Introduction
Who should enroll
Course Highlights
Features
Related Courses
Embark on a comprehensive journey through the complex and dynamic world of international drug regulatory affairs with Royed Training’s specialized course. This self-paced online program is meticulously designed to equip you with the essential knowledge and practical skills required to navigate the intricate regulatory landscapes across various global markets.
This Executive PG Certification in International Drug Regulatory Affairs train regulatory professionals for pharmaceutical and biopharmaceutical industry. This comprehensive drug biologic regulatory affairs training involves the real life job simulation. Hence, the course provides practical knowledge. Moreover, this course focuses on how regulatory professionals work in the company. Therefore, it helps users to understand the key responsibilities and job functions.
This course is ideal for executives working professionals. At the same time, we also have well designed PG certification in Drug Regulatory Affairs course which is ideal for the freshers.
In these online self-paced modules, participants understands about the development to commercialization process in detail. In other words, you will understand stages of drugs, biologics discovery, development, investigational application, marketing authorization application, handling of different phases of clinical trial, generic approval process, Abbreviated drugs approval process. Hence, the course covers fundamentals to advance learning on drugs, biologics development, regulation, registration and strategic management processes.
Most importantly, international drug regulatory affairs course covers comprehensive training all regulatory regions like US, EU, GCC, MENA, Middle East, CIS, African, ASEAN, Japan, Russia, China, India and Rest of the World in a single comprehensive training.
Above all, EPGIDA course covers advanced simulation based learning in AI in regulatory affairs and cmc authoring.
EPGiDRA uses advanced, real-life job simulations to help learners master global regulatory strategies and hands-on dossier preparation across all major markets worldwide. Moreover, the program strengthens practical skills in CTD/eCTD submissions, GMP audits, and lifecycle management through interactive, scenario-based learning. As a result, participants gain industry-ready competence in regulatory affairs and CMC-related documentation.
Course Snapshot:
- Course Code: RYD-092
- Title of the course: Executive PG Certification in International Drug Regulatory Affairs (EPGIDRA)
- Duration of the training: 1 Year
- Eligibility : Any body who wants to acquire drug regulatory affairs competency should attend the course.
- 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.
- Certification: Certificate will be provided at the end of the successful completion of the course.
Who Should Enroll:
- Regulatory Affairs Professionals seeking to enhance their global regulatory knowledge and skills.
- Pharmaceutical and Biopharmaceutical Professionals involved in drug development and regulatory submissions.
- Quality Assurance and Compliance Specialists aiming to broaden their regulatory expertise.
- Professionals transitioning into regulatory roles within the pharmaceutical industry.
- Senior Managers working in Business Development, handling global market for pharmaceutical and biopharmaceuticals.
Course Highlights
- Global Regulatory Frameworks: Gain a thorough understanding of regulatory frameworks governing pharmaceutical products in major markets, including the US, EU, Japan, Latam, ASEAN, Africa and other emerging markets.
- Regulatory Submission Process: Master the art of preparing and submitting regulatory dossiers, ensuring compliance with international guidelines and standards.
- Product Lifecycle Management: Learn to manage the regulatory aspects throughout the product lifecycle, from clinical trials and marketing authorization to post-marketing surveillance.
- Strategic Regulatory Planning: Develop strategic regulatory plans to expedite market entry and ensure ongoing compliance, leveraging regulatory intelligence and risk management techniques.
- Case Studies and Real-World Scenarios: Engage with case studies and real-world scenarios to apply your knowledge in practical settings, enhancing your problem-solving and decision-making abilities.
- Interactive Learning Modules: Experience a dynamic learning environment with interactive modules, quizzes, and assignments designed to reinforce your understanding and application of regulatory concepts.
- Expert Guidance: Benefit from insights and guidance from industry experts, ensuring you stay updated with the latest regulatory trends and best practices.
Features of International Drug Regulatory Affairs
- This course covers all aspects of the drug, biologics regulatory affairs in a single course. Hence, user need not to purchase the drugs, and biologics training separately.
- International Drug Regulatory Affairs course covers both formulation and API regulatory affairs. Hence, the user need not to purchase both the course separately.
- EPGIDRA course covers advanced training how to work on marketing authorization pre-submission, submission, post submission stage.
- And most important key feature of the course is “all inclusive marketing authorization submission training”. Hence course covers US, EU, LATAM, Middle East, GCC, ASEAN, Japan, China, India, AU-NZ, ROW regulation. Therefore no need to go for the separate course.
- Above all EPGIDRA course covers hands on training on Dossier Submission Training, CTD, ECTD, DMF, SMF, Variation filing. Moreover exclusive training is provided on CMC section writing, which today is must have skill for any regulatory professionals.
- Hence this 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 registration steps. Hence, participants will develop advanced competency on drugs, biologics strategic planning.
We also have drug, biologic regulatory affairs with medical devices training under same course. Hence, you can learn drug biologic and medical device in a single comprehensive course. Title of the course is Executive PG Certification in Drug Biologic Medical Devices Regulatory Affairs. Click here to view the course details.
Regulatory Affairs Training Courses
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 11Concept of Exploratory 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
Section 2Innovation Management in Pharmaceutical and Biopharmaceutical Organization
Lecture 34General Introduction to intellectual Property Management
Lecture 35Introduction to Intellectual Property in Life Sciences | Types of IP | Introduction to Patent Portfolio Strategy
Lecture 36Introduction to Patent
Lecture 37Global Pharmaceutical Patent Landscape | Strategic Overview of Global Patent Filing and Protection
Lecture 38Understanding on Patent System
Lecture 39Patent Grant and Managing Patent Filing Procedure
Lecture 40Scope of Patentability
Lecture 41Stages of Patent Grant Procedure
Lecture 42Patent search in Indian Patent Office
Lecture 43Global Pharmaceutical Patent Filing Strategy
Lecture 44PCT Patent Filing Flow
Lecture 45Patentability Criteria in Pharmaceuticals | Practical Case Study
Lecture 46Patent Law Framework for Pharmaceuticals
Lecture 47Understanding and Decoding Section 3(d) of the Indian Patent Act | Case Based Analysis
Lecture 48Evergreening vs Genuine Innovation in Pharmaceutical Patents | Evergreening and Genuine Innovation Evaluation
Lecture 49Pharmaceutical Patent Lifecycle - Integrated Layer Strategy
Lecture 50Blockbuster Drug Patent Thicket Strategy
Lecture 51Types of Pharmaceutical Patents | Patent Layering StrategiesTypes of Pharmaceutical Patents
Lecture 52Understanding Patent Searching Process
Lecture 53IPC and CPC - Importance and Significance in Patent Search
Lecture 54IPC Structures for Pharmaceutical Patents
Lecture 55Freedom-to-Operate (FTO) | FTO Risk Assessment | Strategic Management
Lecture 56FTO Decision Tree – Generic Drug Launch Strategy
Lecture 57Fundamental of Pharmaceutical Patent Drafting | Structure | Component | Claim Anatomy | Effective Claim Writing
Lecture 58Pharmaceutical Patent Risk Management Framework
Lecture 59Patent Claim Coverage - Practical Example
Lecture 60Pharmaceutical Patent Filing Procedure and Global Filing Strategy | PCT Filing | Timeline
Lecture 61Advanced Understanding on Patent Opposition and Patent Litigation in Pharmaceutical Domain
Lecture 62Patent Prosecution and Handling Examiner Objections
Lecture 63Pharmaceutical Patent Portfolio Management | How to build and manage pharma patent portfolio
Lecture 64Pharmaceutical Patent Valuation and Licensing
Section 3 Regulatory Strategic Management and planning
Lecture 65Regulatory Strategies in different phases of Clinical Trial
Lecture 66Advance study on Para IV Filing
Lecture 67Para IV Notice
Lecture 68Evergreening - Patent Life Extension Strategies
Lecture 69Pay For Delay Strategy
Lecture 70REMS Strategic Planning
Lecture 71Compulsory Licensing
Lecture 72Licensing & Technology Transfer
Lecture 73In-Licensing Vs. Outlicensing
Lecture 74LOE Strategies for Innovator Brands with case study
Lecture 75Paediatric Exclusivity and Paediatric Study Plan Development
Lecture 76Drug Re-purposing
Lecture 77Practical Queries on different USFDA application and Filing
Lecture 78Publication Management from Regulatory perspective
Lecture 79Juxtapid Case Study
Lecture 80New Indication Approval Process and Promotion
Lecture 81OTC Switch
Section 4Good Manufacturing Practices
Lecture 82Certification Pharmaceutical Companies / Plants
Lecture 83Premises & Plant Layout Designing
Lecture 84Sanitation and Hygiene
Lecture 85Equipment
Lecture 86Production Modules
Lecture 87GMP Documentation
Lecture 88Quality Control
Lecture 89Handling of Product Complaint
Lecture 90GMP Storage
Lecture 91ISO and ISO Audits
Lecture 92Pharmaceutical SOPs
Lecture 93PDE Value | Importance, Significance | How to calculate PDE value
Lecture 94Quality Risk Management | ICH Q9 | ISO 14971 | Principle of Risk Management
Lecture 95Introduction 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 96WHO-GMP Certification Scheme
Lecture 97Template of Certificate of Pharmaceutical product | Key observations and points to note while working on CoPP
Lecture 98WHO Prequalification Status : Significance | Strategic Importance | Submission Process | WHO PQ Documentation | Case study on WHO PQ submission management
Lecture 99WHO EML Vs. WHO PQ | Significance | Importance in Market Access and Regulatory point of view
Section 5 Submission Dossier : CTD | ACTD | DMF - SMF-ANDA | 505(b)(2) | NCE | Petittion| Prior Approval Submission
Lecture 100Common Technical Document (CTD)
Lecture 101CMC Dossier & Compliance Management
Lecture 102Electronic Common Technical Document (ECTD)
Lecture 103Advance Practical Training on Dossier Preparation focusing on drug registration in export countries
Lecture 104Modules on Stability Study : Stability Study - Fundamental Understanding | Interchangebility | Reports | API & FPP Stability Study
Lecture 105Key Consideration for Drug Master File Preparation and Submission
Lecture 106Practical Understanding on Drug Master File Preparation and Submission
Lecture 107Site Master File - Detailed Understanding
Lecture 108DMF Completeness Assessment
Lecture 109Drug Master File - Fees
Lecture 110Drug Master File - Global Perspective [Across Different Regions]
Lecture 111Importance of effective dossier management
Lecture 112Common deficiencies in CTD submission dossier
Lecture 113Certificate of Analysis
Lecture 114Detailed Understanding on ANDA Fees
Lecture 115Prior Approval Submission
Lecture 116Detailed Understanding on ANDA Fees
Lecture 117Detailed Understanding on 505(b)(2) VS. Suitability Petition : Case Based Learning
Lecture 118NCE Vs. 505b2 application - Case Based Learning
Lecture 119FTF - 180 Days Exclusivity - Case Based Learning
Lecture 120Classic case study of the 505b2 filing : Case Based Learning
Lecture 121Strategic Planning in Combating 30 months stay strategies of innovator company- Case Based Learning
Lecture 122Climate Zone and Stability Study Conditions as per ICH Guidelines
Lecture 123Stability Zone Finder
Lecture 124Stability Studies : Case discussions
Lecture 125Case Study: Managing Stability Study for Zone IV countries
Lecture 126Accelerated and intermediate testing conditions
Lecture 127Long Term Stability Testing Requirements
Lecture 128Testing Frequency
Lecture 129Bracketing
Lecture 130Matrixing
Lecture 131PKPD in Drug Discovery | PK-PD trial | Understanding PKPD from regulatory perspective in drug approval process
Lecture 132Bioequivalence Study | Study design | Different types of BE Studies
Lecture 133Bioequivalence 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 134Biopharmaceutical Classification System (BCS) | Types | Biowaivers | BCS tool for drug development and regulatory submission
Lecture 135Bioequivalence Study - Discussion - Timeline of stability study and bioequivalence study
Lecture 136Bioequivalence Study - Discussion - Dissolution Testing
Lecture 137Bioequivalence Study - Generic Approval and Additives Labeling Requirements
Lecture 138Introduction to Variation Management | Reasons for Variation | Working in Variation Department
Lecture 139Variation Classification | Basis of Classification | US and EU Variation Classification | Other region variation guideline
Lecture 140Setting Dissolution Specification for Generic Products | Regulatory Expectations
Lecture 141Regulatory Requirements for Biosimilar | Stepwise evidence based development | Analytical Similarity | Clinical Study | PKPD study requirements | CMC expectation of Biosimilar
Lecture 142CMC Writing Case Study | Successful Documentation
Lecture 143Structure for CMC Writing | Understanding 3.2.S and 3.2.P section | Documents requirements | Case Study
Lecture 144Well written Vs. Poorly Written CMC Section | Practical Example
Lecture 145Drug Substance Section in CMC | Documentations | Practical Examples | Do’s and Don’ts
Lecture 146Example 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 147Stability Studies and Data Presentation in CMC Writing | Case Based Analysis of Stability Study Data Presentation | Interpretation of stability data
Lecture 148Developing Specifications for a New API
Lecture 149Example of Manufacturing Process and Controls
Lecture 150Interpretation of Stability Table
Lecture 151Critical Stability Scenarios | 8 Different Case Studies | Stability Study - Outcome based action plan creation
Lecture 152Critical Stability Issues - Database | Implication | Action Plan
Lecture 153Common Pitfalls in CMC Writing and How to Avoid Them | Case Study
Lecture 154Grouped Submission | Significance | Importance in Market Access and Regulatory point of view | Case Study
Lecture 155Process Validation Report (PVR) | Sample Process Validation Report Analysis | CPPs and CQAs identification
Lecture 156Case Study - Omissions of CPPs in PVR | Case insight, explanation, action plan | Correlations - CPPs - CQAs - IPCs
Lecture 157Supplemental New Drug Application (sNDA) | Filing and Submission Management | Requirements | Best Practices | Different Forms for sNDA submissions
Lecture 158BA BE Study Design | Comparing different types of the study design
Lecture 1592wco Study Design | Design Table | Importance
Lecture 1603wco Study Design | Design Table | Importance
Lecture 161FRCO Study Design | Design Table | Importance
Lecture 162Parallel Vs. Crossover Study Design
Lecture 163OGD Table - How to Prepare | Sample Tabular Summary Preparation
Lecture 164Impact Assessment in CMC Writing | Case Based Discussion| Scenario Decision Making
Lecture 165RfR in Generic Drug Approval | Overview, Process, and Best Practices
Section 6Quality issues, Warning Letter, CAPA and Data Integrity
Lecture 166Data Integrity issues in Pharmaceutical Industry
Lecture 167Establishment Inspection Report | 483 Observations | USFDA Warning Letter | Handling of FDA inspection | Closing of Warning Letter
Lecture 168Electronic Batch Record for effective compliance management | Key Understanding | Functionalities | Importance in managing data integrity
Lecture 169RTQs | Response to Queries | How to handle Regulatory Queries
Section 7Biopharmaceutical (Biologics and Biosimilar) Regulations
Lecture 170Introduction of Biologics
Lecture 171Classification of Biopharmaceutical
Lecture 172Chemical Drugs Vs. Biologic Drugs
Lecture 173Principle of Naming of Biologics
Lecture 174Global Biologics Market – By Product | By Therapeutic Class | By Region
Lecture 175Recombinant protein
Lecture 176Monoclonal Antibodies Vs. Polyclonal Antibodies
Lecture 177Monoclonal Antibodies
Lecture 178Synthetic Immunomodulators
Lecture 179Production of Monoclonal Antibodies
Lecture 180Cytokines
Lecture 181Interferon
Lecture 182Erythropoiesis-stimulating agent
Lecture 183Biological Licensing Application (BLA) | 351(a) application | Form 356h | Differentiation with NDA | Timeline | Handling FDA queries
Lecture 184Abbreviated Biosimilar Application - 351(k): Advance Strategic Planning Process : Originator Vs. Biosimilar Development and Regulatory Approval Process | Reference Biologic | Purple Book | Data Requirements
Lecture 185Purple Book: Significance | Searching | Assignments
Lecture 186Vaccine development and approval Process
Lecture 187PDUFA For Biologics
Lecture 188Biosimilar Development Process
Lecture 189Strategic Consideration for Biosimilar Development
Lecture 190Bio-Manufacturing Process Information
Lecture 191Studies required for approval of biosimilar
Lecture 192Regulatory Requirements for Biosimilar | Stepwise evidence based development | Analytical Similarity | Clinical Study | PKPD study requirements | CMC expectation of Biosimilar
Lecture 193Comparability of Biologics | Different Categories of Comparability | General Principles
Lecture 194CQA (Critical Quality Attribute) and CPP (Critical Process Parameter)
Lecture 195ATMPs | Types and Classification | Regulatory Mechanism
Lecture 196CAR-T Therapy | Different Types of CAR-T Therapy | Mechanism of action | Challenges | Brainstorming on Concept of Personalized Medicine | Understanding on marketed formulation
Lecture 197Live Biotherapeutic Products | LBPs | Class | Mechanism | Indication Positioning | Regulatory Requirements for LBPs
Section 8European Drug Regulatory Affairs
Lecture 198EU Regulatory System Fundamentals
Lecture 199Introduction to EU Regulation
Lecture 200Orientation to European Countries and National Regulatory Bodies
Lecture 201EMA and EMA Authorisation Process
Lecture 202EMA and EMA Authorisation Process
Lecture 203Centralised vs DCP vs MRP vs National Procedure - Detailed Strategic Insight
Lecture 204EU MA Application Types and Strategic Planning
Lecture 205EU MA Procedure - Centralised, Decentralised, Mutual Recognition, National Procedure
Lecture 206EU MA Strategic Planning: Full, Full-mixed, hybrid applications. Generic, Similar biologic application pathway, Well-established use application, Fixed combination application, Informed consent application
Lecture 207Validity 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 208Structured Practical understanding of EU legal bases | Understanding Data Requirements
Lecture 209Practical understanding of EU legal bases for Marketing Authorisation Applications (MAA) | Decision Tree
Lecture 210Centralised Procedure Timetable and Review Logic
Lecture 211DCP / MRP / National Procedure – Practical Workflow Module
Lecture 212EU Procedures Critical Operational Steps - Validation • Clock-Stop • List of Questions • Approval • National Phase
Lecture 213DCP vs MRP Timeline
Lecture 214EU Adaptive Pathway
Lecture 215European public assessment report (EPAR) - Importance, Component, Management, Updation
Lecture 216SPOR - Concept of Master Data Management
Lecture 217The 'sunset clause' for marketing authorisation of pharmaceuticals
Lecture 218LoQ Response Strategy - EU Regulatory Procedures (CP / DCP / MRP) – Winning the Day 120 / Mid-Cycle Response
Lecture 219Response to list of Questions (LoQ)
Lecture 220Response to list of outstanding issues (LoOI) - Day 180 / Final Assessment Phase Response
Lecture 221Oral Explanation Training Module - CHMP / CMDh Oral Defence Strategy – From Data to Approval
Lecture 222CHMP - Question Bank Real-Life Regulatory Questions + Model Answers (CP / DCP / MRP)
Lecture 223Conditional marketing authorisation | Marketing authorisation under exceptional circumstances
Lecture 224Compassionate Use
Lecture 225EU Prime Designation
Lecture 226MHRA - UK Regulation
Lecture 227Summary of Product Characteristics
Lecture 228Drug Registration and Submission Strategic Planning for Russia and EAEU region
Lecture 229Accelerated assessment by EMEA
Lecture 230Certificate of Suitability (CEP) | Significance | Importance | Understanding Regulatory Compliance and Submission Process | Walkthrough
Lecture 231CEP Dossier DMF - Differences
Lecture 232Policy 0070 | RPDP Submission and Management timeline | Anonymisation Report (AnR) - Significance | AnR in FRDP
Lecture 233Comprehensive EU Clinical Trial Regulatory Affairs – CTA, CTIS, Strategy & Execution
Lecture 234CTIS Operating Model – Advanced EUClinical Trial Execution Module
Lecture 235CTA Structure: Part I / Part II (EU Clinical Trials Regulation)
Lecture 236Country-wise Part II Requirement Master
Lecture 237CTIS Hands-on Simulation Module Step-by-Step Clinical Trial Submission Exercise (CTR Execution Training)
Lecture 238EU CTR Advanced Module - Substantial Modifications, Safety Reporting, Transition Lessons & End-of-Trial Obligation
Lecture 239IMPD | Significance | Format of IMPD | Differences with CTA, IB, IND
Lecture 240Investigator’s Brochure | Significance | Format of IB | Preparing different sections of IB
Lecture 241Patent Landscape & Freedom to Operate (FTO) – EU Perspective - Strategic Regulatory + IP Integration Module (Drugs & Biologics)
Lecture 242EU Data Exclusivity, Market Protection & Orphan Exclusivity
Lecture 243Data Exclusivity and Market Protection - Supplementary Patent Protection, Exclusivity, 6/10 Rule, 8+2+1 Formulae
Lecture 244EU Orphan Medicinal Products Regulation
Lecture 245Paediatric use marketing authorisation (PUMA) & Paediatric Investigation Plan (PIP)
Lecture 246EU Supplementary Protection Certificates (SPC) & Paediatric Rewards
Lecture 247Patent vs Regulatory Exclusivity vs Trademark vs Launch Sequencing (EU Perspective)
Lecture 248“No EU-Style Patent Linkage” – What It Really Means (EU vs US)
Lecture 249EU vs US Regulatory–IP Framework
Lecture 250Global Patent + Exclusivity Timeline Dashboard - Executive-Level Strategic Tool (EU + US + Global Integration)
Lecture 251Full EU Submission Strategy Planner
Section 9ASEAN Drug Regulatory Affairs
Lecture 252ASEAN Countries | Introduction | Geographical Overview
Lecture 253ASEAN countries drug regulatory bodies
Lecture 254ASEAN Common Technical Requirements (ACTRs)
Lecture 255The Pharmaceutical Inspection Co-operation Scheme
Lecture 256CPP Requirements for Drug Registration in ASEAN countries
Lecture 257Dossier Requirements - ACTD/CTD Acceptability
Lecture 258Pharmacopoeias Acceptability
Lecture 259Harmonization of Technical Guidelines
Lecture 260Stability Study requirements for drug registration in ASEAN countries
Lecture 261Guideline on product labelling
Lecture 262Post Approval Changes (Variations) requirements in ASEAN countries
Lecture 263Pharmacovigilance and Risk Management Plan (RMP)
Lecture 264Timeline of Drug Registration Approval
Lecture 265ASEAN Drug Regulations : Comparison Study | Guidelines | Pharmaceutical products Regulatory Submissions | Pharmacopoeia Requirements | stability requirements | Pharmacovigilance | Product labeling | Drug variation information
Lecture 266Drug Registration and Regulation Singapore | Strategic Pathways for Marketing Authorization | Screening, Evaluation of MA applications | Variations Classifications and Management
Lecture 267Drug Registration and Regulation in Brunei
Lecture 268Drug Registration and Regulation in Cambodia
Section 10African Drug Regulatory Affairs
Lecture 269African Continent Overview - Brief introduction to course
Lecture 270African Pharma Market
Lecture 271Drug Registration - African medicines regulatory agencies
Lecture 272Basic Export Requirement for African Countries
Lecture 273Export Documentations & Important Concepts
Lecture 274Drug Registration and Regulation in Nigeria
Lecture 275Drug Registration in Algeria
Lecture 276Drug Registration in Ethiopia
Lecture 277Drug Registration in Kenya
Lecture 278Drug Registration in Egypt
Lecture 279Drug Registration in Ghana
Lecture 280Drug Registration in Botswana
Lecture 281Drug Registration and Regulation in Uganda
Lecture 282Drug Registration in Zambia
Section 11Latam Regulatory Affairs
Lecture 283Introduction to Latam
Lecture 284Drug Registration and Regulation in Argentina
Lecture 285Drug Registration and Regulation in Bolivia
Lecture 286Drug Registration and Regulation in Brazil
Lecture 287Drug Registration and Regulation in CHILE
Lecture 288Drug Registration and Regulation in Colombia
Lecture 289Drug Registration and Regulation in Mexico
Lecture 290Drug regulation and registration in El Salvador
Lecture 291Central 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 292Middle East / MENA / GCC Countries Geographical Orientation
Lecture 293Middle East / MENA / GCC Countries National Regulatory Agencies
Lecture 294GCC Registration Procedure - Centralized and Decentralized Procedure | Detailed understanding on Centralized Registration Process
Lecture 295Drug Registration in Saudi Arabia
Lecture 296Drug Registration in UAE
Lecture 297Drug Registration and Regulatory Strategic Planning for Iran
Lecture 298Drug Registration and Regulatory Strategic Planning for Israel
Lecture 299Drug Registration and Regulatory Strategic Planning for Jordan
Lecture 300Drug Registration and Regulatory Strategic Planning for Iraq
Section 13China Drug Regulatory Affairs
Lecture 301Drug Registration and Regulation in China
Lecture 302China NMPA New Regulation Update July, 2020
Section 14Russia - EAEU Regulatory Affairs
Lecture 303Drug Registration and Submission Strategic Planning for Russia and EAEU region
Lecture 304GMP requirements in Russia
Section 15References | Discussions
Lecture 305Comparison of Requirement of Various Regulatory Bodies
Lecture 306Comparison of Dossier Requirements of Europe and US
Lecture 307Comparison of DMF requirement of various regulatory bodies
Lecture 308ICH CTD Top Level View with Notes and Explanation
Lecture 309ICH CTD Top Level View with Note and Explnation
Lecture 310Comparison of ICH US EU CTD
Lecture 311Regulatory Documents at a glance
Lecture 312Structured CMC Writing Checklist
Lecture 313Comparison of 505J 505b1 and 505b2 Pathway
Lecture 314New Update in Form 356h
Section 16Japan Drug Regulation and Registration Process
Lecture 315Introduction to Japan Drug Regulatory Affairs
Lecture 316Drug Discovery Development to commercialization | PMDA functions | Consultation | Premarket to post market approval
Lecture 317Drug Approval System | GCP | PMDA requirements
Lecture 318New Drug Application | Requirements | Review Process
Lecture 319Generic Drug Application Review and Approval
Lecture 320Marketing Authorization Process for registration of pharmaceutical in Japan
Lecture 321API Registration in Japan | Step By Step Process
Lecture 322Generic Registration | Patent - Patent Term Extension | Exclusivity | Re-examination System | Pediatric Designation | Patent Term Extension Case Studies
Lecture 323Priority Review Application | Criteria | Review Process | Timeline
Lecture 324Orphan Drug Designation in Japan
Lecture 325Japan DMF System | MF filing Process | Key points
Lecture 326Strategic Approval Pathway - Formulation Approval Quoting MF
Lecture 327SAKIGAKE designation
Section 17Drug Registration and Regulation in India
Lecture 328Drug Registration and Regulation in India - Prime Session | CDSCO - Organization Regulatory Functions - Central and State | Import License | Registration Certificate | Inspection, Fees and Process | Export from India | Step by Step Guidance
Lecture 329Medicine Export Criteria from India
Lecture 330Documents for conducting BE Study for Export
Lecture 331New Drug Approval in DCGI
Lecture 332Line Extension New Strength Approval
Section 18Switzerland Drug Regulation and Registration (SWISS Regulation)
Lecture 333Introduction to Switzerland Healthcare System | Location | Country Information | Regulatory Bodies | Structure of Regulation | Market Authorization Types | Drug Biologic Food Dietary Supplement Regulation
Lecture 334Swiss Regulatory System | Simulations
Lecture 335Swiss and EU MRA | 2 Case Simulation | 5 Scenario Based assessments
Lecture 336Switzerland - International Agreement and Treaties
Lecture 337Swiss Pharma Regulatory Pathways | Types of Pathways | Case Based Simulations | Checklist File
Section 19Canada Drug Regulation and Submission Process
Lecture 338Structure of Canada’s Healthcare System | Health Canada | Canada Healthcare Act | CADTH | Provincial Drug Benefit programs | INESS
Lecture 339Important Terminologies with explanation
Lecture 340Key Regulatory Authorities | Functions | Comparison of different Regulatory Authorities
Lecture 341Market Authorization in Canada | Strategic Insights
Lecture 342Product classes and Submission Pathways
Section 20Introduction to AI in Regulatory Affairs
Lecture 343Introduction to AI
Lecture 344Basics of AI ML DL | Key Differences | Application in industry
Lecture 345Types of AI
Lecture 346AI Project | Overview
Lecture 347Comprehensive Training on AI Project | Managing Stages | AI Iteration
Lecture 348How machine learning
Lecture 349Understanding Regulatory Affairs – Traditional vs. Digital | 2 Case Study
Lecture 350Basics of AI for Regulatory Professionals | Understanding different models used in RA | Case Study | Simulation
Lecture 351AI Application across drug life cycle | Case Analysis | Model predictions
Lecture 352AI Terms with Regulatory Significance | Regulatory Applications
Lecture 353NLP in Regulatory Affairs | Conceptual understanding | Usage | NLP in Labeling
Lecture 354Data Grouping with Unsupervised Learning | Case Simulation | Hands on Exercise
Lecture 355Quality Data and Bias | Bias in datasets | Different Types of Bias in Pharma Datasets
Lecture 356AI Data Quality Standard | Checklist
Lecture 357Download AI Data Quality Checklist
Lecture 358Case Study: Accelerated Approval Using Real-World Evidence AI
Lecture 359AI Model for Dossier Submission and Filing - Model Selection | Simulation
Lecture 360AI Technologies in RA
Lecture 361Structured Vs. Unstructured Data | Practical Understanding | Explore Patient Datasets
Lecture 362Sample Data Exercise | Data error | Data Refinement and Cleaning of the data
Section 21AI-Powered Regulatory Document Authoring and CMC Writing
Lecture 363AI-Powered Regulatory Document Authoring and CMC Writing
Lecture 364AI Tools Comparison - Authoring and CMC Writing (Module 2 & 3)
Lecture 365Tips for Selecting AI Tools (CMC Authoring)
Lecture 366CMC - AI Workflow Checklist | Simulation Based Cases
Lecture 367HITL Regulatory Document Authoring
Lecture 368Confidence Score in Regulatory Authoring | Case Simulation in CMC Authoring
Lecture 369Confidence Scores in Data Extract in Regulatory Writing [Case Simulation]
Section 22eCTD v4.0 Training
Lecture 370eCTDV4.0 Fundamental Understanding | Structures | Key Features
Lecture 371eCTDV4.0 Structure | Lifecycle Management
Lecture 372eCTD Validation | Managing Validation | Tool Types | Types of Error | Validation Error Management
Lecture 373eCTD Validation Tools
Lecture 374eCTD Publishing Cycle
Lecture 375HL7 - Structure and Understanding in the context of eCTD V4.0
Lecture 376eCTD Submission Checklist Format
Section 23Risk and Compliance Management
Lecture 377AI and Data Integrity | Regulatory Documentation | Case Based Learning | Understanding Data Integrity Principles | Application and Use Cases
Lecture 378Cases of data breaches with explanation
Lecture 379Case Based Discussion : Data Breach in AI-Assisted CMC Drafting
Section 24AI in Regulatory Labelling and Artwork
Lecture 380CCDS Management
Lecture 381CCDS Management Tools - Native, AI Plus | Key Functionalities
Lecture 382AI Augmented Labelling Compliance System
Lecture 383Label Drift in CCDS Management | Simulation Case Study | AI Based Workflow in Label Drift detection and management
Lecture 384AI Review of Labels, PI and SMPC with help of the Case Based Simulation | 4 Case Simulations
Lecture 385CCDS Management Case Study | Pregnancy Warning Upgrade Case Study
Lecture 386CCDS Management Case Study | Dosage Section Conflict | Case Based Analysis
Lecture 387Centralized Artwork Operation | Mechanism | Operation Step Planning
Lecture 388Case Study on Centralized Artwork Operation [Recall Management]
Lecture 389Artwork Management Terms | Key Understanding on Terminologies | Usage in Artwork Cases
Section 25 Real World Evidence and Real World Data | Strategic Decision Making
Lecture 390Evidence Based Decision Making | Combine evidences for decision making | Do we need more evidence?
Lecture 391RWD and RWE | Potential sources of RWE | Traditional RCTs vs. RWE | Case Study - RWE Programs | Influencing HCP decision-making
Lecture 392RWD and RWE in Product Lifecycle Management
Lecture 393RWD and RWE - Fit to use | Assessment
Lecture 394RWD data sources | Different types | Detailed understanding of each class
Lecture 395RWD Study Design
Lecture 396vRWE Published Tool | Insights on commonly used tools
Lecture 397Healthcare Reimbursement Models : Value Based Care | Fee for Service (FFS) Model | Other Reimbursement Models
Lecture 398Consensus Narrative Review
Lecture 399Electronic Patient Data | EMR | EHR | Differences | Software architecture and characteristics
Lecture 400Active Surveillance Schemes | Active Case Finding |Sentinel Surveillance | Cohort Studies | Vaccine Safety Surveillance | Pharmacovigilance Programs | Disease Registries |Event Monitoring
Lecture 401RWD Characteristics
Lecture 402RCT vs. RWE Comparison | Case Based Analysis
Lecture 403RCT and RWE Comparison
Section 26Working on Healthcare Datasets
Lecture 404Introduction to Healthcare Datasets
Lecture 405Dataset 1: Claims Data (Insurance)
Lecture 406Dataset 2: Retail Pharmacy Prescription Data
Lecture 407Dataset 3: Longitudinal Patient Data
Lecture 408Characteristics of Different Set of Healthcare Data
Lecture 409Reimbursement and Pricing Datasets
Lecture 410RWE Data Sources & Quality Considerations Checklist | Case Based Analysis
Lecture 411Triangulation and benchmarking | Enhancing Data Validation Through Cross-Referencing
Lecture 412RWD & RWE Case Database
Lecture 413RWE Large Dataset for Data Crunching Exercises |Data cleaning & preprocessing | Comparative Effectiveness Analysis
Section 27AI Tools, Ethics and Future Landscape
Lecture 414AI Reg Tools - Review | Understanding Capabilities
Lecture 415Regulatory Authority View on AI Adoption
Lecture 416Data Sensitivity | Levels | Consequences | Management
Lecture 417Governance Flowchart – AI Tools in GxP Environments
Section 28AI Tools
Lecture 418RA Example - Generalist Vs. Specialist AI Tools
Lecture 419AI Generalist Overview (Life Science Focus)
Lecture 420Horizontal vs Vertical AI Tools
Lecture 421AI Tool Assessment Test
Lecture 422Citation Verification Workflow | AI Tools Management | Hallucination and HITL Action Plan
Section 29Prompt Engineering
Lecture 423Prompt Engineering – Basic Foundations of Prompt Writing | Different Prompt Framework | Case Based Examples
Lecture 424Special Prompting Structure - Case Based Prompt Designing
Lecture 425Special Prompting Structure - Case Based Prompt Designing
Lecture 426Workflow for writing AI Prompts with Life Science Industry Use Cases
Lecture 427PE Parameters | Controlling Creativity, Accuracy, and Output Behavior for Life-Science Applications | Simulation based decision making
Lecture 428How to adjust the parameters | Techniques
Lecture 429Creating A Detailed Regulatory Prompt | Designing Structured Prompt in Code Editor
Section 30Request for course certification
Lecture 430Final Certification Examination - EPGIDRA
Lecture 431Request for Course Certificate
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