !
Lecture 21Chemistry, Manufacturing & Controls
Lecture 22Fundamental 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 23505(j) ANDA, 505(b)(2) NDA, 505(b)(1) NDA
Lecture 24Advance Learning on 505B2 Pathway
Lecture 25Authorized Generics: Key Understanding
Lecture 26USFDA expedited programs
Lecture 27Complete Response Letter | Key understanding | Management and Action Plan
Lecture 28Introduction to ICH | Members | Guidelines
Lecture 29ICH Q1 : Stability Guideline | Matrixing | Bracketing
Lecture 30ICH Q2 : Analytical Validation
Lecture 31ICH Q3 : Impurities
Lecture 32Rest of ICH Q Family Guidelines
Lecture 33Emergency Use Authorization (EUA) | EUA Pathways | Criteria | Justification | Early Discussion with FDA | LOA | Factsheets
Lecture 34Handling of orange book
Section 2Innovation / Intellectual Property Management
Lecture 35General Introduction to intellectual Property Management
Lecture 36Introduction to Intellectual Property in Life Sciences | Types of IP | Introduction to Patent Portfolio Strategy
Lecture 37Introduction to Patent
Lecture 38Global Pharmaceutical Patent Landscape | Strategic Overview of Global Patent Filing and Protection
Lecture 39Understanding on Patent System
Lecture 40Patent Grant and Managing Patent Filing Procedure
Lecture 41Scope of Patentability
Lecture 42Stages of Patent Grant Procedure
Lecture 43Patent search in Indian Patent Office
Lecture 44Global Pharmaceutical Patent Filing Strategy
Lecture 45PCT Patent Filing Flow
Lecture 46Patentability Criteria in Pharmaceuticals | Practical Case Study
Lecture 47Patent Law Framework for Pharmaceuticals
Lecture 48Understanding and Decoding Section 3(d) of the Indian Patent Act | Case Based Analysis
Lecture 49Evergreening vs Genuine Innovation in Pharmaceutical Patents | Evergreening and Genuine Innovation Evaluation
Lecture 50Pharmaceutical Patent Lifecycle - Integrated Layer Strategy
Lecture 51Blockbuster Drug Patent Thicket Strategy
Lecture 52Types of Pharmaceutical Patents | Patent Layering StrategiesTypes of Pharmaceutical Patents
Lecture 53Understanding Patent Searching Process
Lecture 54IPC and CPC - Importance and Significance in Patent Search
Lecture 55IPC Structures for Pharmaceutical Patents
Lecture 56Freedom-to-Operate (FTO) | FTO Risk Assessment | Strategic Management
Lecture 57FTO Decision Tree – Generic Drug Launch Strategy
Lecture 58Fundamental of Pharmaceutical Patent Drafting | Structure | Component | Claim Anatomy | Effective Claim Writing
Lecture 59Pharmaceutical Patent Risk Management Framework
Lecture 60Patent Claim Coverage - Practical Example
Lecture 61Pharmaceutical Patent Filing Procedure and Global Filing Strategy | PCT Filing | Timeline
Lecture 62Advanced Understanding on Patent Opposition and Patent Litigation in Pharmaceutical Domain
Lecture 63Patent Prosecution and Handling Examiner Objections
Lecture 64Pharmaceutical Patent Portfolio Management | How to build and manage pharma patent portfolio
Lecture 65Pharmaceutical Patent Valuation and Licensing
Section 3 Regulatory Strategic Management and planning
Lecture 66Regulatory Strategies in different phases of Clinical Trial
Lecture 67Advance study on Para IV Filing
Lecture 68Para IV Notice
Lecture 69Evergreening - Patent Life Extension Strategies
Lecture 70Pay For Delay Strategy
Lecture 71REMS Strategic Planning
Lecture 72Compulsory Licensing
Lecture 73Licensing & Technology Transfer
Lecture 74In-Licensing Vs. Outlicensing
Lecture 75LOE Strategies for Innovator Brands with case study
Lecture 76Paediatric Exclusivity and Paediatric Study Plan Development
Lecture 77Drug Re-purposing
Lecture 78Practical Queries on different USFDA application and Filing
Lecture 79Publication Management from Regulatory perspective
Lecture 80Juxtapid Case Study
Lecture 81New Indication Approval Process and Promotion
Lecture 82OTC Switch
Section 4Good Manufacturing Practices
Lecture 83Certification Pharmaceutical Companies / Plants
Lecture 84Premises & Plant Layout Designing
Lecture 85Sanitation and Hygiene
Lecture 86Equipment
Lecture 87Production Modules
Lecture 88GMP Documentation
Lecture 89Quality Control
Lecture 90Handling of Product Complaint
Lecture 91GMP Storage
Lecture 92ISO and ISO Audits
Lecture 93Pharmaceutical SOPs
Lecture 94PDE Value | Importance, Significance | How to calculate PDE value
Lecture 95Quality Risk Management | ICH Q9 | ISO 14971 | Principle of Risk Management
Lecture 96Introduction 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 97WHO-GMP Certification Scheme
Lecture 98Template of Certificate of Pharmaceutical product | Key observations and points to note while working on CoPP
Section 5 Submission Dossier : CTD | ACTD | DMF - SMF-ANDA | 505(b)(2) | NCE | Petittion| Prior Approval Submission
Lecture 99Introduction to Common Technical Document (CTD)
Lecture 100CMC Dossier & Compliance Management
Lecture 101Electronic Common Technical Document (ECTD)
Lecture 102Advance Practical Training on Dossier Preparation focusing on drug registration in export countries
Lecture 103Modules on Stability Study : Stability Study - Fundamental Understanding | Interchangebility | Reports | API & FPP Stability Study
Lecture 104Key Consideration for Drug Master File Preparation and Submission
Lecture 105Practical Understanding on Drug Master File Preparation and Submission
Lecture 106Site Master File - Detailed Understanding
Lecture 107DMF Completeness Assessment
Lecture 108Drug Master File - Fees
Lecture 109Drug Master File - Global Perspective [Across Different Regions]
Lecture 110Importance of effective dossier management
Lecture 111Common deficiencies in CTD submission dossier
Lecture 112Certificate of Analysis
Lecture 113Detailed Understanding on ANDA Fees
Lecture 114Prior Approval Submission
Lecture 115Detailed Understanding on ANDA Fees
Lecture 116Detailed Understanding on 505(b)(2) VS. Suitability Petition : Case Based Learning
Lecture 117NCE Vs. 505b2 application - Case Based Learning
Lecture 118FTF - 180 Days Exclusivity - Case Based Learning
Lecture 119Classic case study of the 505b2 filing : Case Based Learning
Lecture 120Strategic Planning in Combating 30 months stay strategies of innovator company- Case Based Learning
Lecture 121Climate Zone
Lecture 122Stability Zone Finder
Lecture 123Stability Studies : Case discussions
Lecture 124Case Study: Managing Stability Study for Zone IV countries
Lecture 125Accelerated and intermediate testing conditions
Lecture 126Long Term Stability Testing Requirements
Lecture 127Stability Study Protocol Development - Dosage form: Capsule
Lecture 128Stability Data Sheet
Lecture 129Dossier Stability Test
Lecture 130Testing Frequency
Lecture 131Bracketing
Lecture 132Matrixing
Lecture 133PKPD in Drug Discovery | PK-PD trial | Understanding PKPD from regulatory perspective in drug approval process
Lecture 134Bioequivalence Study | Study design | Different types of BE Studies
Lecture 135Bioequivalence 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 136Biopharmaceutical Classification System (BCS) | Types | Biowaivers | BCS tool for drug development and regulatory submission
Lecture 137Bioequivalence Study - Discussion - Timeline of stability study and bioequivalence study
Lecture 138Bioequivalence Study - Discussion - Dissolution Testing
Lecture 139Bioequivalence Study - Generic Approval and Additives Labeling Requirements
Lecture 140Introduction to Variation Management | Reasons for Variation | Working in Variation Department
Lecture 141Variation Classification | Basis of Classification | US and EU Variation Classification | Other region variation guideline.
Lecture 142Health Supplement - Stability Study | Study Design - Batch Selection | Testing Frequency | Reduced Batches | Storage Condition | Container Closure System
Lecture 143Setting Dissolution Specification for Generic Products | Regulatory Expectations
Lecture 144Regulatory Requirements for Biosimilar | Stepwise evidence based development | Analytical Similarity | Clinical Study | PKPD study requirements | CMC expectation of Biosimilar
Lecture 145CMC Writing Case Study | Successful Documentation
Lecture 146Structure for CMC Writing | Understanding 3.2.S and 3.2.P section | Documents requirements | Case Study
Lecture 147Well written Vs. Poorly Written CMC Section | Practical Example
Lecture 148Drug Substance Section in CMC | Documentations | Practical Examples | Do’s and Don’ts
Lecture 149Example 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 150Stability Studies and Data Presentation in CMC Writing | Case Based Analysis of Stability Study Data Presentation | Interpretation of stability data
Lecture 151Developing Specifications for a New API
Lecture 152Example of Manufacturing Process and Controls
Lecture 153Interpretation of Stability Table
Lecture 154Critical Stability Scenarios | 8 Different Case Studies | Stability Study - Outcome based action plan creation
Lecture 155Critical Stability Issues - Database | Implication | Action Plan
Lecture 156Common Pitfalls in CMC Writing and How to Avoid Them | Case Study
Lecture 157Grouped Submission | Significance | Importance in Market Access and Regulatory point of view | Case Study
Lecture 158Process Validation Report (PVR) | Sample Process Validation Report Analysis | CPPs and CQAs identification
Lecture 159Case Study - Omissions of CPPs in PVR | Case insight, explanation, action plan | Correlations - CPPs - CQAs - IPCs
Lecture 160Supplemental New Drug Application (sNDA) | Filing and Submission Management | Requirements | Best Practices | Different Forms for sNDA submissions
Lecture 161BA BE Study Design | Comparing different types of the study design
Lecture 1622wco Study Design | Design Table | Importance
Lecture 1633wco Study Design | Design Table | Importance
Lecture 164FRCO Study Design | Design Table | Importance
Lecture 165Parallel Vs. Crossover Study Design
Lecture 166OGD Table - How to Prepare | Sample Tabular Summary Preparation
Lecture 167Impact Assessment in CMC Writing | Case Based Discussion| Scenario Decision Making
Lecture 168RfR in Generic Drug Approval | Overview, Process, and Best Practices
Section 6Quality issues, Warning Letter, CAPA and Data Integrity
Lecture 169Data Integrity issues in Pharmaceutical Industry
Lecture 170Establishment Inspection Report | 483 Observations | USFDA Warning Letter | Handling of FDA inspection | Closing of Warning Letter
Lecture 171Electronic Batch Record for effective compliance management | Key Understanding | Functionalities | Importance in managing data integrity
Lecture 172RTQs | Response to Queries | How to handle Regulatory Queries
Section 7Biopharmaceutical (Biologics and Biosimilar) Regulations
Lecture 173Introduction of Biologics
Lecture 174Classification of Biopharmaceutical | Global Biologics Market – By Product | By Therapeutic Class | By Region
Lecture 175Introduction to Biologics and Biosimilar | Key differences | Concept of Reference Product
Lecture 176Differences in Chemical Drug Vs. Biologic Drugs | Key features of Biologic
Lecture 177Principle of Naming of Biologic | Understanding on MAB naming system
Lecture 178Recombinant protein
Lecture 179Monoclonal Antibodies Vs. Polyclonal Antibodies
Lecture 180Monoclonal Antibodies
Lecture 181Synthetic Immunomodulators
Lecture 182Production of Monoclonal Antibodies
Lecture 183Cytokines
Lecture 184Interferon
Lecture 185Erythropoiesis-stimulating agent
Lecture 186Biological Licensing Application (BLA) | 351(a) application | Form 356h | Differentiation with NDA | Timeline | Handling FDA queries
Lecture 187Abbreviated Biosimilar Application - 351(k): Advance Strategic Planning Process : Originator Vs. Biosimilar Development and Regulatory Approval Process | Reference Biologic | Purple Book | Data Requirements
Lecture 188Purple Book: Significance | Searching | Assignments
Lecture 189Vaccine development and approval Process
Lecture 190PDUFA For Biologics
Lecture 191Biosimilar Development Process
Lecture 192Strategic Consideration for Biosimilar Development
Lecture 193Bio-Manufacturing Process Information
Lecture 194Studies required for approval of biosimilar
Lecture 195Regulatory Requirements for Biosimilar | Stepwise evidence based development | Analytical Similarity | Clinical Study | PKPD study requirements | CMC expectation of Biosimilar
Lecture 196Comparability of Biologics | Different Categories of Comparability | General Principles
Lecture 197CQA (Critical Quality Attribute) and CPP (Critical Process Parameter)
Lecture 198ATMPs | Types and Classification | Regulatory Mechanism
Lecture 199mAB - At a glance
Lecture 200ATMPs - at a glance
Lecture 201CAR-T Therapy | Different Types of CAR-T Therapy | Mechanism of action | Challenges | Brainstorming on Concept of Personalized Medicine | Understanding on marketed formulation
Lecture 202Live Biotherapeutic Products | LBPs | Class | Mechanism | Indication Positioning | Regulatory Requirements for LBPs
Lecture 203Regulatory Requirements for Biosimilar | Stepwise evidence based development | Analytical Similarity | Clinical Study | PKPD study requirements | CMC expectation of Biosimilar
Section 8European Drug Regulatory Affairs
Lecture 204Introduction to EU Market Access Planning
Lecture 205EU Regulatory System Fundamentals
Lecture 206Introduction to EU Regulation
Lecture 207Orientation to European Countries and National Regulatory Bodies
Lecture 208EMA and EMA Authorisation Process
Lecture 209EU Regulatory Pathways | Decision Flow | Complexity Breakdown | Pathway Simulation | Mistake to avoid
Lecture 210Centralised vs DCP vs MRP vs National Procedure - Detailed Strategic Insight
Lecture 211EU MA Application Types and Strategic Planning
Lecture 212EU MA Procedure - Centralised, Decentralised, Mutual Recognition, National Procedure
Lecture 213EU Legal Basis Guide
Lecture 214EU MA Strategic Planning: Full, Full-mixed, hybrid applications. Generic, Similar biologic application pathway, Well-established use application, Fixed combination application, Informed consent application
Lecture 215Validity of the EU MA - Renewal steps, Cessation of the marketing authorisation, Significance of "Placed in Union Market", Suspension or withdrawal & EU MA for licensed products
Lecture 216Structured Practical understanding of EU legal bases | Understanding Data Requirements
Lecture 217Practical understanding of EU legal bases for Marketing Authorisation Applications (MAA) | Decision Tree
Lecture 218Centralised Procedure Timetable and Review Logic
Lecture 219DCP / MRP / National Procedure – Practical Workflow Module
Lecture 220EU Drug Approval System - Simulation | Case Based Discussion
Lecture 221EU Procedures Critical Operational Steps - Validation • Clock-Stop • List of Questions • Approval • National Phase
Lecture 222DCP vs MRP Timeline
Lecture 223Clock Stop and LOQ Response
Lecture 224EU Adaptive Pathway
Lecture 225SPOR - Concept of Master Data Management
Lecture 226The 'sunset clause' for marketing authorisation of pharmaceuticals
Lecture 227LoQ Response Strategy - EU Regulatory Procedures (CP / DCP / MRP) – Winning the Day 120 / Mid-Cycle Response
Lecture 228Response to list of Questions (LoQ)
Lecture 229Response to list of outstanding issues (LoOI) - Day 180 / Final Assessment Phase Response
Lecture 230Oral Explanation Training Module - CHMP / CMDh Oral Defence Strategy – From Data to Approval
Lecture 231CHMP - Question Bank Real-Life Regulatory Questions + Model Answers (CP / DCP / MRP)
Lecture 232Conditional marketing authorisation | Marketing authorisation under exceptional circumstances
Lecture 233Compassionate Use
Lecture 234EU Prime Designation
Lecture 235Accelerated assessment by EMEA
Lecture 236Certificate of Suitability (CEP) | Significance | Importance | Understanding Regulatory Compliance and Submission Process | Walkthrough
Lecture 237Policy 0070 | RPDP Submission and Management timeline | Anonymisation Report (AnR) - Significance | AnR in FRDP
Lecture 238Mastering CTIS & CTR | CTIS Operating Model | Part I & Part II | 4 Country Simulation | Timeline
Lecture 239Decoding EU CTA | Strategic Guide to Structuring Managing and Derisking CTA
Lecture 240Comprehensive EU Clinical Trial Regulatory Affairs – CTA, CTIS, Strategy & Execution Password: 5402 Password: 2349
Lecture 241EU Clinical Trial Application - Master Blueprint & Local Permits
Lecture 242CTIS Operating Model – Advanced EUClinical Trial Execution Module
Lecture 243CTIS Operating Model - Advanced Execution for EU Clinical Trials
Lecture 244The EU CITIS CTR Operation Blueprint | Strategy Submission and Lifecycle Control
Lecture 245CTA Structure: Part I / Part II (EU Clinical Trials Regulation)
Lecture 246Winning the Country | CTIS Part II Execution Playbook
Lecture 247Country-wise Part II Requirement Master
Lecture 248CTIS Hands-on Simulation Module Step-by-Step Clinical Trial Submission Exercise (CTR Execution Training)
Lecture 249EU CTR Advanced Module - Substantial Modifications, Safety Reporting, Transition Lessons & End-of-Trial Obligation
Lecture 250IMPD | Significance | Format of IMPD | Differences with CTA, IB, IND
Lecture 251Investigator’s Brochure | Significance | Format of IB | Preparing different sections of IB
Lecture 252EU Patent Landscape | Market Access Equation | EU IP Traps | Plotting FTO Paths | Biologic FTO Risks
Lecture 253Patent Landscape & Freedom to Operate (FTO) – EU Perspective - Strategic Regulatory + IP Integration Module (Drugs & Biologics)
Lecture 254EU Data Exclusivity, Market Protection & Orphan Exclusivity
Lecture 255Data Exclusivity and Market Protection - Supplementary Patent Protection, Exclusivity, 6/10 Rule, 8+2+1 Formulae
Lecture 256EU Orphan Medicinal Products Regulation
Lecture 257Paediatric use marketing authorisation (PUMA) & Paediatric Investigation Plan (PIP)
Lecture 258EU Supplementary Protection Certificates (SPC) & Paediatric Rewards
Lecture 259Patent vs Regulatory Exclusivity vs Trademark vs Launch Sequencing (EU Perspective)
Lecture 260“No EU-Style Patent Linkage” – What It Really Means (EU vs US)
Lecture 261EU vs US Regulatory–IP Framework
Lecture 262Global Patent + Exclusivity Timeline Dashboard - Executive-Level Strategic Tool (EU + US + Global Integration)
Lecture 263Full EU Submission Strategy Planner
Lecture 264Navigating EU Market Entry | Aligning Patent Regulatory Trademark and Commercial Sequencing Strategies
Lecture 265EU Market Access Entry | The IP and Regulatory Blueprint | Strategic Playbook for Patent FTO and Launch Timing Alignment
Lecture 266EU Variation Management | Grouping Strategy | Executing Work sharing | Mitigation Risk
Lecture 267Variation Classification | Basis of Classification | US and EU Variation Classification | Other region variation guideline
Lecture 268EU variation -Types, Requirement & Planning - IA, IAIN, IB, II ; US FDA Variation AR, CBE-0, CBE-30, PAS - Strategic Discussion | Similarities & Differentiation
Lecture 269EU Post Approval Variations Legal Framework
Lecture 270Identify EU Reference Product | Three Reference Anchor | Logic By Application Types | Selection Method | Reference Strategy
Section 9ASEAN Drug Regulatory Affairs
Lecture 271Introduction to ASEAN - Drug Regulatory Affairs
Lecture 272ASEAN Countries | Introduction | Geographical Overview
Lecture 273ASEAN countries drug regulatory bodies
Lecture 274ASEAN Common Technical Requirements (ACTRs)
Lecture 275The Pharmaceutical Inspection Co-operation Scheme
Lecture 276CPP Requirements for Drug Registration in ASEAN countries
Lecture 277Dossier Requirements - ACTD/CTD Acceptability
Lecture 278Pharmacopoeias Acceptability
Lecture 279Harmonization of Technical Guidelines
Lecture 280Stability Study requirements for drug registration in ASEAN countries
Lecture 281Guideline on product labelling
Lecture 282Post Approval Changes (Variations) requirements in ASEAN countries
Lecture 283Pharmacovigilance and Risk Management Plan (RMP)
Lecture 284Timeline of Drug Registration Approval
Lecture 285ASEAN Drug Regulations : Comparison Study | Guidelines | Pharmaceutical products Regulatory Submissions | Pharmacopoeia Requirements | stability requirements | Pharmacovigilance | Product labeling | Drug variation information
Lecture 286Drug Registration and Regulation Singapore | Strategic Pathways for Marketing Authorization | Screening, Evaluation of MA applications | Variations Classifications and Management
Lecture 287Drug Registration and Regulation in Brunei
Lecture 288Drug Registration and Regulation in Cambodia
Section 10African Drug Regulatory Affairs
Lecture 289African Continent Overview - Brief introduction to course
Lecture 290African Pharma Market
Lecture 291Drug Registration - African medicines regulatory agencies
Lecture 292Basic Export Requirement for African Countries
Lecture 293Export Documentations & Important Concepts
Lecture 294Drug Registration and Regulation in Nigeria
Lecture 295Drug Registration in Algeria
Lecture 296Drug Registration in Ethiopia
Lecture 297Drug Registration in Kenya
Lecture 298Drug Registration in Egypt
Lecture 299Drug Registration in Ghana
Lecture 300Drug Registration in Botswana
Lecture 301Drug Registration and Regulation in Uganda
Lecture 302Drug Registration in Zambia
Section 11Latam Regulatory Affairs
Lecture 303Introduction to Latam
Lecture 304Drug Registration and Regulation in Argentina
Lecture 305Drug Registration and Regulation in Bolivia
Lecture 306Drug Registration and Regulation in Brazil
Lecture 307Drug Registration and Regulation in CHILE
Lecture 308Drug Registration and Regulation in Colombia
Lecture 309Drug Registration and Regulation in Mexico
Lecture 310Drug regulation and registration in El Salvador
Lecture 311Central America Drug Regulatory Affairs | Panama, Costa Rica, Guatemala, El Salvador, Honduras, Dominican Republic | RTCA guideline [2022]
Section 12Middle East and GCC Drug Regulatory Affairs
Lecture 312Middle East / MENA / GCC Countries Geographical Orientation
Lecture 313Middle East / MENA / GCC Countries National Regulatory Agencies
Lecture 314GCC Registration Procedure - Centralized and Decentralized Procedure | Detailed understanding on Centralized Registration Process
Lecture 315Drug Registration in Saudi Arabia
Lecture 316Drug Registration in Kuwait
Lecture 317Drug Registration and Regulatory Strategic Planning for Iran
Lecture 318Drug Registration and Regulatory Strategic Planning for Israel
Lecture 319Drug Registration and Regulatory Strategic Planning for Jordan
Lecture 320Drug Registration and Regulatory Strategic Planning for Iraq
Section 13China Drug Regulatory Affairs
Lecture 321Drug Registration and Regulation in China
Lecture 322China NMPA New Regulation Update July, 2020
Section 14Russia Drug Regulatory Affairs
Lecture 323Drug Registration and Submission Strategic Planning for Russia and EAEU region
Lecture 324GMP requirements in Russia
Section 15References | Discussions
Lecture 325Comparison of Requirement of Various Regulatory Bodies
Lecture 326Comparison of Dossier Requirements of Europe and US
Lecture 327Comparison of DMF requirement of various regulatory bodies
Lecture 328ICH CTD Top Level View with Notes and Explanation
Lecture 329ICH CTD Top Level View with Note and Explnation
Lecture 330Comparison of ICH US EU CTD
Lecture 331Regulatory Documents at a glance
Lecture 332Structured CMC Writing Checklist
Lecture 333Comparison of 505J 505b1 and 505b2 Pathway
Lecture 334New Update in Form 356h
Section 16Drug Registration and Regulation in Japan
Lecture 335Introduction to Japan Drug Regulatory Affairs
Lecture 336Drug Discovery Development to commercialization | PMDA functions | Consultation | Premarket to post market approval
Lecture 337Drug Approval System | GCP | PMDA requirements
Lecture 338New Drug Application | Requirements | Review Process
Lecture 339Generic Drug Application Review and Approval
Lecture 340Marketing Authorization Process for registration of pharmaceutical in Japan
Lecture 341API Registration in Japan | Step By Step Process
Lecture 342Generic Registration | Patent - Patent Term Extension | Exclusivity | Re-examination System | Pediatric Designation | Patent Term Extension Case Studies
Lecture 343Priority Review Application | Criteria | Review Process | Timeline
Lecture 344Orphan Drug Designation in Japan
Lecture 345Japan DMF System | MF filing Process | Key points
Lecture 346Strategic Approval Pathway - Formulation Approval Quoting MF
Lecture 347SAKIGAKE designation
Section 17Drug Registration in India
Lecture 348Import Export of Pharmaceuticals from India
Lecture 349Medicine Export Criteria from India
Lecture 350Documents for conducting BE Study for Export
Lecture 351New Drug Approval in DCGI
Lecture 352Line Extension New Strength Approval
Section 18US MEDICAL DEVICES | Development to Commercialization Cycle
Lecture 353Overview of US Medical Devices Market
Lecture 354Definition of Medical Devices
Lecture 355Classification of Medical Devices
Lecture 356Medical Devices Classification : Work File
Lecture 357Medical Device Development to Commercialization Process | Understanding Key Stages and respective stage level activities | Important MDR terminologies
Lecture 358How to establish the classification of the medical device
Lecture 359FDA Product Code Database : Hands on Training
Lecture 360513(g) Application : Request, User Fees, Review Process
Section 19510K PRE-MARKET NOTIFICATION
Lecture 361510k - Pre-market Notification
Lecture 362Predicate Devices | Substantially Equivalent (SE)
Lecture 363Understanding on 510k | Types of the 510k | Timeline | Difference with PMA
Lecture 364FDA decision making process for different classes of 510k applications
Lecture 365Review Test
Section 20PREMARKET APPROVAL (PMA) APPLICATION
Lecture 366Premarket approval (PMA) application
Lecture 367Differences between 510k VS. PMA
Lecture 368Data Requirements for A Premarket Approval (PMA) application
Lecture 369Data Requirements for A Premarket Approval (PMA) application
Lecture 370PMA Post Submission - Management of CRL - Timeline and Strategic Planning
Lecture 371Labeling Requirement for Medical Devices
Lecture 372Investigational Device Exemption | Device Clinical Research | Early/Expanded Access of Medical Devices | Q-Sub | IDE Submission Requirements
Lecture 373Medical Devices Development to Commercialization Stages | Devices Clinical Trial | Stages | Critical differences with pharmaceutical clinical trial
Lecture 374Medical Devices Post Approval Variations | PMA supplement | PMA amendments | Variation Management Strategic Planning
Lecture 375Expedited review of devices
Lecture 376Expiration Dating
Lecture 377Device Master Files
Lecture 378Unapproved use of Medical Devices
Lecture 379Marketing, Advertising and Promotion of Medical Devices
Lecture 380FDA 513(g)
Lecture 381DeNovo Petition - Types of DeNovo Pathways | Details of Review Process | Strategic Planning
Lecture 382Humanitarian Device Exemption (HDE)
Section 21EU Regulation of Medical Devices
Lecture 383EU MDR Classification
Lecture 384EU MDD | EU MDR | Articles | Rules | Pages | Annex | Key Changes in EU MDR
Lecture 385EU MDR | Annexes | Key notes
Lecture 386EU Medical Device Regulation System | MDR | IVDR | UDI | EUDAMED | Requirements for manufacturer | Importer | Distributor | Declaration of Conformity (DoC)
Lecture 387EU MDR Guideline | EU MDR - Annexes
Lecture 388EU MDR Conformity Assessment procedure | Assessment of various classes and types of the devices | Key points to consider | Conformity assessment master chart
Lecture 389EU MDR Authorized Representatives | Mandate | Role and Responsibilities
Lecture 390EU MDR Compliance Process
Lecture 391Thumb Rules of Classification as per EU MDR Guideline | Invasive | Non-invasive | Active | Special Devices
Lecture 392Review : DDF DHF DMR MDF DHR
Lecture 393Comprehensive MDR Class-Wise Requirement Matrix
Section 22QMS, Documentation and Dossier Preparation
Lecture 394Medical Device Technical File
Lecture 395Medical Device Dossier Preparation | Section Wise Dossier Preparation | Key Requirements regarding dossier | Points to note regarding each section of the dossier
Lecture 396Quality Risk Management | ICH Q9 | ISO 14971 | Principle of Risk Management
Lecture 397Comparing Medical Device Regulations | 510k Submission | Technical File | Design History File | Design Master File
Lecture 398Medical Device Essential Principle Checklist | Documentation | Open file
Lecture 399Implant Card | Regulatory Importance | Content | How to design
Section 23Medical Device Labeling Guideline | General Principles | Wherever applicable (specific) Labeling contents
Lecture 400Medical Device Labeling Guideline | General Principles | Wherever applicable (specific) Labeling contents
Lecture 401Instruction for Use (IFU) | Design and Development of IFU
Lecture 402UDI | Different Component | How to design
Lecture 403Medical Device Labeling Guideline | General Principles | Wherever applicable (specific) Labeling contents
Section 24CE Marking
Lecture 404CE Marking | Introduction | Self Certification | General principles of the CE marking | Manufacturer Responsibilities | Third Party Medical Device Manufacturing & CE Marking | Step By Step CE Marking Process
Lecture 405CE Certification Readiness Checklist
Lecture 406NB Mock Audit Weighted Scoring Model Aligned with Severity Grading
Lecture 407Notified Body (NB) Audit Defense Documentation Framework
Lecture 408NB Audit Defense Question Bank - Defense Response
Lecture 409Executive CE Risk Heat Map
Lecture 410CE Certification Prime Module
Lecture 411CE Certification Case Studies
Lecture 412CE Self-Certification Vs NB Route Comparison [Royed Training]
Lecture 413CE Route Decision Tree
Section 25ISO 13485
Lecture 414Introduction to ISO 13485 | Importance | Comparison with various other standards
Lecture 415ISO 13485 Documentations | Different Sections | Case Studies
Lecture 416ISO 13485: 2016 - Different Clauses
Section 26Combination Product Regulatory Affairs
Lecture 417Combination Products Regulatory Affairs | Definition | Types | Requirements | cGMP considerations | Risk Management | CAPA
Lecture 418Combination Product RFD Designation Process | Importance | Timeline | Outcome Management
Lecture 419Combination Products Pre-market Approval Process | Lead centers | Concept of Primary Mode of Action | Strategic Submission Pathways
Section 27Medical Device Regulation in India | CDSCO Regulation
Lecture 420Medical Devices Regulation in India | Overall understanding
Lecture 421Regulatory Landscape in India
Lecture 422Classification of the Medical Devices in India | Strategic Planning for the Submission
Lecture 423Notified and Non-notified Device | Submission Strategic Planning
Lecture 424Medical Devices Classification in India - Work Doc
Lecture 425Notified Devices | Registration Process
Lecture 426Medical Device Submission Strategic Pathways | Step by step Process
Lecture 427Medical Device Forms | Purposes
Lecture 428Non Regulatory Medical Devices
Lecture 429Medical Device Voluntary Registration | Documentation | Process
Lecture 430List of Notified Devices | Newly Notified Devices | Significance
Lecture 431List of Notified Bodies with CDSCO
Section 28Medical Devices Regulation in Asian Countries - UAE, Bangladesh, Bahrain, Indonesia, China, India, Iran, Jordan, Japan, Kuwait, Korea, Lebanon, Malaysia, Pakistan, Philippines, Saudi Arabia, Singapore, Vietnam
Section 29Medical Devices Regulation in Latam Countries: Argentina, Brazil, Colombia, Chile, Mexico, Paraguay, Uruguay
Section 30Medical Devices Regulation in African Countries: Algeria, Kenya, Nigeria, South Africa, Egypt
Lecture 434Medical Devices Regulation in African Countries: Algeria, Kenya, Nigeria, South Africa, Egypt
Lecture 435South Africa Medical Device Regulation
Lecture 436Egypt Medical Device Regulation
Lecture 437Kenya Medical Device Regulation
Lecture 438Nigeria Medical Device Regulation
Section 31MDSAP Training
Lecture 439Introduction to MDSAP | Objective | Significance | Role and responsibilities of stakeholders | Key benefits | MDSAP Process structure and Audit Tasks
Lecture 440QMS and MDSAP | Differences and Similarities | MDSAP Vs. ISO 13485 : Key objectives and differences
Lecture 441MDSAP Stakeholders
Lecture 442MDSAP Process Structure Audit Task
Lecture 443MDSAP Document Preparation
Section 32Food and Dietary Supplement Regulatory Affairs
Lecture 444Introduction to Food Regulations
Lecture 445Certifications for Food Business | Understanding on various types of certification
Lecture 446Regulatory Affairs functions in food business
Lecture 447New Food Product Development | Food Commercialization Process | NPD and Regulatory Activities
Lecture 448Introduction to Food Hygiene and Safety
Lecture 449Food | Definition| Classification| Unsafe and Hazardous foods
Lecture 450Principle of Safe Food Preparation
Lecture 451Food Control | Important Principles | Component of food control system | Responsibility for food controls | HACCP
Lecture 452Food Law | Overview of EU regulations
Lecture 453Dietary Supplements and Regulations | Premarket activities | labeling requirements | Claims, Approval requirements | Manufacturing Requirements
Lecture 454Introduction to Nutraceutical | Functional Food | Dietary Supplement | Health Food | Regulation and Approval Process
Lecture 455Dietary Supplement Vs. Nutraceuticals | Analysis of terms
Lecture 456Nutraceutical Product Classification | Nutraceutical Product Portfolio Management
Lecture 457Dietary Supplement (DS) | Nutraceutical | NHPs | Functional Food | Phytochemicals | Multivitamin - Mineral Supplement - Differentiations, Similarities, Regulation requirement assessment
Lecture 458Dietary Supplement Products & Ingredients | New Dietary Ingredients (NDIs)
Lecture 459NDIs Premarket notification
Lecture 460Case Studies - NDI designation Process
Lecture 461NDI – Notification Requirements and Adulteration Standard
Lecture 462Developing Safety Profile for New Dietary Ingredient | Dietary Supplement Safety Narratives | common error about margin of safety in NDI notifications
Lecture 463NOEL | NOAEL
Lecture 464Safety Factor Determination based on Animal Toxicity Study
Lecture 465Margin of Safety | Safety factor | Safety Discussion in NDI notification | EDI | ADI | Calculation | Case Studies
Lecture 466NDI notification and generally recognized as safe (GRAS)
Lecture 467NDIN Dossier | Notification Documentation | Different Sections
Lecture 468NDIN Safety Information Package | Documentation | Different Sections | Templates
Lecture 469FDA response to NDIN | Post submission action plan
Lecture 470NDIN Case Studies and Discussion
Lecture 471NDIN Master File
Lecture 472Food Product - Risk Management - Introduction
Lecture 473ISO and ISO Audits
Lecture 474BRCGS Certifications
Lecture 475ISO 22000
Lecture 476FSSC 22000
Lecture 477PrimusGFS
Lecture 478NON GMO
Lecture 479The Plant-Based Certification Program - PBS
Lecture 480HALAL Certifications
Lecture 481Other quality Certfiications for Food Businesses
Lecture 482Food Dossier Compilation
Lecture 483Detailed Understanding on Food Labeling | Parts of Labels | EU Regulations
Lecture 484Nutrition Fact Labels | Sections of the Labels | Update as per new label guidelines
Lecture 485Label Claims for conventional food and dietary supplement
Lecture 486Food Label | PDP | Information Panel designing | Compliance from Regulatory Perspective
Lecture 487Net Quantity of content statement
Lecture 488Expiration Dating | Best Before | Use By | Sell By Dates
Lecture 489Gluten Free Labeling of the food | Rules | Claim Establishment
Lecture 490Traffic Light Labels | How to design | Reference Intake
Lecture 491Daily Value (DV) | % Daily Value (% DV)
Lecture 492Stability Study of Processed Food
Lecture 493Health Supplement - Stability Study | Study Design - Batch Selection | Testing Frequency | Reduced Batches | Storage Condition | Container Closure System
Section 33Cosmetic Regulation and Submission Management
Lecture 494Cosmetic Global Legal Perspective | Concepts | Understanding definition | Classification System | Boderline Evaluation
Lecture 495Cosmetic Boderline Determination Classification | Misclassification | Reclassification
Lecture 496Cosmetic Risk Philosophy | Risk Structuring | Product Safety Responsibility Model | Practical Case Analysis
Lecture 497Simulation - Risk Based Regulatory System for Cosmetics
Lecture 498Risk-based safety classification table for cosmetic product types (RA working model)
Lecture 499Risk-Based Cosmetic Safety Classification & RA Intake Template
Lecture 500Brainstorming Session : Claim Reframing in Cosmetic Regulatory Affairs
Lecture 501Claim Reframing Matrix
Lecture 502Case Study : Reclassification of a Skin Brightening Serum
Lecture 503How Marketing Claims Trigger Reclassification
Lecture 504EU Cosmetic Regulation | Framework | CPNP | PIF | CPSP
Lecture 505CPNP Pathway & Framework
Lecture 506PIF Documentation | Sectionwise understanding
Lecture 507EU Product Information File (PIF) - Master Template Structure
Lecture 508EINECS Number | ELINCS Number | EC Number
Lecture 509CAS Number | Importance in Sourcing | Case study
Lecture 510NLP Number | Cosmetic Identifier Strategic Significance
Lecture 511REACH Compliance Verification
Lecture 512Cosmetic Product Safety Report (CPSR) : Writing Guidance Module
Lecture 513Sample CPSR | MOS Calculation
Lecture 514Annex II - Detailed Regulatory Understanding
Lecture 515Annex II Categorization
Lecture 516Detailed understanding on Annex III
Lecture 517Annex III Master List
Lecture 518Colorant in Cosmetic Formulation | Annex IV
Lecture 519CI Numbers – Detailed Regulatory Understanding
Lecture 520Annex IV Master CI
Lecture 521Preservative in Cosmetic Formulation
Lecture 522Preservative Annex V Master List
Lecture 523Annex VI – UV Filters | Classification of UV Filters | Strategic Regulatory Considerations
Lecture 524UV Filters Master List | Annex VI Positive List
Lecture 525Simulation : Sunscreen Regulatory Evaluation Simulation
Lecture 526EU Cosmetic Regulation - Review Test
Lecture 527EU Cosmetic Regulation - Case Studies
Lecture 528Introduction to US Cosmetic Regulation
Lecture 529Voluntary Cosmetic Registration Program (VCRP)
Lecture 530VCRP Filing Process and Checklist | Checklist for FDA VCRP Registration and Product Filing Process
Lecture 531Modernization of Cosmetics Regulation Act (MoCRA)
Lecture 532Transitioning from MoCRA to VCRP
Lecture 533MoCRA Exemptions | Exemption Calculation | Exemption templates | Scenario based case studies | Declaration | Open format Template
Lecture 534MoCRA Compliance Checklist
Lecture 535MoCRA Advanced Case Study | Regulatory Strategic Planning
Lecture 536MoCRA Regulation Decision Tree | Action Plans
Lecture 537MoCRA Case Based Assignment
Lecture 538MoCRA Forms
Lecture 539Global Cosmetic Regulation - Review Test 1
Lecture 540US Cosmetic Regulation - At A Glance | Compliance Snapshots
Lecture 541Strategic Pathway for US Cosmetic Formulation Market Access
Lecture 542Cosmetic vs Drug Claim - Decision Tree
Lecture 543US Cosmetic vs OTC Drug Claim Risk Scoring Matrix
Lecture 544Cosmetic Claim Rewriting Guide
Section 34Introduction to Artificial Intelligence (AI) in Regulatory Affairs
Lecture 545Introduction to AI
Lecture 546Basics of AI ML DL | Key Differences | Application in industry
Lecture 547Types of AI
Lecture 548AI Project | Overview
Lecture 549Comprehensive Training on AI Project | Managing Stages | AI Iteration
Lecture 550How machine learning
Lecture 551Understanding Regulatory Affairs – Traditional vs. Digital | 2 Case Study
Lecture 552Basics of AI for Regulatory Professionals | Understanding different models used in RA | Case Study | Simulation
Lecture 553AI Application across drug life cycle | Case Analysis | Model predictions
Lecture 554AI Terms with Regulatory Significance | Regulatory Applications
Lecture 555NLP in Regulatory Affairs | Conceptual understanding | Usage | NLP in Labeling
Lecture 556Data Grouping with Unsupervised Learning | Case Simulation | Hands on Exercise
Lecture 557Quality Data and Bias | Bias in datasets | Different Types of Bias in Pharma Datasets
Lecture 558AI Data Quality Standard | Checklist
Lecture 559Download AI Data Quality Checklist
Lecture 560Case Study: Accelerated Approval Using Real-World Evidence AI
Lecture 561AI Model for Dossier Submission and Filing - Model Selection | Simulation
Lecture 562AI Technologies in RA
Lecture 563Structured Vs. Unstructured Data | Practical Understanding | Explore Patient Datasets
Lecture 564Sample Data Exercise | Data error | Data Refinement and Cleaning of the data
Section 35AI in Regulatory Authoring and CMC Writing
Lecture 565AI-Powered Regulatory Document Authoring and CMC Writing
Lecture 566AI Tools Comparison - Authoring and CMC Writing (Module 2 & 3)
Lecture 567Tips for Selecting AI Tools (CMC Authoring)
Lecture 568CMC - AI Workflow Checklist | Simulation Based Cases
Lecture 569HITL Regulatory Document Authoring
Lecture 570Confidence Score in Regulatory Authoring | Case Simulation in CMC Authoring
Lecture 571Confidence Scores in Data Extract in Regulatory Writing [Case Simulation]
Section 36eCTD v4.0 Training
Lecture 572eCTDV4.0 Fundamental Understanding | Structures | Key Features
Lecture 573eCTDV4.0 Structure | Lifecycle Management
Lecture 574eCTD Validation | Managing Validation | Tool Types | Types of Error | Validation Error Management
Lecture 575eCTD Validation Tools
Lecture 576eCTD Publishing Cycle
Lecture 577HL7 - Structure and Understanding in the context of eCTD V4.0
Lecture 578Tips and Submission Readiness Checklist
Lecture 579eCTD Submission Checklist Format
Lecture 580Regulatory Publishing Document Control Challenges
Lecture 581Document Control Checklist
Lecture 582Leaf Structure Analysis | Common Error in Leaf Structuring
Lecture 583Formatting Rules Templated and Agency Specification
Lecture 584Versioning for Regulatory Publishing
Lecture 585File Naming Standard
Lecture 586Text Recognition and Optical Character Recognition (OCR)
Lecture 587Versioning File Naming OCR - How they work together
Lecture 588Final Document Assembly
Lecture 589Visual Diagram : eCTD Structure and XML Hierarchy
Lecture 590TOC and CI Management
Lecture 591Initial Submission & Maintenance Submission
Lecture 592Managing Lifecycle Operators - NEW REPLACE DELETE APPEND
Lecture 593eCTD Dossier Lifecycle - Multi Sequence View
Lecture 59410 Year eCTD Lifecycle : Sequence Evolution Diagram
Lecture 595Global Decision Tree - Classifying Post Approval Changes
Lecture 596eCTD Technical Validation | Typical issues | Resolutions
Lecture 597eCTD Validation Readiness Checklist
Lecture 598QC Checklist Design and Pre Submission Review
Lecture 599Submission Gateway | FDA ESG • EMA CESP • Health Canada Portal • PMDA Gateway
Lecture 600Regulatory Publishing Simulation
Lecture 601Pre-Gateway Submission Review Checklist | Post Submission Confirmation
Section 37AI and Data Integrity
Lecture 602AI and Data Integrity | Regulatory Documentation | Case Based Learning | Understanding Data Integrity Principles | Application and Use Cases
Lecture 603Cases of data breaches with explanation
Lecture 604Case Based Discussion : Data Breach in AI-Assisted CMC Drafting
Section 38Regulatory Labelling Artwork and CCDS Management
Lecture 605CCDS Management
Lecture 606CCDS Management Tools - Native, AI Plus | Key Functionalities
Lecture 607AI Augmented Labelling Compliance System
Lecture 608Label Drift in CCDS Management | Simulation Case Study | AI Based Workflow in Label Drift detection and management
Lecture 609AI Review of Labels, PI and SMPC with help of the Case Based Simulation | 4 Case Simulations
Lecture 610CCDS Management Case Study | Pregnancy Warning Upgrade Case Study
Lecture 611CCDS Management Case Study | Dosage Section Conflict | Case Based Analysis
Lecture 612Centralized Artwork Operation | Mechanism | Operation Step Planning
Lecture 613Case Study on Centralized Artwork Operation [Recall Management]
Lecture 614Artwork Management Terms | Key Understanding on Terminologies | Usage in Artwork Cases
Lecture 615Introduction to Labelling | Regulatory vs Commercial Perspective of Labelling | Labelling Compliance Function
Lecture 616Artwork & Packaging Lifecycle | Artwork Management Lifecycle Workflow
Lecture 617Global Artwork Labelling Framework | 5 Case Simulation
Lecture 618Country-Specific Labelling Requirements
Lecture 619Summary of Product Characteristics (SmPC)
Lecture 620Patient Information Leaflet (PIL)
Lecture 621Summary of Product Characteristics (SmPC) – Review Checklist
Lecture 622Patient Information Leaflet (PIL) – Review Checklist
Lecture 623US Prescribing Information (PI) | Differences with EU SmPC
Lecture 624US Prescribing Information (PI) - Review Checklist
Lecture 625Fundamental Understanding on Medication Guide
Lecture 626Regulatory Decision Flow: When Is a Medication Guide Required? - Step Based Decision Making
Lecture 627Medication Guide - Review Checklist | Inspection Checklist
Lecture 628PI Vs. Medication Guide Comparison
Lecture 629Patient Information Leaflet (PIL) vs Medication Guide
Lecture 630Label Components | Key considerations for effective designing of label
Lecture 631Label Review Checklist
Lecture 632Pharmaceutical Artwork Design Specification Worksheet - Complete Tracker
Lecture 633Color Proofing, Dielines & Version Control
Lecture 634CDR File - Monocarton | Outercarton | Keyline | Design Parameters
Lecture 635Injection Labels - Labels and Cartons
Lecture 636Various Design Component Placement Understanding (Injectables)
Lecture 637Concept of Logo File | Open and Curve File Importance
Lecture 638QC and Proof Reading in Labelling and Artwork
Lecture 639QC and Proofreading Checklist
Lecture 640Template Management and Creative Brief
Lecture 641Pre approval Labelling | ANDA Labelling | ANDA Labelling
Lecture 642Post approval Labelling | PAS | CBE-30 | Annual Reportable Changes
Lecture 643Decision Tree - PAS CBE-0 CBE-30 Annual Reportable Change Determination
Lecture 644Bulk Pack Labelling
Lecture 645Bulk Pack Labelling Checklist
Lecture 646OTC vs Prescription Labelling | Claim Limitations & Consumer Safety Requirements
Lecture 647OTC vs Prescription (Rx) Label Checklist
Lecture 648OTC Approval Matrix
Lecture 649OTC Claim Risk Scoring System
Section 39 Real World Evidence and Real World Data | Strategic Regulatory Decision Making
Lecture 650Evidence Based Decision Making | Combine evidences for decision making | Do we need more evidence?
Lecture 651RWD and RWE | Potential sources of RWE | Traditional RCTs vs. RWE | Case Study - RWE Programs | Influencing HCP decision-making
Lecture 652RWD and RWE in Product Lifecycle Management
Lecture 653RWD and RWE - Fit to use | Assessment
Lecture 654RWD data sources | Different types | Detailed understanding of each class
Lecture 655RWD Study Design
Lecture 656RWE Published Tool | Insights on commonly used tools
Lecture 657Healthcare Reimbursement Models : Value Based Care | Fee for Service (FFS) Model | Other Reimbursement Models
Lecture 658Consensus Narrative Review
Lecture 659Electronic Patient Data | EMR | EHR | Differences | Software architecture and characteristics
Lecture 660Active Surveillance Schemes | Active Case Finding |Sentinel Surveillance | Cohort Studies | Vaccine Safety Surveillance | Pharmacovigilance Programs | Disease Registries |Event Monitoring
Lecture 661RWD Characteristics
Lecture 662RCT vs. RWE Comparison | Case Based Analysis
Lecture 663RCT and RWE Comparison
Lecture 664Introduction to Healthcare Datasets
Lecture 665Dataset 1: Claims Data (Insurance)
Lecture 666Dataset 2: Retail Pharmacy Prescription Data
Lecture 667Dataset 3: Longitudinal Patient Data
Lecture 668Characteristics of Different Set of Healthcare Data
Lecture 669Reimbursement and Pricing Datasets
Lecture 670RWE Data Sources & Quality Considerations Checklist | Case Based Analysis
Lecture 671Triangulation and benchmarking | Enhancing Data Validation Through Cross-Referencing
Lecture 672RWD & RWE Case Database
Lecture 673RWE Large Dataset for Data Crunching Exercises |Data cleaning & preprocessing | Comparative Effectiveness Analysis
Section 40AI Tools, Ethics and Future Landscape
Lecture 674AI Reg Tools - Review | Understanding Capabilities
Lecture 675Regulatory Authority View on AI Adoption
Lecture 676Data Sensitivity | Levels | Consequences | Management
Lecture 677Governance Flowchart – AI Tools in GxP Environments
Section 41AI Tools
Lecture 678RA Example - Generalist Vs. Specialist AI Tools
Lecture 679AI Generalist Overview (Life Science Focus)
Lecture 680Horizontal vs Vertical AI Tools
Lecture 681AI Tool Assessment Test
Lecture 682Citation Verification Workflow | AI Tools Management | Hallucination and HITL Action Plan
Section 42Prompt Engineering
Lecture 683Prompt Engineering – Basic Foundations of Prompt Writing | Different Prompt Framework | Case Based Examples
Lecture 684Special Prompting Structure - Case Based Prompt Designing
Lecture 685Special Prompting Structure - Case Based Prompt Designing
Lecture 686Workflow for writing AI Prompts with Life Science Industry Use Cases
Lecture 687PE Parameters | Controlling Creativity, Accuracy, and Output Behavior for Life-Science Applications | Simulation based decision making
Lecture 688How to adjust the parameters | Techniques
Lecture 689Creating A Detailed Regulatory Prompt | Designing Structured Prompt in Code Editor
Section 43Request for course certificate
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