Section 1US MEDICAL DEVICES
Lecture 1Overall Understanding of US Medical Devices
Lecture 2Definition of Medical Devices
Lecture 3Classification of Medical Devices
Lecture 4Examples of Medical Devices
Lecture 5Medical Device Development to Commercialization Process | Understanding Key Stages and respective stage level activities | Important MDR terminologies
Lecture 6How to establish the classification of the medical deviceÂ
Lecture 7FDA Product Code Database : Hands on Training
Lecture 8513(g) Application : Request, User Fees, Review Process
Section 2510K PRE-MARKET NOTIFICATION
Lecture 9Overall Understanding
Lecture 10Predicate Devices | Substantially Equivalent (SE)
Lecture 11Understanding on 510k | Types of the 510k | Timeline | Difference with PMA
Lecture 12FDA decision making process for different classes of 510k applications
Lecture 13Review Test
Section 3PREMARKET APPROVAL (PMA) APPLICATION
Lecture 14Premarket approval (PMA) application
Lecture 15Differences between 510k VS. PMA
Lecture 16Data Requirements for A Premarket Approval (PMA) application
Lecture 17Data Requirements for A Premarket Approval (PMA) application
Lecture 18PMA Post Submission - Management of CRL - Timeline and Strategic Planning
Lecture 19Labeling Requirement for Medical Devices
Lecture 20Investigational Device Exemption | Device Clinical Research | Early/Expanded Access of Medical Devices | Q-Sub | IDE Submission Requirements
Lecture 21Medical Devices Development to Commercialization Stages | Devices Clinical Trial | Stages | Critical differences with pharmaceutical clinical trial
Lecture 22Medical Devices Post Approval Variations | PMA supplement | PMA amendments | Variation Management Strategic Planning
Lecture 23Expedited Review of PMA application
Lecture 24Expiration Dates
Lecture 25Device Master Files
Lecture 26Unapproved use of Medical Devices
Lecture 27Marketing, Advertising and Promotion of Medical Devices
Lecture 28Significance of Submitting a FDA 513(g)
Lecture 29DeNovo Petition - Types of DeNovo Pathways | Details of Review Process | Strategic Planning
Lecture 30Humanitarian Device Exemption (HDE)
Section 4COMBINATION PRODUCTS
Lecture 31Definition of combination products
Lecture 32Examples of Combination Products
Lecture 33Premarket Review and Postmarket Regulation of Combination Products
Lecture 34Drug Led Combination Product Pathway - R&D Process & drug discovery pathwayÂ
Lecture 35Drug Led Combination Product Pathway - NDA
Lecture 36Drug Led Combination Product Pathway - Abbreviated New Drug Application (ANDA)Â
Lecture 37Drug Led Combination Product Pathway - Biological Licensing Application (BLA)Â
Lecture 38Drug Led Combination Product Pathway - Abbreviated Biosimilar Application - 351(k)
Section 5MEDICAL DEVICES REGULATION IN CANADA
Section 6EU REGULATION FOR MEDICAL DEVICES
Lecture 40EU MDR Classification
Lecture 41EU MDD | EU MDR | Articles | Rules | Pages | Annex | Key Changes in EU MDR
Lecture 42EU MDRÂ | Annexes | Key notes
Lecture 43EU Medical Device Regulation System | MDR | IVDR | UDI | EUDAMED | Requirements for manufacturer | Importer | Distributor | Declaration of Conformity (DoC)
Lecture 44EU MDR Guideline | EU MDR - AnnexesÂ
Lecture 45EU MDR Conformity Assessment procedure | Assessment of various classes and types of the devices | Key points to consider | Conformity assessment master chartÂ
Lecture 46Medical Device Technical File
Lecture 47Medical Device Dossier Preparation | Section Wise Dossier Preparation | Key Requirements regarding dossier | Points to note regarding each section of the dossierÂ
Lecture 48Quality Management System (QMS) for medical devices companyÂ
Lecture 49Quality Risk Management | ICH Q9 | ISO 14971 | Principle of Risk ManagementÂ
Lecture 50Comparing Medical Device Regulations | 510k Submission | Technical File | Design History File | Design Master FileÂ
Lecture 51Medical Device Essential Principle Checklist | Documentation |Â Open file
Lecture 52Implant Card | Regulatory Importance | Content | How to designÂ
Section 7483 Observations, Warning Letter, Data Integrity
Lecture 53Establishment Inspection Report | 483 Observations | USFDA Warning Letter | Handling of FDA inspection | Closing of Warning LetterÂ
Lecture 54Documentation | Good Documentation Practices
Lecture 55Training on Handling and Management of Data Integrity issues in Pharmaceutical, Biopharmaceutical and Medical Devices Industry
Section 8MEDICAL DEVICES REGULATION IN INDIA
Lecture 56Medical Devices Regulation in India | Overall understanding
Lecture 57Regulatory Landscape in India
Lecture 58Classification of the Medical Devices in India | Strategic Planning for the SubmissionÂ
Lecture 59Notified and Non-notified Device | Submission Strategic PlanningÂ
Lecture 60Medical Devices Classification in India - Work Doc
Lecture 61Notified Devices | Registration Process
Lecture 62Medical Device Submission Strategic Pathways | Step by step ProcessÂ
Lecture 63Medical Device Forms | Purposes
Lecture 64Non Regulatory Medical Devices
Lecture 65Medical Device Voluntary Registration | Documentation | Process
Lecture 66List of Notified Devices | Newly Notified Devices | Significance
Lecture 67List of Notified Bodies with CDSCO
Section 9Medical Device Technical Document Preparation
Lecture 68DMRs : Content | Technical SpecificationÂ
Lecture 69DHRs : Content | Technical Specification
Lecture 70DHFs : Content | Technical Specification
Lecture 71Validation RecordsÂ
Lecture 72Complaint File
Section 10ISO 13485:2016 : IMPLEMENTATION IN MEDICAL DEVICE ORGANIZATION
Lecture 73Introduction to ISO 13485:2016
Lecture 74ISO 13485:2016 Audit Checklist
Section 11Medical 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 12Medical Devices Regulation in Latam Countries:Â Argentina, Brazil, Colombia, Chile, Mexico, Paraguay, Uruguay
Section 13Medical Devices Regulation in African Countries: Algeria, Kenya, Nigeria, South Africa, Egypt
Lecture 77Medical Devices Regulation in African Countries
Lecture 78South Africa Medical Device Regulation
Lecture 79Egypt Medical Device Regulation
Lecture 80Kenya Medical Device Regulation
Lecture 81Nigeria Medical Device Regulation
Section 14Medical Device Branding and Marketing
Lecture 82Product Life cycle for Medical Device
Lecture 83Advanced Strategic Planning in Medical Devices Product Life cycle Management
Lecture 84Segmentation, Targeting and Positioning of Medical Devices
Lecture 85Pricing of Medical Devices
Lecture 86Promotion in medical device Industry : Communication Model, Effective promotional communication, Push Vs. Pull Strategy and Buying Decision Process
Lecture 87Method of Promotional Budgeting
Lecture 88Brand Recall | Brand Recognition |Top of mind - How to calculate brand recall value?
Lecture 89Advertising - Introduction | Objective | Types of AdvertisingÂ
Lecture 90ATL, BTL & TTL Advertising
Lecture 91Advertising Agency - Understanding on various types of advertising agency
Lecture 92Selection of Advertising Agency
Lecture 93What is creative Briefing? How to Prepare !
Lecture 94Creative Briefing - Practical Simulation
Lecture 95Request for Proposal | Concepts in advertising
Lecture 96Advertising Message Strategy Development and Evaluation
Lecture 97Creative Approach and Styles
Lecture 98Steps of Development of Creatives
Lecture 99Advertisement Copy Development
Lecture 100How to prepare Ad Campaign Step By Step
Lecture 101New Product Development | Product Levels | Concept of Augmented Product
Lecture 102Market Research Process | Primary Research | Secondary Research | How Market Research carried out | CMI Team
Lecture 103Brand Logo Development : Introduction | Design Basics | Understanding of various components
Lecture 104Brand Name : Fundamental understanding on Brand Name Selection
Lecture 105Logo colour theme | Colour system | Colour coding | Significance of colour
Lecture 106How to design an excellent brand logo : Tricks of the trade
Lecture 107Trademark Searching Process | Hands on Practical Training
Lecture 108Brand Tagline or Punchline for Medical Device
Lecture 109Tagline - Development, Finalization and Protection
Lecture 110Medical Devices Brand Plan Development : Step by step preparation of the brand plan Development
Lecture 111Practical Training in visual aid designing | Step By Step Visual Aid Preparation | Creative Designing | Guideline on Proofing | USPs to differentiate the visual aidÂ
Lecture 112Visual Aid Printing | Establishing Visual Aid Printing Specs for effective management of the vendorsÂ
Lecture 113Guideline on visual aid development
Lecture 114Interactive Visual Aid | E-detailing | Remote Detailing | Analysis of Animated Video based e-detailing visual aidsÂ
Lecture 115Artwork Development Process by Product Management Team / Brand Management TeamÂ
Section 15Medical Device Export Documentation
Lecture 116Introduction to Medical Device Export
Lecture 117Introduction of Export Documentation | Understanding of important terminologies
Lecture 118Proforma Invoice - Detailed understanding how to prepare Proforma Invoice
Lecture 119Export Contract | Importance | Considerations | Things to include in Export Contract
Lecture 120Commercial Invoice | Importance | Differences with Proforma InvoiceÂ
Lecture 121Custom House Agent | Role, Responsibilities, How they work | Freight Forwarder - Difference with CHA | Case Study
Lecture 122Letter of Credit | How it works | Different types of LC | LC terms and conditions | Sight LC | Case Studies
Lecture 123Bank Guarantee (BG) | How BG works | Differences between BG and LC | Applicability of BG
Lecture 124LC Discounting | How it works | How to calculate the LC discounting
Lecture 125Packing List | Importance | Things to include in packing list
Lecture 126Incoterms | 2020 Incoterms | Practical understanding on different types of Incoterms | Choosing the right incoterm
Lecture 127Logical selection of Incoterms | Landing in right incoterms for your business
Lecture 128Pre-shipment certificates
Lecture 129Preshipment Inspection CertificateÂ
Section 16Medical Device Business Development and Licensing
Lecture 130Business Development Job Functionality | Strategic Planning Process | Knowledge Area of Business Development | Lead targeting | Licensing term sheets
Lecture 131Portfolio Management Process | Portfolio Characteristics | Portfolio Analysis | Balancing the Portfolio | BD and Strategic Planning DepartmentÂ
Lecture 132Identifying the corporate Need of business development | Objective – Strategy - Tactics | Portfolio constraints | SWOT | Numerical SWOT
Lecture 133Profiling and Searching | Objectives | Search Database | Creating Opportunity Anatomy for deal analysis | Mind Mapping | Searching Tools and Techniques - Web Search | Conference | Confidentaility - CDA | MTA
Lecture 134Modelling and Deal Valuation - Top Down Model | Epidemiology data method | Complex Model | Forecasting | Heuristic or ‘prophesy’ method | Different value perspectives | Deal Structuring Structuring the deal
Lecture 135Market Size Determination - Market Share | Relative Market Share | Total Vs. Actual Vs. Penetrated Market
Lecture 136Forecasting : Tools and Techniques
Lecture 137Types of Strategic Alliances: Unilateral technology licensing | Cross technology licensing | R&D contracts | R&D collaborations | Minority-equity-based R&D alliances | JV | Manufacturing and marketing agreementsÂ
Lecture 138Licensing and Technology Transfer
Lecture 139Licensing - Advance LearningÂ
Lecture 140Distribution Licensing | Geography | Indication Splitting | Execlusive and Non-Exclusive Licensing | Sub Licenses
Lecture 141Negotiation Skill Training
Lecture 142Licensing Agreement : Confidentiality Agreement | MTA | A deed of Assignment | Exclusive | Non-Exclusive License | Sole License | Components - Terms - Duration - Key Considerations
Lecture 143Step By Step Implementation of Licensing Deal
Lecture 144Due Diligence Activities in Licensing
Section 17Financials of deal management
Lecture 145Training on Basic Finance | Understanding Financial Statement | Income Statement | Balance Sheet | Cash Flow Statement
Lecture 146Training on Valuation Methods: DCF | rNPV | Sunk Cost Method | Comparables | Sum of Parts | Deterministic Vs. Probabilistic rNPV |Â Peak Sales - Max-Min Approach
Lecture 147Valuation Methods: EBITDA method of valuation | Enterprise Value and Enterprise Multiple Calculation
Lecture 148Business Development Simulation and Decision Making | Early Stage VS. Late Stage Valuation Methodology | Stair Step Model
Section 18Digital Marketing for Medical Devices
Lecture 149Introduction to Digital Marketing | Different Types of Media | Paid media | Earned Media | Owned Media | E-business | E-commerce | E-commerce architecture | E-communication Tools | Strategy and KPIsÂ
Lecture 150Inbound and Outbound Marketing
Lecture 151Digital Media Marketing Macro-Environment Analysis | Mapping of online market place | Internet marketing conversion process | Conversion Process Digital VS. Traditional | Publisher revenue model | Affiliate revenue model
Lecture 152Digital Media Marketing Micro - Environment Analysis | Web server | Web browser | http vs. https - Significance and hands on understanding | Privacy and ethical issues in internet marketing
Lecture 153Digital marketing strategy development | Planning process | E-Marketing Plan | Planning for MNC Vs. Start Up | Strategic Outcome measurement
Lecture 154Relationship marketing using digital platform | CRM | Concept of permission marketing | User Satisfaction and loyalty management | Feedback mechanism
Lecture 155Campaign planning for digital media | Goal setting | Tracking | Campaign insight | Segmentation and targeting | Message Development | Media Mix Selection | Media scheduling | Practical understanding to campaign performance matrics | CPC | CPA | PPC | ROI | CPS
Lecture 156Web Analytics - Tool and ImplementationÂ
Lecture 157Web Host - Check the hosting detailsÂ
Lecture 158Page Speed- importance and practical understanding | Check the web speedÂ
Lecture 159Search Engine Optimization | Search Engine Marketing | Social Media Marketing
Lecture 160Keyword | Keyword Planning for SEO and SEM | Keyword Planner
Lecture 161Mobile Responsive | Tracking the SiteÂ
Lecture 162Google Ad - Practical Training on Campaign Development and Execution
Lecture 163Brand Portal Development
Lecture 164Public Relation - PR firm | PR Campaign | Press Release | Technical understanding of press release writing | Digital Press Release
Section 19MDSAP Training
Lecture 165Introduction to MDSAP | Objective | Significance | Role and responsibilities of stakeholders | Key benefits | MDSAP Process structure and Audit Tasks
Lecture 166QMS and MDSAP | Differences and Similarities | MDSAP Vs. ISO 13485 : Key objectives and differencesÂ
Lecture 167MDSAP StakeholdersÂ
Lecture 168MDSAP Process Structure Audit Task
Lecture 169MDSAP Document Preparation
Lecture 170MDSAP Checklist
Section 20Medical Device Market Access
Lecture 171Introduction to Market Access | Objectives | Various Key Terminologies | Steps of Market Access | Understanding on Pricing and Reimbursement
Lecture 172Market Access Functions : Role and Responsibilities | Key Job Areas | Understanding Job Description
Lecture 173Market Access Strategic Planning : Steps and Logical Sequencing for Market Access Strategy Development
Lecture 174Market Access Value Dossier : What it is | Significance | Components | What to include
Lecture 175AMCP Market Access Dossier PreparationÂ
Lecture 176Target product profile (TPP) | Quality Target product profile (QTPP) | Critical Quality Attributes (CQAs) | Quality By Design (QbD)
Lecture 177Practical Training on Value Dossier Preparation | Sample Value Dossier with each section with data | Key points to consider while preparing value dossierÂ
Lecture 178Clinical Data in Value Dossier | Understanding in different types of clinical study with rationale | Case based example on clinical study section writing
Lecture 179
Section 21Health Economics and HTA in Medical Device
Lecture 180Introduction to Health Economics | Key terminologies related to health economics
Lecture 181HEOR Application
Lecture 182Introduction to Pharmacoeconomics | Different Types of Economic Evaluation | Cost-effectiveness plane | Economic modeling |Sensitivity Analysis | One way sensitivity analysis | Probabilistic sensitivity analysisÂ
Lecture 183Economic Evaluation Methods | Various methods | Importance of perspective in health economics | Discounting | UncertaintyÂ
Lecture 184Core fundamentals of Health Economics | Clinical and economic burden | Public Health Care Payer Vs. Patient and Societal | Positioning a new treatment with the current treatment | QALY | ICER | Threshold value | Clinical trials vs health economics assessment
Lecture 185QALY | How to calculate QALY | Importance and SignificanceÂ
Lecture 186ICER | How to calculate ICER | Importance and Significance | Incremental Effectiveness determinationÂ
Lecture 187Pharmacoeconomic Evaluation Checklist | Health Economics Map | Economic evaluation cycle | Checklist of economic evaluation | Costs and Outcome relevant to different groups | Comparators | Problem of choosing the comparators
Lecture 188Pharmacoeconomic Evaluation - Resource and Cost | Fixed, Variable and Total Cost | Calculation | Average vs. marginal cost | Importance of marginal cost | Discounting | Discounting calculation | Preferable discounting rate | Sources of unit cost data | Reference costs
Lecture 189Pharmacoeconomic Evaluation - Benefits and Outcome | C/E Ratio | Intermediate Vs. Final Outcome | Sources of Effectiveness Data | QALY | Utility Weight | WTP | VPF | ATP | Difference between WTP & ATPÂ
Lecture 190Pharmaco-economic evaluation – analysis and results | Different Types of Models | Understanding Decision Tree - Components with practical Example | Markov modelÂ
Lecture 191CER and PCOR
Lecture 192Budget Impact Analysis | Importance | Significance | Steps involved | Total Budget Impact Calculation | Simulation - BIA of novel molecule with real life example | Total Budget Impact Calculation
Lecture 193Markov Model | Significance | Importance | Time horizon - Significance | Real Life Development of Markov Model | Calculation
Lecture 194HEOR Consensus Narrative ReviewÂ
Section 22Medical Device Pricing and Reimbursement
Lecture 195Pricing Methodologies - I
Lecture 196Pricing Methodologies II
Lecture 197Formulary Placement | Different Tiers | How to classify the medication in different tiers | Formulary negotiation process | Rebates | Copay differential | Step-edits | Case Simulations - teasers
Lecture 198Case Study : Pricing and Reimbursement Planning for new launches | Reimbursement Rate CalculationÂ
Lecture 199HCPCS and CPT Codes | Importance | Significance and Characteristics | Differences between HCPCS and CPT CodesÂ
Lecture 200Rebates | Importance | Factors affecting Rebates | Deductibles and Rebates
Lecture 201Medicare | Medicaid | Medigap | Different plans | Related Terminologies| Advanced training on Medicare Part D
Lecture 202Concept of Reference Pricing | IRP | ERP | Differences | Practical Examples
Section 23Real World Evidence
Lecture 203Evidence Based Decision Making | Combine evidences for decision making | Do we need more evidence?Â
Lecture 204RWD and RWE | Potential sources of RWE | Traditional RCTs vs. RWE | Case Study - RWE Programs | Influencing HCP decision-making
Lecture 205RWD and RWE - Fit to use | AssessmentÂ
Lecture 206RWD data sources | Different types | Detailed understanding of each classÂ
Lecture 207RWD Study Design
Lecture 208RWE Published Tool | Insights on commonly used tools
Lecture 209RWD Study Design
Lecture 210Healthcare Reimbursement Models : Value Based Care | Fee for Service (FFS) Model | Other Reimbursement Models
Lecture 211Electronic Patient Data | EMR | EHR | Differences | Software architecture and characteristics
Lecture 212Active Surveillance Schemes | Active Case Finding |Sentinel Surveillance | Cohort Studies | Vaccine Safety Surveillance | Pharmacovigilance Programs | Disease Registries |Event Monitoring
Lecture 213RWD Characteristics
Lecture 214RCT vs. RWE Comparison | Case Based Analysis
Lecture 215RCT and RWE Comparison