Introduction
Who should attend this course?
Features
Related Courses
About RA
This online drugs biologics medical devices regulatory affairs course provides understanding of regulation, registration process and strategic planning. This PG Certification trains Regulatory Affairs professionals for drug, biologic and medical devices Industry. This comprehensive drugs biologics medical devices 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.
Advance Your Regulatory Career Across All Fronts!
Drug | Biologic | Medical Device
Royed Training’s Drug, Biologic & Medical Device Regulatory Affairs Online Certification is a 360° comprehensive training covering:
- Understanding of product classification & global regulatory framework
- ️Detailed registration pathways
- Submission management & dossier preparation for all 3 domains
- AI in Regulatory Affairs – Ai powered regulatory authoring and Submission management
✅ Perfect for professionals aiming to master regulatory affairs in pharmaceuticals, biologics & medical devices – all in one power-packed course!
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 and medical devices discovery, development, investigational application, marketing authorization application, handling of different phases of clinical trial, generic approval process, Abbreviated drugs or medical devices approval process. Hence, the course covers fundamentals to advance learning on drugs, biologics and medical devices development, regulation, registration, ai in regulatory affairs and strategic management processes.
This comprehensive course in Drug, Biologic, and Medical Device Regulatory Affairs provides an in-depth understanding of the regulatory framework governing the development, approval, and post-market compliance of pharmaceuticals, biologics, and medical devices. This dynamic field plays a pivotal role in ensuring the safety and efficacy of healthcare products, as well as their timely market access. Participants will gain the knowledge and skills necessary to navigate the complex regulatory landscape, making them valuable assets to pharmaceutical and medical device companies, regulatory agencies, and related organizations.
Course Snapshots
- Course Code: RYD-077
- Title of the course: PG Certification in Drug, Biologic and Medical Devices Regulatory Affairs (PGDBMRA)
- Nature of the course : Online distance learning course. Hence, this course can be accessed online across anywhere 24×7. Moreover, you can attend the course at your convenience in your flexible time. For example, you want to attend the session at your 11 pm at night, you can do that.
- Duration of the course : 1 Year
- Eligibility: Graduation in any discipline.
- Course Certification : Certificate will be provided at the end of the successful completion of the course
Who should attend this course?
- Those who are in the regulatory affairs and related department.
- Professionals from drugs, biologics and medical devices industry.
- Anyone requiring an overview and detail understanding on working of regulatory affairs.
- Fresher or beginners, Those who want to make a career in the regulatory department.
- Healthcare professionals and researchers.
- Quality assurance and quality control personnel.
- FDA professionals and Government regulatory agency staff.
- Those seeking a career in regulatory affairs.
Objective of the course
- Understand the regulatory requirements and processes for drugs, biologics, and medical devices in various global markets.
- Gain insights into the lifecycle of these products, from development and clinical trials to post-market surveillance.
- Learn to interpret and apply relevant regulations, guidelines, and standards from regulatory authorities, including the FDA, EMA, and other agencies.
- Develop proficiency in preparing regulatory submissions and ensuring compliance with regulatory requirements.
- Appreciate the ethical and safety considerations integral to regulatory affairs, including pharmacovigilance and quality management.
- Acquire the skills to assess, mitigate, and manage risks associated with regulatory compliance.
Features of Drugs, Biologics and Medical Devices Regulatory Affairs Course
- This course covers all aspects of the drug, biologics and medical devices regulatory affairs in a single course. Hence, user need not to purchase the drugs, medical devices and biologics training separately.
- The course provides orientation to job related practical aspects of the regulatory managers. Therefore, on completion of the course, the participants will develop the hands on understanding on the regulatory affairs working.
- One of the important feature of the course is real life simulation on critical decision making process. Hence, these simulations help to enhance the regulatory strategic decision making.
Case Based Learning
- Advance training on drug registration requirements for various regulatory bodies.
- Access to Case Studies to learn about the drug and medical device registration steps. Hence, participants will develop advanced competency on drugs, biologics and medical devices strategic planning.
We also have 1 year Executive PG certification in International Drug Regulatory Affairs course. This course covers comprehensive regulatory training on pharmaceutical and biopharmaceuticals. Hence, those who don’t require Medical Devices regulatory knowledge can opt for the international drug regulatory affairs course.
Regulatory Affairs Training Courses
Career in Regulatory Affairs
A career in Regulatory Affairs is very challenging, but highly rewarding. But at the same time, it opens up lot of opportunities for professionals. Companies always look for the trained professionals for regulatory affairs department. This is because, the regulatory job covers a variety of disciplines. Hence, Regulatory professional involved involved in regulatory submission, compliance, clinical trials, quality assurance, drug safety, pharmacovigilance.
Comprehensive coverage of the topic from across different regional bodies
The drug, biologic and medical devices industry is growing at a rapid pace, but there is a rising concern over the safety and efficacy. Hence, the major objective of the regulatory department is to maintain safety and efficacy of the drugs and biopharmaceutical molecules. In fact, to maintain safety and efficacy in pharmaceutical and biopharmaceutical products, regulatory agencies like US FDA, EMA, MHRA UK, DCGI, TGA – Autrallia, NMPA – China etc. all over the world are imposing number of regulation. Moreover, these regulations are evolving and changing every other day. Regulatory professionals must have thorough knowledge about the updated regulations. Sound regulatory knowledge helps them to take strategic decision effectively. This has resulted in creation of regulatory department with certified regulatory affairs professionals. And it help companies to meet these requirements with ease.
Section 1Fundamental of Drug Discovery and Development
Lecture 1Introduction to R&D Process & drug discovery
Lecture 2Investigational New Drug Application
Lecture 3New Drug Application (NDA)
Lecture 4Basic concept and understanding of the Generic Drug
Lecture 5Abbreviated New Drug Application (ANDA)
Lecture 6Preformulation Study in Drug Development
Lecture 7Regulatory Requirements for Preformulation Study
Lecture 8Logical Sequence of Preformulation Study | Case Insights | Strategies for preformulation studies
Lecture 9Regulatory Requirements for Non-clinical Studies | Types of Non-clinical studies
Lecture 10Types and Timing of Non-clinical Studies
Lecture 11Exploratory IND Vs. Traditional IND
Lecture 12Patent & Exclusivity - Strategic Understanding | Patent Restoration| Orphan Drug Exclusivity (ODE) | NCE & NCI Exclusivity | GAIN Exclusivity | Pediatric Exclusivity | 180 days exclusivity
Lecture 13Orphan Drug Designation
Lecture 14Review on Drug Discovery and Development
Lecture 15Understanding on Clinical Trials and Clinical Research
Lecture 16Clinical Trial Protocol Writing
Lecture 17Ethics in Clinical Research
Lecture 18Informed Consent | Practical Training on preparing ICF | Ready Templates
Lecture 19FDA Forms and How to fill the resources
Lecture 20Strategic Discussion: PreIND, EOP1, EOP2 - What to expect !
Lecture 21Chemistry, Manufacturing & Controls
Lecture 22Fundamental of CMC | Detailed understanding of CMC section writing | Important Points regarding CMC | Drug Product and Drug Substance | Excipient, FP, Analysis and Stability Study Requirements
Lecture 23505(j) ANDA, 505(b)(2) NDA, 505(b)(1) NDA
Lecture 24Advance Learning on 505B2 Pathway
Lecture 25Authorized Generics: Key Understanding
Lecture 26USFDA expedited programs
Lecture 27Complete Response Letter | Key understanding | Management and Action Plan
Lecture 28Introduction to ICH | Members | Guidelines
Lecture 29ICH Q1 : Stability Guideline | Matrixing | Bracketing
Lecture 30ICH Q2 : Analytical Validation
Lecture 31ICH Q3 : Impurities
Lecture 32Rest of ICH Q Family Guidelines
Lecture 33Emergency Use Authorization (EUA) | EUA Pathways | Criteria | Justification | Early Discussion with FDA | LOA | Factsheets
Lecture 34Handling of orange book
Section 2Innovation / Intellectual Property Management
Lecture 35General Introduction to intellectual Property Management
Lecture 36Introduction to Intellectual Property in Life Sciences | Types of IP | Introduction to Patent Portfolio Strategy
Lecture 37Introduction to Patent
Lecture 38Global Pharmaceutical Patent Landscape | Strategic Overview of Global Patent Filing and Protection
Lecture 39Understanding on Patent System
Lecture 40Patent Grant and Managing Patent Filing Procedure
Lecture 41Scope of Patentability
Lecture 42Stages of Patent Grant Procedure
Lecture 43Patent search in Indian Patent Office
Lecture 44Global Pharmaceutical Patent Filing Strategy
Lecture 45PCT Patent Filing Flow
Lecture 46Patentability Criteria in Pharmaceuticals | Practical Case Study
Lecture 47Patent Law Framework for Pharmaceuticals
Lecture 48Understanding and Decoding Section 3(d) of the Indian Patent Act | Case Based Analysis
Lecture 49Evergreening vs Genuine Innovation in Pharmaceutical Patents | Evergreening and Genuine Innovation Evaluation
Lecture 50Pharmaceutical Patent Lifecycle - Integrated Layer Strategy
Lecture 51Blockbuster Drug Patent Thicket Strategy
Lecture 52Types of Pharmaceutical Patents | Patent Layering StrategiesTypes of Pharmaceutical Patents
Lecture 53Understanding Patent Searching Process
Lecture 54IPC and CPC - Importance and Significance in Patent Search
Lecture 55IPC Structures for Pharmaceutical Patents
Lecture 56Freedom-to-Operate (FTO) | FTO Risk Assessment | Strategic Management
Lecture 57FTO Decision Tree – Generic Drug Launch Strategy
Lecture 58Fundamental of Pharmaceutical Patent Drafting | Structure | Component | Claim Anatomy | Effective Claim Writing
Lecture 59Pharmaceutical Patent Risk Management Framework
Lecture 60Patent Claim Coverage - Practical Example
Lecture 61Pharmaceutical Patent Filing Procedure and Global Filing Strategy | PCT Filing | Timeline
Lecture 62Advanced Understanding on Patent Opposition and Patent Litigation in Pharmaceutical Domain
Lecture 63Patent Prosecution and Handling Examiner Objections
Lecture 64Pharmaceutical Patent Portfolio Management | How to build and manage pharma patent portfolio
Lecture 65Pharmaceutical Patent Valuation and Licensing
Section 3 Regulatory Strategic Management and planning
Lecture 66Regulatory Strategies in different phases of Clinical Trial
Lecture 67Advance study on Para IV Filing
Lecture 68Para IV Notice
Lecture 69Evergreening - Patent Life Extension Strategies
Lecture 70Pay For Delay Strategy
Lecture 71REMS Strategic Planning
Lecture 72Compulsory Licensing
Lecture 73Licensing & Technology Transfer
Lecture 74In-Licensing Vs. Outlicensing
Lecture 75LOE Strategies for Innovator Brands with case study
Lecture 76Paediatric Exclusivity and Paediatric Study Plan Development
Lecture 77Drug Re-purposing
Lecture 78Practical Queries on different USFDA application and Filing
Lecture 79Publication Management from Regulatory perspective
Lecture 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 100Introduction to Common 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
Lecture 123Stability Zone Finder
Lecture 124Stability Studies : Case discussions
Lecture 125Stability Data for Zone IV countries
Lecture 126Accelerated and intermediate testing conditions
Lecture 127Long Term Stability Testing Requirements
Lecture 128Stability Study Protocol Development - Dosage form: Capsule
Lecture 129Stability Data Sheet
Lecture 130Dossier Stability Test
Lecture 131Testing Frequency
Lecture 132Bracketing
Lecture 133Matrixing
Lecture 134PKPD in Drug Discovery | PK-PD trial | Understanding PKPD from regulatory perspective in drug approval process
Lecture 135Bioequivalence Study | Study design | Different types of BE Studies
Lecture 136Bioequivalence 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 137Biopharmaceutical Classification System (BCS) | Types | Biowaivers | BCS tool for drug development and regulatory submission
Lecture 138Bioequivalence Study - Discussion - Timeline of stability study and bioequivalence study
Lecture 139Bioequivalence Study - Discussion - Dissolution Testing
Lecture 140Bioequivalence Study - Generic Approval and Additives Labeling Requirements
Lecture 141Introduction to Variation Management | Reasons for Variation | Working in Variation Department
Lecture 142Variation Classification | Basis of Classification | US and EU Variation Classification | Other region variation guideline.
Lecture 143Health Supplement - Stability Study | Study Design - Batch Selection | Testing Frequency | Reduced Batches | Storage Condition | Container Closure System
Lecture 144CMC Writing Case Study | Successful Documentation
Lecture 145Structure for CMC Writing | Understanding 3.2.S and 3.2.P section | Documents requirements | Case Study
Lecture 146Well written Vs. Poorly Written CMC Section | Practical Example
Lecture 147Drug Substance Section in CMC | Documentations | Practical Examples | Do’s and Don’ts
Lecture 148Example 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 149Stability Studies and Data Presentation in CMC Writing | Case Based Analysis of Stability Study Data Presentation | Interpretation of stability data
Lecture 150Developing Specifications for a New API
Lecture 151Example of Manufacturing Process and Controls
Lecture 152Interpretation of Stability Table
Lecture 153Critical Stability Scenarios | 8 Different Case Studies | Stability Study - Outcome based action plan creation
Lecture 154Critical Stability Issues - Database | Implication | Action Plan
Lecture 155Common Pitfalls in CMC Writing and How to Avoid Them | Case Study
Lecture 156Grouped Submission | Significance | Importance in Market Access and Regulatory point of view | Case Study
Lecture 157Process Validation Report (PVR) | Sample Process Validation Report Analysis | CPPs and CQAs identification
Lecture 158Case Study - Omissions of CPPs in PVR | Case insight, explanation, action plan | Correlations - CPPs - CQAs - IPCs
Lecture 159Supplemental New Drug Application (sNDA) | Filing and Submission Management | Requirements | Best Practices | Different Forms for sNDA submissions
Lecture 160BA BE Study Design | Comparing different types of the study design
Lecture 1612wco Study Design | Design Table | Importance
Lecture 1623wco Study Design | Design Table | Importance
Lecture 163FRCO Study Design | Design Table | Importance
Lecture 164Parallel Vs. Crossover Study Design
Lecture 165OGD Table - How to Prepare | Sample Tabular Summary Preparation
Lecture 166Impact Assessment in CMC Writing | Case Based Discussion| Scenario Decision Making
Lecture 167RfR in Generic Drug Approval | Overview, Process, and Best Practices
Section 6Quality issues, Warning Letter, CAPA and Data Integrity
Lecture 168Data Integrity issues in Pharmaceutical Industry
Lecture 169Establishment Inspection Report | 483 Observations | USFDA Warning Letter | Handling of FDA inspection | Closing of Warning Letter
Lecture 170Electronic Batch Record for effective compliance management | Key Understanding | Functionalities | Importance in managing data integrity
Lecture 171RTQs | Response to Queries | How to handle Regulatory Queries
Section 7Biopharmaceutical (Biologics and Biosimilar) Regulations
Lecture 172Introduction of Biologics
Lecture 173Classification of Biopharmaceutical | Global Biologics Market – By Product | By Therapeutic Class | By Region
Lecture 174Introduction to Biologics and Biosimilar | Key differences | Concept of Reference Product
Lecture 175Differences in Chemical Drug Vs. Biologic Drugs | Key features of Biologic
Lecture 176Principle of Naming of Biologic | Understanding on MAB naming system
Lecture 177Recombinant protein
Lecture 178Monoclonal Antibodies Vs. Polyclonal Antibodies
Lecture 179Monoclonal Antibodies
Lecture 180Synthetic Immunomodulators
Lecture 181Production of Monoclonal Antibodies
Lecture 182Cytokines
Lecture 183Interferon
Lecture 184Erythropoiesis-stimulating agent
Lecture 185Biological Licensing Application (BLA) | 351(a) application | Form 356h | Differentiation with NDA | Timeline | Handling FDA queries
Lecture 186Abbreviated Biosimilar Application - 351(k): Advance Strategic Planning Process : Originator Vs. Biosimilar Development and Regulatory Approval Process | Reference Biologic | Purple Book | Data Requirements
Lecture 187Purple Book: Significance | Searching | Assignments
Lecture 188Vaccine development and approval Process
Lecture 189PDUFA For Biologics
Lecture 190Biosimilar Development Process
Lecture 191Strategic Consideration for Biosimilar Development
Lecture 192Bio-Manufacturing Process Information
Lecture 193Studies required for approval of biosimilar
Lecture 194Regulatory Requirements for Biosimilar | Stepwise evidence based development | Analytical Similarity | Clinical Study | PKPD study requirements | CMC expectation of Biosimilar
Lecture 195Comparability of Biologics | Different Categories of Comparability | General Principles
Lecture 196CQA (Critical Quality Attribute) and CPP (Critical Process Parameter)
Lecture 197ATMPs | Types and Classification | Regulatory Mechanism
Lecture 198mAB - At a glance
Lecture 199ATMPs - at a glance
Lecture 200CAR-T Therapy | Different Types of CAR-T Therapy | Mechanism of action | Challenges | Brainstorming on Concept of Personalized Medicine | Understanding on marketed formulation
Lecture 201Live Biotherapeutic Products | LBPs | Class | Mechanism | Indication Positioning | Regulatory Requirements for LBPs
Section 8European Drug Regulatory Affairs
Lecture 202EU Regulatory System Fundamentals
Lecture 203Introduction to EU Regulation
Lecture 204Orientation to European Countries and National Regulatory Bodies
Lecture 205EMA and EMA Authorisation Process
Lecture 206EMA and EMA Authorisation Process
Lecture 207Centralised vs DCP vs MRP vs National Procedure - Detailed Strategic Insight
Lecture 208EU MA Application Types and Strategic Planning
Lecture 209EU MA Procedure - Centralised, Decentralised, Mutual Recognition, National Procedure
Lecture 210EU MA Strategic Planning: Full, Full-mixed, hybrid applications. Generic, Similar biologic application pathway, Well-established use application, Fixed combination application, Informed consent application
Lecture 211Validity 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 212Structured Practical understanding of EU legal bases | Understanding Data Requirements
Lecture 213Practical understanding of EU legal bases for Marketing Authorisation Applications (MAA) | Decision Tree
Lecture 214Centralised Procedure Timetable and Review Logic
Lecture 215DCP / MRP / National Procedure – Practical Workflow Module
Lecture 216EU Procedures Critical Operational Steps - Validation • Clock-Stop • List of Questions • Approval • National Phase
Lecture 217DCP vs MRP Timeline
Lecture 218EU Adaptive Pathway
Lecture 219European public assessment report (EPAR) - Importance, Component, Management, Updation
Lecture 220SPOR - Concept of Master Data Management
Lecture 221The 'sunset clause' for marketing authorisation of pharmaceuticals
Lecture 222LoQ Response Strategy - EU Regulatory Procedures (CP / DCP / MRP) – Winning the Day 120 / Mid-Cycle Response
Lecture 223Response to list of Questions (LoQ)
Lecture 224Response to list of outstanding issues (LoOI) - Day 180 / Final Assessment Phase Response
Lecture 225Oral Explanation Training Module - CHMP / CMDh Oral Defence Strategy – From Data to Approval
Lecture 226CHMP - Question Bank Real-Life Regulatory Questions + Model Answers (CP / DCP / MRP)
Lecture 227Conditional marketing authorisation | Marketing authorisation under exceptional circumstances
Lecture 228Compassionate Use
Lecture 229EU Prime Designation
Lecture 230MHRA - UK Regulation
Lecture 231Summary of Product Characteristics
Lecture 232Drug Registration and Submission Strategic Planning for Russia and EAEU region
Lecture 233Accelerated assessment by EMEA
Lecture 234Certificate of Suitability (CEP) | Significance | Importance | Understanding Regulatory Compliance and Submission Process | Walkthrough
Lecture 235CEP Dossier DMF - Differences
Lecture 236Policy 0070 | RPDP Submission and Management timeline | Anonymisation Report (AnR) - Significance | AnR in FRDP
Lecture 237Comprehensive EU Clinical Trial Regulatory Affairs – CTA, CTIS, Strategy & Execution
Lecture 238CTIS Operating Model – Advanced EUClinical Trial Execution Module
Lecture 239CTA Structure: Part I / Part II (EU Clinical Trials Regulation)
Lecture 240Country-wise Part II Requirement Master
Lecture 241CTIS Hands-on Simulation Module Step-by-Step Clinical Trial Submission Exercise (CTR Execution Training)
Lecture 242EU CTR Advanced Module - Substantial Modifications, Safety Reporting, Transition Lessons & End-of-Trial Obligation
Lecture 243IMPD | Significance | Format of IMPD | Differences with CTA, IB, IND
Lecture 244Investigator’s Brochure | Significance | Format of IB | Preparing different sections of IB
Lecture 245Patent Landscape & Freedom to Operate (FTO) – EU Perspective - Strategic Regulatory + IP Integration Module (Drugs & Biologics)
Lecture 246EU Data Exclusivity, Market Protection & Orphan Exclusivity
Lecture 247Data Exclusivity and Market Protection - Supplementary Patent Protection, Exclusivity, 6/10 Rule, 8+2+1 Formulae
Lecture 248EU Orphan Medicinal Products Regulation
Lecture 249Paediatric use marketing authorisation (PUMA) & Paediatric Investigation Plan (PIP)
Lecture 250EU Supplementary Protection Certificates (SPC) & Paediatric Rewards
Lecture 251Patent vs Regulatory Exclusivity vs Trademark vs Launch Sequencing (EU Perspective)
Lecture 252“No EU-Style Patent Linkage” – What It Really Means (EU vs US)
Lecture 253EU vs US Regulatory–IP Framework
Lecture 254Global Patent + Exclusivity Timeline Dashboard - Executive-Level Strategic Tool (EU + US + Global Integration)
Lecture 255Full EU Submission Strategy Planner
Section 9ASEAN Drug Regulatory Affairs
Lecture 256ASEAN Countries | Introduction | Geographical Overview
Lecture 257ASEAN countries drug regulatory bodies
Lecture 258ASEAN Common Technical Requirements (ACTRs)
Lecture 259The Pharmaceutical Inspection Co-operation Scheme
Lecture 260CPP Requirements for Drug Registration in ASEAN countries
Lecture 261Dossier Requirements - ACTD/CTD Acceptability
Lecture 262Pharmacopoeias Acceptability
Lecture 263Harmonization of Technical Guidelines
Lecture 264Stability Study requirements for drug registration in ASEAN countries
Lecture 265Guideline on product labelling
Lecture 266Post Approval Changes (Variations) requirements in ASEAN countries
Lecture 267Pharmacovigilance and Risk Management Plan (RMP)
Lecture 268Timeline of Drug Registration Approval
Lecture 269ASEAN Drug Regulations : Comparison Study | Guidelines | Pharmaceutical products Regulatory Submissions | Pharmacopoeia Requirements | stability requirements | Pharmacovigilance | Product labeling | Drug variation information
Lecture 270Drug Registration and Regulation Singapore | Strategic Pathways for Marketing Authorization | Screening, Evaluation of MA applications | Variations Classifications and Management
Lecture 271Drug Registration and Regulation in Brunei
Lecture 272Drug Registration and Regulation in Cambodia
Section 10African Drug Regulatory Affairs
Lecture 273African Continent Overview - Brief introduction to course
Lecture 274African Pharma Market
Lecture 275Drug Registration - African medicines regulatory agencies
Lecture 276Basic Export Requirement for African Countries
Lecture 277Export Documentations & Important Concepts
Lecture 278Drug Registration and Regulation in Nigeria
Lecture 279Drug Registration in Algeria
Lecture 280Drug Registration in Ethiopia
Lecture 281Drug Registration in Kenya
Lecture 282Drug Registration in Egypt
Lecture 283Drug Registration in Ghana
Lecture 284Drug Registration in Botswana
Lecture 285Drug Registration and Regulation in Uganda
Lecture 286Drug Registration in Zambia
Section 11Latam Regulatory Affairs
Lecture 287Introduction to Latam
Lecture 288Drug Registration and Regulation in Argentina
Lecture 289Drug Registration and Regulation in Bolivia
Lecture 290Drug Registration and Regulation in Brazil
Lecture 291Drug Registration and Regulation in CHILE
Lecture 292Drug Registration and Regulation in Colombia
Lecture 293Drug Registration and Regulation in Mexico
Lecture 294Drug regulation and registration in El Salvador
Lecture 295Central 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 296Middle East / MENA / GCC Countries Geographical Orientation
Lecture 297Middle East / MENA / GCC Countries National Regulatory Agencies
Lecture 298GCC Registration Procedure - Centralized and Decentralized Procedure | Detailed understanding on Centralized Registration Process
Lecture 299Drug Registration in Saudi Arabia
Lecture 300Drug Registration in Kuwait
Lecture 301Drug Registration and Regulatory Strategic Planning for Iran
Lecture 302Drug Registration and Regulatory Strategic Planning for Israel
Lecture 303Drug Registration and Regulatory Strategic Planning for Jordan
Lecture 304Drug Registration and Regulatory Strategic Planning for Iraq
Section 13China Drug Regulatory Affairs
Lecture 305Drug Registration and Regulation in China
Lecture 306China NMPA New Regulation Update July, 2020
Section 14Russia Drug Regulatory Affairs
Lecture 307Drug Registration and Submission Strategic Planning for Russia and EAEU region
Lecture 308GMP requirements in Russia
Section 15References | Discussions
Lecture 309Comparison of Requirement of Various Regulatory Bodies
Lecture 310Comparison of Dossier Requirements of Europe and US
Lecture 311Comparison of DMF requirement of various regulatory bodies
Lecture 312ICH Guidelines - Comprehensive View
Lecture 313ICH CTD Top Level View with Notes and Explanation
Lecture 314Comparison of ICH US EU CTD
Lecture 315Regulatory Documents - at a glance
Lecture 316Structured CMC Writing Checklist
Lecture 317Comparison of 505J 505b1 and 505b2 Pathway
Lecture 318New Update in Form 356h
Section 16Drug Registration and Regulation in Japan
Lecture 319Introduction to Japan Drug Regulatory Affairs
Lecture 320Drug Discovery Development to commercialization | PMDA functions | Consultation | Premarket to post market approval
Lecture 321Drug Approval System | GCP | PMDA requirements
Lecture 322New Drug Application | Requirements | Review Process
Lecture 323Generic Drug Application Review and Approval
Lecture 324Marketing Authorization Process for registration of pharmaceutical in Japan
Lecture 325API Registration in Japan | Step By Step Process
Lecture 326Generic Registration | Patent - Patent Term Extension | Exclusivity | Re-examination System | Pediatric Designation | Patent Term Extension Case Studies
Lecture 327Priority Review Application | Criteria | Review Process | Timeline
Lecture 328Orphan Drug Designation in Japan
Lecture 329Japan DMF System | MF filing Process | Key points
Lecture 330Strategic Approval Pathway - Formulation Approval Quoting MF
Lecture 331SAKIGAKE designation
Section 17Drug Registration in India
Lecture 332Import Export of Pharmaceuticals from India
Lecture 333Medicine Export Criteria from India
Lecture 334Documents for conducting BE Study for Export
Lecture 335New Drug Approval in DCGI
Lecture 336Line Extension New Strength Approval
Section 18US MEDICAL DEVICES | Development to Commercialization Cycle
Lecture 337Overview of US Medical Devices Market
Lecture 338Definition of Medical Devices
Lecture 339Classification of Medical Devices
Lecture 340Medical Devices Classification : Work File
Lecture 341Medical Device Development to Commercialization Process | Understanding Key Stages and respective stage level activities | Important MDR terminologies
Lecture 342How to establish the classification of the medical device
Lecture 343FDA Product Code Database : Hands on Training
Lecture 344513(g) Application : Request, User Fees, Review Process
Section 19510K PRE-MARKET NOTIFICATION
Lecture 345510k - Pre-market Notification
Lecture 346Predicate Devices | Substantially Equivalent (SE)
Lecture 347Understanding on 510k | Types of the 510k | Timeline | Difference with PMA
Lecture 348FDA decision making process for different classes of 510k applications
Lecture 349Review Test
Section 20PREMARKET APPROVAL (PMA) APPLICATION
Lecture 350Premarket approval (PMA) application
Lecture 351Differences between 510k VS. PMA
Lecture 352Data Requirements for A Premarket Approval (PMA) application
Lecture 353Data Requirements for A Premarket Approval (PMA) application
Lecture 354PMA Post Submission - Management of CRL - Timeline and Strategic Planning
Lecture 355Labeling Requirement for Medical Devices
Lecture 356Investigational Device Exemption | Device Clinical Research | Early/Expanded Access of Medical Devices | Q-Sub | IDE Submission Requirements
Lecture 357Medical Devices Development to Commercialization Stages | Devices Clinical Trial | Stages | Critical differences with pharmaceutical clinical trial
Lecture 358Medical Devices Post Approval Variations | PMA supplement | PMA amendments | Variation Management Strategic Planning
Lecture 359Expedited review of devices
Lecture 360Expiration Dating
Lecture 361Device Master Files
Lecture 362Unapproved use of Medical Devices
Lecture 363Marketing, Advertising and Promotion of Medical Devices
Lecture 364FDA 513(g)
Lecture 365DeNovo Petition - Types of DeNovo Pathways | Details of Review Process | Strategic Planning
Lecture 366Humanitarian Device Exemption (HDE)
Section 21EU Regulation of Medical Devices
Lecture 367EU MDR Classification
Lecture 368EU MDD | EU MDR | Articles | Rules | Pages | Annex | Key Changes in EU MDR
Lecture 369EU MDR | Annexes | Key notes
Lecture 370EU Medical Device Regulation System | MDR | IVDR | UDI | EUDAMED | Requirements for manufacturer | Importer | Distributor | Declaration of Conformity (DoC)
Lecture 371EU MDR Guideline | EU MDR - Annexes
Lecture 372EU MDR Conformity Assessment procedure | Assessment of various classes and types of the devices | Key points to consider | Conformity assessment master chart
Lecture 373EU MDR Authorized Representatives | Mandate | Role and Responsibilities
Lecture 374EU MDR Compliance Process
Lecture 375Thumb Rules of Classification as per EU MDR Guideline | Invasive | Non-invasive | Active | Special Devices
Lecture 376Review : DDF DHF DMR MDF DHR
Section 22QMS, Documentation and Dossier Preparation
Lecture 377Medical Device Technical File
Lecture 378Medical Device Dossier Preparation | Section Wise Dossier Preparation | Key Requirements regarding dossier | Points to note regarding each section of the dossier
Lecture 379Quality Management System (QMS) for medical devices company
Lecture 380Quality Risk Management | ICH Q9 | ISO 14971 | Principle of Risk Management
Lecture 381Comparing Medical Device Regulations | 510k Submission | Technical File | Design History File | Design Master File
Lecture 382Medical Device Essential Principle Checklist | Documentation | Open file
Lecture 383Implant Card | Regulatory Importance | Content | How to design
Lecture 384c-GMP Requirement for Medical Devices
Lecture 385cGMP Scenario Analysis | Simulations
Section 23Medical Device Labeling Guideline | General Principles | Wherever applicable (specific) Labeling contents
Lecture 386Medical Device Labeling Guideline | General Principles | Wherever applicable (specific) Labeling contents
Lecture 387Instruction for Use (IFU) | Design and Development of IFU
Lecture 388UDI | Different Component | How to design
Section 24CE Marking
Lecture 389CE Marking | Introduction | Self Certification | General principles of the CE marking | Manufacturer Responsibilities | Third Party Medical Device Manufacturing & CE Marking | Step By Step CE Marking Process
Lecture 390CE- Self Certification
Lecture 391General principles of the CE marking
Lecture 392Manufacturer Responsibilities
Lecture 393Third Party Medical Device Manufacturing & CE Marking
Lecture 394Classifying Medical Devices Based on the Type of Manufacturing Operation
Lecture 395Few Common Terminologies used in Medical Devices Industry
Lecture 396Step By Step CE Marking Process
Lecture 397Case Study
Section 25ISO 13485
Lecture 398Introduction to ISO 13485 | Importance | Comparison with various other standards
Lecture 399ISO 13485 Documentations | Different Sections | Case Studies
Lecture 400ISO 13485: 2016 - Different Clauses
Section 26Combination Product Regulatory Affairs
Lecture 401Combination Products Regulatory Affairs | Definition | Types | Requirements | cGMP considerations | Risk Management | CAPA
Lecture 402Combination Product RFD Designation Process | Importance | Timeline | Outcome Management
Lecture 403Combination Products Pre-market Approval Process | Lead centers | Concept of Primary Mode of Action | Strategic Submission Pathways
Section 27From Voluntary Registration to Mandatory Licensing – Current Status (2025)
Lecture 404Medical Devices Regulation in India | Overall understanding
Lecture 405Regulatory Landscape in India
Lecture 406Classification of the Medical Devices in India | Strategic Planning for the Submission
Lecture 407Notified and Non-notified Device | Submission Strategic Planning
Lecture 408Medical Devices Classification in India - Work Doc
Lecture 409Notified Devices | Registration Process
Lecture 410Medical Device Submission Strategic Pathways | Step by step Process
Lecture 411Medical Device Forms | Purposes
Lecture 412Non Regulatory Medical Devices
Lecture 413Medical Device Voluntary Registration | Documentation | Process
Lecture 414List of Notified Devices | Newly Notified Devices | Significance
Lecture 415List of Notified Bodies with CDSCO
Section 28Medical Devices Regulation in Asian Countries - UAE, Bangladesh, Bahrain, Indonesia, China, India, Iran, Jordan, Japan, Kuwait, Korea, Lebanon, Malaysia, Pakistan, Philippines, Saudi Arabia, Singapore, Vietnam
Section 29Medical Devices Regulation in Latam Countries: Argentina, Brazil, Colombia, Chile, Mexico, Paraguay, Uruguay
Section 30Medical Devices Regulation in African Countries: Algeria, Kenya, Nigeria, South Africa, Egypt
Lecture 418Medical Devices Regulation in African Countries: Algeria, Kenya, Nigeria, South Africa, Egypt
Lecture 419South Africa Medical Device Regulation
Lecture 420Egypt Medical Device Regulation
Lecture 421Kenya Medical Device Regulation
Lecture 422Nigeria Medical Device Regulation
Section 31MDSAP Training
Lecture 423Introduction to MDSAP | Objective | Significance | Role and responsibilities of stakeholders | Key benefits | MDSAP Process structure and Audit Tasks
Lecture 424QMS and MDSAP | Differences and Similarities | MDSAP Vs. ISO 13485 : Key objectives and differences
Lecture 425MDSAP Stakeholders
Lecture 426MDSAP Process Structure Audit Task
Lecture 427MDSAP Document Preparation
Section 32Swiss Regulatory Affairs
Lecture 428Introduction to Switzerland Healthcare System | Location | Country Information | Regulatory Bodies | Structure of Regulation | Market Authorization Types | Drug Biologic Food Dietary Supplement Regulation
Lecture 429Swiss Regulatory System | Simulations
Lecture 430Swiss and EU MRA | 2 Case Simulation | 5 Scenario Based assessments
Lecture 431Switzerland - International Agreement and Treaties
Lecture 432Swiss Pharma Regulatory Pathways | Types of Pathways | Case Based Simulations | Checklist File
Section 33Introduction to AI in Regulatory Affairs
Lecture 433Introduction to AI
Lecture 434Basics of AI ML DL | Key Differences | Application in industry
Lecture 435Types of AI
Lecture 436AI Project | Overview
Lecture 437Comprehensive Training on AI Project | Managing Stages | AI Iteration
Lecture 438How machine learning
Lecture 439Understanding Regulatory Affairs – Traditional vs. Digital | 2 Case Study
Lecture 440Basics of AI for Regulatory Professionals | Understanding different models used in RA | Case Study | Simulation
Lecture 441AI Application across drug life cycle | Case Analysis | Model predictions
Lecture 442AI Terms with Regulatory Significance | Regulatory Applications
Lecture 443NLP in Regulatory Affairs | Conceptual understanding | Usage | NLP in Labeling
Lecture 444Data Grouping with Unsupervised Learning | Case Simulation | Hands on Exercise
Lecture 445Quality Data and Bias | Bias in datasets | Different Types of Bias in Pharma Datasets
Lecture 446AI Data Quality Standard | Checklist
Lecture 447Download AI Data Quality Checklist
Lecture 448Case Study: Accelerated Approval Using Real-World Evidence AI
Lecture 449AI Model for Dossier Submission and Filing - Model Selection | Simulation
Lecture 450AI Technologies in RA
Lecture 451Structured Vs. Unstructured Data | Practical Understanding | Explore Patient Datasets
Lecture 452Sample Data Exercise | Data error | Data Refinement and Cleaning of the data
Section 34AI in Regulatory Authoring and CMC Writing
Lecture 453AI-Powered Regulatory Document Authoring and CMC Writing
Lecture 454AI Tools Comparison - Authoring and CMC Writing (Module 2 & 3)
Lecture 455Tips for Selecting AI Tools (CMC Authoring)
Lecture 456CMC - AI Workflow Checklist | Simulation Based Cases
Lecture 457HITL Regulatory Document Authoring
Lecture 458Confidence Score in Regulatory Authoring | Case Simulation in CMC Authoring
Lecture 459Confidence Scores in Data Extract in Regulatory Writing [Case Simulation]
Section 35eCTD v4.0 Training
Lecture 460eCTDV4.0 Fundamental Understanding | Structures | Key Features
Lecture 461eCTDV4.0 Structure | Lifecycle Management
Lecture 462eCTD Validation | Managing Validation | Tool Types | Types of Error | Validation Error Management
Lecture 463eCTD Validation Tools
Lecture 464eCTD Publishing Cycle
Lecture 465HL7 - Structure and Understanding in the context of eCTD V4.0
Lecture 466Tips and Submission Readiness Checklist
Lecture 467eCTD Submission Checklist Format
Section 36Risk and Compliance Management
Lecture 468AI and Data Integrity | Regulatory Documentation | Case Based Learning | Understanding Data Integrity Principles | Application and Use Cases
Lecture 469Cases of data breaches with explanation
Lecture 470Case Based Discussion : Data Breach in AI-Assisted CMC Drafting
Section 37AI in Regulatory Labelling and Artwork
Lecture 471CCDS Management
Lecture 472CCDS Management Tools - Native, AI Plus | Key Functionalities
Lecture 473AI Augmented Labelling Compliance System
Lecture 474abel Drift in CCDS Management | Simulation Case Study | AI Based Workflow in Label Drift detection and management
Lecture 475AI Review of Labels, PI and SMPC with help of the Case Based Simulation | 4 Case Simulations
Lecture 476CCDS Management Case Study | Pregnancy Warning Upgrade Case Study
Lecture 477CCDS Management Case Study | Dosage Section Conflict | Case Based Analysis
Lecture 478Centralized Artwork Operation | Mechanism | Operation Step Planning
Lecture 479Case Study on Centralized Artwork Operation [Recall Management]
Lecture 480Artwork Management Terms | Key Understanding on Terminologies | Usage in Artwork Cases
Section 38 Real World Evidence and Real World Data | Strategic Decision Making
Lecture 481Evidence Based Decision Making | Combine evidences for decision making | Do we need more evidence?
Lecture 482RWD and RWE | Potential sources of RWE | Traditional RCTs vs. RWE | Case Study - RWE Programs | Influencing HCP decision-making
Lecture 483RWD and RWE in Product Lifecycle Management
Lecture 484RWD and RWE - Fit to use | Assessment
Lecture 485RWD data sources | Different types | Detailed understanding of each class
Lecture 486RWD Study Design
Lecture 487RWE Published Tool | Insights on commonly used tools
Lecture 488Healthcare Reimbursement Models : Value Based Care | Fee for Service (FFS) Model | Other Reimbursement Models
Lecture 489Consensus Narrative Review
Lecture 490Electronic Patient Data | EMR | EHR | Differences | Software architecture and characteristics
Lecture 491Active Surveillance Schemes | Active Case Finding |Sentinel Surveillance | Cohort Studies | Vaccine Safety Surveillance | Pharmacovigilance Programs | Disease Registries |Event Monitoring
Lecture 492RWD Characteristics
Lecture 493RCT vs. RWE Comparison | Case Based Analysis
Lecture 494RCT and RWE Comparison
Section 39
Lecture 495Introduction to Healthcare Datasets
Lecture 496Dataset 1: Claims Data (Insurance)
Lecture 497Dataset 2: Retail Pharmacy Prescription Data
Lecture 498Dataset 3: Longitudinal Patient Data
Lecture 499Characteristics of Different Set of Healthcare Data
Lecture 500Reimbursement and Pricing Datasets
Lecture 501RWE Data Sources & Quality Considerations Checklist | Case Based Analysis
Lecture 502Triangulation and benchmarking | Enhancing Data Validation Through Cross-Referencing
Lecture 503RWD & RWE Case Database
Lecture 504RWE Large Dataset for Data Crunching Exercises |Data cleaning & preprocessing | Comparative Effectiveness Analysis
Section 40AI Tools, Ethics and Future Landscape
Lecture 505AI Reg Tools - Review | Understanding Capabilities
Lecture 506Regulatory Authority View on AI Adoption
Lecture 507Data Sensitivity | Levels | Consequences | Management
Lecture 508Governance Flowchart – AI Tools in GxP Environments
Section 41AI Tools
Lecture 509RA Example - Generalist Vs. Specialist AI Tools
Lecture 510AI Generalist Overview (Life Science Focus)
Lecture 511Horizontal vs Vertical AI Tools
Lecture 512AI Tool Assessment Test
Lecture 513Citation Verification Workflow | AI Tools Management | Hallucination and HITL Action Plan
Section 42Prompt Engineering
Lecture 514Prompt Engineering – Basic Foundations of Prompt Writing | Different Prompt Framework | Case Based Examples
Lecture 515Special Prompting Structure - Case Based Prompt Designing
Lecture 516Special Prompting Structure - Case Based Prompt Designing
Lecture 517PE04 Workflow for writing AI Prompts with Life Science Industry Use Cases
Lecture 518PE06 PE Parameters | Controlling Creativity, Accuracy, and Output Behavior for Life-Science Applications | Simulation based decision making
Lecture 519How to adjust the parameters | Techniques
Lecture 520Creating A Detailed Regulatory Prompt | Designing Structured Prompt in Code Editor
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