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 93SOP Automation
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
Lecture 99WHO Prequalification Status : Significance | Strategic Importance | Submission Process | WHO PQ Documentation | Case study on WHO PQ submission management
Lecture 100WHO 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 101Common Technical Document (CTD)
Lecture 102CMC Dossier & Compliance Management
Lecture 103Electronic Common Technical Document (ECTD)
Lecture 104Advance Practical Training on Dossier Preparation focusing on drug registration in export countries
Lecture 105Modules on Stability Study : Stability Study - Fundamental Understanding | Interchangebility | Reports | API & FPP Stability Study
Lecture 106Key Consideration for Drug Master File Preparation and Submission
Lecture 107Practical Understanding on Drug Master File Preparation and Submission
Lecture 108Site Master File - Detailed Understanding
Lecture 109DMF Completeness Assessment
Lecture 110Drug Master File - Fees
Lecture 111Drug Master File - Global Perspective [Across Different Regions]
Lecture 112Importance of effective dossier management
Lecture 113Common deficiencies in CTD submission dossier
Lecture 114Certificate of Analysis
Lecture 115Detailed Understanding on ANDA Fees
Lecture 116Prior Approval Submission
Lecture 117Detailed Understanding on ANDA Fees
Lecture 118Detailed Understanding on 505(b)(2) VS. Suitability Petition : Case Based Learning
Lecture 119NCE Vs. 505b2 application - Case Based Learning
Lecture 120FTF - 180 Days Exclusivity - Case Based Learning
Lecture 121Classic case study of the 505b2 filing : Case Based Learning
Lecture 122Strategic Planning in Combating 30 months stay strategies of innovator company- Case Based Learning
Lecture 123Climate Zone and Stability Study Conditions as per ICH Guidelines
Lecture 124Stability Zone Finder
Lecture 125Stability Studies : Case discussions
Lecture 126Case Study: Managing Stability Study for Zone IV countries
Lecture 127Accelerated and intermediate testing conditions
Lecture 128Long Term Stability Testing Requirements
Lecture 129Testing Frequency
Lecture 130Bracketing
Lecture 131Matrixing
Lecture 132PKPD in Drug Discovery | PK-PD trial | Understanding PKPD from regulatory perspective in drug approval process
Lecture 133Bioequivalence Study | Study design | Different types of BE Studies
Lecture 134Bioequivalence 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 135Biopharmaceutical Classification System (BCS) | Types | Biowaivers | BCS tool for drug development and regulatory submission
Lecture 136Bioequivalence Study - Discussion - Timeline of stability study and bioequivalence study
Lecture 137Bioequivalence Study - Discussion - Dissolution Testing
Lecture 138Bioequivalence Study - Generic Approval and Additives Labeling Requirements
Lecture 139Introduction to Variation Management | Reasons for Variation | Working in Variation Department
Lecture 140Variation Classification | Basis of Classification | US and EU Variation Classification | Other region variation guideline
Lecture 141Setting Dissolution Specification for Generic Products | Regulatory Expectations
Lecture 142Regulatory Requirements for Biosimilar | Stepwise evidence based development | Analytical Similarity | Clinical Study | PKPD study requirements | CMC expectation of Biosimilar
Lecture 143CMC Writing Case Study | Successful Documentation
Lecture 144Structure for CMC Writing | Understanding 3.2.S and 3.2.P section | Documents requirements | Case Study
Lecture 145Well written Vs. Poorly Written CMC Section | Practical Example
Lecture 146Drug Substance Section in CMC | Documentations | Practical Examples | Do’s and Don’ts
Lecture 147Example 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 148Stability Studies and Data Presentation in CMC Writing | Case Based Analysis of Stability Study Data Presentation | Interpretation of stability data
Lecture 149Developing Specifications for a New API
Lecture 150Example of Manufacturing Process and Controls
Lecture 151Interpretation of Stability Table
Lecture 152Critical Stability Scenarios | 8 Different Case Studies | Stability Study - Outcome based action plan creation
Lecture 153Critical Stability Issues - Database | Implication | Action Plan
Lecture 154Common Pitfalls in CMC Writing and How to Avoid Them | Case Study
Lecture 155Grouped Submission | Significance | Importance in Market Access and Regulatory point of view | Case Study
Lecture 156Process Validation Report (PVR) | Sample Process Validation Report Analysis | CPPs and CQAs identification
Lecture 157Case Study - Omissions of CPPs in PVR | Case insight, explanation, action plan | Correlations - CPPs - CQAs - IPCs
Lecture 158Supplemental New Drug Application (sNDA) | Filing and Submission Management | Requirements | Best Practices | Different Forms for sNDA submissions
Lecture 159BA BE Study Design | Comparing different types of the study design
Lecture 1602wco Study Design | Design Table | Importance
Lecture 1613wco Study Design | Design Table | Importance
Lecture 162FRCO Study Design | Design Table | Importance
Lecture 163Parallel Vs. Crossover Study Design
Lecture 164OGD Table - How to Prepare | Sample Tabular Summary Preparation
Lecture 165Impact Assessment in CMC Writing | Case Based Discussion| Scenario Decision Making
Lecture 166RfR in Generic Drug Approval | Overview, Process, and Best Practices
Section 6Quality issues, Warning Letter, CAPA and Data Integrity
Lecture 167Data Integrity issues in Pharmaceutical Industry
Lecture 168Establishment Inspection Report | 483 Observations | USFDA Warning Letter | Handling of FDA inspection | Closing of Warning Letter
Lecture 169Electronic Batch Record for effective compliance management | Key Understanding | Functionalities | Importance in managing data integrity
Lecture 170RTQs | Response to Queries | How to handle Regulatory Queries
Section 7Biopharmaceutical (Biologics and Biosimilar) Regulations
Lecture 171Introduction of Biologics
Lecture 172Classification of Biopharmaceutical
Lecture 173Chemical Drugs Vs. Biologic Drugs
Lecture 174Principle of Naming of Biologics
Lecture 175Global Biologics Market – By Product | By Therapeutic Class | By Region
Lecture 176Recombinant protein
Lecture 177Monoclonal Antibodies Vs. Polyclonal Antibodies
Lecture 178Monoclonal Antibodies
Lecture 179Synthetic Immunomodulators
Lecture 180Production of Monoclonal Antibodies
Lecture 181Cytokines
Lecture 182Interferon
Lecture 183Erythropoiesis-stimulating agent
Lecture 184Biological Licensing Application (BLA) | 351(a) application | Form 356h | Differentiation with NDA | Timeline | Handling FDA queries
Lecture 185Abbreviated Biosimilar Application - 351(k): Advance Strategic Planning Process : Originator Vs. Biosimilar Development and Regulatory Approval Process | Reference Biologic | Purple Book | Data Requirements
Lecture 186Purple Book: Significance | Searching | Assignments
Lecture 187Vaccine development and approval Process
Lecture 188PDUFA For Biologics
Lecture 189Biosimilar Development Process
Lecture 190Strategic Consideration for Biosimilar Development
Lecture 191Bio-Manufacturing Process Information
Lecture 192Studies required for approval of biosimilar
Lecture 193Regulatory Requirements for Biosimilar | Stepwise evidence based development | Analytical Similarity | Clinical Study | PKPD study requirements | CMC expectation of Biosimilar
Lecture 194Comparability of Biologics | Different Categories of Comparability | General Principles
Lecture 195CQA (Critical Quality Attribute) and CPP (Critical Process Parameter)
Lecture 196ATMPs | Types and Classification | Regulatory Mechanism
Lecture 197CAR-T Therapy | Different Types of CAR-T Therapy | Mechanism of action | Challenges | Brainstorming on Concept of Personalized Medicine | Understanding on marketed formulation
Lecture 198Live Biotherapeutic Products | LBPs | Class | Mechanism | Indication Positioning | Regulatory Requirements for LBPs
Section 8European Drug Regulatory Affairs
Lecture 199EU Regulatory System Fundamentals
Lecture 200Introduction to EU Regulation
Lecture 201Orientation to European Countries and National Regulatory Bodies
Lecture 202EMA and EMA Authorisation Process
Lecture 203EMA and EMA Authorisation Process
Lecture 204Centralised vs DCP vs MRP vs National Procedure - Detailed Strategic Insight
Lecture 205EU MA Application Types and Strategic Planning
Lecture 206EU MA Procedure - Centralised, Decentralised, Mutual Recognition, National Procedure
Lecture 207EU MA Strategic Planning: Full, Full-mixed, hybrid applications. Generic, Similar biologic application pathway, Well-established use application, Fixed combination application, Informed consent application
Lecture 208Validity 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 209Structured Practical understanding of EU legal bases | Understanding Data Requirements
Lecture 210Practical understanding of EU legal bases for Marketing Authorisation Applications (MAA) | Decision Tree
Lecture 211Centralised Procedure Timetable and Review Logic
Lecture 212DCP / MRP / National Procedure – Practical Workflow Module
Lecture 213EU Procedures Critical Operational Steps - Validation • Clock-Stop • List of Questions • Approval • National Phase
Lecture 214DCP vs MRP Timeline
Lecture 215EU Adaptive Pathway
Lecture 216European public assessment report (EPAR) - Importance, Component, Management, Updation
Lecture 217SPOR - Concept of Master Data Management
Lecture 218The 'sunset clause' for marketing authorisation of pharmaceuticals
Lecture 219LoQ Response Strategy - EU Regulatory Procedures (CP / DCP / MRP) – Winning the Day 120 / Mid-Cycle Response
Lecture 220Response to list of Questions (LoQ)
Lecture 221Response to list of outstanding issues (LoOI) - Day 180 / Final Assessment Phase Response
Lecture 222Oral Explanation Training Module - CHMP / CMDh Oral Defence Strategy – From Data to Approval
Lecture 223CHMP - Question Bank Real-Life Regulatory Questions + Model Answers (CP / DCP / MRP)
Lecture 224Conditional marketing authorisation | Marketing authorisation under exceptional circumstances
Lecture 225Compassionate Use
Lecture 226EU Prime Designation
Lecture 227MHRA - UK Regulation
Lecture 228Summary of Product Characteristics
Lecture 229Drug Registration and Submission Strategic Planning for Russia and EAEU region
Lecture 230Accelerated assessment by EMEA
Lecture 231Certificate of Suitability (CEP) | Significance | Importance | Understanding Regulatory Compliance and Submission Process | Walkthrough
Lecture 232CEP Dossier DMF - Differences
Lecture 233Policy 0070 | RPDP Submission and Management timeline | Anonymisation Report (AnR) - Significance | AnR in FRDP
Lecture 234Comprehensive EU Clinical Trial Regulatory Affairs – CTA, CTIS, Strategy & Execution
Lecture 235CTIS Operating Model – Advanced EUClinical Trial Execution Module
Lecture 236CTA Structure: Part I / Part II (EU Clinical Trials Regulation)
Lecture 237Country-wise Part II Requirement Master
Lecture 238CTIS Hands-on Simulation Module Step-by-Step Clinical Trial Submission Exercise (CTR Execution Training)
Lecture 239EU CTR Advanced Module - Substantial Modifications, Safety Reporting, Transition Lessons & End-of-Trial Obligation
Lecture 240IMPD | Significance | Format of IMPD | Differences with CTA, IB, IND
Lecture 241Investigator’s Brochure | Significance | Format of IB | Preparing different sections of IB
Lecture 242Patent Landscape & Freedom to Operate (FTO) – EU Perspective - Strategic Regulatory + IP Integration Module (Drugs & Biologics)
Lecture 243EU Data Exclusivity, Market Protection & Orphan Exclusivity
Lecture 244Data Exclusivity and Market Protection - Supplementary Patent Protection, Exclusivity, 6/10 Rule, 8+2+1 Formulae
Lecture 245EU Orphan Medicinal Products Regulation
Lecture 246Paediatric use marketing authorisation (PUMA) & Paediatric Investigation Plan (PIP)
Lecture 247EU Supplementary Protection Certificates (SPC) & Paediatric Rewards
Lecture 248Patent vs Regulatory Exclusivity vs Trademark vs Launch Sequencing (EU Perspective)
Lecture 249“No EU-Style Patent Linkage” – What It Really Means (EU vs US)
Lecture 250EU vs US Regulatory–IP Framework
Lecture 251Global Patent + Exclusivity Timeline Dashboard - Executive-Level Strategic Tool (EU + US + Global Integration)
Lecture 252Full EU Submission Strategy Planner
Section 9ASEAN Drug Regulatory Affairs
Lecture 253ASEAN Countries | Introduction | Geographical Overview
Lecture 254ASEAN countries drug regulatory bodies
Lecture 255ASEAN Common Technical Requirements (ACTRs)
Lecture 256The Pharmaceutical Inspection Co-operation Scheme
Lecture 257CPP Requirements for Drug Registration in ASEAN countries
Lecture 258Dossier Requirements - ACTD/CTD Acceptability
Lecture 259Pharmacopoeias Acceptability
Lecture 260Harmonization of Technical Guidelines
Lecture 261Stability Study requirements for drug registration in ASEAN countries
Lecture 262Guideline on product labelling
Lecture 263Post Approval Changes (Variations) requirements in ASEAN countries
Lecture 264Pharmacovigilance and Risk Management Plan (RMP)
Lecture 265Timeline of Drug Registration Approval
Lecture 266ASEAN Drug Regulations : Comparison Study | Guidelines | Pharmaceutical products Regulatory Submissions | Pharmacopoeia Requirements | stability requirements | Pharmacovigilance | Product labeling | Drug variation information
Lecture 267Drug Registration and Regulation Singapore | Strategic Pathways for Marketing Authorization | Screening, Evaluation of MA applications | Variations Classifications and Management
Lecture 268Drug Registration and Regulation in Brunei
Lecture 269Drug Registration and Regulation in Cambodia
Section 10African Drug Regulatory Affairs
Lecture 270African Continent Overview - Brief introduction to course
Lecture 271African Pharma Market
Lecture 272Drug Registration - African medicines regulatory agencies
Lecture 273Basic Export Requirement for African Countries
Lecture 274Export Documentations & Important Concepts
Lecture 275Drug Registration and Regulation in Nigeria
Lecture 276Drug Registration in Algeria
Lecture 277Drug Registration in Ethiopia
Lecture 278Drug Registration in Kenya
Lecture 279Drug Registration in Egypt
Lecture 280Drug Registration in Ghana
Lecture 281Drug Registration in Botswana
Lecture 282Drug Registration and Regulation in Uganda
Lecture 283Drug Registration in Zambia
Section 11Latam Regulatory Affairs
Lecture 284Introduction to Latam
Lecture 285Drug Registration and Regulation in Argentina
Lecture 286Drug Registration and Regulation in Bolivia
Lecture 287Drug Registration and Regulation in Brazil
Lecture 288Drug Registration and Regulation in CHILE
Lecture 289Drug Registration and Regulation in Colombia
Lecture 290Drug Registration and Regulation in Mexico
Lecture 291Drug regulation and registration in El Salvador
Lecture 292Central 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 293Middle East / MENA / GCC Countries Geographical Orientation
Lecture 294Middle East / MENA / GCC Countries National Regulatory Agencies
Lecture 295GCC Registration Procedure - Centralized and Decentralized Procedure | Detailed understanding on Centralized Registration Process
Lecture 296Drug Registration in Saudi Arabia
Lecture 297Drug Registration in UAE
Lecture 298Drug Registration and Regulatory Strategic Planning for Iran
Lecture 299Drug Registration and Regulatory Strategic Planning for Israel
Lecture 300Drug Registration and Regulatory Strategic Planning for Jordan
Lecture 301Drug Registration and Regulatory Strategic Planning for Iraq
Section 13China Drug Regulatory Affairs
Lecture 302Drug Registration and Regulation in China
Lecture 303China NMPA New Regulation Update July, 2020
Section 14Russia - EAEU Regulatory Affairs
Lecture 304Drug Registration and Submission Strategic Planning for Russia and EAEU region
Lecture 305GMP requirements in Russia
Section 15References | Discussions
Lecture 306Comparison of Requirement of Various Regulatory Bodies
Lecture 307Comparison of Dossier Requirements of Europe and US
Lecture 308Comparison of DMF requirement of various regulatory bodies
Lecture 309ICH CTD Top Level View with Notes and Explanation
Lecture 310ICH CTD Top Level View with Note and Explnation
Lecture 311Comparison of ICH US EU CTD
Lecture 312Regulatory Documents at a glance
Lecture 313Structured CMC Writing Checklist
Lecture 314Comparison of 505J 505b1 and 505b2 Pathway
Lecture 315New Update in Form 356h
Section 16Japan Drug Regulation and Registration Process
Lecture 316Introduction to Japan Drug Regulatory Affairs
Lecture 317Drug Discovery Development to commercialization | PMDA functions | Consultation | Premarket to post market approval
Lecture 318Drug Approval System | GCP | PMDA requirements
Lecture 319New Drug Application | Requirements | Review Process
Lecture 320Generic Drug Application Review and Approval
Lecture 321Marketing Authorization Process for registration of pharmaceutical in Japan
Lecture 322API Registration in Japan | Step By Step Process
Lecture 323Generic Registration | Patent - Patent Term Extension | Exclusivity | Re-examination System | Pediatric Designation | Patent Term Extension Case Studies
Lecture 324Priority Review Application | Criteria | Review Process | Timeline
Lecture 325Orphan Drug Designation in Japan
Lecture 326Japan DMF System | MF filing Process | Key points
Lecture 327Strategic Approval Pathway - Formulation Approval Quoting MF
Lecture 328SAKIGAKE designation
Section 17Drug Registration and Regulation in India
Lecture 329Drug 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 330Medicine Export Criteria from India
Lecture 331Documents for conducting BE Study for Export
Lecture 332New Drug Approval in DCGI
Lecture 333Line Extension New Strength Approval
Section 18Switzerland Drug Regulation and Registration (SWISS Regulation)
Lecture 334Introduction to Switzerland Healthcare System | Location | Country Information | Regulatory Bodies | Structure of Regulation | Market Authorization Types | Drug Biologic Food Dietary Supplement Regulation
Lecture 335Swiss Regulatory System | Simulations
Lecture 336Swiss and EU MRA | 2 Case Simulation | 5 Scenario Based assessments
Lecture 337Switzerland - International Agreement and Treaties
Lecture 338Swiss Pharma Regulatory Pathways | Types of Pathways | Case Based Simulations | Checklist File
Section 19Canada Drug Regulation and Submission Process
Lecture 339Structure of Canada’s Healthcare System | Health Canada | Canada Healthcare Act | CADTH | Provincial Drug Benefit programs | INESS
Lecture 340Important Terminologies with explanation
Lecture 341Key Regulatory Authorities | Functions | Comparison of different Regulatory Authorities
Lecture 342Market Authorization in Canada | Strategic Insights
Lecture 343Product classes and Submission Pathways
Section 20Introduction to AI in Regulatory Affairs
Lecture 344Introduction to AI
Lecture 345Basics of AI ML DL | Key Differences | Application in industry
Lecture 346Types of AI
Lecture 347AI Project | Overview
Lecture 348Comprehensive Training on AI Project | Managing Stages | AI Iteration
Lecture 349How machine learning
Lecture 350Understanding Regulatory Affairs – Traditional vs. Digital | 2 Case Study
Lecture 351Basics of AI for Regulatory Professionals | Understanding different models used in RA | Case Study | Simulation
Lecture 352AI Application across drug life cycle | Case Analysis | Model predictions
Lecture 353AI Terms with Regulatory Significance | Regulatory Applications
Lecture 354NLP in Regulatory Affairs | Conceptual understanding | Usage | NLP in Labeling
Lecture 355Data Grouping with Unsupervised Learning | Case Simulation | Hands on Exercise
Lecture 356Quality Data and Bias | Bias in datasets | Different Types of Bias in Pharma Datasets
Lecture 357AI Data Quality Standard | Checklist
Lecture 358Download AI Data Quality Checklist
Lecture 359Case Study: Accelerated Approval Using Real-World Evidence AI
Lecture 360AI Model for Dossier Submission and Filing - Model Selection | Simulation
Lecture 361AI Technologies in RA
Lecture 362Structured Vs. Unstructured Data | Practical Understanding | Explore Patient Datasets
Lecture 363Sample Data Exercise | Data error | Data Refinement and Cleaning of the data
Section 21AI-Powered Regulatory Document Authoring and CMC Writing
Lecture 364AI-Powered Regulatory Document Authoring and CMC Writing
Lecture 365AI Tools Comparison - Authoring and CMC Writing (Module 2 & 3)
Lecture 366Tips for Selecting AI Tools (CMC Authoring)
Lecture 367CMC - AI Workflow Checklist | Simulation Based Cases
Lecture 368HITL Regulatory Document Authoring
Lecture 369Confidence Score in Regulatory Authoring | Case Simulation in CMC Authoring
Lecture 370Confidence Scores in Data Extract in Regulatory Writing [Case Simulation]
Section 22eCTD v4.0 Training
Lecture 371eCTDV4.0 Fundamental Understanding | Structures | Key Features
Lecture 372eCTDV4.0 Structure | Lifecycle Management
Lecture 373eCTD Validation | Managing Validation | Tool Types | Types of Error | Validation Error Management
Lecture 374eCTD Validation Tools
Lecture 375eCTD Publishing Cycle
Lecture 376HL7 - Structure and Understanding in the context of eCTD V4.0
Lecture 377eCTD Submission Checklist Format
Section 23Risk and Compliance Management
Lecture 378AI and Data Integrity | Regulatory Documentation | Case Based Learning | Understanding Data Integrity Principles | Application and Use Cases
Lecture 379Cases of data breaches with explanation
Lecture 380Case Based Discussion : Data Breach in AI-Assisted CMC Drafting
Section 24AI in Regulatory Labelling and Artwork
Lecture 381CCDS Management
Lecture 382CCDS Management Tools - Native, AI Plus | Key Functionalities
Lecture 383AI Augmented Labelling Compliance System
Lecture 384Label Drift in CCDS Management | Simulation Case Study | AI Based Workflow in Label Drift detection and management
Lecture 385AI Review of Labels, PI and SMPC with help of the Case Based Simulation | 4 Case Simulations
Lecture 386CCDS Management Case Study | Pregnancy Warning Upgrade Case Study
Lecture 387CCDS Management Case Study | Dosage Section Conflict | Case Based Analysis
Lecture 388Centralized Artwork Operation | Mechanism | Operation Step Planning
Lecture 389Case Study on Centralized Artwork Operation [Recall Management]
Lecture 390Artwork Management Terms | Key Understanding on Terminologies | Usage in Artwork Cases
Section 25 Real World Evidence and Real World Data | Strategic Decision Making
Lecture 391Evidence Based Decision Making | Combine evidences for decision making | Do we need more evidence?
Lecture 392RWD and RWE | Potential sources of RWE | Traditional RCTs vs. RWE | Case Study - RWE Programs | Influencing HCP decision-making
Lecture 393RWD and RWE in Product Lifecycle Management
Lecture 394RWD and RWE - Fit to use | Assessment
Lecture 395RWD data sources | Different types | Detailed understanding of each class
Lecture 396RWD Study Design
Lecture 397vRWE Published Tool | Insights on commonly used tools
Lecture 398Healthcare Reimbursement Models : Value Based Care | Fee for Service (FFS) Model | Other Reimbursement Models
Lecture 399Consensus Narrative Review
Lecture 400Electronic Patient Data | EMR | EHR | Differences | Software architecture and characteristics
Lecture 401Active Surveillance Schemes | Active Case Finding |Sentinel Surveillance | Cohort Studies | Vaccine Safety Surveillance | Pharmacovigilance Programs | Disease Registries |Event Monitoring
Lecture 402RWD Characteristics
Lecture 403RCT vs. RWE Comparison | Case Based Analysis
Lecture 404RCT and RWE Comparison
Section 26Working on Healthcare Datasets
Lecture 405Introduction to Healthcare Datasets
Lecture 406Dataset 1: Claims Data (Insurance)
Lecture 407Dataset 2: Retail Pharmacy Prescription Data
Lecture 408Dataset 3: Longitudinal Patient Data
Lecture 409Characteristics of Different Set of Healthcare Data
Lecture 410Reimbursement and Pricing Datasets
Lecture 411RWE Data Sources & Quality Considerations Checklist | Case Based Analysis
Lecture 412Triangulation and benchmarking | Enhancing Data Validation Through Cross-Referencing
Lecture 413RWD & RWE Case Database
Lecture 414RWE Large Dataset for Data Crunching Exercises |Data cleaning & preprocessing | Comparative Effectiveness Analysis
Section 27AI Tools, Ethics and Future Landscape
Lecture 415AI Reg Tools - Review | Understanding Capabilities
Lecture 416Regulatory Authority View on AI Adoption
Lecture 417Data Sensitivity | Levels | Consequences | Management
Lecture 418Governance Flowchart – AI Tools in GxP Environments
Section 28AI Tools
Lecture 419RA Example - Generalist Vs. Specialist AI Tools
Lecture 420AI Generalist Overview (Life Science Focus)
Lecture 421Horizontal vs Vertical AI Tools
Lecture 422AI Tool Assessment Test
Lecture 423Citation Verification Workflow | AI Tools Management | Hallucination and HITL Action Plan
Section 29Prompt Engineering
Lecture 424Prompt Engineering – Basic Foundations of Prompt Writing | Different Prompt Framework | Case Based Examples
Lecture 425Special Prompting Structure - Case Based Prompt Designing
Lecture 426Special Prompting Structure - Case Based Prompt Designing
Lecture 427Workflow for writing AI Prompts with Life Science Industry Use Cases
Lecture 428PE Parameters | Controlling Creativity, Accuracy, and Output Behavior for Life-Science Applications | Simulation based decision making
Lecture 429How to adjust the parameters | Techniques
Lecture 430Creating A Detailed Regulatory Prompt | Designing Structured Prompt in Code Editor
Section 30Request for course certification
Lecture 431Final Certification Examination - EPGIDRA
Lecture 432Request for Course Certificate
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