Introduction
Who should attend
Features
Related Courses
About RA
This online life Science Regulatory Affair course provides understanding of regulation, registration process and strategic planning. This PG Certification trains Regulatory Affairs professionals for drug, biologic, medical devices, fmcg, food, dietary supplement / nutraceutical, cosmetic Industry. This comprehensive regulatory affairs training involves the real life job simulations. Hence, the course provides practical knowledge. Moreover, this course focuses on how regulatory professionals work in the life science company. Therefore, it helps users to understand the key responsibilities and job functions.
In these comprehensive self-paced modules, participants gain a deep understanding of the entire development-to-commercialization journey of drugs, biologics, and medical devices. Step by step, you’ll explore how innovative products progress from discovery and development to investigational applications, clinical trials, and marketing authorization.
Moreover, the course goes beyond traditional learning—it dives into generic drug approval processes, abbreviated pathways, and accelerated approvals for drugs and medical devices, ensuring you grasp every critical regulatory milestone.
Transitioning from fundamentals to advanced concepts, the program covers diverse regulated sectors including pharmaceuticals, biologics, medical devices, cosmetics, food, and nutraceuticals. You’ll not only master the regulatory, registration, and strategic management frameworks, but also understand how these domains interconnect in today’s global life-science ecosystem.
Most importantly, the course features a dedicated focus on Artificial Intelligence (AI) in Regulatory Affairs—a revolutionary area shaping the future of compliance, dossier preparation, and regulatory submissions. With AI now driving efficiency, accuracy, and decision-making across the regulatory lifecycle, this module empowers professionals to stay ahead in an increasingly digital regulatory environment.
In short, this training helps you transform from a traditional regulatory professional into an AI-empowered expert, ready to navigate evolving global regulations with confidence and strategic insight.
One of the standout features of Royed Training’s course is its expansive reach. This program doesn’t limit itself to just one segment of the life sciences industry. Instead, it encompasses a wide range of sectors, including:
- Pharmaceuticals: Understanding drug regulations and compliance.
- Biologics: Navigating complex biological product approvals.
- Medical Devices: Meeting safety standards and regulatory requirements for medical equipment.
- Food and FMCG: Comprehending food safety regulations and compliance for fast-moving consumer goods.
- Cosmetics: Ensuring adherence to cosmetic regulatory guidelines.
- Dietary Supplements/Nutraceuticals: Mastering rules governing nutritional products.
Hence, this comprehensive course in life science Regulatory Affairs provides an in-depth understanding of the regulatory framework governing the development, approval, and post-market compliance. This dynamic field plays a pivotal role in ensuring the safety and efficacy of healthcare products, as well as their timely market access. In fact, 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-119
- Title of the course: Executive PG Certification in Life Science Regulatory Affairs (EPLsRA)
- 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, medical devices, food, dietary supplement, cosmetics 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 Life Science Regulatory Affairs course. This course covers comprehensive regulatory training on pharmaceutical and biopharmaceuticals regulatory affairs.
Life Science Training Courses
Course Code |
Course |
Duration |
RYD-118 |
Life Science Global Management |
1 Year |
RYD-112 |
Life Science Business Consulting |
1 Year |
RYD-119 |
Life Science Regulatory Affairs |
1 Year |
Regulatory Affairs Training Courses
Career in Life Science Regulatory Affairs
Life Science Regulatory Affairs is a field within the life sciences industry that deals with the regulatory requirements and processes necessary for the development, approval, and marketing of pharmaceuticals, medical devices, biologics, food, dietary supplment / nutraceutical. cosmetic and other healthcare products. It involves ensuring that these products meet the standards and regulations set by governmental agencies such as the Food and Drug Administration (FDA) in the United States, the European Medicines Agency (EMA) in Europe, and similar regulatory bodies worldwide.
Professionals in this field are responsible for interpreting and implementing regulations, preparing and submitting regulatory documents for approval, communicating with regulatory agencies on behalf of their companies, and ensuring compliance throughout the product lifecycle. They play a critical role in helping companies navigate the complex regulatory landscape to bring safe and effective products to market while meeting legal requirements.
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 80Juxtapid Case Study
Lecture 81New Indication Approval Process and Promotion
Lecture 82OTC Switch
Section 4Good Manufacturing Practices
Lecture 83Certification Pharmaceutical Companies / Plants
Lecture 84Premises & Plant Layout Designing
Lecture 85Sanitation and Hygiene
Lecture 86Equipment
Lecture 87Production Modules
Lecture 88GMP Documentation
Lecture 89Quality Control
Lecture 90Handling of Product Complaint
Lecture 91GMP Storage
Lecture 92ISO and ISO Audits
Lecture 93Pharmaceutical SOPs
Lecture 94PDE Value | Importance, Significance | How to calculate PDE value
Lecture 95Quality Risk Management | ICH Q9 | ISO 14971 | Principle of Risk Management
Lecture 96Introduction to Certificate of Pharmaceutical Product | Types of CoPP | List of Countries / Regulatory Authorities who requires CoPP | CoPP as a part of generic market expansion planning
Lecture 97WHO-GMP Certification Scheme
Lecture 98Template of Certificate of Pharmaceutical product | Key observations and points to note while working on CoPP
Section 5 Submission Dossier : CTD | ACTD | DMF - SMF-ANDA | 505(b)(2) | NCE | Petittion| Prior Approval Submission
Lecture 99Introduction to Common Technical Document (CTD)
Lecture 100CMC Dossier & Compliance Management
Lecture 101Electronic Common Technical Document (ECTD)
Lecture 102Advance Practical Training on Dossier Preparation focusing on drug registration in export countries
Lecture 103Modules on Stability Study : Stability Study - Fundamental Understanding | Interchangebility | Reports | API & FPP Stability Study
Lecture 104Key Consideration for Drug Master File Preparation and Submission
Lecture 105Practical Understanding on Drug Master File Preparation and Submission
Lecture 106Site Master File - Detailed Understanding
Lecture 107DMF Completeness Assessment
Lecture 108Drug Master File - Fees
Lecture 109Drug Master File - Global Perspective [Across Different Regions]
Lecture 110Importance of effective dossier management
Lecture 111Common deficiencies in CTD submission dossier
Lecture 112Certificate of Analysis
Lecture 113Detailed Understanding on ANDA Fees
Lecture 114Prior Approval Submission
Lecture 115Detailed Understanding on ANDA Fees
Lecture 116Detailed Understanding on 505(b)(2) VS. Suitability Petition : Case Based Learning
Lecture 117NCE Vs. 505b2 application - Case Based Learning
Lecture 118FTF - 180 Days Exclusivity - Case Based Learning
Lecture 119Classic case study of the 505b2 filing : Case Based Learning
Lecture 120Strategic Planning in Combating 30 months stay strategies of innovator company- Case Based Learning
Lecture 121Climate Zone
Lecture 122Stability Zone Finder
Lecture 123Stability Studies : Case discussions
Lecture 124Case Study: Managing Stability Study for Zone IV countries
Lecture 125Accelerated and intermediate testing conditions
Lecture 126Long Term Stability Testing Requirements
Lecture 127Stability Study Protocol Development - Dosage form: Capsule
Lecture 128Stability Data Sheet
Lecture 129Dossier Stability Test
Lecture 130Testing Frequency
Lecture 131Bracketing
Lecture 132Matrixing
Lecture 133PKPD in Drug Discovery | PK-PD trial | Understanding PKPD from regulatory perspective in drug approval process
Lecture 134Bioequivalence Study | Study design | Different types of BE Studies
Lecture 135Bioequivalence 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 136Biopharmaceutical Classification System (BCS) | Types | Biowaivers | BCS tool for drug development and regulatory submission
Lecture 137Bioequivalence Study - Discussion - Timeline of stability study and bioequivalence study
Lecture 138Bioequivalence Study - Discussion - Dissolution Testing
Lecture 139Bioequivalence Study - Generic Approval and Additives Labeling Requirements
Lecture 140Introduction to Variation Management | Reasons for Variation | Working in Variation Department
Lecture 141Variation Classification | Basis of Classification | US and EU Variation Classification | Other region variation guideline.
Lecture 142Health Supplement - Stability Study | Study Design - Batch Selection | Testing Frequency | Reduced Batches | Storage Condition | Container Closure System
Lecture 143Setting Dissolution Specification for Generic Products | Regulatory Expectations
Lecture 144Regulatory Requirements for Biosimilar | Stepwise evidence based development | Analytical Similarity | Clinical Study | PKPD study requirements | CMC expectation of Biosimilar
Lecture 145CMC Writing Case Study | Successful Documentation
Lecture 146Structure for CMC Writing | Understanding 3.2.S and 3.2.P section | Documents requirements | Case Study
Lecture 147Well written Vs. Poorly Written CMC Section | Practical Example
Lecture 148Drug Substance Section in CMC | Documentations | Practical Examples | Do’s and Don’ts
Lecture 149Example 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 150Stability Studies and Data Presentation in CMC Writing | Case Based Analysis of Stability Study Data Presentation | Interpretation of stability data
Lecture 151Developing Specifications for a New API
Lecture 152Example of Manufacturing Process and Controls
Lecture 153Interpretation of Stability Table
Lecture 154Critical Stability Scenarios | 8 Different Case Studies | Stability Study - Outcome based action plan creation
Lecture 155Critical Stability Issues - Database | Implication | Action Plan
Lecture 156Common Pitfalls in CMC Writing and How to Avoid Them | Case Study
Lecture 157Grouped Submission | Significance | Importance in Market Access and Regulatory point of view | Case Study
Lecture 158Process Validation Report (PVR) | Sample Process Validation Report Analysis | CPPs and CQAs identification
Lecture 159Case Study - Omissions of CPPs in PVR | Case insight, explanation, action plan | Correlations - CPPs - CQAs - IPCs
Lecture 160Supplemental New Drug Application (sNDA) | Filing and Submission Management | Requirements | Best Practices | Different Forms for sNDA submissions
Lecture 161BA BE Study Design | Comparing different types of the study design
Lecture 1622wco Study Design | Design Table | Importance
Lecture 1633wco Study Design | Design Table | Importance
Lecture 164FRCO Study Design | Design Table | Importance
Lecture 165Parallel Vs. Crossover Study Design
Lecture 166OGD Table - How to Prepare | Sample Tabular Summary Preparation
Lecture 167Impact Assessment in CMC Writing | Case Based Discussion| Scenario Decision Making
Lecture 168RfR in Generic Drug Approval | Overview, Process, and Best Practices
Section 6Quality issues, Warning Letter, CAPA and Data Integrity
Lecture 169Data Integrity issues in Pharmaceutical Industry
Lecture 170Establishment Inspection Report | 483 Observations | USFDA Warning Letter | Handling of FDA inspection | Closing of Warning Letter
Lecture 171Electronic Batch Record for effective compliance management | Key Understanding | Functionalities | Importance in managing data integrity
Lecture 172RTQs | Response to Queries | How to handle Regulatory Queries
Section 7Biopharmaceutical (Biologics and Biosimilar) Regulations
Lecture 173Introduction of Biologics
Lecture 174Classification of Biopharmaceutical | Global Biologics Market – By Product | By Therapeutic Class | By Region
Lecture 175Introduction to Biologics and Biosimilar | Key differences | Concept of Reference Product
Lecture 176Differences in Chemical Drug Vs. Biologic Drugs | Key features of Biologic
Lecture 177Principle of Naming of Biologic | Understanding on MAB naming system
Lecture 178Recombinant protein
Lecture 179Monoclonal Antibodies Vs. Polyclonal Antibodies
Lecture 180Monoclonal Antibodies
Lecture 181Synthetic Immunomodulators
Lecture 182Production of Monoclonal Antibodies
Lecture 183Cytokines
Lecture 184Interferon
Lecture 185Erythropoiesis-stimulating agent
Lecture 186Biological Licensing Application (BLA) | 351(a) application | Form 356h | Differentiation with NDA | Timeline | Handling FDA queries
Lecture 187Abbreviated Biosimilar Application - 351(k): Advance Strategic Planning Process : Originator Vs. Biosimilar Development and Regulatory Approval Process | Reference Biologic | Purple Book | Data Requirements
Lecture 188Purple Book: Significance | Searching | Assignments
Lecture 189Vaccine development and approval Process
Lecture 190PDUFA For Biologics
Lecture 191Biosimilar Development Process
Lecture 192Strategic Consideration for Biosimilar Development
Lecture 193Bio-Manufacturing Process Information
Lecture 194Studies required for approval of biosimilar
Lecture 195Regulatory Requirements for Biosimilar | Stepwise evidence based development | Analytical Similarity | Clinical Study | PKPD study requirements | CMC expectation of Biosimilar
Lecture 196Comparability of Biologics | Different Categories of Comparability | General Principles
Lecture 197CQA (Critical Quality Attribute) and CPP (Critical Process Parameter)
Lecture 198ATMPs | Types and Classification | Regulatory Mechanism
Lecture 199mAB - At a glance
Lecture 200ATMPs - at a glance
Lecture 201CAR-T Therapy | Different Types of CAR-T Therapy | Mechanism of action | Challenges | Brainstorming on Concept of Personalized Medicine | Understanding on marketed formulation
Lecture 202Live Biotherapeutic Products | LBPs | Class | Mechanism | Indication Positioning | Regulatory Requirements for LBPs
Lecture 203Regulatory Requirements for Biosimilar | Stepwise evidence based development | Analytical Similarity | Clinical Study | PKPD study requirements | CMC expectation of Biosimilar
Section 8European Drug Regulatory Affairs
Lecture 204Introduction to EU Regulation
Lecture 205Orientation to European Countries and National Regulatory Bodies
Lecture 206EU Drug Discovery Development to Commercialization (Step By Step)
Lecture 207Overview of EU Regulation
Lecture 208EMA and EMA Authorisation Process
Lecture 209EU MA Application Types and Strategic Planning
Lecture 210EU MA Procedure - Centralised, Decentralised, Mutual Recognition, National Procedure
Lecture 211EU MA Strategic Planning: Full, Full-mixed, hybrid applications. Generic, Similar biologic application pathway, Well-established use application, Fixed combination application, Informed consent application
Lecture 212Validity 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 213Data Exclusivity and Market Protection - Supplementary Patent Protection, Exclusivity, 6/10 Rule, 8+2+1 Formulae
Lecture 214EU Orphan Medicinal Products Regulation
Lecture 215Conditional marketing authorisation | Marketing authorisation under exceptional circumstances
Lecture 216Summary of Product Characteristics
Lecture 217Compassionate Use
Lecture 218MHRA - UK Regulation
Lecture 219The 'sunset clause' for marketing authorisation of pharmaceuticals
Lecture 220Paediatric use marketing authorisation (PUMA) & Paediatric Investigation Plan (PIP)
Lecture 221EU variation -Types, Requirement & Planning - IA, IAIN, IB, II ; US FDA Variation AR, CBE-0, CBE-30, PAS - Strategic Discussion | Similarities & Differentiation
Lecture 222EU Prime Designation
Lecture 223Accelerated assessment by EMEA
Lecture 224EU Adaptive Pathway
Lecture 225European public assessment report (EPAR) - Importance, Component, Management, Updation
Lecture 226SPOR - Concept of Master Data Management
Lecture 227PDE Value : What is PDE value of API? Significance and How PDE value is derived?
Section 9ASEAN Drug Regulatory Affairs
Lecture 228Introduction to ASEAN - Drug Regulatory Affairs
Lecture 229ASEAN Countries | Introduction | Geographical Overview
Lecture 230ASEAN countries drug regulatory bodies
Lecture 231ASEAN Common Technical Requirements (ACTRs)
Lecture 232The Pharmaceutical Inspection Co-operation Scheme
Lecture 233CPP Requirements for Drug Registration in ASEAN countries
Lecture 234Dossier Requirements - ACTD/CTD Acceptability
Lecture 235Pharmacopoeias Acceptability
Lecture 236Harmonization of Technical Guidelines
Lecture 237Stability Study requirements for drug registration in ASEAN countries
Lecture 238Guideline on product labelling
Lecture 239Post Approval Changes (Variations) requirements in ASEAN countries
Lecture 240Pharmacovigilance and Risk Management Plan (RMP)
Lecture 241Timeline of Drug Registration Approval
Lecture 242ASEAN Drug Regulations : Comparison Study | Guidelines | Pharmaceutical products Regulatory Submissions | Pharmacopoeia Requirements | stability requirements | Pharmacovigilance | Product labeling | Drug variation information
Lecture 243Drug Registration and Regulation Singapore | Strategic Pathways for Marketing Authorization | Screening, Evaluation of MA applications | Variations Classifications and Management
Lecture 244Drug Registration and Regulation in Brunei
Lecture 245Drug Registration and Regulation in Cambodia
Section 10African Drug Regulatory Affairs
Lecture 246African Continent Overview - Brief introduction to course
Lecture 247African Pharma Market
Lecture 248Drug Registration - African medicines regulatory agencies
Lecture 249Basic Export Requirement for African Countries
Lecture 250Export Documentations & Important Concepts
Lecture 251Drug Registration and Regulation in Nigeria
Lecture 252Drug Registration in Algeria
Lecture 253Drug Registration in Ethiopia
Lecture 254Drug Registration in Kenya
Lecture 255Drug Registration in Egypt
Lecture 256Drug Registration in Ghana
Lecture 257Drug Registration in Botswana
Lecture 258Drug Registration and Regulation in Uganda
Lecture 259Drug Registration in Zambia
Section 11Latam Regulatory Affairs
Lecture 260Introduction to Latam
Lecture 261Drug Registration and Regulation in Argentina
Lecture 262Drug Registration and Regulation in Bolivia
Lecture 263Drug Registration and Regulation in Brazil
Lecture 264Drug Registration and Regulation in CHILE
Lecture 265Drug Registration and Regulation in Colombia
Lecture 266Drug Registration and Regulation in Mexico
Lecture 267Drug regulation and registration in El Salvador
Lecture 268Central 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 269Middle East / MENA / GCC Countries Geographical Orientation
Lecture 270Middle East / MENA / GCC Countries National Regulatory Agencies
Lecture 271GCC Registration Procedure - Centralized and Decentralized Procedure | Detailed understanding on Centralized Registration Process
Lecture 272Drug Registration in Saudi Arabia
Lecture 273Drug Registration in Kuwait
Lecture 274Drug Registration and Regulatory Strategic Planning for Iran
Lecture 275Drug Registration and Regulatory Strategic Planning for Israel
Lecture 276Drug Registration and Regulatory Strategic Planning for Jordan
Lecture 277Drug Registration and Regulatory Strategic Planning for Iraq
Section 13China Drug Regulatory Affairs
Lecture 278Drug Registration and Regulation in China
Lecture 279China NMPA New Regulation Update July, 2020
Section 14Russia Drug Regulatory Affairs
Lecture 280Drug Registration and Submission Strategic Planning for Russia and EAEU region
Lecture 281GMP requirements in Russia
Section 15References | Discussions
Lecture 282Comparison of Requirement of Various Regulatory Bodies
Lecture 283Comparison of Dossier Requirements of Europe and US
Lecture 284Comparison of DMF requirement of various regulatory bodies
Lecture 285ICH CTD Top Level View with Notes and Explanation
Lecture 286ICH CTD Top Level View with Note and Explnation
Lecture 287Comparison of ICH US EU CTD
Lecture 288Regulatory Documents at a glance
Lecture 289Structured CMC Writing Checklist
Lecture 290Comparison of 505J 505b1 and 505b2 Pathway
Lecture 291New Update in Form 356h
Section 16Drug Registration and Regulation in Japan
Lecture 292Introduction to Japan Drug Regulatory Affairs
Lecture 293Drug Discovery Development to commercialization | PMDA functions | Consultation | Premarket to post market approval
Lecture 294Drug Approval System | GCP | PMDA requirements
Lecture 295New Drug Application | Requirements | Review Process
Lecture 296Generic Drug Application Review and Approval
Lecture 297Marketing Authorization Process for registration of pharmaceutical in Japan
Lecture 298API Registration in Japan | Step By Step Process
Lecture 299Generic Registration | Patent - Patent Term Extension | Exclusivity | Re-examination System | Pediatric Designation | Patent Term Extension Case Studies
Lecture 300Priority Review Application | Criteria | Review Process | Timeline
Lecture 301Orphan Drug Designation in Japan
Lecture 302Japan DMF System | MF filing Process | Key points
Lecture 303Strategic Approval Pathway - Formulation Approval Quoting MF
Lecture 304SAKIGAKE designation
Section 17Drug Registration in India
Lecture 305Import Export of Pharmaceuticals from India
Lecture 306Medicine Export Criteria from India
Lecture 307Documents for conducting BE Study for Export
Lecture 308New Drug Approval in DCGI
Lecture 309Line Extension New Strength Approval
Section 18US MEDICAL DEVICES | Development to Commercialization Cycle
Lecture 310Overview of US Medical Devices Market
Lecture 311Definition of Medical Devices
Lecture 312Classification of Medical Devices
Lecture 313Medical Devices Classification : Work File
Lecture 314Medical Device Development to Commercialization Process | Understanding Key Stages and respective stage level activities | Important MDR terminologies
Lecture 315How to establish the classification of the medical device
Lecture 316FDA Product Code Database : Hands on Training
Lecture 317513(g) Application : Request, User Fees, Review Process
Section 19510K PRE-MARKET NOTIFICATION
Lecture 318510k - Pre-market Notification
Lecture 319Predicate Devices | Substantially Equivalent (SE)
Lecture 320Understanding on 510k | Types of the 510k | Timeline | Difference with PMA
Lecture 321FDA decision making process for different classes of 510k applications
Lecture 322Review Test
Section 20PREMARKET APPROVAL (PMA) APPLICATION
Lecture 323Premarket approval (PMA) application
Lecture 324Differences between 510k VS. PMA
Lecture 325Data Requirements for A Premarket Approval (PMA) application
Lecture 326Data Requirements for A Premarket Approval (PMA) application
Lecture 327PMA Post Submission - Management of CRL - Timeline and Strategic Planning
Lecture 328Labeling Requirement for Medical Devices
Lecture 329Investigational Device Exemption | Device Clinical Research | Early/Expanded Access of Medical Devices | Q-Sub | IDE Submission Requirements
Lecture 330Medical Devices Development to Commercialization Stages | Devices Clinical Trial | Stages | Critical differences with pharmaceutical clinical trial
Lecture 331Medical Devices Post Approval Variations | PMA supplement | PMA amendments | Variation Management Strategic Planning
Lecture 332Expedited review of devices
Lecture 333Expiration Dating
Lecture 334Device Master Files
Lecture 335Unapproved use of Medical Devices
Lecture 336Marketing, Advertising and Promotion of Medical Devices
Lecture 337FDA 513(g)
Lecture 338DeNovo Petition - Types of DeNovo Pathways | Details of Review Process | Strategic Planning
Lecture 339Humanitarian Device Exemption (HDE)
Section 21EU Regulation of Medical Devices
Lecture 340EU MDR Classification
Lecture 341EU MDD | EU MDR | Articles | Rules | Pages | Annex | Key Changes in EU MDR
Lecture 342EU MDR | Annexes | Key notes
Lecture 343EU Medical Device Regulation System | MDR | IVDR | UDI | EUDAMED | Requirements for manufacturer | Importer | Distributor | Declaration of Conformity (DoC)
Lecture 344EU MDR Guideline | EU MDR - Annexes
Lecture 345EU MDR Conformity Assessment procedure | Assessment of various classes and types of the devices | Key points to consider | Conformity assessment master chart
Lecture 346EU MDR Authorized Representatives | Mandate | Role and Responsibilities
Lecture 347EU MDR Compliance Process
Lecture 348Thumb Rules of Classification as per EU MDR Guideline | Invasive | Non-invasive | Active | Special Devices
Lecture 349Review : DDF DHF DMR MDF DHR
Lecture 350Comprehensive MDR Class-Wise Requirement Matrix
Section 22QMS, Documentation and Dossier Preparation
Lecture 351Medical Device Technical File
Lecture 352Medical Device Dossier Preparation | Section Wise Dossier Preparation | Key Requirements regarding dossier | Points to note regarding each section of the dossier
Lecture 353Quality Risk Management | ICH Q9 | ISO 14971 | Principle of Risk Management
Lecture 354Comparing Medical Device Regulations | 510k Submission | Technical File | Design History File | Design Master File
Lecture 355Medical Device Essential Principle Checklist | Documentation | Open file
Lecture 356Implant Card | Regulatory Importance | Content | How to design
Section 23Medical Device Labeling Guideline | General Principles | Wherever applicable (specific) Labeling contents
Lecture 357Medical Device Labeling Guideline | General Principles | Wherever applicable (specific) Labeling contents
Lecture 358Instruction for Use (IFU) | Design and Development of IFU
Lecture 359UDI | Different Component | How to design
Lecture 360Medical Device Labeling Guideline | General Principles | Wherever applicable (specific) Labeling contents
Section 24CE Marking
Lecture 361CE 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 362CE Certification Readiness Checklist
Lecture 363NB Mock Audit Weighted Scoring Model Aligned with Severity Grading
Lecture 364Notified Body (NB) Audit Defense Documentation Framework
Lecture 365NB Audit Defense Question Bank - Defense Response
Lecture 366Executive CE Risk Heat Map
Lecture 367CE Certification Prime Module
Lecture 368CE Certification Case Studies
Lecture 369CE Self-Certification Vs NB Route Comparison [Royed Training]
Lecture 370CE Route Decision Tree
Section 25ISO 13485
Lecture 371Introduction to ISO 13485 | Importance | Comparison with various other standards
Lecture 372ISO 13485 Documentations | Different Sections | Case Studies
Lecture 373ISO 13485: 2016 - Different Clauses
Section 26Combination Product Regulatory Affairs
Lecture 374Combination Products Regulatory Affairs | Definition | Types | Requirements | cGMP considerations | Risk Management | CAPA
Lecture 375Combination Product RFD Designation Process | Importance | Timeline | Outcome Management
Lecture 376Combination Products Pre-market Approval Process | Lead centers | Concept of Primary Mode of Action | Strategic Submission Pathways
Section 27Medical Device Regulation in India | CDSCO Regulation
Lecture 377Medical Devices Regulation in India | Overall understanding
Lecture 378Regulatory Landscape in India
Lecture 379Classification of the Medical Devices in India | Strategic Planning for the Submission
Lecture 380Notified and Non-notified Device | Submission Strategic Planning
Lecture 381Medical Devices Classification in India - Work Doc
Lecture 382Notified Devices | Registration Process
Lecture 383Medical Device Submission Strategic Pathways | Step by step Process
Lecture 384Medical Device Forms | Purposes
Lecture 385Non Regulatory Medical Devices
Lecture 386Medical Device Voluntary Registration | Documentation | Process
Lecture 387List of Notified Devices | Newly Notified Devices | Significance
Lecture 388List 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 391Medical Devices Regulation in African Countries: Algeria, Kenya, Nigeria, South Africa, Egypt
Lecture 392South Africa Medical Device Regulation
Lecture 393Egypt Medical Device Regulation
Lecture 394Kenya Medical Device Regulation
Lecture 395Nigeria Medical Device Regulation
Section 31MDSAP Training
Lecture 396Introduction to MDSAP | Objective | Significance | Role and responsibilities of stakeholders | Key benefits | MDSAP Process structure and Audit Tasks
Lecture 397QMS and MDSAP | Differences and Similarities | MDSAP Vs. ISO 13485 : Key objectives and differences
Lecture 398MDSAP Stakeholders
Lecture 399MDSAP Process Structure Audit Task
Lecture 400MDSAP Document Preparation
Section 32Food and Dietary Supplement Regulatory Affairs
Lecture 401Introduction to Food Regulations
Lecture 402Certifications for Food Business | Understanding on various types of certification
Lecture 403Regulatory Affairs functions in food business
Lecture 404New Food Product Development | Food Commercialization Process | NPD and Regulatory Activities
Lecture 405Introduction to Food Hygiene and Safety
Lecture 406Food | Definition| Classification| Unsafe and Hazardous foods
Lecture 407Principle of Safe Food Preparation
Lecture 408Food Control | Important Principles | Component of food control system | Responsibility for food controls | HACCP
Lecture 409Food Law | Overview of EU regulations
Lecture 410Dietary Supplements and Regulations | Premarket activities | labeling requirements | Claims, Approval requirements | Manufacturing Requirements
Lecture 411Introduction to Nutraceutical | Functional Food | Dietary Supplement | Health Food | Regulation and Approval Process
Lecture 412Dietary Supplement Vs. Nutraceuticals | Analysis of terms
Lecture 413Nutraceutical Product Classification | Nutraceutical Product Portfolio Management
Lecture 414Dietary Supplement (DS) | Nutraceutical | NHPs | Functional Food | Phytochemicals | Multivitamin - Mineral Supplement - Differentiations, Similarities, Regulation requirement assessment
Lecture 415Dietary Supplement Products & Ingredients | New Dietary Ingredients (NDIs)
Lecture 416NDIs Premarket notification
Lecture 417Case Studies - NDI designation Process
Lecture 418NDI – Notification Requirements and Adulteration Standard
Lecture 419Developing Safety Profile for New Dietary Ingredient | Dietary Supplement Safety Narratives | common error about margin of safety in NDI notifications
Lecture 420NOEL | NOAEL
Lecture 421Safety Factor Determination based on Animal Toxicity Study
Lecture 422Margin of Safety | Safety factor | Safety Discussion in NDI notification | EDI | ADI | Calculation | Case Studies
Lecture 423NDI notification and generally recognized as safe (GRAS)
Lecture 424NDIN Dossier | Notification Documentation | Different Sections
Lecture 425NDIN Safety Information Package | Documentation | Different Sections | Templates
Lecture 426FDA response to NDIN | Post submission action plan
Lecture 427NDIN Case Studies and Discussion
Lecture 428NDIN Master File
Lecture 429Food Product - Risk Management - Introduction
Lecture 430ISO and ISO Audits
Lecture 431BRCGS Certifications
Lecture 432ISO 22000
Lecture 433FSSC 22000
Lecture 434PrimusGFS
Lecture 435NON GMO
Lecture 436The Plant-Based Certification Program - PBS
Lecture 437HALAL Certifications
Lecture 438Other quality Certfiications for Food Businesses
Lecture 439Food Dossier Compilation
Lecture 440Detailed Understanding on Food Labeling | Parts of Labels | EU Regulations
Lecture 441Nutrition Fact Labels | Sections of the Labels | Update as per new label guidelines
Lecture 442Label Claims for conventional food and dietary supplement
Lecture 443Food Label | PDP | Information Panel designing | Compliance from Regulatory Perspective
Lecture 444Net Quantity of content statement
Lecture 445Expiration Dating | Best Before | Use By | Sell By Dates
Lecture 446Gluten Free Labeling of the food | Rules | Claim Establishment
Lecture 447Traffic Light Labels | How to design | Reference Intake
Lecture 448Daily Value (DV) | % Daily Value (% DV)
Lecture 449Stability Study of Processed Food
Lecture 450Health Supplement - Stability Study | Study Design - Batch Selection | Testing Frequency | Reduced Batches | Storage Condition | Container Closure System
Section 33Cosmetic Regulation and Submission Management
Lecture 451Cosmetic Global Legal Perspective | Concepts | Understanding definition | Classification System | Boderline Evaluation
Lecture 452Cosmetic Boderline Determination Classification | Misclassification | Reclassification
Lecture 453Cosmetic Risk Philosophy | Risk Structuring | Product Safety Responsibility Model | Practical Case Analysis
Lecture 454Simulation - Risk Based Regulatory System for Cosmetics
Lecture 455Risk-based safety classification table for cosmetic product types (RA working model)
Lecture 456Risk-Based Cosmetic Safety Classification & RA Intake Template
Lecture 457Brainstorming Session : Claim Reframing in Cosmetic Regulatory Affairs
Lecture 458Claim Reframing Matrix
Lecture 459Case Study : Reclassification of a Skin Brightening Serum
Lecture 460How Marketing Claims Trigger Reclassification
Lecture 461EU Cosmetic Regulation | Framework | CPNP | PIF | CPSP
Lecture 462CPNP Pathway & Framework
Lecture 463PIF Documentation | Sectionwise understanding
Lecture 464EU Product Information File (PIF) - Master Template Structure
Lecture 465EINECS Number | ELINCS Number | EC Number
Lecture 466CAS Number | Importance in Sourcing | Case study
Lecture 467NLP Number | Cosmetic Identifier Strategic Significance
Lecture 468REACH Compliance Verification
Lecture 469Cosmetic Product Safety Report (CPSR) : Writing Guidance Module
Lecture 470Sample CPSR | MOS Calculation
Lecture 471Annex II - Detailed Regulatory Understanding
Lecture 472Annex II Categorization
Lecture 473Detailed understanding on Annex III
Lecture 474Annex III Master List
Lecture 475Colorant in Cosmetic Formulation | Annex IV
Lecture 476CI Numbers – Detailed Regulatory Understanding
Lecture 477Annex IV Master CI
Lecture 478Preservative in Cosmetic Formulation
Lecture 479Preservative Annex V Master List
Lecture 480Annex VI – UV Filters | Classification of UV Filters | Strategic Regulatory Considerations
Lecture 481UV Filters Master List | Annex VI Positive List
Lecture 482Simulation : Sunscreen Regulatory Evaluation Simulation
Lecture 483EU Cosmetic Regulation - Review Test
Lecture 484EU Cosmetic Regulation - Case Studies
Lecture 485Introduction to US Cosmetic Regulation
Lecture 486Voluntary Cosmetic Registration Program (VCRP)
Lecture 487VCRP Filing Process and Checklist | Checklist for FDA VCRP Registration and Product Filing Process
Lecture 488Modernization of Cosmetics Regulation Act (MoCRA)
Lecture 489Transitioning from MoCRA to VCRP
Lecture 490MoCRA Exemptions | Exemption Calculation | Exemption templates | Scenario based case studies | Declaration | Open format Template
Lecture 491MoCRA Compliance Checklist
Lecture 492MoCRA Advanced Case Study | Regulatory Strategic Planning
Lecture 493MoCRA Regulation Decision Tree | Action Plans
Lecture 494MoCRA Case Based Assignment
Lecture 495MoCRA Forms
Lecture 496Global Cosmetic Regulation - Review Test 1
Lecture 497US Cosmetic Regulation - At A Glance | Compliance Snapshots
Lecture 498Strategic Pathway for US Cosmetic Formulation Market Access
Lecture 499Cosmetic vs Drug Claim - Decision Tree
Lecture 500US Cosmetic vs OTC Drug Claim Risk Scoring Matrix
Lecture 501Cosmetic Claim Rewriting Guide
Section 34Introduction to Artificial Intelligence (AI) in Regulatory Affairs
Lecture 502Introduction to AI
Lecture 503Basics of AI ML DL | Key Differences | Application in industry
Lecture 504Types of AI
Lecture 505AI Project | Overview
Lecture 506Comprehensive Training on AI Project | Managing Stages | AI Iteration
Lecture 507How machine learning
Lecture 508Understanding Regulatory Affairs – Traditional vs. Digital | 2 Case Study
Lecture 509Basics of AI for Regulatory Professionals | Understanding different models used in RA | Case Study | Simulation
Lecture 510AI Application across drug life cycle | Case Analysis | Model predictions
Lecture 511AI Terms with Regulatory Significance | Regulatory Applications
Lecture 512NLP in Regulatory Affairs | Conceptual understanding | Usage | NLP in Labeling
Lecture 513Data Grouping with Unsupervised Learning | Case Simulation | Hands on Exercise
Lecture 514Quality Data and Bias | Bias in datasets | Different Types of Bias in Pharma Datasets
Lecture 515AI Data Quality Standard | Checklist
Lecture 516Download AI Data Quality Checklist
Lecture 517Case Study: Accelerated Approval Using Real-World Evidence AI
Lecture 518AI Model for Dossier Submission and Filing - Model Selection | Simulation
Lecture 519AI Technologies in RA
Lecture 520Structured Vs. Unstructured Data | Practical Understanding | Explore Patient Datasets
Lecture 521Sample Data Exercise | Data error | Data Refinement and Cleaning of the data
Section 35AI in Regulatory Authoring and CMC Writing
Lecture 522AI-Powered Regulatory Document Authoring and CMC Writing
Lecture 523AI Tools Comparison - Authoring and CMC Writing (Module 2 & 3)
Lecture 524Tips for Selecting AI Tools (CMC Authoring)
Lecture 525CMC - AI Workflow Checklist | Simulation Based Cases
Lecture 526HITL Regulatory Document Authoring
Lecture 527Confidence Score in Regulatory Authoring | Case Simulation in CMC Authoring
Lecture 528Confidence Scores in Data Extract in Regulatory Writing [Case Simulation]
Section 36eCTD v4.0 Training
Lecture 529eCTDV4.0 Fundamental Understanding | Structures | Key Features
Lecture 530eCTDV4.0 Structure | Lifecycle Management
Lecture 531eCTD Validation | Managing Validation | Tool Types | Types of Error | Validation Error Management
Lecture 532eCTD Validation Tools
Lecture 533eCTD Publishing Cycle
Lecture 534HL7 - Structure and Understanding in the context of eCTD V4.0
Lecture 535Tips and Submission Readiness Checklist
Lecture 536eCTD Submission Checklist Format
Lecture 537Regulatory Publishing Document Control Challenges
Lecture 538Document Control Checklist
Lecture 539Leaf Structure Analysis | Common Error in Leaf Structuring
Lecture 540Formatting Rules Templated and Agency Specification
Lecture 541Versioning for Regulatory Publishing
Lecture 542File Naming Standard
Lecture 543Text Recognition and Optical Character Recognition (OCR)
Lecture 544Versioning File Naming OCR - How they work together
Lecture 545Final Document Assembly
Lecture 546Visual Diagram : eCTD Structure and XML Hierarchy
Lecture 547TOC and CI Management
Lecture 548Initial Submission & Maintenance Submission
Lecture 549Managing Lifecycle Operators - NEW REPLACE DELETE APPEND
Lecture 550eCTD Dossier Lifecycle - Multi Sequence View
Lecture 55110 Year eCTD Lifecycle : Sequence Evolution Diagram
Lecture 552Global Decision Tree - Classifying Post Approval Changes
Lecture 553eCTD Technical Validation | Typical issues | Resolutions
Lecture 554eCTD Validation Readiness Checklist
Lecture 555QC Checklist Design and Pre Submission Review
Lecture 556Submission Gateway | FDA ESG • EMA CESP • Health Canada Portal • PMDA Gateway
Lecture 557Regulatory Publishing Simulation
Lecture 558Pre-Gateway Submission Review Checklist | Post Submission Confirmation
Section 37AI and Data Integrity
Lecture 559AI and Data Integrity | Regulatory Documentation | Case Based Learning | Understanding Data Integrity Principles | Application and Use Cases
Lecture 560Cases of data breaches with explanation
Lecture 561Case Based Discussion : Data Breach in AI-Assisted CMC Drafting
Section 38Regulatory Labelling Artwork and CCDS Management
Lecture 562CCDS Management
Lecture 563CCDS Management Tools - Native, AI Plus | Key Functionalities
Lecture 564AI Augmented Labelling Compliance System
Lecture 565Label Drift in CCDS Management | Simulation Case Study | AI Based Workflow in Label Drift detection and management
Lecture 566AI Review of Labels, PI and SMPC with help of the Case Based Simulation | 4 Case Simulations
Lecture 567CCDS Management Case Study | Pregnancy Warning Upgrade Case Study
Lecture 568CCDS Management Case Study | Dosage Section Conflict | Case Based Analysis
Lecture 569Centralized Artwork Operation | Mechanism | Operation Step Planning
Lecture 570Case Study on Centralized Artwork Operation [Recall Management]
Lecture 571Artwork Management Terms | Key Understanding on Terminologies | Usage in Artwork Cases
Lecture 572Introduction to Labelling | Regulatory vs Commercial Perspective of Labelling | Labelling Compliance Function
Lecture 573Artwork & Packaging Lifecycle | Artwork Management Lifecycle Workflow
Lecture 574Global Artwork Labelling Framework | 5 Case Simulation
Lecture 575Country-Specific Labelling Requirements
Lecture 576Summary of Product Characteristics (SmPC)
Lecture 577Patient Information Leaflet (PIL)
Lecture 578Summary of Product Characteristics (SmPC) – Review Checklist
Lecture 579Patient Information Leaflet (PIL) – Review Checklist
Lecture 580US Prescribing Information (PI) | Differences with EU SmPC
Lecture 581US Prescribing Information (PI) - Review Checklist
Lecture 582Fundamental Understanding on Medication Guide
Lecture 583Regulatory Decision Flow: When Is a Medication Guide Required? - Step Based Decision Making
Lecture 584Medication Guide - Review Checklist | Inspection Checklist
Lecture 585PI Vs. Medication Guide Comparison
Lecture 586Patient Information Leaflet (PIL) vs Medication Guide
Lecture 587Label Components | Key considerations for effective designing of label
Lecture 588Label Review Checklist
Lecture 589Pharmaceutical Artwork Design Specification Worksheet - Complete Tracker
Lecture 590Color Proofing, Dielines & Version Control
Lecture 591CDR File - Monocarton | Outercarton | Keyline | Design Parameters
Lecture 592Injection Labels - Labels and Cartons
Lecture 593Various Design Component Placement Understanding (Injectables)
Lecture 594Concept of Logo File | Open and Curve File Importance
Lecture 595QC and Proof Reading in Labelling and Artwork
Lecture 596QC and Proofreading Checklist
Lecture 597Template Management and Creative Brief
Lecture 598Pre approval Labelling | ANDA Labelling | ANDA Labelling
Lecture 599Post approval Labelling | PAS | CBE-30 | Annual Reportable Changes
Lecture 600Decision Tree - PAS CBE-0 CBE-30 Annual Reportable Change Determination
Lecture 601Bulk Pack Labelling
Lecture 602Bulk Pack Labelling Checklist
Lecture 603OTC vs Prescription Labelling | Claim Limitations & Consumer Safety Requirements
Lecture 604OTC vs Prescription (Rx) Label Checklist
Lecture 605OTC Approval Matrix
Lecture 606OTC Claim Risk Scoring System
Section 39 Real World Evidence and Real World Data | Strategic Regulatory Decision Making
Lecture 607Evidence Based Decision Making | Combine evidences for decision making | Do we need more evidence?
Lecture 608RWD and RWE | Potential sources of RWE | Traditional RCTs vs. RWE | Case Study - RWE Programs | Influencing HCP decision-making
Lecture 609RWD and RWE in Product Lifecycle Management
Lecture 610RWD and RWE - Fit to use | Assessment
Lecture 611RWD data sources | Different types | Detailed understanding of each class
Lecture 612RWD Study Design
Lecture 613RWE Published Tool | Insights on commonly used tools
Lecture 614Healthcare Reimbursement Models : Value Based Care | Fee for Service (FFS) Model | Other Reimbursement Models
Lecture 615Consensus Narrative Review
Lecture 616Electronic Patient Data | EMR | EHR | Differences | Software architecture and characteristics
Lecture 617Active Surveillance Schemes | Active Case Finding |Sentinel Surveillance | Cohort Studies | Vaccine Safety Surveillance | Pharmacovigilance Programs | Disease Registries |Event Monitoring
Lecture 618RWD Characteristics
Lecture 619RCT vs. RWE Comparison | Case Based Analysis
Lecture 620RCT and RWE Comparison
Lecture 621Introduction to Healthcare Datasets
Lecture 622Dataset 1: Claims Data (Insurance)
Lecture 623Dataset 2: Retail Pharmacy Prescription Data
Lecture 624Dataset 3: Longitudinal Patient Data
Lecture 625Characteristics of Different Set of Healthcare Data
Lecture 626Reimbursement and Pricing Datasets
Lecture 627RWE Data Sources & Quality Considerations Checklist | Case Based Analysis
Lecture 628Triangulation and benchmarking | Enhancing Data Validation Through Cross-Referencing
Lecture 629RWD & RWE Case Database
Lecture 630RWE Large Dataset for Data Crunching Exercises |Data cleaning & preprocessing | Comparative Effectiveness Analysis
Section 40AI Tools, Ethics and Future Landscape
Lecture 631AI Reg Tools - Review | Understanding Capabilities
Lecture 632Regulatory Authority View on AI Adoption
Lecture 633Data Sensitivity | Levels | Consequences | Management
Lecture 634Governance Flowchart – AI Tools in GxP Environments
Section 41AI Tools
Lecture 635RA Example - Generalist Vs. Specialist AI Tools
Lecture 636AI Generalist Overview (Life Science Focus)
Lecture 637Horizontal vs Vertical AI Tools
Lecture 638AI Tool Assessment Test
Lecture 639Citation Verification Workflow | AI Tools Management | Hallucination and HITL Action Plan
Section 42Prompt Engineering
Lecture 640Prompt Engineering – Basic Foundations of Prompt Writing | Different Prompt Framework | Case Based Examples
Lecture 641Special Prompting Structure - Case Based Prompt Designing
Lecture 642Special Prompting Structure - Case Based Prompt Designing
Lecture 643Workflow for writing AI Prompts with Life Science Industry Use Cases
Lecture 644PE Parameters | Controlling Creativity, Accuracy, and Output Behavior for Life-Science Applications | Simulation based decision making
Lecture 645How to adjust the parameters | Techniques
Lecture 646Creating A Detailed Regulatory Prompt | Designing Structured Prompt in Code Editor
Section 43Request for course certificate
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