Life Science Business Consulting

Introduction

Features

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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.

Few of the similar courses

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 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 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

Lecture 52Patent Cliff | How to calculate the patent cliff

Section 2Strategic Business Management - European Market

Lecture 53Introduction to EU Regulation

Lecture 54Orientation to European Countries and National Regulatory Bodies

Lecture 55EU Drug Discovery Development to Commercialization (Step By Step)

Lecture 56Overview of EU Regulation

Lecture 57EMA and EMA Authorisation Process

Lecture 58EU MA Application Types and Strategic Planning

Lecture 59EU MA Procedure - Centralised, Decentralised, Mutual Recognition, National Procedure

Lecture 60EU MA Strategic Planning: Full, Full-mixed, hybrid applications. Generic, Similar biologic application pathway, Well-established use application, Fixed combination application, Informed consent application

Lecture 61Validity 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 62Data Exclusivity and Market Protection - Supplementary Patent Protection, Exclusivity, 6/10 Rule, 8+2+1 Formulae

Lecture 63EU Orphan Medicinal Products Regulation

Lecture 64Conditional marketing authorisation | Marketing authorisation under exceptional circumstances

Lecture 65Summary of Product Characteristics

Lecture 66Compassionate Use

Lecture 67The 'sunset clause' for marketing authorisation of pharmaceuticals

Lecture 68Paediatric use marketing authorisation (PUMA) & Paediatric Investigation Plan (PIP) - EU Requirments

Lecture 69EU Prime Designation

Lecture 70Accelerated assessment by EMEA

Lecture 71EU Adaptive Pathway

Section 3HEOR, Market Access & Pricing, Reimbursement, Forecasting

Lecture 72Introduction to Market Access | Objectives | Various Key Terminologies | Steps of Market Access | Understanding on Pricing and Reimbursement

Lecture 73Market Access Functions : Role and Responsibilities | Key Job Areas | Understanding Job Description

Lecture 74Introduction to Health Economics | Key terminologies related to health economics.

Lecture 75HEOR Application in Pharmaceutical and Biopharmaceutical Industry

Lecture 77Economic Evaluation Methods | Various methods | Importance of perspective in health economics | Discounting | Uncertainty

Lecture 82Patient Based Forecasting Model | Applying more filters and variables

Lecture 83QALY | How to calculate QALY | Importance and Significance

Lecture 84ICER | How to calculate ICER | Importance and Significance | Incremental Effectiveness determination

Lecture 85CER and PCOR

Lecture 86Market Access Strategic Planning : Steps and Logical Sequencing for Market Access Strategy Development

Lecture 87Indication Sequencing | Indication Prioritization | Development of Indication Timeline | Indication Matrix | Value Based Indication Prioritization

Lecture 88Market Access Value Dossier : What it is | Significance | Components | What to include

Lecture 89AMCP Market Access Dossier Preparation

Lecture 90Target product profile (TPP) | Quality Target product profile (QTPP) | Critical Quality Attributes (CQAs) | Quality By Design (QbD)

Lecture 91Drug Pricing Methodologies - I

Lecture 92Drug Pricing Methodologies - II

Lecture 94Pharma Market Access Pricing Case Study: interchangeable Pricing

Lecture 95Sales Forecasting in Life Science Industry

Lecture 96New Product Forecast Algorithm

Lecture 97Patient Based Forecasting Model | Applying more filters and variables

Lecture 98Prescription Based Forecasting Model | Differences between Patient Based and Prescription Based Forecasting Model | Which model to use and when?

Lecture 99Prevalence Vs. Incidence Model

Lecture 100EPI Based Forecasting | Sales Based Forecasting | When and where to apply which forecasting model

Lecture 101Sales Forecasting Tools | New Product Forecasting | In Market Forecasting

Lecture 102Market Size Assignment 1 [Oncology Brand] - Applying sales forecasting tools to carry out next 6 years sales forecast | Excel Based Model

Lecture 103Market Size Assignment 2 [Asthma Brand] - Applying sales forecasting tools to carry out multiple years sales forecast | Excel Based Model

Lecture 104Patient Based Model Vs. Patient Flow Model | Critical Differences in Model | Concept of Black Box in Patient Flow Model | Application of both model

Lecture 105Concomitancy and polypharmacy | How it alter the basic forecasting algorithm | Practical Working | Comorbidity

Lecture 107Bottom-up or Top-down Forecasting | LRx | Significance of LRx data analysis

Lecture 108Simulation on Bottom-up forecasting

Lecture 109Assessment on Bottom-up forecasting

Lecture 110Oncology Brand Forecasting

Lecture 111Revenue Forecasting Case Study - Novel Antihypertensive

Lecture 112Portfolio Based Forecasting | Forecasting Model Development in Excel

Lecture 113Evidence Based Decision Making | Combine evidences for decision making | Do we need more evidence?

Lecture 114RWD and RWE | Potential sources of RWE | Traditional RCTs vs. RWE | Case Study - RWE Programs | Influencing HCP decision-making

Lecture 115RWD and RWE in Product Lifecycle Management

Lecture 116RWD and RWE - Fit to use | Assessment

Lecture 117RWD data sources | Different types | Detailed understanding of each class

Lecture 118First-in-class | Best-in-class | Market Access Strategic Decision Making

Lecture 119Forecasting Biosimilar | Key Factors to consider

Lecture 120Consensus Meeting

Lecture 121One Number Vs. Multi Number Forecasting

Lecture 122Active Vs. Passive Cannibalization | Impact on forecasting | Case Study

Lecture 123Rebates | Importance | Factors affecting Rebates | Deductibles and Rebates

Lecture 125Treatment Algorithm and Forecasting : Case Based Learning

Lecture 126Chronic and Acute Segment | Forecasting on Chronic and Acute Segment Drugs

Lecture 127Prescription Value Calculation

Lecture 128Practical Training on Value Dossier Preparation | Sample Value Dossier with each section with data | Key points to consider while preparing value dossier

Lecture 129Clinical Data in Value Dossier | Understanding in different types of clinical study with rationale | Case based example on clinical study section writing

Lecture 132Case Study : Pharma Pricing and Reimbursement Planning for new launches | Reimbursement Rate Calculation

Lecture 133HCPCS and CPT Codes | Importance | Significance and Characteristics | Differences between HCPCS and CPT Codes

Lecture 134Basics of Pharma Forecasting | Qualitative | Quantitative | Time Series Forecasting | Case Based Example

Lecture 135Quantitative Vs. Qualitative Forecasting | Application in different scenarios | Practical Case Example | Scenarios

Lecture 137Time Series Forecasting | Step by step time series forecasting | Characteristics of Time Series forecasting

Lecture 138ARIMA Model

Lecture 139ARIMA Model application on pharmaceutical industry | Application in different domains of pharma | Logical step by step Arima Model Development

Lecture 140Exponential Smoothing : in pharma forecasting | Smoothing Factor | Step by step working on Time Series Data by applying Exponential Smoothing

Lecture 141Causal Model of Forecasting | Steps & Key components | Case Based Application

Lecture 142Sample Time Series Analysis Data for a Pharma Brand

Lecture 14310 Time Series Curve with explanation

Lecture 144Assignment : Developing Causal Model of Forecasting | Asthma Drug | Antihypertensives

Lecture 145Judgmental Forecasting | Understanding | Forecasting Technique | Delphi Method | Case Study - Judgmental Forecasting of Alzheimer Drug

Lecture 146Important Pharma Data Sources

Lecture 147Flu Vaccine Forecasting

Lecture 148Forecasting Methods for different classes of pharmaceuticals

Lecture 149Meaning Significance Example of Different Forecasting Strategies

Section 4Branding & Brand Management

Lecture 150Marketing Orientation

Lecture 151Why Is Market Research Important in Pharmaceutical Business?

Lecture 152Market Research - Customer Engagement through feedback mechanism

Lecture 153Product Life cycle

Lecture 154Advance - Strategic Planning in Product Life cycle Management

Lecture 155Segmentation, Targeting and Positioning

Lecture 156A Pharmaceutical Segmentation outlook

Lecture 157Distribution Channel in Pharmaceutical Industry

Lecture 158Promotion in Pharmaceutical Industry : Communication Model, Effective promotional communication, Push Vs. Pull Strategy and Buying Decision Process

Lecture 159Practical understanding on Prescription Accelerating Materials used in pharmaceutical promotion

Lecture 160Method of Promotional Budgeting

Lecture 161Brand Recall | Brand Recognition |Top of mind - How to calculate brand recall value?

Lecture 162Advertising - Introduction | Objective | Types of Advertising

Lecture 163ATL, BTL & TTL Advertising

Lecture 164Advertising Agency - Understanding on various types of advertising agency

Lecture 165Selection of Advertising Agency

Lecture 166What is creative Briefing? How to Prepare !

Lecture 167Creative Briefing - Practical Simulation

Lecture 168Request for Proposal | Concepts in advertising

Lecture 169Advertising Message Strategy Development and Evaluation

Lecture 170Creative Approach and Styles

Lecture 171Steps of Development of Creatives

Lecture 172Advertisement Copy Development

Lecture 173How to prepare Ad Campaign Step By Step

Lecture 174Brand Name | Brand Logo | Designing of Brand Logo | Trademarking

Lecture 175Advance Understanding of Pharmaceutical Brand Logo Development

Lecture 176Component of Brand Logo

Lecture 177Brand Name and Trademark Registration Process

Lecture 178Trademark Searching Process | Hands on Practical Training

Lecture 179How to design an excellent brand logo : Tricks of the trade

Lecture 180Logo colour theme | Colour system | Colour coding | Significance of colour

Lecture 181Few Case Studies related to brand names and logos

Lecture 182Can one innovator company keep 2 or more brand name?

Lecture 183Traditional Vs. Non-Traditional trademark | Significance of Colour in Pharma Branding

Lecture 184Global Trademarking : Brand Protection Globally

Lecture 185Logo Rebranding - Reasons | Practical Examples | How to handle logo rebranding | Forced Rebranding

Lecture 186Brand Logo Development: Real Life Simulation

Lecture 187Tagline - Development, Finalization and Protection

Lecture 188Pharma Brand Name Generator

Lecture 189Fundamental of Pharma Marketing Plan

Lecture 190Basic Understanding how to launch a pharmaceutical product into the market

Lecture 191Practical Training on Marketing Plan Preparation with real life example

Lecture 192Marketing Campaign Development : Importance of Target Audience Segmentation for effective targeting

Lecture 193Sample Marketing Plan

Lecture 194Decide about brand USP -What to promote

Lecture 195How to prepare promotogram. Download sample Promotogram

Lecture 196Importance and Handling of Cycle Meeting and its importance

Lecture 197Sample Marketing Plan

Lecture 198Sample Marketing Plan

Lecture 199Sample Marketing Plan

Lecture 200CSR Campaign

Lecture 201Increase the brand reach with advance segmentation

Lecture 202Concept of uniform branding for better brand acceptability

Lecture 203Concept of Brand Differentiation

Lecture 204Introduction to visual aid designing | V3M Concept | Components of the visual aid page

Lecture 205Practical Training in visual aid designing | Step By Step Visual Aid Preparation | Creative Designing | Guideline on Proofing | USPs to differentiate the visual aid

Lecture 206Visual Aid Printing | Establishing Visual Aid Printing Specs for effective management of the vendors

Lecture 207Visual Aid Analysis with practical example

Lecture 208Guideline on visual aid development

Lecture 209Marketing Plan followed by Visual Aid Development

Lecture 210Visual Aid, Literature reference Sample

Lecture 211Interactive Visual Aid | E-detailing | Remote Detailing | Analysis of Animated Video based e-detailing visual aids

Lecture 212Visual aid detailing story writing

Lecture 213Artwork Development Process in PMT Department

Lecture 214Product List and Reminder card development

Lecture 215Catch Cover Development

Lecture 216Packaging Development

Lecture 217Prescribing Information and Patient Information Leaflet development

Lecture 218Pharma Packaging Case Studies

Lecture 219DHCP letter

Lecture 220Product Packshot Designing : Practical Knowledge

Lecture 221Creativity to develop brand essence

Lecture 222Advance Training on Pharmaceutical Packaging - Creative Packaging for Brand Differentiation

Lecture 223Unique identifier & anti-tampering device on outer packaging

Section 5Licensing and Valuation

Lecture 224Training on Basic Finance | Understanding Financial Statment | Income Statement | Balance Sheet | Cash Flow Statement

Lecture 225Moving Average | Moving Annual Total | YTD | How to calculate

Lecture 226Compound Annual Growth Rate | CAGR Calculation

Lecture 227Business Development Job Functionality | Strategic Planning Process | Knowledge Area of Business Development | Lead targeting | Licensing term sheets

Lecture 228Portfolio Management Process | Portfolio Characteristics | Portfolio Analysis | Balancing the Portfolio | BD and Strategic Planning Department

Lecture 229Identifying the corporate Need of business development | Objective – Strategy - Tactics | Portfolio constraints | SWOT | Numerical SWOT

Lecture 231Numerical SWOT Practical training

Lecture 233Market Size Determination - Market Share | Relative Market Share | Total Vs. Actual Vs. Penetrated Market

Lecture 234Forecasting : Tools and Techniques

Lecture 235Market Sizing & Forecasting Case Study

Lecture 237Average Royalty Rate

Lecture 238Factor affecting the Royalty Rate in Pharmaceutical and Biopharmaceutical Deal

Lecture 239Distribution Licensing | Geography | Indication Splitting | Exclusive and Non-Exclusive Licensing | Sub Licenses

Lecture 241Joint Ventures in Pharmaceutical and Biopharmaceutical Industry

Lecture 242SPECIAL PURPOSE VEHICLES (SPV)

Lecture 243Indication Splitting | Concept | Implementation feasibility analysis

Lecture 244Types of Deals from Discovery to Commercialization

Lecture 245What are the fundamental areas of business development

Lecture 246Licensing Term Sheet | Content Structuring | Sample Term Sheet

Lecture 247Licensing Payment Scheduling: Different Types

Lecture 249Valuation Methods: EBITDA method of valuation | Enterprise Value and Enterprise Multiple Calculation

Lecture 250Negotiation 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 251Business Development Simulation and Decision Making | Early Stage VS. Late Stage Valuation Methodology | Stair Step Model

Lecture 253Benchmarking | Benchmarking through consortium | How to use benchmarking for drug discovery development projects

Lecture 254DCF Calculation : Concept and Calculation - Step by step understanding

Lecture 255Net Present Value (NPV) method : Calculation

Lecture 256Risk-Adjusted Discount Rate Method - Calculation | Concept of Risk Premium

Lecture 257Valuation Metric - P/E Ratio and EPS : Calculation

Lecture 258Comparable Company Analysis method : Calculation

Section 6Biopharmaceutical Management and Regulation

Lecture 259Introduction : Biopharmaceuticals

Lecture 260Classification of Biopharmaceutical

Lecture 261Important Concept regarding Biopharmaceuticals

Lecture 262Introduction to Biologics and Biosimilar | Key differences | Concept of Reference Product

Lecture 263Key features of Biologic | Differences in Chemical Drug Vs. Biologic Drugs

Lecture 264Principle of Naming of Biologic | Understanding on MAB naming system

Lecture 265Global Biopahrma Market Trends

Lecture 266Recombinant protein

Lecture 267Monoclonal Antibodies Vs. Polyclonal Antibodies

Lecture 268Monoclonal Antibodies

Lecture 269Synthetic Immunomodulators

Lecture 270Production of Monoclonal Antibodies

Lecture 271Cytokines

Lecture 272Interferon

Lecture 273Erythropoiesis-stimulating agent

Lecture 274Vaccine development and approval Process

Lecture 275Biosimilar Development Process

Lecture 276Strategic Consideration for Biosimilar Development

Lecture 277Bio-Manufacturing Process Information

Lecture 278Studies required for approval of biosimilar

Lecture 279Biosimilar Approval and Patent Management | Strategic Pathway of Patent Negotiation and Litigation in Biosimilar Approval | Patent Dance | FAQs on Biologic Patent Management

Lecture 280Biosimilar launch case study | Patent Dance Framework

Lecture 281Biosimilar Launch Framework

Lecture 282Biosimilar 180 Day Notice

Lecture 2833(A) List | Significance | Importance | How to interpret

Lecture 284Steps to win over innovator patents | Step wise planning

Lecture 285Biosimilar Launch Project Roadmap with defined stages of project

Lecture 286Timing of Biosimilar Submission and Approvals | Two Scenario based timeline assessments

Lecture 287Hands on Training on Reference Biologic Patent | Classify RPS Biologic Patents | Case Simulation

Lecture 288How to work on RPS’s Patent | Walkthrough | Case Study

Lecture 289Biosimilar Launch Project With Milestones

Lecture 290Analysis of Biologic Patents | Work Assignments

Lecture 291Biologic Patent Insight Worksheet

Lecture 292Patent Thickets | Concept | Implication | Case Based Learning

Section 7Medical Device - Strategic Management - US Market

Lecture 293US Medical Devices Market Insight

Lecture 294Definition of Medical Devices

Lecture 295Classification of Medical Devices

Lecture 296Medical Devices Classification : Work File

Lecture 297Medical Device Development to Commercialization Process | Understanding Key Stages and respective stage level activities | Important MDR terminologies

Lecture 298510k - Pre-market Notification

Lecture 299Predicate Devices | Substantially Equivalent (SE)

Lecture 300Understanding on 510k | Types of the 510k | Timeline | Difference with PMA

Lecture 301FDA decision making process for different classes of 510k applications

Lecture 302Review Test

Lecture 303Premarket approval (PMA) application

Lecture 304Differences between 510k VS. PMA

Lecture 305Data Requirements for A Premarket Approval (PMA) application

Lecture 306PMA Post Submission - Management of CRL - Timeline and Strategic Planning

Lecture 307Labeling Requirement for Medical Devices

Lecture 308Investigational Device Exemption | Device Clinical Research | Early/Expanded Access of Medical Devices | Q-Sub | IDE Submission Requirements

Lecture 309Medical Devices Development to Commercialization Stages | Devices Clinical Trial | Stages | Critical differences with pharmaceutical clinical trial

Lecture 310Medical Devices Post Approval Variations | PMA supplement | PMA amendments | Variation Management Strategic Planning

Lecture 311Unapproved use of Medical Devices

Lecture 312DeNovo Petition - Types of DeNovo Pathways | Details of Review Process | Strategic Planning

Lecture 313Humanitarian Device Exemption (HDE)

Lecture 315Combination Product RFD Designation Process | Importance | Timeline | Outcome Management

Lecture 316Combination Products Pre-market Approval Process | Lead centers | Concept of Primary Mode of Action | Strategic Submission Pathways

Section 8EU Medical Device - Strategic Insight

Lecture 317EU MDR Classification

Lecture 319EU MDR | Annexes | Key notes

Lecture 321EU MDR Guideline | EU MDR - Annexes

Lecture 322EU MDR Conformity Assessment procedure | Assessment of various classes and types of the devices | Key points to consider | Conformity assessment master chart

Lecture 323EU MDR Authorized Representatives | Mandate | Role and Responsibilities

Lecture 324Medical Device Technical File

Lecture 325Medical Device Dossier Preparation | Section Wise Dossier Preparation | Key Requirements regarding dossier | Points to note regarding each section of the dossier

Lecture 326Quality Management System (QMS) for medical devices company

Lecture 327Quality Risk Management | ICH Q9 | ISO 14971 | Principle of Risk Management

Lecture 328Comparing Medical Device Regulations | 510k Submission | Technical File | Design History File | Design Master File

Lecture 329Medical Device Essential Principle Checklist | Documentation | Open file

Lecture 330Implant Card | Regulatory Importance | Content | How to design

Lecture 331Medical Device Labeling Guideline | General Principles | Wherever applicable (specific) Labeling contents

Lecture 332Instruction for Use (IFU) | Design and Development of IFU

Lecture 333UDI | Different Component | How to design

Section 9Pharmacovigilance and Safety Management

Lecture 336Introduction to ADR | Definition | Importance of ADR management | Classification | Prevention of ADR

Lecture 337Terminologies related to ADR

Lecture 338ADR Reporting System | ADR information loop | ADR reporting system in various countries

Lecture 339DoTS

Lecture 3404 Elements of AEs

Lecture 341ADR Seriousness Determination

Lecture 342ADR Reporting Limitations

Lecture 343ADR Detection - Pre Marketing Vs. Post Marketing Trial

Lecture 344PSUR

Lecture 345Pharmacovigilance Application Path

Lecture 346Pharmacovigilance Risk Management

Lecture 347REMS Strategic Planning

Lecture 348Coding and ADR | MedDRA Principle of ADR Coding | Level of terms | Case Study

Lecture 349MedDRA Coding | Level of terms | Multi Axial Terminology | Practical Example Case Discussion

Lecture 352Signal Detection | Process | Different Types of Signal Detection Methods

Lecture 353Signal Detection in post-marketing surveillance

Lecture 354Pharmacovigilance Framework

Lecture 355Corporate Pharmacovigilance Program

Lecture 356National Pharmacovigilance Program

Lecture 357 Pharmacovigilance Software

Lecture 358ICSR in E2B Format | E2B(R3)

Section 10Data Visualization in Life Science Consulting

Lecture 359Line Chart vs. Spline Chart

Lecture 360Basic Area Charts

Lecture 361Stacked Area Chart

Lecture 362Basic Bar Charts

Lecture 363Stacked Bar Charts

Lecture 364Basic Column Charts

Lecture 365Stacked Column Charts

Lecture 366Pie Chart

Lecture 367Donut Chart

Lecture 368Scatter Plot

Lecture 369Case Study: New Oncology Drug Launch Forecasting

Lecture 370Treemap Plot

Lecture 371Spiderweb chart

Lecture 372Polar Chart

Lecture 3733D Funnel Chart

Lecture 374Heatmap Chart

Section 11Case Studies in Life Science Forecasting, Market Access, Portfolio Management

Lecture 375Case Study: Forecasting DMD Drug

Lecture 376Case Study: Forecasting the Uptake of a New Cancer Drug After Launch in a Specific Region

Lecture 377Case Study: Forecasting Demand for a New Cancer Treatment Expected to Generate Billions in Sales Globally

Lecture 378Generic Drug Forecasting - Post Patent Expiry

Lecture 379Case Study: Estimating the Market Uptake of a Generic Version of a Popular Cholesterol-Lowering Drug

Lecture 380Data-Driven Forecasting Case Study: Market Share Forecast for a New Hypertension Drug

Lecture 381Forecasting During Early Stage of Development

Lecture 382Case Simulation : Demographic-Based Forecasting

Lecture 383Forecasting and Valuation for Weight Loss Drugs | Forecasting Model | Model Assumptions | Data Inputs | Projected Revenue Calculations

Lecture 384Forecasting Assignment

Section 12Handling and Managing Datasets

Lecture 385Basic Introduction to Healthcare Datasets | Significance | Importance | Practical Usage

Lecture 386Dataset 1: Claims Data (Insurance)

Lecture 387Dataset 2: Retail Pharmacy Prescription Data

Lecture 388Dataset 3: Longitudinal Patient Data

Lecture 389Characteristics of Different Set of Healthcare Data

Lecture 390Reimbursement and Pricing Datasets

Section 13Biosimilar Strategic Management

Lecture 391Biosimilar Approval and Patent Management | Strategic Pathway of Patent Negotiation and Litigation in Biosimilar Approval | Patent Dance | FAQs on Biologic Patent Management

Lecture 392Biosimilar launch case study | Patent Dance Framework

Lecture 393Biosimilar Launch Framework

Lecture 394Biosimilar 180 Day Notice

Lecture 3953(A) List | Significance | Importance | How to interpret

Lecture 396Steps to win over innovator patents | Step wise planning

Lecture 397Biosimilar Launch Project Roadmap with defined stages of project

Lecture 398Timing of Biosimilar Submission and Approvals | Two Scenario based timeline assessments

Lecture 399Hands on Training on Reference Biologic Patent | Classify RPS Biologic Patents | Case Simulation

Lecture 400How to work on RPS’s Patent | Walkthrough | Case Study

Lecture 401Biosimilar Launch Project With Milestones

Lecture 402Analysis of Biologic Patents | Work Assignments

Lecture 403Biologic Patent Insight Worksheet

Lecture 404Patent Thickets | Concept | Implication | Case Based Learning

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Introduction

Features

Related Courses

About Life Science Consulting

Who should attend this course?

Key details about the course:

Features of Life Science Consulting Business Training Course

Case Based Learning

Few of the similar courses

What is Life Science Consulting?

Life Science Business Consulting

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Introduction

Features

Related Courses

About Life Science Consulting

Who should attend this course?

Key details about the course:

Features of Life Science Consulting Business Training Course

Case Based Learning

Few of the similar courses

What is Life Science Consulting?