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Life Science Business Consulting



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About Life Science Consulting

Life Science Consulting training

This online Lifesceience business consulting course provides hands on training to enhance skill competency of Lifesceience consultant.

This course ideal for the professionals who are working or planning to shift into pharmaceutical and biopharmaceutical consulting domain.

Life Science Consulting course includes training of pharmaceutical, Biopharmaceutical and Medical Device industry.

Life Science and Healthcare Consulting primarily focus on advising for pharmaceutical and medical device companies/products. There are many capabilities specific to each company but broad ones can include:

  • Pharmaceutical, Biopharmaceutical and Medical Device Launch Excellence – Discovery, Development to commercialization.
  • Forecasting and Valuation, In and Outlicensing.
  • Brand Acquisition and Company Acquisition
  • Market Research with physicians and payers.
  • Pharmacoeconomics and HEOR.
  • Drug Pricing and Reimbursement optimization.
  • Sales Force and Market Access strategic planning.
  • Pharmacovigilance and Safety Management.
  • Medical Device Market Access.
  • Medical Device Strategic Planning – Regulation, Registration, Market Insights.

Moreover, this comprehensive Life Science Consulting training involves the real life job simulation. Hence, the course provides practical knowledge. Moreover, this course focuses on how pharma business development, strategic management, regulatory and licensing professionals working in the company. Therefore, it helps advance professionals to acquire cutting edged life sciences business consulting skills. 

Above all, this is ideal course which provides participants understanding about the development to commercialization process in detail. In other words, you will understand portfolio strategic management. Hence, the course covers fundamentals to advance learning on various skill areas. 

Who should attend this course? 

  • Those who are in the working in Life Science Consulting Domain. Hence this course provides training for those who are already working in the Life Science Consulting domain. 
  • Also this course will be ideal for the professional who are in consulting business but want to work into Life Science Consulting.
  • Moreover, this course is ideal choice for the professionals who want to join in Life Science Consulting.

Key details about the course:

  • Course Code: RYD-114
  • Title of the course: Executive PG Certification in Life Science Business Consulting [PGLSCON]
  • Type of the course: Self paced Online 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. Course can completed within 1 year based on own speed of access.
  • Course Certificate: Certificate will be provided at the end of the successful completion of the course
  • Top Performer of the course : Click here to view

Features of Life Science Consulting Business Training Course

  • This course covers all aspects of the strategic management from drug discovery development, regulatory, commercialization, market access, pricing and various other domains where life science consultants work day to day basis.
  • Hence this course provides orientation to job related practical aspects of the Life Science Consultants. Therefore, on completion of the course, the participants will develop the hands on understanding how Life Science Consulting Professionals works.
  • Moreover the course provides real life simulation on critical decision making process. Therefore, these simulations help to enhance the licensing and  decision making skills which is the core aspects of the Life Science Consulting working.

Case Based Learning

  • Advance training on drug and biologics discovery, development to commercialization.
  • Course provides hands on training on portfolio management skills including market access, forecasting and valuations.
  • Access to Case Studies to learn about the drug commercialization steps. Hence, participants will develop advanced competency on strategic portfolio management.

What is Life Science Consulting?

Life science consulting is a specialized field of consulting that focuses on providing strategic, operational, regulatory, and scientific expertise to businesses and organizations operating in the life sciences industry. In fact, the life sciences industry encompasses a wide range of sectors, including pharmaceuticals, biotechnology, medical devices, healthcare, and biopharmaceuticals. Life science consultants assist clients in navigating the complex and highly regulated landscape of these industries to achieve their business goals and improve their overall performance.

Life science consulting firms often comprise interdisciplinary teams of experts, including scientists, regulatory specialists, business analysts, and healthcare professionals. These teams work collaboratively to address the unique challenges and opportunities within the life science sector, helping clients achieve their objectives while ensuring compliance with industry-specific regulations and standards. Hence, Life science consulting is integral to the success and growth of companies in this highly regulated and dynamic field.

Section 1Pharma R&D Management- Discovery to Development | Strategic Management for US Market
Lecture 1R&D Process & Introduction to drug discovery
Lecture 2Investigational New Drug Application (INDA)
Lecture 3New Drug Application (NDA) 
Lecture 4Basic concept and understanding of the Generic Drug
Lecture 5Abbreviated New Drug Application (ANDA) 
Lecture 6Biological Licensing Application (BLA)  | 351(a) application | Form 356h | Differentiation with NDA | Timeline | Handling FDA queries
Lecture 7Abbreviated Biosimilar Application - 351(k): Advance Strategic Planning Process : Originator Vs. Biosimilar Development and Regulatory Approval Process | Reference Biologic | Purple Book | Data Requirements
Lecture 8Purple Book: Significance | Searching | Assignments
Lecture 9Handling of orange book
Lecture 10USFDA expedited programs
Lecture 11Practical Training on INDA, NDA, ANDA filing
Lecture 12505(j) ANDA, 505(b)(2) NDA, 505(b)(1) NDA
Lecture 13Authorized Generics: Key Understanding
Lecture 14Exploratory IND Vs. Traditional IND
Lecture 15Patents Vs. exclusivity 
Lecture 16Orphan Drug Designation 
Lecture 17Advance Learning on 505B2 Pathway
Lecture 18Chemistry, Manufacturing & Controls 
Lecture 19Patent & Exclusivity - Strategic Understanding | Patent Restoration| Orphan Drug Exclusivity (ODE) | NCE & NCI Exclusivity | GAIN Exclusivity | Pediatric Exclusivity | 180 days exclusivity
Lecture 20Clinical Research | Terminologies and definition in Clinical Research | Phases |Expanded access trial | Observational Study |Randomized controlled and Placebo controlled study | Active comparator study
Lecture 21Clinical Trial Protocol Writing
Lecture 22Ethics in Clinical Research
Lecture 23Informed Consent | Practical Training on preparing ICF | Ready Templates
Lecture 24FDA Forms and How to fill the resources
Lecture 25Strategic Discussion: PreIND, EOP1, EOP2 - What to expect !
Lecture 26Importance and Significance of Phase 2b Clinical Trial 
Lecture 27Regulatory Strategies in different phases of Clinical Trial
Lecture 28Para IV Filing - Strategic Insight
Lecture 29Para IV Notices
Lecture 30Evergreening - Patent Life Extension Strategies
Lecture 31Pay For Delay Strategy
Lecture 32REMS Strategic Planning 
Lecture 33Compulsory Licensing
Lecture 34Licensing & Technology Transfer
Lecture 35In-Licensing Vs. Outlicensing
Lecture 36LOE Strategies for Innovator Brands with case study
Lecture 37Pediatric Exclusivity and Pediatric Study Plan Development
Lecture 38Drug Repurposing
Lecture 39Advance understanding of the portfolio Management 
Lecture 40New Indication Approval Process and Promotion 
Lecture 41OTC Switch 
Lecture 42Detailed Understanding on 505(b)(2) VS. Suitability Petition : Case Based Learning
Lecture 43NCE Vs. 505b2 application - Case Based Learning 
Lecture 44FTF - 180 Days Exclusivity - Case Based Learning
Lecture 45Classic case study of the 505b2 filing : Case Based Learning
Lecture 46Strategic Planning in Combating 30 months stay strategies of innovator company- Case Based Learning
Lecture 47What is meaning of 'Pipeline in a Molecule'?
Lecture 48USFDA Emergency Use Authorization (EUA)
Lecture 49Target product profile (TPP) | Quality Target product profile (QTPP) | Critical Quality Attributes (CQAs) | Quality By Design (QbD)
Lecture 50Fundamental 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 51Review on Drug Discovery and Development 
Section 2Strategic Business Management - European Market
Lecture 52Introduction to EU Regulation 
Lecture 53Orientation to European Countries and National Regulatory Bodies
Lecture 54EU Drug Discovery Development to Commercialization (Step By Step)
Lecture 55Overview of EU Regulation 
Lecture 56EMA and EMA Authorisation Process
Lecture 57EU MA Application Types and Strategic Planning
Lecture 58EU MA Procedure - Centralised, Decentralised, Mutual Recognition, National Procedure 
Lecture 59EU MA Strategic Planning: Full, Full-mixed, hybrid applications. Generic, Similar biologic application pathway, Well-established use application, Fixed combination application, Informed consent application
Lecture 60Validity 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 61Data Exclusivity and Market Protection - Supplementary Patent Protection, Exclusivity, 6/10 Rule, 8+2+1 Formulae
Lecture 62EU Orphan Medicinal Products Regulation
Lecture 63Conditional marketing authorisation | Marketing authorisation under exceptional circumstances
Lecture 64Summary of Product Characteristics 
Lecture 65Compassionate Use
Lecture 66The 'sunset clause' for marketing authorisation of pharmaceuticals
Lecture 67Paediatric use marketing authorisation (PUMA) & Paediatric Investigation Plan (PIP) - EU Requirments
Lecture 68EU Prime Designation
Lecture 69Accelerated assessment by EMEA
Lecture 70EU Adaptive Pathway
Section 3HEOR, Market Access & Pricing, Reimbursement, Forecasting
Lecture 71Introduction to Market Access | Objectives | Various Key Terminologies | Steps of Market Access | Understanding on Pricing and Reimbursement
Lecture 72Market Access Functions : Role and Responsibilities | Key Job Areas | Understanding Job Description
Lecture 73Introduction to Health Economics | Key terminologies related to health economics.
Lecture 74HEOR Application in Pharmaceutical and Biopharmaceutical Industry
Lecture 75Introduction to Pharmacoeconomics | Different Types of Economic Evaluation | Cost-effectiveness plane | Economic modeling |Sensitivity Analysis | One way sensitivity analysis | Probabilistic sensitivity analysis
Lecture 76Economic Evaluation Methods | Various methods | Importance of perspective in health economics | Discounting | Uncertainty
Lecture 77Core 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 78Pharmacoeconomic 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 79Pharmacoeconomic 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 80Pharmacoeconomic Evaluation - Benefits and Outcome | C/E Ratio | Intermediate Vs. Final Outcome | Sources of Effectiveness Data | QALY | Utility Weight | WTP | VPF | ATP | Difference between WTP & ATP 
Lecture 81Patient Based Forecasting Model | Applying more filters and variables
Lecture 82QALY | How to calculate QALY | Importance and Significance 
Lecture 83ICER | How to calculate ICER | Importance and Significance | Incremental Effectiveness determination 
Lecture 84CER and PCOR
Lecture 85Market Access Strategic Planning : Steps and Logical Sequencing for Market Access Strategy Development
Lecture 86Indication Sequencing | Indication Prioritization | Development of Indication Timeline | Indication Matrix | Value Based Indication Prioritization
Lecture 87Market Access Value Dossier : What it is | Significance | Components | What to include
Lecture 88AMCP Market Access Dossier Preparation 
Lecture 89Target product profile (TPP) | Quality Target product profile (QTPP) | Critical Quality Attributes (CQAs) | Quality By Design (QbD)
Lecture 90Drug Pricing Methodologies - I
Lecture 91Drug Pricing Methodologies - II
Lecture 92Formulary Placement | Different Tiers | How to classify the medication in different tiers | Formulary negotiation process | Rebates | Copay differential | Step-edits | Case Simulations - teasers
Lecture 93Pharma Market Access Pricing Case Study: interchangeable Pricing 
Lecture 94Sales Forecasting in Life Science Industry
Lecture 95New Product Forecast Algorithm
Lecture 96Patient Based Forecasting Model | Applying more filters and variables
Lecture 97Prescription Based Forecasting Model | Differences between Patient Based and Prescription Based Forecasting Model | Which model to use and when?
Lecture 98Prevalence Vs. Incidence Model
Lecture 99EPI Based Forecasting | Sales Based Forecasting | When and where to apply which forecasting model
Lecture 100Sales Forecasting Tools | New Product Forecasting | In Market Forecasting
Lecture 101Market Size Assignment 1 [Oncology Brand] - Applying sales forecasting tools to carry out next 6 years sales forecast | Excel Based Model
Lecture 102Market Size Assignment 2 [Asthma Brand] - Applying sales forecasting tools to carry out multiple years sales forecast | Excel Based Model
Lecture 103Patient Based Model Vs. Patient Flow Model | Critical Differences in Model | Concept of Black Box in Patient Flow Model | Application of both model
Lecture 104Concomitancy and polypharmacy | How it alter the basic forecasting algorithm | Practical Working | Comorbidity
Lecture 105Forecasting Techniques | Simple Conjoint-type Models | Zipf's Law | Simple Elasticity Model | The Bass Model |Simple Extrapolation
Lecture 106Bottom-up or Top-down Forecasting | LRx | Significance of LRx data analysis
Lecture 107Simulation on Bottom-up forecasting
Lecture 108Assessment on Bottom-up forecasting
Lecture 109Oncology Brand Forecasting
Lecture 110Revenue Forecasting Case Study - Novel Antihypertensive 
Lecture 111Portfolio Based Forecasting | Forecasting Model Development in Excel 
Lecture 112Evidence Based Decision Making | Combine evidences for decision making | Do we need more evidence? 
Lecture 113RWD and RWE | Potential sources of RWE | Traditional RCTs vs. RWE | Case Study - RWE Programs | Influencing HCP decision-making
Lecture 114RWD and RWE in Product Lifecycle Management
Lecture 115RWD and RWE - Fit to use | Assessment
Lecture 116RWD data sources | Different types | Detailed understanding of each class
Lecture 117First-in-class | Best-in-class | Market Access Strategic Decision Making 
Lecture 118Forecasting Biosimilar | Key Factors to consider
Lecture 119Consensus Meeting 
Lecture 120One Number Vs. Multi Number Forecasting
Lecture 121Active Vs. Passive Cannibalization | Impact on forecasting | Case Study
Lecture 122Rebates | Importance | Factors affecting Rebates | Deductibles and Rebates
Lecture 123Medicare | Medicaid | Medigap | Different plans | Related Terminologies| Advanced training on Medicare Part D
Lecture 124Treatment Algorithm and Forecasting : Case Based Learning
Lecture 125Chronic and Acute Segment | Forecasting on Chronic and Acute Segment Drugs
Lecture 126Prescription Value Calculation 
Section 4Branding & Brand Management
Lecture 127Marketing Orientation
Lecture 128Why Is Market Research Important in Pharmaceutical Business?
Lecture 129Market Research - Customer Engagement through feedback mechanism 
Lecture 130Product Life cycle 
Lecture 131Advance - Strategic Planning in Product Life cycle Management
Lecture 132Segmentation, Targeting and Positioning
Lecture 133A Pharmaceutical Segmentation outlook
Lecture 134Distribution Channel in Pharmaceutical Industry 
Lecture 135Promotion in Pharmaceutical Industry : Communication Model, Effective promotional communication, Push Vs. Pull Strategy and Buying Decision Process
Lecture 136Practical understanding on Prescription Accelerating Materials used in pharmaceutical promotion
Lecture 137Method of Promotional Budgeting
Lecture 138Brand Recall | Brand Recognition |Top of mind - How to calculate brand recall value?
Lecture 139Advertising - Introduction | Objective | Types of Advertising 
Lecture 140ATL, BTL & TTL Advertising
Lecture 141Advertising Agency - Understanding on various types of advertising agency
Lecture 142Selection of Advertising Agency
Lecture 143What is creative Briefing? How to Prepare !
Lecture 144Creative Briefing - Practical Simulation
Lecture 145Request for Proposal | Concepts in advertising
Lecture 146Advertising Message Strategy Development and Evaluation
Lecture 147Creative Approach and Styles
Lecture 148Steps of Development of Creatives
Lecture 149Advertisement Copy Development
Lecture 150How to prepare Ad Campaign Step By Step
Lecture 151Brand Name | Brand Logo | Designing of Brand Logo | Trademarking
Lecture 152Advance Understanding of Pharmaceutical Brand Logo Development 
Lecture 153Component of Brand Logo
Lecture 154Brand Name and Trademark Registration Process
Lecture 155Trademark Searching Process | Hands on Practical Training
Lecture 156How to design an excellent brand logo : Tricks of the trade
Lecture 157Logo colour theme | Colour system | Colour coding | Significance of colour
Lecture 158Few Case Studies related to brand names and logos
Lecture 159Can one innovator company keep 2 or more brand name?
Lecture 160Traditional Vs. Non-Traditional trademark | Significance of Colour in Pharma Branding 
Lecture 161Global Trademarking : Brand Protection Globally 
Lecture 162Logo Rebranding - Reasons | Practical Examples | How to handle logo rebranding | Forced Rebranding 
Lecture 163Brand Logo Development: Real Life Simulation
Lecture 164Tagline - Development, Finalization and Protection
Lecture 165Pharma Brand Name Generator
Lecture 166Fundamental of Pharma Marketing Plan 
Lecture 167Basic Understanding how to launch a pharmaceutical product into the market
Lecture 168Practical Training on Marketing Plan Preparation with real life example
Lecture 169Marketing Campaign Development : Importance of Target Audience Segmentation for effective targeting 
Lecture 170Sample Marketing Plan 
Lecture 171Decide about brand USP -What to promote 
Lecture 172How to prepare promotogram. Download sample Promotogram
Lecture 173Importance and Handling of Cycle Meeting and its importance 
Lecture 174Sample Marketing Plan
Lecture 175Sample Marketing Plan
Lecture 176Sample Marketing Plan
Lecture 177CSR Campaign 
Lecture 178Increase the brand reach with advance segmentation
Lecture 179Concept of uniform branding for better brand acceptability
Lecture 180Concept of Brand Differentiation
Lecture 181Introduction to visual aid designing  | V3M Concept | Components of the visual aid page
Lecture 182Practical Training in visual aid designing  | Step By Step Visual Aid Preparation | Creative Designing | Guideline on Proofing | USPs to differentiate the visual aid 
Lecture 183Visual Aid Printing  | Establishing Visual Aid Printing Specs for effective management of the vendors 
Lecture 184Visual Aid Analysis with practical example
Lecture 185Guideline on visual aid development
Lecture 186Marketing Plan followed by Visual Aid Development
Lecture 187Visual Aid, Literature reference Sample
Lecture 188Interactive Visual Aid | E-detailing | Remote Detailing | Analysis of Animated Video based e-detailing visual aids 
Lecture 189Visual aid detailing story writing
Lecture 190Artwork Development Process in PMT Department
Lecture 191Product List and Reminder card development
Lecture 192Catch Cover Development
Lecture 193Packaging Development 
Lecture 194Prescribing Information and Patient Information Leaflet development
Lecture 195Pharma Packaging Case Studies
Lecture 196DHCP letter
Lecture 197Product Packshot Designing : Practical Knowledge
Lecture 198Creativity to develop brand essence
Lecture 199Advance Training on Pharmaceutical Packaging -  Creative Packaging for Brand Differentiation 
Lecture 200Unique identifier & anti-tampering device on outer packaging
Section 5Licensing and Valuation
Lecture 201Training on Basic Finance  |  Understanding Financial Statment | Income Statement | Balance Sheet | Cash Flow Statement
Lecture 202Moving Average | Moving Annual Total | YTD | How to calculate 
Lecture 203Compound Annual Growth Rate | CAGR Calculation
Lecture 204Business Development Job Functionality | Strategic Planning Process | Knowledge Area of Business Development | Lead targeting | Licensing term sheets
Lecture 205Portfolio Management Process | Portfolio Characteristics | Portfolio Analysis | Balancing the Portfolio | BD and Strategic Planning Department 
Lecture 206Identifying the corporate Need of business development | Objective – Strategy - Tactics | Portfolio constraints | SWOT | Numerical SWOT
Lecture 207Profiling and Searching | Objectives | Search Database | Creating Opportunity Anatomy for deal analysis | Mind Mapping | Searching Tools and Techniques - Web Search | Conference | Confidentaility - CDA | MTA
Lecture 208Numerical SWOT Practical training
Lecture 209Modelling 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 210Market Size Determination - Market Share | Relative Market Share | Total Vs. Actual Vs. Penetrated Market
Lecture 211Forecasting : Tools and Techniques
Lecture 212Market Sizing & Forecasting Case Study
Lecture 213Royalty Management - Royalty structuring | Royalty Calculation Method| Tiered Royalties | Terms | Royalty Reductions | Royalty Stacking - Concept and Calculation | Minimum Annual Royalties | Reach through royalties
Lecture 214Average Royalty Rate
Lecture 215Factor affecting the Royalty Rate in Pharmaceutical and Biopharmaceutical Deal
Lecture 216Distribution Licensing | Geography | Indication Splitting | Exclusive and Non-Exclusive Licensing | Sub Licenses
Lecture 217Acquisition in Pharma  | Product Acquisition| Company Acquisitions| Steps in acquisition | Financing acquisition deals | Trademark Assignment Process
Lecture 218Joint Ventures in Pharmaceutical and Biopharmaceutical Industry
Lecture 220Indication Splitting | Concept | Implementation feasibility analysis 
Lecture 221Types of Deals from Discovery to Commercialization
Lecture 222What are the fundamental areas of business development
Lecture 223Licensing Term Sheet | Content Structuring | Sample Term Sheet
Lecture 224Licensing Payment Scheduling: Different Types
Lecture 225Valuation Methods: DCF | rNPV | Sunk Cost Method | Comparables | Sum of Parts | Deterministic Vs. Probabilistic rNPV |  Peak Sales - Max-Min Approach
Lecture 226Valuation Methods: EBITDA method of valuation | Enterprise Value and Enterprise Multiple Calculation
Lecture 227Negotiation Skill Training for BD personnel | Mind Mapping Tools | Practical Case Based Learning | Do and Don’ts in Pharma Business development Negotiations | Role of Scribes
Lecture 228Business Development Simulation and Decision Making | Early Stage VS. Late Stage Valuation Methodology | Stair Step Model
Lecture 229Types 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 agreements | big pharma firms with dedicated biotechnology firms 
Lecture 230Benchmarking | Benchmarking through consortium | How to use benchmarking for drug discovery development projects 
Section 6Biopharmaceutical Management and Regulation
Lecture 231Introduction : Biopharmaceuticals
Lecture 232Classification of Biopharmaceutical 
Lecture 233Important Concept regarding Biopharmaceuticals
Lecture 234Introduction to Biologics and Biosimilar | Key differences | Concept of Reference Product
Lecture 235Key features of Biologic | Differences in Chemical Drug Vs. Biologic Drugs
Lecture 236Principle of Naming of Biologic | Understanding on MAB naming system
Lecture 237Global Biopahrma Market Trends
Lecture 238Recombinant protein
Lecture 239Monoclonal Antibodies Vs. Polyclonal Antibodies
Lecture 240Monoclonal Antibodies
Lecture 241Synthetic Immunomodulators
Lecture 242Production of Monoclonal Antibodies
Lecture 243Cytokines
Lecture 244Interferon
Lecture 245Erythropoiesis-stimulating agent
Lecture 246Vaccine development and approval Process
Lecture 247Biosimilar Development Process
Lecture 248Strategic Consideration for Biosimilar Development 
Lecture 249Bio-Manufacturing Process Information
Lecture 250Studies required for approval of biosimilar
Section 7Medical Device - Strategic Management - US Market
Lecture 251US Medical Devices Market Insight
Lecture 252Definition of Medical Devices
Lecture 253Classification of Medical Devices
Lecture 254Medical Devices Classification : Work File 
Lecture 255Medical Device Development to Commercialization Process | Understanding Key Stages and respective stage level activities | Important MDR terminologies
Lecture 256510k - Pre-market Notification
Lecture 257Predicate Devices | Substantially Equivalent (SE)
Lecture 258Understanding on 510k | Types of the 510k | Timeline | Difference with PMA
Lecture 259FDA decision making process for different classes of 510k applications
Lecture 260Review Test
Lecture 261Premarket approval (PMA) application
Lecture 262Differences between 510k VS. PMA
Lecture 263Data Requirements for A Premarket Approval (PMA) application
Lecture 264PMA Post Submission - Management of CRL - Timeline and Strategic Planning
Lecture 265Labeling Requirement for Medical Devices 
Lecture 266Investigational Device Exemption | Device Clinical Research | Early/Expanded Access of Medical Devices | Q-Sub | IDE Submission Requirements
Lecture 267Medical Devices Development to Commercialization Stages | Devices Clinical Trial | Stages | Critical differences with pharmaceutical clinical trial
Lecture 268Medical Devices Post Approval Variations | PMA supplement | PMA amendments | Variation Management Strategic Planning
Lecture 269Unapproved use of Medical Devices 
Lecture 270DeNovo Petition - Types of DeNovo Pathways | Details of Review Process | Strategic Planning
Lecture 271Humanitarian Device Exemption (HDE)
Lecture 272Combination Products Regulatory Affairs | Definition |  Types | Requirements | cGMP considerations | Risk Management | CAPA
Lecture 273Combination Product RFD Designation Process | Importance | Timeline | Outcome Management
Lecture 274Combination Products Pre-market Approval Process | Lead centers | Concept of Primary Mode of Action | Strategic Submission Pathways
Section 8EU Medical Device - Strategic Insight
Lecture 275EU MDR Classification
Lecture 276EU MDD | EU MDR | Articles | Rules | Pages | Annex | Key Changes in EU MDR
Lecture 277EU MDR  | Annexes | Key notes
Lecture 278EU Medical Device Regulation System | MDR | IVDR | UDI | EUDAMED | Requirements for manufacturer | Importer | Distributor | Declaration of Conformity (DoC)
Lecture 279EU MDR Guideline | EU MDR - Annexes 
Lecture 280EU MDR Conformity Assessment procedure | Assessment of various classes and types of the devices | Key points to consider | Conformity assessment master chart 
Lecture 281EU MDR Authorized Representatives | Mandate | Role and Responsibilities
Lecture 282Medical Device Technical File
Lecture 283Medical Device Dossier Preparation | Section Wise Dossier Preparation | Key Requirements regarding dossier | Points to note regarding each section of the dossier 
Lecture 284Quality Management System (QMS) for medical devices company 
Lecture 285Quality Risk Management | ICH Q9 | ISO 14971 | Principle of Risk Management 
Lecture 286Comparing Medical Device Regulations | 510k Submission | Technical File | Design History File | Design Master File 
Lecture 287Medical Device Essential Principle Checklist | Documentation |  Open file
Lecture 288Implant Card | Regulatory Importance | Content | How to design 
Lecture 289Medical Device Labeling Guideline | General Principles | Wherever applicable (specific) Labeling contents
Lecture 290Instruction for Use (IFU) | Design and Development of IFU 
Lecture 291UDI | Different Component | How to design  
Lecture 292CE 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
Section 9Pharmacovigilance and Safety Management
Lecture 293Introduction to Pharmacovigilance |Definition| Importance |Focus Area | Regulatory compliance | PV activities
Lecture 294Introduction to ADR | Definition | Importance of ADR management | Classification | Prevention of ADR
Lecture 295Terminologies related to ADR 
Lecture 296ADR Reporting System | ADR information loop | ADR reporting system in various countries
Lecture 297DoTS
Lecture 2984 Elements of AEs
Lecture 299ADR Seriousness Determination 
Lecture 300ADR Reporting Limitations
Lecture 301ADR Detection - Pre Marketing Vs. Post Marketing Trial
Lecture 302PSUR
Lecture 303Pharmacovigilance Application Path
Lecture 304Pharmacovigilance Risk Management 
Lecture 305REMS Strategic Planning 
Lecture 306Coding and ADR | MedDRA Principle of ADR Coding | Level of terms | Case Study
Lecture 307MedDRA Coding | Level of terms | Multi Axial Terminology | Practical Example Case Discussion 
Lecture 308Active Surveillance Schemes | Active Case Finding |Sentinel Surveillance | Cohort Studies | Vaccine Safety Surveillance | Pharmacovigilance Programs | Disease Registries |Event Monitoring
Lecture 309Pharmacovigilance Databases : VigiBase | FDA Adverse Event Reporting System (FAERS) | EudraVigilance | MedWatch  | Canadian Vigilance Program| UK Yellow Card Scheme | Chinese Adverse Drug Reaction Monitoring System (CAMS) 
Lecture 310Signal Detection | Process | Different Types of Signal Detection Methods 
Lecture 311Signal Detection in post-marketing surveillance
Lecture 312Pharmacovigilance Framework
Lecture 313Corporate Pharmacovigilance Program 
Lecture 314National Pharmacovigilance Program 
Lecture 315 Pharmacovigilance Software
Lecture 316ICSR in E2B Format | E2B(R3)