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 34Introduction to intellectual Property Management
Lecture 35Clinical Trial Protocol Writing
Lecture 36Understanding on Patent System
Lecture 37Patent Grant and Managing Patent Filing Procedure
Lecture 38Scope of Patentability
Lecture 39Patent Grant and Handling Process in India
Lecture 40Stages of Patent Grant Procedure
Lecture 41Patent search in Indian Patent Office
Lecture 42Differences in US and European Patent
Lecture 43Patent Claim | Types of Patent Claims
Lecture 44Patent Cliff | How to calculate the patent cliff
Lecture 45Terminologies related to patent, trademark, copyright and licensing
Lecture 46Patent Infringement
Lecture 47Introduction to Trademark | Trademark filing procedure
Lecture 48Trademark Searching Process | EUIPO Searching | USPTO Searching | IPINDIA Searching
Lecture 49Trademark Infringement | Passing off | Practical Cases
Lecture 50Trademark Classes | How to search the right trademark class for for filing trademark application
Section 3 Regulatory Strategic Management and planning
Lecture 51Regulatory Strategies in different phases of Clinical Trial
Lecture 52Advance study on Para IV Filing
Lecture 53Para IV Notice
Lecture 54Evergreening - Patent Life Extension Strategies
Lecture 55Pay For Delay Strategy
Lecture 56REMS Strategic Planning
Lecture 57Compulsory Licensing
Lecture 58Licensing & Technology Transfer
Lecture 59In-Licensing Vs. Outlicensing
Lecture 60LOE Strategies for Innovator Brands with case study
Lecture 61Paediatric Exclusivity and Paediatric Study Plan Development
Lecture 62Drug Re-purposing
Lecture 63Practical Queries on different USFDA application and Filing
Lecture 64Publication Management from Regulatory perspective
Lecture 65Juxtapid Case Study
Lecture 66New Indication Approval Process and Promotion
Lecture 67OTC Switch
Section 4Good Manufacturing Practices
Lecture 68Certification Pharmaceutical Companies / Plants
Lecture 69Premises & Plant Layout Designing
Lecture 70Sanitation and Hygiene
Lecture 71Equipment
Lecture 72Production Modules
Lecture 73GMP Documentation
Lecture 74Quality Control
Lecture 75Handling of Product Complaint
Lecture 76GMP Storage
Lecture 77ISO and ISO Audits
Lecture 78Pharmaceutical SOPs
Lecture 79SOP Automation
Lecture 80PDE Value | Importance, Significance | How to calculate PDE value
Lecture 81Quality Risk Management | ICH Q9 | ISO 14971 | Principle of Risk Management
Lecture 82Introduction 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 83WHO-GMP Certification Scheme
Lecture 84Template of Certificate of Pharmaceutical product | Key observations and points to note while working on CoPP
Lecture 85WHO Prequalification Status : Significance | Strategic Importance | Submission Process | WHO PQ Documentation | Case study on WHO PQ submission management
Lecture 86WHO 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 87Common Technical Document (CTD)
Lecture 88CMC Dossier & Compliance Management
Lecture 89Electronic Common Technical Document (ECTD)
Lecture 90Advance Practical Training on Dossier Preparation focusing on drug registration in export countries
Lecture 91Modules on Stability Study : Stability Study - Fundamental Understanding | Interchangebility | Reports | API & FPP Stability Study
Lecture 92Key Consideration for Drug Master File Preparation and Submission
Lecture 93Practical Understanding on Drug Master File Preparation and Submission
Lecture 94Site Master File - Detailed Understanding
Lecture 95DMF Completeness Assessment
Lecture 96Drug Master File - Fees
Lecture 97Drug Master File - Global Perspective [Across Different Regions]
Lecture 98Importance of effective dossier management
Lecture 99Common deficiencies in CTD submission dossier
Lecture 100Certificate of Analysis
Lecture 101Detailed Understanding on ANDA Fees
Lecture 102Prior Approval Submission
Lecture 103Detailed Understanding on ANDA Fees
Lecture 104Detailed Understanding on 505(b)(2) VS. Suitability Petition : Case Based Learning
Lecture 105NCE Vs. 505b2 application - Case Based Learning
Lecture 106FTF - 180 Days Exclusivity - Case Based Learning
Lecture 107Classic case study of the 505b2 filing : Case Based Learning
Lecture 108Strategic Planning in Combating 30 months stay strategies of innovator company- Case Based Learning
Lecture 109Climate Zone and Stability Study Conditions as per ICH Guidelines
Lecture 110Stability Zone Finder
Lecture 111Stability Studies : Case discussions
Lecture 112Case Study: Managing Stability Study for Zone IV countries
Lecture 113Accelerated and intermediate testing conditions
Lecture 114Long Term Stability Testing Requirements
Lecture 115Testing Frequency
Lecture 116Bracketing
Lecture 117Matrixing
Lecture 118PKPD in Drug Discovery | PK-PD trial | Understanding PKPD from regulatory perspective in drug approval process
Lecture 119Bioequivalence Study | Study design | Different types of BE Studies
Lecture 120Bioequivalence 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 121Biopharmaceutical Classification System (BCS) | Types | Biowaivers | BCS tool for drug development and regulatory submission
Lecture 122Bioequivalence Study - Discussion - Timeline of stability study and bioequivalence study
Lecture 123Bioequivalence Study - Discussion - Dissolution Testing
Lecture 124Bioequivalence Study - Generic Approval and Additives Labeling Requirements
Lecture 125Introduction to Variation Management | Reasons for Variation | Working in Variation Department
Lecture 126Variation Classification | Basis of Classification | US and EU Variation Classification | Other region variation guideline
Lecture 127Setting Dissolution Specification for Generic Products | Regulatory Expectations
Lecture 128Regulatory Requirements for Biosimilar | Stepwise evidence based development | Analytical Similarity | Clinical Study | PKPD study requirements | CMC expectation of Biosimilar
Lecture 129CMC Writing Case Study | Successful Documentation
Lecture 130Structure for CMC Writing | Understanding 3.2.S and 3.2.P section | Documents requirements | Case Study
Lecture 131Well written Vs. Poorly Written CMC Section | Practical Example
Lecture 132Drug Substance Section in CMC | Documentations | Practical Examples | Do’s and Don’ts
Lecture 133Example 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 134Stability Studies and Data Presentation in CMC Writing | Case Based Analysis of Stability Study Data Presentation | Interpretation of stability data
Lecture 135Developing Specifications for a New API
Lecture 136Example of Manufacturing Process and Controls
Lecture 137Interpretation of Stability Table
Lecture 138Critical Stability Scenarios | 8 Different Case Studies | Stability Study - Outcome based action plan creation
Lecture 139Critical Stability Issues - Database | Implication | Action Plan
Lecture 140Common Pitfalls in CMC Writing and How to Avoid Them | Case Study
Lecture 141Grouped Submission | Significance | Importance in Market Access and Regulatory point of view | Case Study
Lecture 142Process Validation Report (PVR) | Sample Process Validation Report Analysis | CPPs and CQAs identification
Lecture 143Case Study - Omissions of CPPs in PVR | Case insight, explanation, action plan | Correlations - CPPs - CQAs - IPCs
Lecture 144Supplemental New Drug Application (sNDA) | Filing and Submission Management | Requirements | Best Practices | Different Forms for sNDA submissions
Lecture 145BA BE Study Design | Comparing different types of the study design
Lecture 1462wco Study Design | Design Table | Importance
Lecture 1473wco Study Design | Design Table | Importance
Lecture 148FRCO Study Design | Design Table | Importance
Lecture 149Parallel Vs. Crossover Study Design
Lecture 150OGD Table - How to Prepare | Sample Tabular Summary Preparation
Lecture 151Impact Assessment in CMC Writing | Case Based Discussion| Scenario Decision Making
Lecture 152RfR in Generic Drug Approval | Overview, Process, and Best Practices
Section 6Quality issues, Warning Letter, CAPA and Data Integrity
Lecture 153Data Integrity issues in Pharmaceutical Industry
Lecture 154Establishment Inspection Report | 483 Observations | USFDA Warning Letter | Handling of FDA inspection | Closing of Warning Letter
Lecture 155Electronic Batch Record for effective compliance management | Key Understanding | Functionalities | Importance in managing data integrity
Lecture 156RTQs | Response to Queries | How to handle Regulatory Queries
Section 7Biopharmaceutical (Biologics and Biosimilar) Regulations
Lecture 157Introduction of Biologics
Lecture 158Classification of Biopharmaceutical
Lecture 159Chemical Drugs Vs. Biologic Drugs
Lecture 160Principle of Naming of Biologics
Lecture 161Global Biologics Market – By Product | By Therapeutic Class | By Region
Lecture 162Recombinant protein
Lecture 163Monoclonal Antibodies Vs. Polyclonal Antibodies
Lecture 164Monoclonal Antibodies
Lecture 165Synthetic Immunomodulators
Lecture 166Production of Monoclonal Antibodies
Lecture 167Cytokines
Lecture 168Interferon
Lecture 169Erythropoiesis-stimulating agent
Lecture 170Biological Licensing Application (BLA) | 351(a) application | Form 356h | Differentiation with NDA | Timeline | Handling FDA queries
Lecture 171Abbreviated Biosimilar Application - 351(k): Advance Strategic Planning Process : Originator Vs. Biosimilar Development and Regulatory Approval Process | Reference Biologic | Purple Book | Data Requirements
Lecture 172Purple Book: Significance | Searching | Assignments
Lecture 173Vaccine development and approval Process
Lecture 174PDUFA For Biologics
Lecture 175Biosimilar Development Process
Lecture 176Strategic Consideration for Biosimilar Development
Lecture 177Bio-Manufacturing Process Information
Lecture 178Studies required for approval of biosimilar
Lecture 179Regulatory Requirements for Biosimilar | Stepwise evidence based development | Analytical Similarity | Clinical Study | PKPD study requirements | CMC expectation of Biosimilar
Lecture 180Comparability of Biologics | Different Categories of Comparability | General Principles
Lecture 181CQA (Critical Quality Attribute) and CPP (Critical Process Parameter)
Lecture 182ATMPs | Types and Classification | Regulatory Mechanism
Lecture 183CAR-T Therapy | Different Types of CAR-T Therapy | Mechanism of action | Challenges | Brainstorming on Concept of Personalized Medicine | Understanding on marketed formulation
Lecture 184Live Biotherapeutic Products | LBPs | Class | Mechanism | Indication Positioning | Regulatory Requirements for LBPs
Section 8European Drug Regulatory Affairs
Lecture 185Introduction to EU Regulation
Lecture 186Orientation to European Countries and National Regulatory Bodies
Lecture 187EU Drug Discovery Development to Commercialization (Step By Step)
Lecture 188Overview of EU Regulation
Lecture 189EMA and EMA Authorisation Process
Lecture 190EU MA Application Types and Strategic Planning
Lecture 191EU MA Procedure - Centralised, Decentralised, Mutual Recognition, National Procedure
Lecture 192EU MA Strategic Planning: Full, Full-mixed, hybrid applications. Generic, Similar biologic application pathway, Well-established use application, Fixed combination application, Informed consent application
Lecture 193Validity 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 194Data Exclusivity and Market Protection - Supplementary Patent Protection, Exclusivity, 6/10 Rule, 8+2+1 Formulae
Lecture 195EU Orphan Medicinal Products Regulation
Lecture 196Conditional marketing authorisation | Marketing authorisation under exceptional circumstances
Lecture 197Summary of Product Characteristics
Lecture 198Compassionate Use
Lecture 199IMPD | Significance | Format of IMPD | Differences with CTA, IB, IND
Lecture 200Investigator’s Brochure | Significance | Format of IB | Preparing different sections of IB
Lecture 201Paediatric use marketing authorisation (PUMA) & Paediatric Investigation Plan (PIP)
Lecture 202EU variation -Types, Requirement & Planning - IA, IAIN, IB, II ; US FDA Variation AR, CBE-0, CBE-30, PAS - Strategic Discussion | Similarities & Differentiation
Lecture 203EU Prime Designation
Lecture 204Accelerated assessment by EMEA
Lecture 205EU Adaptive Pathway
Lecture 206European public assessment report (EPAR) - Importance, Component, Management, Updation
Lecture 207SPOR - Concept of Master Data Management
Lecture 208PDE Value : What is PDE value of API? Significance and How PDE value is derived?
Lecture 209MHRA - UK Regulation
Lecture 210The 'sunset clause' for marketing authorisation of pharmaceuticals
Lecture 211Certificate of Suitability (CEP) | Significance | Importance | Understanding Regulatory Compliance and Submission Process | Walkthrough
Lecture 212CEP Dossier DMF - Differences
Lecture 213Policy 0070 | RPDP Submission and Management timeline | Anonymisation Report (AnR) - Significance | AnR in FRDP
Section 9ASEAN Drug Regulatory Affairs
Lecture 214ASEAN Countries | Introduction | Geographical Overview
Lecture 215ASEAN countries drug regulatory bodies
Lecture 216ASEAN Common Technical Requirements (ACTRs)
Lecture 217The Pharmaceutical Inspection Co-operation Scheme
Lecture 218CPP Requirements for Drug Registration in ASEAN countries
Lecture 219Dossier Requirements - ACTD/CTD Acceptability
Lecture 220Pharmacopoeias Acceptability
Lecture 221Harmonization of Technical Guidelines
Lecture 222Stability Study requirements for drug registration in ASEAN countries
Lecture 223Guideline on product labelling
Lecture 224Post Approval Changes (Variations) requirements in ASEAN countries
Lecture 225Pharmacovigilance and Risk Management Plan (RMP)
Lecture 226Timeline of Drug Registration Approval
Lecture 227ASEAN Drug Regulations : Comparison Study | Guidelines | Pharmaceutical products Regulatory Submissions | Pharmacopoeia Requirements | stability requirements | Pharmacovigilance | Product labeling | Drug variation information
Lecture 228Drug Registration and Regulation Singapore | Strategic Pathways for Marketing Authorization | Screening, Evaluation of MA applications | Variations Classifications and Management
Lecture 229Drug Registration and Regulation in Brunei
Lecture 230Drug Registration and Regulation in Cambodia
Section 10African Drug Regulatory Affairs
Lecture 231African Continent Overview - Brief introduction to course
Lecture 232African Pharma Market
Lecture 233Drug Registration - African medicines regulatory agencies
Lecture 234Basic Export Requirement for African Countries
Lecture 235Export Documentations & Important Concepts
Lecture 236Drug Registration and Regulation in Nigeria
Lecture 237Drug Registration in Algeria
Lecture 238Drug Registration in Ethiopia
Lecture 239Drug Registration in Kenya
Lecture 240Drug Registration in Egypt
Lecture 241Drug Registration in Ghana
Lecture 242Drug Registration in Botswana
Lecture 243Drug Registration and Regulation in Uganda
Lecture 244Drug Registration in Zambia
Section 11Latam Regulatory Affairs
Lecture 245Introduction to Latam
Lecture 246Drug Registration and Regulation in Argentina
Lecture 247Drug Registration and Regulation in Bolivia
Lecture 248Drug Registration and Regulation in Brazil
Lecture 249Drug Registration and Regulation in CHILE
Lecture 250Drug Registration and Regulation in Colombia
Lecture 251Drug Registration and Regulation in Mexico
Lecture 252Drug regulation and registration in El Salvador
Lecture 253Central 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 254Middle East / MENA / GCC Countries Geographical Orientation
Lecture 255Middle East / MENA / GCC Countries National Regulatory Agencies
Lecture 256GCC Registration Procedure - Centralized and Decentralized Procedure | Detailed understanding on Centralized Registration Process
Lecture 257Drug Registration in Saudi Arabia
Lecture 258Drug Registration in UAE
Lecture 259Drug Registration and Regulatory Strategic Planning for Iran
Lecture 260Drug Registration and Regulatory Strategic Planning for Israel
Lecture 261Drug Registration and Regulatory Strategic Planning for Jordan
Lecture 262Drug Registration and Regulatory Strategic Planning for Iraq
Section 13China Drug Regulatory Affairs
Lecture 263Drug Registration and Regulation in China
Lecture 264China NMPA New Regulation Update July, 2020
Section 14Russia - EAEU Regulatory Affairs
Lecture 265Drug Registration and Submission Strategic Planning for Russia and EAEU region
Lecture 266GMP requirements in Russia
Section 15References | Discussions
Lecture 267Comparison of Requirement of Various Regulatory Bodies
Lecture 268Comparison of Dossier Requirements of Europe and US
Lecture 269Comparison of DMF requirement of various regulatory bodies
Lecture 270ICH CTD Top Level View with Notes and Explanation
Lecture 271ICH CTD Top Level View with Note and Explnation
Lecture 272Comparison of ICH US EU CTD
Lecture 273Regulatory Documents at a glance
Lecture 274Structured CMC Writing Checklist
Lecture 275Comparison of 505J 505b1 and 505b2 Pathway
Lecture 276New Update in Form 356h
Section 16Japan Drug Regulation and Registration Process
Lecture 277Introduction to Japan Drug Regulatory Affairs
Lecture 278Drug Discovery Development to commercialization | PMDA functions | Consultation | Premarket to post market approval
Lecture 279Drug Approval System | GCP | PMDA requirements
Lecture 280New Drug Application | Requirements | Review Process
Lecture 281Generic Drug Application Review and Approval
Lecture 282Marketing Authorization Process for registration of pharmaceutical in Japan
Lecture 283API Registration in Japan | Step By Step Process
Lecture 284Generic Registration | Patent - Patent Term Extension | Exclusivity | Re-examination System | Pediatric Designation | Patent Term Extension Case Studies
Lecture 285Priority Review Application | Criteria | Review Process | Timeline
Lecture 286Orphan Drug Designation in Japan
Lecture 287Japan DMF System | MF filing Process | Key points
Lecture 288Strategic Approval Pathway - Formulation Approval Quoting MF
Lecture 289SAKIGAKE designation
Section 17Drug Registration and Regulation in India
Lecture 290Drug 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 291Medicine Export Criteria from India
Lecture 292Documents for conducting BE Study for Export
Lecture 293New Drug Approval in DCGI
Lecture 294Line Extension New Strength Approval
Section 18Switzerland Drug Regulation and Registration (SWISS Regulation)
Lecture 295Introduction to Switzerland Healthcare System | Location | Country Information | Regulatory Bodies | Structure of Regulation | Market Authorization Types | Drug Biologic Food Dietary Supplement Regulation
Lecture 296Swiss Regulatory System | Simulations
Lecture 297Swiss and EU MRA | 2 Case Simulation | 5 Scenario Based assessments
Lecture 298Switzerland - International Agreement and Treaties
Lecture 299Swiss Pharma Regulatory Pathways | Types of Pathways | Case Based Simulations | Checklist File
Section 19Canada Drug Regulation and Submission Process
Lecture 300Structure of Canada’s Healthcare System | Health Canada | Canada Healthcare Act | CADTH | Provincial Drug Benefit programs | INESS
Lecture 301Important Terminologies with explanation
Lecture 302Key Regulatory Authorities | Functions | Comparison of different Regulatory Authorities
Lecture 303Market Authorization in Canada | Strategic Insights
Lecture 304Product classes and Submission Pathways
Section 20Introduction to AI in Regulatory Affairs
Lecture 305Introduction to AI
Lecture 306Basics of AI ML DL | Key Differences | Application in industry
Lecture 307Types of AI
Lecture 308AI Project | Overview
Lecture 309Comprehensive Training on AI Project | Managing Stages | AI Iteration
Lecture 310How machine learning
Lecture 311Understanding Regulatory Affairs – Traditional vs. Digital | 2 Case Study
Lecture 312Basics of AI for Regulatory Professionals | Understanding different models used in RA | Case Study | Simulation
Lecture 313AI Application across drug life cycle | Case Analysis | Model predictions
Lecture 314AI Terms with Regulatory Significance | Regulatory Applications
Lecture 315NLP in Regulatory Affairs | Conceptual understanding | Usage | NLP in Labeling
Lecture 316Data Grouping with Unsupervised Learning | Case Simulation | Hands on Exercise
Lecture 317Quality Data and Bias | Bias in datasets | Different Types of Bias in Pharma Datasets
Lecture 318AI Data Quality Standard | Checklist
Lecture 319Download AI Data Quality Checklist
Lecture 320Case Study: Accelerated Approval Using Real-World Evidence AI
Lecture 321AI Model for Dossier Submission and Filing - Model Selection | Simulation
Lecture 322AI Technologies in RA
Lecture 323Structured Vs. Unstructured Data | Practical Understanding | Explore Patient Datasets
Lecture 324Sample Data Exercise | Data error | Data Refinement and Cleaning of the data
Section 21AI-Powered Regulatory Document Authoring and CMC Writing
Lecture 325AI-Powered Regulatory Document Authoring and CMC Writing
Lecture 326AI Tools Comparison - Authoring and CMC Writing (Module 2 & 3)
Lecture 327Tips for Selecting AI Tools (CMC Authoring)
Lecture 328CMC - AI Workflow Checklist | Simulation Based Cases
Lecture 329HITL Regulatory Document Authoring
Lecture 330Confidence Score in Regulatory Authoring | Case Simulation in CMC Authoring
Lecture 331Confidence Scores in Data Extract in Regulatory Writing [Case Simulation]
Section 22eCTD v4.0 Training
Lecture 332eCTDV4.0 Fundamental Understanding | Structures | Key Features
Lecture 333eCTDV4.0 Structure | Lifecycle Management
Lecture 334eCTD Validation | Managing Validation | Tool Types | Types of Error | Validation Error Management
Lecture 335eCTD Validation Tools
Lecture 336eCTD Publishing Cycle
Lecture 337HL7 - Structure and Understanding in the context of eCTD V4.0
Lecture 338eCTD Submission Checklist Format
Section 23Risk and Compliance Management
Lecture 339AI and Data Integrity | Regulatory Documentation | Case Based Learning | Understanding Data Integrity Principles | Application and Use Cases
Lecture 340Cases of data breaches with explanation
Lecture 341Case Based Discussion : Data Breach in AI-Assisted CMC Drafting
Section 24AI in Regulatory Labelling and Artwork
Lecture 342CCDS Management
Lecture 343CCDS Management Tools - Native, AI Plus | Key Functionalities
Lecture 344AI Augmented Labelling Compliance System
Lecture 345Label Drift in CCDS Management | Simulation Case Study | AI Based Workflow in Label Drift detection and management
Lecture 346AI Review of Labels, PI and SMPC with help of the Case Based Simulation | 4 Case Simulations
Lecture 347CCDS Management Case Study | Pregnancy Warning Upgrade Case Study
Lecture 348CCDS Management Case Study | Dosage Section Conflict | Case Based Analysis
Lecture 349Centralized Artwork Operation | Mechanism | Operation Step Planning
Lecture 350Case Study on Centralized Artwork Operation [Recall Management]
Lecture 351Artwork Management Terms | Key Understanding on Terminologies | Usage in Artwork Cases
Section 25 Real World Evidence and Real World Data | Strategic Decision Making
Lecture 352Evidence Based Decision Making | Combine evidences for decision making | Do we need more evidence?
Lecture 353RWD and RWE | Potential sources of RWE | Traditional RCTs vs. RWE | Case Study - RWE Programs | Influencing HCP decision-making
Lecture 354RWD and RWE in Product Lifecycle Management
Lecture 355RWD and RWE - Fit to use | Assessment
Lecture 356RWD data sources | Different types | Detailed understanding of each class
Lecture 357RWD Study Design
Lecture 358vRWE Published Tool | Insights on commonly used tools
Lecture 359Healthcare Reimbursement Models : Value Based Care | Fee for Service (FFS) Model | Other Reimbursement Models
Lecture 360Consensus Narrative Review
Lecture 361Electronic Patient Data | EMR | EHR | Differences | Software architecture and characteristics
Lecture 362Active Surveillance Schemes | Active Case Finding |Sentinel Surveillance | Cohort Studies | Vaccine Safety Surveillance | Pharmacovigilance Programs | Disease Registries |Event Monitoring
Lecture 363RWD Characteristics
Lecture 364RCT vs. RWE Comparison | Case Based Analysis
Lecture 365RCT and RWE Comparison
Section 26Working on Healthcare Datasets
Lecture 366Introduction to Healthcare Datasets
Lecture 367Dataset 1: Claims Data (Insurance)
Lecture 368Dataset 2: Retail Pharmacy Prescription Data
Lecture 369Dataset 3: Longitudinal Patient Data
Lecture 370Characteristics of Different Set of Healthcare Data
Lecture 371Reimbursement and Pricing Datasets
Lecture 372RWE Data Sources & Quality Considerations Checklist | Case Based Analysis
Lecture 373Triangulation and benchmarking | Enhancing Data Validation Through Cross-Referencing
Lecture 374RWD & RWE Case Database
Lecture 375RWE Large Dataset for Data Crunching Exercises |Data cleaning & preprocessing | Comparative Effectiveness Analysis
Section 27AI Tools, Ethics and Future Landscape
Lecture 376AI Reg Tools - Review | Understanding Capabilities
Lecture 377Regulatory Authority View on AI Adoption
Lecture 378Data Sensitivity | Levels | Consequences | Management
Lecture 379Governance Flowchart – AI Tools in GxP Environments
Section 28AI Tools
Lecture 380RA Example - Generalist Vs. Specialist AI Tools
Lecture 381AI Generalist Overview (Life Science Focus)
Lecture 382Horizontal vs Vertical AI Tools
Lecture 383AI Tool Assessment Test
Lecture 384Citation Verification Workflow | AI Tools Management | Hallucination and HITL Action Plan
Section 29Prompt Engineering
Lecture 385Prompt Engineering – Basic Foundations of Prompt Writing | Different Prompt Framework | Case Based Examples
Lecture 386Special Prompting Structure - Case Based Prompt Designing
Lecture 387Special Prompting Structure - Case Based Prompt Designing
Lecture 388Workflow for writing AI Prompts with Life Science Industry Use Cases
Lecture 389PE Parameters | Controlling Creativity, Accuracy, and Output Behavior for Life-Science Applications | Simulation based decision making
Lecture 390How to adjust the parameters | Techniques
Lecture 391Creating A Detailed Regulatory Prompt | Designing Structured Prompt in Code Editor
Section 30Request for course certification
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