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 35Introduction to intellectual Property Management
Lecture 36Introduction to Patent
Lecture 37Understanding on Patent System
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 65New Indication Approval Process and Promotion
Lecture 66OTC Switch
Section 4Good Manufacturing Practices
Lecture 67Certification Pharmaceutical Companies / Plants
Lecture 68Premises & Plant Layout Designing
Lecture 69Sanitation and Hygiene
Lecture 70Equipment
Lecture 71Production Modules
Lecture 72GMP Documentation
Lecture 73Quality Control
Lecture 74Handling of Product Complaint
Lecture 75GMP Storage
Lecture 76ISO and ISO Audits
Lecture 77Pharmaceutical SOPs
Lecture 78PDE Value | Importance, Significance | How to calculate PDE value
Lecture 79Quality Risk Management | ICH Q9 | ISO 14971 | Principle of Risk Management
Lecture 80Introduction 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 81WHO-GMP Certification Scheme
Lecture 82Template of Certificate of Pharmaceutical product | Key observations and points to note while working on CoPP
Lecture 83WHO Prequalification Status : Significance | Strategic Importance | Submission Process | WHO PQ Documentation | Case study on WHO PQ submission management
Lecture 84WHO 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 85Introduction to Common Technical Document (CTD)
Lecture 86CMC Dossier & Compliance Management
Lecture 87Electronic Common Technical Document (ECTD)
Lecture 88Advance Practical Training on Dossier Preparation focusing on drug registration in export countries
Lecture 89Modules on Stability Study : Stability Study - Fundamental Understanding | Interchangebility | Reports | API & FPP Stability Study
Lecture 90Key Consideration for Drug Master File Preparation and Submission
Lecture 91Practical Understanding on Drug Master File Preparation and Submission
Lecture 92Site Master File - Detailed Understanding
Lecture 93DMF Completeness Assessment
Lecture 94Drug Master File - Fees
Lecture 95Drug Master File - Global Perspective [Across Different Regions]
Lecture 96Importance of effective dossier management
Lecture 97Common deficiencies in CTD submission dossier
Lecture 98Certificate of Analysis
Lecture 99Detailed Understanding on ANDA Fees
Lecture 100Prior Approval Submission
Lecture 101Detailed Understanding on ANDA Fees
Lecture 102Detailed Understanding on 505(b)(2) VS. Suitability Petition : Case Based Learning
Lecture 103NCE Vs. 505b2 application - Case Based Learning
Lecture 104FTF - 180 Days Exclusivity - Case Based Learning
Lecture 105Classic case study of the 505b2 filing : Case Based Learning
Lecture 106Strategic Planning in Combating 30 months stay strategies of innovator company- Case Based Learning
Lecture 107Climate Zone
Lecture 108Stability Zone Finder
Lecture 109Stability Studies : Case discussions
Lecture 110Stability Data for Zone IV countries
Lecture 111Accelerated and intermediate testing conditions
Lecture 112Long Term Stability Testing Requirements
Lecture 113Stability Study Protocol Development - Dosage form: Capsule
Lecture 114Stability Data Sheet
Lecture 115Dossier Stability Test
Lecture 116Testing Frequency
Lecture 117Bracketing
Lecture 118Matrixing
Lecture 119PKPD in Drug Discovery | PK-PD trial | Understanding PKPD from regulatory perspective in drug approval process
Lecture 120Bioequivalence Study | Study design | Different types of BE Studies
Lecture 121Bioequivalence 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 122Biopharmaceutical Classification System (BCS) | Types | Biowaivers | BCS tool for drug development and regulatory submission
Lecture 123Bioequivalence Study - Discussion - Timeline of stability study and bioequivalence study
Lecture 124Bioequivalence Study - Discussion - Dissolution Testing
Lecture 125Bioequivalence Study - Generic Approval and Additives Labeling Requirements
Lecture 126Introduction to Variation Management | Reasons for Variation | Working in Variation Department
Lecture 127Variation Classification | Basis of Classification | US and EU Variation Classification | Other region variation guideline.
Lecture 128Health Supplement - Stability Study | Study Design - Batch Selection | Testing Frequency | Reduced Batches | Storage Condition | Container Closure System
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 | Global Biologics Market – By Product | By Therapeutic Class | By Region
Lecture 159Introduction to Biologics and Biosimilar | Key differences | Concept of Reference Product
Lecture 160Differences in Chemical Drug Vs. Biologic Drugs | Key features of Biologic
Lecture 161Principle of Naming of Biologic | Understanding on MAB naming system
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 183mAB - At a glance
Lecture 184ATMPs - at a glance
Lecture 185CAR-T Therapy | Different Types of CAR-T Therapy | Mechanism of action | Challenges | Brainstorming on Concept of Personalized Medicine | Understanding on marketed formulation
Lecture 186Live Biotherapeutic Products | LBPs | Class | Mechanism | Indication Positioning | Regulatory Requirements for LBPs
Section 8European Drug Regulatory Affairs
Lecture 187Introduction to EU Regulation
Lecture 188Orientation to European Countries and National Regulatory Bodies
Lecture 189EU Drug Discovery Development to Commercialization (Step By Step)
Lecture 190Overview of EU Regulation
Lecture 191EMA and EMA Authorisation Process
Lecture 192EU MA Application Types and Strategic Planning
Lecture 193EU MA Procedure - Centralised, Decentralised, Mutual Recognition, National Procedure
Lecture 194EU MA Strategic Planning: Full, Full-mixed, hybrid applications. Generic, Similar biologic application pathway, Well-established use application, Fixed combination application, Informed consent application
Lecture 195Validity 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 196Data Exclusivity and Market Protection - Supplementary Patent Protection, Exclusivity, 6/10 Rule, 8+2+1 Formulae
Lecture 197EU Orphan Medicinal Products Regulation
Lecture 198Conditional marketing authorisation | Marketing authorisation under exceptional circumstances
Lecture 199Summary of Product Characteristics
Lecture 200Compassionate Use
Lecture 201MHRA - UK Regulation
Lecture 202The 'sunset clause' for marketing authorisation of pharmaceuticals
Lecture 203Paediatric use marketing authorisation (PUMA) & Paediatric Investigation Plan (PIP)
Lecture 204EU variation -Types, Requirement & Planning - IA, IAIN, IB, II ; US FDA Variation AR, CBE-0, CBE-30, PAS - Strategic Discussion | Similarities & Differentiation
Lecture 205EU Prime Designation
Lecture 206Accelerated assessment by EMEA
Lecture 207EU Adaptive Pathway
Lecture 208European public assessment report (EPAR) - Importance, Component, Management, Updation
Lecture 209SPOR - Concept of Master Data Management
Lecture 210PDE Value : What is PDE value of API? Significance and How PDE value is derived?
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 Kuwait
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 Drug 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 Guidelines - Comprehensive View
Lecture 271ICH CTD Top Level View with Notes and Explanation
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 16Drug Registration and Regulation in Japan
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 in India
Lecture 290Import Export of Pharmaceuticals from India
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 18US MEDICAL DEVICES | Development to Commercialization Cycle
Lecture 295Overview of US Medical Devices Market
Lecture 296Definition of Medical Devices
Lecture 297Classification of Medical Devices
Lecture 298Medical Devices Classification : Work File
Lecture 299Medical Device Development to Commercialization Process | Understanding Key Stages and respective stage level activities | Important MDR terminologies
Lecture 300How to establish the classification of the medical device
Lecture 301FDA Product Code Database : Hands on Training
Lecture 302513(g) Application : Request, User Fees, Review Process
Section 19510K PRE-MARKET NOTIFICATION
Lecture 303510k - Pre-market Notification
Lecture 304Predicate Devices | Substantially Equivalent (SE)
Lecture 305Understanding on 510k | Types of the 510k | Timeline | Difference with PMA
Lecture 306FDA decision making process for different classes of 510k applications
Lecture 307Review Test
Section 20PREMARKET APPROVAL (PMA) APPLICATION
Lecture 308Premarket approval (PMA) application
Lecture 309Differences between 510k VS. PMA
Lecture 310Data Requirements for A Premarket Approval (PMA) application
Lecture 311Data Requirements for A Premarket Approval (PMA) application
Lecture 312PMA Post Submission - Management of CRL - Timeline and Strategic Planning
Lecture 313Labeling Requirement for Medical Devices
Lecture 314Investigational Device Exemption | Device Clinical Research | Early/Expanded Access of Medical Devices | Q-Sub | IDE Submission Requirements
Lecture 315Medical Devices Development to Commercialization Stages | Devices Clinical Trial | Stages | Critical differences with pharmaceutical clinical trial
Lecture 316Medical Devices Post Approval Variations | PMA supplement | PMA amendments | Variation Management Strategic Planning
Lecture 317Expedited review of devices
Lecture 318Expiration Dating
Lecture 319Device Master Files
Lecture 320Unapproved use of Medical Devices
Lecture 321Marketing, Advertising and Promotion of Medical Devices
Lecture 322FDA 513(g)
Lecture 323DeNovo Petition - Types of DeNovo Pathways | Details of Review Process | Strategic Planning
Lecture 324Humanitarian Device Exemption (HDE)
Section 21EU Regulation of Medical Devices
Lecture 325EU MDR Classification
Lecture 326EU MDD | EU MDR | Articles | Rules | Pages | Annex | Key Changes in EU MDR
Lecture 327EU MDR | Annexes | Key notes
Lecture 328EU Medical Device Regulation System | MDR | IVDR | UDI | EUDAMED | Requirements for manufacturer | Importer | Distributor | Declaration of Conformity (DoC)
Lecture 329EU MDR Guideline | EU MDR - Annexes
Lecture 330EU MDR Conformity Assessment procedure | Assessment of various classes and types of the devices | Key points to consider | Conformity assessment master chart
Lecture 331EU MDR Authorized Representatives | Mandate | Role and Responsibilities
Lecture 332EU MDR Compliance Process
Lecture 333Thumb Rules of Classification as per EU MDR Guideline | Invasive | Non-invasive | Active | Special Devices
Lecture 334Review : DDF DHF DMR MDF DHR
Section 22QMS, Documentation and Dossier Preparation
Lecture 335Medical Device Technical File
Lecture 336Medical Device Dossier Preparation | Section Wise Dossier Preparation | Key Requirements regarding dossier | Points to note regarding each section of the dossier
Lecture 337Quality Management System (QMS) for medical devices company
Lecture 338Quality Risk Management | ICH Q9 | ISO 14971 | Principle of Risk Management
Lecture 339Comparing Medical Device Regulations | 510k Submission | Technical File | Design History File | Design Master File
Lecture 340Medical Device Essential Principle Checklist | Documentation | Open file
Lecture 341Implant Card | Regulatory Importance | Content | How to design
Lecture 342c-GMP Requirement for Medical Devices
Lecture 343cGMP Scenario Analysis | Simulations
Section 23Medical Device Labeling Guideline | General Principles | Wherever applicable (specific) Labeling contents
Lecture 344Medical Device Labeling Guideline | General Principles | Wherever applicable (specific) Labeling contents
Lecture 345Instruction for Use (IFU) | Design and Development of IFU
Lecture 346UDI | Different Component | How to design
Section 24CE Marking
Lecture 347CE 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 348CE- Self Certification
Lecture 349General principles of the CE marking
Lecture 350Manufacturer Responsibilities
Lecture 351Third Party Medical Device Manufacturing & CE Marking
Lecture 352Classifying Medical Devices Based on the Type of Manufacturing Operation
Lecture 353Few Common Terminologies used in Medical Devices Industry
Lecture 354Step By Step CE Marking Process
Lecture 355Case Study
Section 25ISO 13485
Lecture 356Introduction to ISO 13485 | Importance | Comparison with various other standards
Lecture 357ISO 13485 Documentations | Different Sections | Case Studies
Lecture 358ISO 13485: 2016 - Different Clauses
Section 26Combination Product Regulatory Affairs
Lecture 359Combination Products Regulatory Affairs | Definition | Types | Requirements | cGMP considerations | Risk Management | CAPA
Lecture 360Combination Product RFD Designation Process | Importance | Timeline | Outcome Management
Lecture 361Combination 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 362Medical Devices Regulation in India | Overall understanding
Lecture 363Regulatory Landscape in India
Lecture 364Classification of the Medical Devices in India | Strategic Planning for the Submission
Lecture 365Notified and Non-notified Device | Submission Strategic Planning
Lecture 366Medical Devices Classification in India - Work Doc
Lecture 367Notified Devices | Registration Process
Lecture 368Medical Device Submission Strategic Pathways | Step by step Process
Lecture 369Medical Device Forms | Purposes
Lecture 370Non Regulatory Medical Devices
Lecture 371Medical Device Voluntary Registration | Documentation | Process
Lecture 372List of Notified Devices | Newly Notified Devices | Significance
Lecture 373List 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 376Medical Devices Regulation in African Countries: Algeria, Kenya, Nigeria, South Africa, Egypt
Lecture 377South Africa Medical Device Regulation
Lecture 378Egypt Medical Device Regulation
Lecture 379Kenya Medical Device Regulation
Lecture 380Nigeria Medical Device Regulation
Section 31MDSAP Training
Lecture 381Introduction to MDSAP | Objective | Significance | Role and responsibilities of stakeholders | Key benefits | MDSAP Process structure and Audit Tasks
Lecture 382QMS and MDSAP | Differences and Similarities | MDSAP Vs. ISO 13485 : Key objectives and differences
Lecture 383MDSAP Stakeholders
Lecture 384MDSAP Process Structure Audit Task
Lecture 385MDSAP Document Preparation
Section 32Swiss Regulatory Affairs
Lecture 386Introduction to Switzerland Healthcare System | Location | Country Information | Regulatory Bodies | Structure of Regulation | Market Authorization Types | Drug Biologic Food Dietary Supplement Regulation
Lecture 387Swiss Regulatory System | Simulations
Lecture 388Swiss and EU MRA | 2 Case Simulation | 5 Scenario Based assessments
Lecture 389Switzerland - International Agreement and Treaties
Lecture 390Swiss Pharma Regulatory Pathways | Types of Pathways | Case Based Simulations | Checklist File
Section 33Introduction to AI in Regulatory Affairs
Lecture 391Introduction to AI
Lecture 392Basics of AI ML DL | Key Differences | Application in industry
Lecture 393Types of AI
Lecture 394AI Project | Overview
Lecture 395Comprehensive Training on AI Project | Managing Stages | AI Iteration
Lecture 396How machine learning
Lecture 397Understanding Regulatory Affairs – Traditional vs. Digital | 2 Case Study
Lecture 398Basics of AI for Regulatory Professionals | Understanding different models used in RA | Case Study | Simulation
Lecture 399AI Application across drug life cycle | Case Analysis | Model predictions
Lecture 400AI Terms with Regulatory Significance | Regulatory Applications
Lecture 401NLP in Regulatory Affairs | Conceptual understanding | Usage | NLP in Labeling
Lecture 402Data Grouping with Unsupervised Learning | Case Simulation | Hands on Exercise
Lecture 403Quality Data and Bias | Bias in datasets | Different Types of Bias in Pharma Datasets
Lecture 404AI Data Quality Standard | Checklist
Lecture 405Download AI Data Quality Checklist
Lecture 406Case Study: Accelerated Approval Using Real-World Evidence AI
Lecture 407AI Model for Dossier Submission and Filing - Model Selection | Simulation
Lecture 408AI Technologies in RA
Lecture 409Structured Vs. Unstructured Data | Practical Understanding | Explore Patient Datasets
Lecture 410Sample Data Exercise | Data error | Data Refinement and Cleaning of the data
Section 34AI in Regulatory Authoring and CMC Writing
Lecture 411AI-Powered Regulatory Document Authoring and CMC Writing
Lecture 412AI Tools Comparison - Authoring and CMC Writing (Module 2 & 3)
Lecture 413Tips for Selecting AI Tools (CMC Authoring)
Lecture 414CMC - AI Workflow Checklist | Simulation Based Cases
Lecture 415HITL Regulatory Document Authoring
Lecture 416Confidence Score in Regulatory Authoring | Case Simulation in CMC Authoring
Lecture 417Confidence Scores in Data Extract in Regulatory Writing [Case Simulation]
Section 35eCTD v4.0 Training
Lecture 418eCTDV4.0 Fundamental Understanding | Structures | Key Features
Lecture 419eCTDV4.0 Structure | Lifecycle Management
Lecture 420eCTD Validation | Managing Validation | Tool Types | Types of Error | Validation Error Management
Lecture 421eCTD Validation Tools
Lecture 422eCTD Publishing Cycle
Lecture 423HL7 - Structure and Understanding in the context of eCTD V4.0
Lecture 424Tips and Submission Readiness Checklist
Lecture 425eCTD Submission Checklist Format
Section 36Risk and Compliance Management
Lecture 426AI and Data Integrity | Regulatory Documentation | Case Based Learning | Understanding Data Integrity Principles | Application and Use Cases
Lecture 427Cases of data breaches with explanation
Lecture 428Case Based Discussion : Data Breach in AI-Assisted CMC Drafting
Section 37AI in Regulatory Labelling and Artwork
Lecture 429CCDS Management
Lecture 430CCDS Management Tools - Native, AI Plus | Key Functionalities
Lecture 431AI Augmented Labelling Compliance System
Lecture 432abel Drift in CCDS Management | Simulation Case Study | AI Based Workflow in Label Drift detection and management
Lecture 433AI Review of Labels, PI and SMPC with help of the Case Based Simulation | 4 Case Simulations
Lecture 434CCDS Management Case Study | Pregnancy Warning Upgrade Case Study
Lecture 435CCDS Management Case Study | Dosage Section Conflict | Case Based Analysis
Lecture 436Centralized Artwork Operation | Mechanism | Operation Step Planning
Lecture 437Case Study on Centralized Artwork Operation [Recall Management]
Lecture 438Artwork Management Terms | Key Understanding on Terminologies | Usage in Artwork Cases
Section 38 Real World Evidence and Real World Data | Strategic Decision Making
Lecture 439Evidence Based Decision Making | Combine evidences for decision making | Do we need more evidence?
Lecture 440RWD and RWE | Potential sources of RWE | Traditional RCTs vs. RWE | Case Study - RWE Programs | Influencing HCP decision-making
Lecture 441RWD and RWE in Product Lifecycle Management
Lecture 442RWD and RWE - Fit to use | Assessment
Lecture 443RWD data sources | Different types | Detailed understanding of each class
Lecture 444RWD Study Design
Lecture 445RWE Published Tool | Insights on commonly used tools
Lecture 446Healthcare Reimbursement Models : Value Based Care | Fee for Service (FFS) Model | Other Reimbursement Models
Lecture 447Consensus Narrative Review
Lecture 448Electronic Patient Data | EMR | EHR | Differences | Software architecture and characteristics
Lecture 449Active Surveillance Schemes | Active Case Finding |Sentinel Surveillance | Cohort Studies | Vaccine Safety Surveillance | Pharmacovigilance Programs | Disease Registries |Event Monitoring
Lecture 450RWD Characteristics
Lecture 451RCT vs. RWE Comparison | Case Based Analysis
Lecture 452RCT and RWE Comparison
Section 39
Lecture 453Introduction to Healthcare Datasets
Lecture 454Dataset 1: Claims Data (Insurance)
Lecture 455Dataset 2: Retail Pharmacy Prescription Data
Lecture 456Dataset 3: Longitudinal Patient Data
Lecture 457Characteristics of Different Set of Healthcare Data
Lecture 458Reimbursement and Pricing Datasets
Lecture 459RWE Data Sources & Quality Considerations Checklist | Case Based Analysis
Lecture 460Triangulation and benchmarking | Enhancing Data Validation Through Cross-Referencing
Lecture 461RWD & RWE Case Database
Lecture 462RWE Large Dataset for Data Crunching Exercises |Data cleaning & preprocessing | Comparative Effectiveness Analysis
Section 40AI Tools, Ethics and Future Landscape
Lecture 463AI Reg Tools - Review | Understanding Capabilities
Lecture 464Regulatory Authority View on AI Adoption
Lecture 465Data Sensitivity | Levels | Consequences | Management
Lecture 466Governance Flowchart – AI Tools in GxP Environments
Section 41AI Tools
Lecture 467RA Example - Generalist Vs. Specialist AI Tools
Lecture 468AI Generalist Overview (Life Science Focus)
Lecture 469Horizontal vs Vertical AI Tools
Lecture 470AI Tool Assessment Test
Lecture 471Citation Verification Workflow | AI Tools Management | Hallucination and HITL Action Plan
Section 42Prompt Engineering
Lecture 472Prompt Engineering – Basic Foundations of Prompt Writing | Different Prompt Framework | Case Based Examples
Lecture 473Special Prompting Structure - Case Based Prompt Designing
Lecture 474Special Prompting Structure - Case Based Prompt Designing
Lecture 475PE04 Workflow for writing AI Prompts with Life Science Industry Use Cases
Lecture 476PE06 PE Parameters | Controlling Creativity, Accuracy, and Output Behavior for Life-Science Applications | Simulation based decision making
Lecture 477How to adjust the parameters | Techniques
Lecture 478Creating A Detailed Regulatory Prompt | Designing Structured Prompt in Code Editor
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