Life Science Global Management

Introduction

Target Audience

Features

Related Courses

Career in Life Science

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Life Science Global management training

Life Science global management course provides hands-on training to enhance skill competency of managers working in the Life Science domain. In this course, we will delve into the intricacies of pharmaceuticals, biopharmaceuticals, medical devices, fmcg, food, dietary supplements/nutraceuticals, and cosmetics, providing you with a holistic understanding of these diverse domains. Aim is to empower you to navigate the complex landscape of the life science sector confidently.

This comprehensive life science global management training involves the real life job simulation. Hence, the course provides hands-on practical knowledge. Moreover, this course focuses on how Life Science business development, strategic management, regulatory and licensing professionals work in the company. Therefore, it helps advance professionals to acquire cutting edge business skills.

In these online self-paced modules, participants understand about the development to commercialization process in detail. In other words, you will understand strategic management in life science industry. Hence, Life Science global management course covers fundamentals to advance learning on various skill areas.

Key details about the course:

Course Code: RYD-118
Title: Executive PG Certification in Life Science Global Management (EPLSGM)
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. Participants can complete the course within 18 months anytime.
Course Certificate: Certificate will be provided at the end of the successful completion of the course.

The Life Science Global Management course tailors to meet the needs of a diverse range of professionals and individuals. In fact, this course is ideal for advancing their careers in the life science industry. This course is particularly beneficial for:

Professionals in the Life Science Sector

Whether you’re working in pharmaceuticals, biopharmaceuticals, medical devices, food, dietary supplements/nutraceuticals, cosmetics, or related fields, this course will provide you with valuable insights and skills to enhance your expertise and accelerate your career growth.

Regulatory Affairs Specialists

Professionals involved in regulatory affairs will benefit from gaining a comprehensive understanding of global regulations and compliance requirements across various life science domains.

Quality Assurance and Quality Control Professionals

Individuals responsible for ensuring product quality and regulatory compliance will gain essential knowledge and strategies to enhance quality management practices within their organizations.

Product Development and R&D Professionals

Professionals involved in product development and research and development (R&D) will learn how to navigate the innovation landscape and develop market-driven strategies to bring products to market successfully.

Marketing and Business Development Professionals

Those working in marketing, sales, and business development roles will gain insights into consumer trends, market dynamics, and strategic approaches specific to the life science industry.

Entrepreneurs and Start-up Founders

Aspiring entrepreneurs and founders of start-ups in the life science sector will benefit from learning about industry best practices, market opportunities, and strategies for launching and scaling their ventures.

Consultants and Advisors

Consultants, advisors, and industry analysts seeking to deepen their understanding of the life science industry and provide strategic insights to clients will find this course invaluable.

Students and Researchers

Undergraduate and graduate students, as well as researchers, interested in pursuing careers or conducting research in the life science industry, will gain a comprehensive overview of the sector and its various domains.

Professionals Transitioning to the Life Science Industry

Individuals from other industries looking to transition into the life science sector will acquire the knowledge and skills necessary to make a successful career switch.

Features of Life Science Global Management Course

This Life Science global management course covers all aspects of the strategic management from discovery development, regulatory, commercialization, regulatory, market access, sales and marketing, branding, business development etc.
The course provides orientation to job related practical aspects of the business development managers. Therefore, on completion of the course, the participants will develop the hands on understanding how Business Development Professional works.
One of the important feature of the course is real life simulation on critical decision making process. Hence, these simulations help to enhance the licensing and decision making skills which is the core aspects of the pharmaceutical management working.

Case Based Learning

Life Science global management course provides advanced training on strategic management based on the various business regions.
Course covers regional business development, regulatory requirements specific to US, EU, Middle East, GCC, MENA, African, ASEAN, Latam, China, Japan, India etc.
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

Career in Life Science Company

A career in a life science company can be incredibly rewarding and offers a wide range of opportunities for individuals with diverse backgrounds and skill sets. Here’s an overview of potential career paths within a life science company:

Research and Development (R&D):

Scientists: Conduct research to discover and develop new drugs, therapies, medical devices, and products.
Research Associates/Technicians: Assist scientists in conducting experiments, collecting data, and analyzing results.
Clinical Research Associates (CRAs): Manage clinical trials to evaluate the safety and efficacy of new treatments.
Regulatory Affairs: Regulatory Affairs Specialists/Managers: Ensure compliance with regulations and guidelines set by regulatory agencies, such as the FDA or EMA, throughout the product development process. Regulatory Affairs Associates Assist in preparing regulatory submissions and maintaining compliance documentation.

Market Access

Market Access Managers/Directors: Develop strategies to ensure that products gain reimbursement. Provides access to patients through payers, such as insurance companies and government agencies.
Health Economics Managers/Analysts: Conduct economic evaluations and cost-effectiveness analyses to demonstrate the value of products and inform pricing and reimbursement decisions.
Reimbursement Specialists: Navigate reimbursement processes and negotiate coverage agreements with payers to optimize market access for products.

Health Economics and Outcomes Research (HEOR)

HEOR Scientists/Analysts: Design and conduct studies to evaluate the clinical and economic outcomes associated with healthcare interventions, including pharmaceuticals, medical devices, and procedures.
Health Economists: Apply economic principles and statistical methods to analyze healthcare data and generate evidence to support decision-making by stakeholders, including payers, providers, and policymakers.
Outcomes Research Managers: Lead HEOR initiatives and collaborate with cross-functional teams to generate evidence that demonstrates the value of products and informs market access and commercialization strategies.

Strategic Management

Strategic Planning Managers/Directors: Develop and implement long-term strategic plans that align with the company’s goals and objectives, considering factors such as market trends, competitive dynamics, and regulatory changes.
Strategy Analysts/Consultants: Conduct market research, competitive analysis, and scenario planning to identify opportunities and threats and inform strategic decision-making.
Corporate Development Managers: Identify and evaluate opportunities for mergers, acquisitions, partnerships, and alliances to enhance the company’s strategic position and drive growth.

Manufacturing and Operations:

Manufacturing Engineers/Managers: Oversee the production process and optimize manufacturing operations to ensure efficiency and quality.
Supply Chain Managers/Logistics Coordinators: Manage the flow of materials and products from suppliers to customers, ensuring timely delivery and inventory management.

Quality Assurance (QA) and Quality Control (QC):

Quality Assurance Specialists/Managers: Develop and implement quality systems to ensure products meet regulatory standards and customer requirements.
Quality Control Analysts/Technicians: Perform testing and inspections to verify product quality and adherence to specifications.

Sales and Marketing:

Sales Representatives/Managers: Promote and sell products to healthcare professionals, distributors, and other customers.
Marketing Specialists/Managers: Develop marketing strategies and campaigns to educate healthcare professionals and consumers about products and treatments.

Medical Affairs:

Medical Science Liaisons (MSLs): Build relationships with key opinion leaders and provide scientific and medical information about products.
Medical Writers: Prepare scientific documents, such as clinical study reports and regulatory submissions, for publication and regulatory review.

Business Development and Licensing:

Business Development Managers/Directors: Identify and pursue partnerships, collaborations, and licensing opportunities to expand the company’s portfolio and revenue streams.
Licensing Associates/Managers: Evaluate potential licensing and acquisition opportunities and negotiate agreements with external partners.

Compliance and Legal Affairs:

Compliance Officers/Managers: Ensure adherence to regulations and internal policies, conduct audits, and provide training on compliance issues.
Legal Counsel: Provide legal advice and support on matters such as intellectual property, contracts, and regulatory compliance.

Clinical Operations and Project Management:

Clinical Project Managers: Coordinate and oversee clinical trials, managing timelines, budgets, and resources to ensure successful study execution.
Clinical Research Coordinators (CRCs): Assist in the planning, implementation, and monitoring of clinical trials, ensuring compliance with protocols and regulations.

These are just a few examples of the diverse career opportunities available within the life science industry. Whether you have a background in science, engineering, business, or another field, there are roles suited to a wide range of skills and interests. Continuous learning and professional development are key to advancing your career in this dynamic and rapidly evolving field.

⭐ 3 Free Add-On Courses with Certification
✔ Boost your credentials with additional specialized learning opportunities.

✔ Choose any course of your choice – 1 – one month and 2 one week / 3 days certification. Choose add on course from here.

Note: Add-on courses can only be applied for and accessed during the active course admission period.

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

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 66MHRA - UK Regulation

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

Lecture 72European public assessment report (EPAR) - Importance, Component, Management, Updation

Lecture 73SPOR - Concept of Master Data Management

Section 3Pharma International Business - Product Registration, Plant Certification, Dossier Preparation and Export Documentation

Lecture 74Introduction to Pharmaceutical Export

Lecture 75Introduction of Export Documentation | Understanding of important terminologies

Lecture 76Proforma Invoice - Detailed understanding how to prepare Proforma Invoice

Lecture 77Export Contract | Importance | Considerations | Things to include in Export Contract

Lecture 78Commercial Invoice | Importance | Differences with Proforma Invoice

Lecture 79Custom House Agent | Role, Responsibilities, How they work | Freight Forwarder - Difference with CHA | Case Study

Lecture 81Bank Guarantee (BG) | How BG works | Differences between BG and LC | Applicability of BG

Lecture 82LC Discounting | How it works | How to calculate the LC discounting

Lecture 83Packing List | Importance | Things to include in packing list

Lecture 84Incoterms | 2020 Incoterms | Practical understanding on different types of Incoterms | Choosing the right incoterm

Lecture 85Logical selection of Incoterms | Landing in right incoterms for your business

Lecture 87Transport Documents | Bill of Lading | Different Types of Bill of Lading | Airway Bill

Lecture 88Certification Pharmaceutical Companies / Plants

Lecture 90Introduction 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 91WHO-GMP Certification Scheme

Lecture 92Template of Certificate of Pharmaceutical product | Key observations and points to note while working on CoPP

Lecture 93Certificate of Analysis

Lecture 94Certificate of Origin (COO)

Lecture 95Non-conviction certificate

Lecture 96ISO Certification

Lecture 97Common Technical Document (CTD)

Lecture 98Electronic Common Technical Document (ECTD)

Lecture 99Dossier Preparation focusing on drug registration in export countries

Lecture 100Modules on Stability Study : Stability Study - Fundamental Understanding | Interchangebility | Reports | API & FPP Stability Study

Lecture 101Importance of effective dossier management

Lecture 102Detailed Understanding on ANDA Submission Dossier

Lecture 103Prior Approval Submission

Lecture 104Detailed Understanding on ANDA Fees

Lecture 105Discussion on 85 common deficiency in CTD submission dossier

Lecture 106Introduction 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 107WHO-GMP Certification Scheme

Lecture 108Template of Certificate of Pharmaceutical product | Key observations and points to note while working on CoPP

Section 4Plant Management and Certification | Quality Management

Lecture 109Premises & Plant Layout Designing

Lecture 110Sanitation and Hygiene

Lecture 111Equipment Modules

Lecture 112Production Modules

Lecture 113Documentation

Lecture 114Quality Control

Lecture 115Product Complaint

Lecture 116Storage Module

Lecture 117Pharmaceutical SOPs Management from regulatory perspective

Lecture 118Establishment Inspection Report | 483 Observations | USFDA Warning Letter | Handling of FDA inspection | Closing of Warning Letter

Lecture 119Data Integrity issues in Pharmaceutical Industry

Lecture 120Electronic Batch Record for effective compliance management | Key Understanding | Functionalities | Importance in managing data integrity

Lecture 121Quality Risk Management | ICH Q9 | ISO 14971 | Principle of Risk Management

Section 5HEOR, Market Access & Pricing, Reimbursement, Forecasting

Lecture 122Introduction to Market Access | Objectives | Various Key Terminologies | Steps of Market Access | Understanding on Pricing and Reimbursement

Lecture 123Market Access Functions : Role and Responsibilities | Key Job Areas | Understanding Job Description

Lecture 124Introduction to Health Economics | Key terminologies related to health economics.

Lecture 125HEOR Application in Pharmaceutical and Biopharmaceutical Industry

Lecture 127Economic Evaluation Methods | Various methods | Importance of perspective in health economics | Discounting | Uncertainty

Lecture 132Patient Based Forecasting Model | Applying more filters and variables

Lecture 133QALY | How to calculate QALY | Importance and Significance

Lecture 134ICER | How to calculate ICER | Importance and Significance | Incremental Effectiveness determination

Lecture 135CER and PCOR

Lecture 136Market Access Strategic Planning : Steps and Logical Sequencing for Market Access Strategy Development

Lecture 137Indication Sequencing | Indication Prioritization | Development of Indication Timeline | Indication Matrix | Value Based Indication Prioritization

Lecture 138Market Access Value Dossier : What it is | Significance | Components | What to include

Lecture 139AMCP Market Access Dossier Preparation

Lecture 140Target product profile (TPP) | Quality Target product profile (QTPP) | Critical Quality Attributes (CQAs) | Quality By Design (QbD)

Lecture 141Drug Pricing Methodologies - I

Lecture 142Drug Pricing Methodologies - II

Lecture 144Pharma Market Access Pricing Case Study: interchangeable Pricing

Lecture 145Sales Forecasting in Life Science Industry

Lecture 146New Product Forecast Algorithm

Lecture 147Patient Based Forecasting Model | Applying more filters and variables

Lecture 148Prescription Based Forecasting Model | Differences between Patient Based and Prescription Based Forecasting Model | Which model to use and when?

Lecture 149Prevalence Vs. Incidence Model

Lecture 150EPI Based Forecasting | Sales Based Forecasting | When and where to apply which forecasting model

Lecture 151Sales Forecasting Tools | New Product Forecasting | In Market Forecasting

Lecture 152Market Size Assignment 1 [Oncology Brand] - Applying sales forecasting tools to carry out next 6 years sales forecast | Excel Based Model

Lecture 153Market Size Assignment 2 [Asthma Brand] - Applying sales forecasting tools to carry out multiple years sales forecast | Excel Based Model

Lecture 154Patient Based Model Vs. Patient Flow Model | Critical Differences in Model | Concept of Black Box in Patient Flow Model | Application of both model

Lecture 155Concomitancy and polypharmacy | How it alter the basic forecasting algorithm | Practical Working | Comorbidity

Lecture 157Bottom-up or Top-down Forecasting | LRx | Significance of LRx data analysis

Lecture 158Simulation on Bottom-up forecasting

Lecture 159Assessment on Bottom-up forecasting

Lecture 160Oncology Brand Forecasting

Lecture 161Revenue Forecasting Case Study - Novel Antihypertensive

Lecture 162Portfolio Based Forecasting | Forecasting Model Development in Excel

Lecture 163Evidence Based Decision Making | Combine evidences for decision making | Do we need more evidence?

Lecture 164First-in-class | Best-in-class | Market Access Strategic Decision Making

Lecture 165Forecasting Biosimilar | Key Factors to consider

Lecture 166Consensus Meeting

Lecture 167One Number Vs. Multi Number Forecasting

Lecture 168Active Vs. Passive Cannibalization | Impact on forecasting | Case Study

Lecture 169Rebates | Importance | Factors affecting Rebates | Deductibles and Rebates

Lecture 171Treatment Algorithm and Forecasting : Case Based Learning

Lecture 172Chronic and Acute Segment | Forecasting on Chronic and Acute Segment Drugs

Lecture 173Prescription Value Calculation

Lecture 174Practical Training on Value Dossier Preparation | Sample Value Dossier with each section with data | Key points to consider while preparing value dossier

Lecture 175Clinical Data in Value Dossier | Understanding in different types of clinical study with rationale | Case based example on clinical study section writing

Lecture 178Basics of Pharma Forecasting | Qualitative | Quantitative | Time Series Forecasting | Case Based Example

Lecture 179Quantitative Vs. Qualitative Forecasting | Application in different scenarios | Practical Case Example | Scenarios

Lecture 181Time Series Forecasting | Step by step time series forecasting | Characteristics of Time Series forecasting

Lecture 182ARIMA Model

Lecture 183ARIMA Model application on pharmaceutical industry | Application in different domains of pharma | Logical step by step Arima Model Development

Lecture 184Exponential Smoothing : in pharma forecasting | Smoothing Factor | Step by step working on Time Series Data by applying Exponential Smoothing

Lecture 185Causal Model of Forecasting | Steps & Key components | Case Based Application

Lecture 186Sample Time Series Analysis Data for a Pharma Brand

Lecture 18710 Time Series Curve with explanation

Lecture 188Assignment : Developing Causal Model of Forecasting | Asthma Drug | Antihypertensives

Lecture 189Judgmental Forecasting | Understanding | Forecasting Technique | Delphi Method | Case Study - Judgmental Forecasting of Alzheimer Drug

Lecture 190Important Pharma Data Sources

Lecture 191Flu Vaccine Forecasting

Lecture 192Forecasting Methods for different classes of pharmaceuticals

Lecture 193Meaning Significance Example of Different Forecasting Strategies

Section 6Business Development | Licensing

Lecture 194Training on Basic Finance | Understanding Financial Statment | Income Statement | Balance Sheet | Cash Flow Statement

Lecture 195Moving Average | Moving Annual Total | YTD | How to calculate

Lecture 196Compound Annual Growth Rate | CAGR Calculation

Lecture 197Business Development Job Functionality | Strategic Planning Process | Knowledge Area of Business Development | Lead targeting | Licensing term sheets

Lecture 198Portfolio Management Process | Portfolio Characteristics | Portfolio Analysis | Balancing the Portfolio | BD and Strategic Planning Department

Lecture 199Identifying the corporate Need of business development | Objective – Strategy - Tactics | Portfolio constraints | SWOT | Numerical SWOT

Lecture 201Numerical SWOT Practical training

Lecture 203Market Size Determination - Market Share | Relative Market Share | Total Vs. Actual Vs. Penetrated Market

Lecture 204Forecasting : Tools and Techniques

Lecture 205Market Sizing & Forecasting Case Study

Lecture 207Average Royalty Rate

Lecture 208Factor affecting the Royalty Rate in Pharmaceutical and Biopharmaceutical Deal

Lecture 209Distribution Licensing | Geography | Indication Splitting | Exclusive and Non-Exclusive Licensing | Sub Licenses

Lecture 211Joint Ventures in Pharmaceutical and Biopharmaceutical Industry

Lecture 212SPECIAL PURPOSE VEHICLES (SPV)

Lecture 213Indication Splitting | Concept | Implementation feasibility analysis

Lecture 214Types of Deals from Discovery to Commercialization

Lecture 215What are the fundamental areas of business development

Lecture 216Licensing Term Sheet | Content Structuring | Sample Term Sheet

Lecture 217Licensing Payment Scheduling: Different Types

Lecture 219Valuation Methods: EBITDA method of valuation | Enterprise Value and Enterprise Multiple Calculation

Lecture 220Negotiation 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 221Business Development Simulation and Decision Making | Early Stage VS. Late Stage Valuation Methodology | Stair Step Model

Lecture 223Benchmarking | Benchmarking through consortium | How to use benchmarking for drug discovery development projects

Lecture 224DCF Calculation : Concept and Calculation - Step by step understanding

Lecture 225Net Present Value (NPV) method : Calculation

Lecture 226Risk-Adjusted Discount Rate Method - Calculation | Concept of Risk Premium

Lecture 227Valuation Metric - P/E Ratio and EPS : Calculation

Lecture 228Comparable Company Analysis method : Calculation

Lecture 230Pipeline Benchmarking | Significance and Importance in Bio Pharma BD&L | Analyzing sample portfolio | Comparative outcome in business development

Lecture 231Comparative pipeline benchmarking analysis | Level of Benchmarking | Primary - Secondary - Tertiary Benchmarking Metrics | Case Based Analysis of three companies comparative pipeline benchmarking

Lecture 232Pipeline Diversity Scores | Significance | How to Calculate | Comparative Study of Pipeline Diversity Scores

Lecture 233Design, Analysis, Assessment and Feedback on Real Time Portfolio Tracker

Lecture 234Research Productivity Index | Concept | Significance | Calculation Methodology | Comparative RPI benchmarking Exercise

Lecture 235WACC in Biopharma Valuation | Significance | WACC benchmarking

Lecture 236WACC Calculation | Step by Step Calculation | Insight on WACC components

Lecture 237rNPV Model | Step by Step Calculation | Insight on Probability and Cumulative Probability | Factoring WACC for Discounting

Lecture 238Probability and Cumulative Probability | Calculation | Benchmarking | Factoring for WACC and rNPV

Lecture 239Real Options Valuation (ROV) for Biopharma assets | Model Development | Calculation | Case Based Insight in the context of inlicensing and outlicensing | Early stage asset valuation with ROV

Lecture 240ROV Scenario Based Case Study

Lecture 241ROV Scenario Based Case Study

Section 7Data Visualization in Pharma Forecasting

Lecture 242Line Chart vs. Spline Chart

Lecture 243Basic Area Charts

Lecture 244Stacked Area Chart

Lecture 245Basic Bar Charts

Lecture 246Stacked Bar Charts

Lecture 247Basic Column Charts

Lecture 248Stacked Column Charts

Lecture 249Pie Chart

Lecture 250Donut Chart

Lecture 251What is a Scatter Plot?

Lecture 252Case Study: New Oncology Drug Launch Forecasting

Lecture 253Treemap Plot

Lecture 254Spiderweb chart

Lecture 255Polar Chart

Lecture 2563D Funnel Chart

Lecture 257Heatmap Chart

Section 8Market Access and Forecasting Case Studies

Lecture 258Demand Forecasting for a Drug Targeting Duchenne Muscular Dystrophy (DMD) | Rare Disease Forecasting | Model Development | Assignment | Download Excel Work File

Lecture 259Forecasting the Uptake of a New Cancer Drug After Launch in a Specific Region

Lecture 260Case Study: Forecasting Demand for a New Cancer Treatment Expected to Generate Billions in Sales Globally

Lecture 261Generic Drug Forecasting - Post Patent Expiry

Lecture 262Case Study: Estimating the Market Uptake of a Generic Version of a Popular Cholesterol-Lowering Drug

Lecture 263Case Study: Market Share Forecast for a New Hypertension Drug

Lecture 264Forecasting During Early Stage of Development

Lecture 265Case Simulation : Demographic-Based Forecasting

Lecture 266Forecasting and Valuation for Weight Loss Drugs | Forecasting Model | Model Assumptions | Data Inputs | Projected Revenue Calculations

Lecture 267Case Based Forecasting Forecasting Assignment | Work File Preparation

Section 9HEOR, Market Access & Pricing, Reimbursement, Forecasting

Lecture 268RWD and RWE | Potential sources of RWE | Traditional RCTs vs. RWE | Case Study - RWE Programs | Influencing HCP decision-making

Lecture 269RWD and RWE in Product Lifecycle Management

Lecture 270RWD and RWE - Fit to use | Assessment

Lecture 271RWD data sources | Different types | Detailed understanding of each class

Section 10Real World Data and Real World Evidence

Lecture 272RWD and RWE | Potential sources of RWE | Traditional RCTs vs. RWE | Case Study - RWE Programs | Influencing HCP decision-making

Lecture 273RWD and RWE in Product Lifecycle Management

Lecture 274RWD and RWE - Fit to use | Assessment

Lecture 275RWD data sources | Different types | Detailed understanding of each class

Section 11Pharma Global Brand Management

Lecture 276Marketing Orientation

Lecture 277Why Is Market Research Important in Pharmaceutical Business?

Lecture 278Market Research - Customer Engagement through feedback mechanism

Lecture 279Product Life cycle

Lecture 280Advance - Strategic Planning in Product Life cycle Management

Lecture 281Segmentation, Targeting and Positioning

Lecture 282A Pharmaceutical Segmentation outlook

Lecture 283Distribution Channel in Pharmaceutical Industry

Lecture 284Promotion in Pharmaceutical Industry : Communication Model, Effective promotional communication, Push Vs. Pull Strategy and Buying Decision Process

Lecture 285Practical understanding on Prescription Accelerating Materials used in pharmaceutical promotion

Lecture 286Method of Promotional Budgeting

Lecture 287Brand Recall | Brand Recognition |Top of mind - How to calculate brand recall value?

Lecture 288Advertising - Introduction | Objective | Types of Advertising

Lecture 289ATL, BTL & TTL Advertising

Lecture 290Advertising Agency - Understanding on various types of advertising agency

Lecture 291Selection of Advertising Agency

Lecture 292What is creative Briefing? How to Prepare !

Lecture 293Creative Briefing - Practical Simulation

Lecture 294Request for Proposal | Concepts in advertising

Lecture 295Advertising Message Strategy Development and Evaluation

Lecture 296Creative Approach and Styles

Lecture 297Steps of Development of Creatives

Lecture 298Advertisement Copy Development

Lecture 299How to prepare Ad Campaign Step By Step

Lecture 300Brand Name | Brand Logo | Designing of Brand Logo | Trademarking

Lecture 301Advance Understanding of Pharmaceutical Brand Logo Development

Lecture 302Brand Name and Trademark Registration Process

Lecture 303Trademark Searching Process | Hands on Practical Training

Lecture 304How to design an excellent brand logo : Tricks of the trade

Lecture 305Logo colour theme | Colour system | Colour coding | Significance of colour

Lecture 306Few Case Studies related to brand names and logos

Lecture 307Can one innovator company keep 2 or more brand name?

Lecture 308Traditional Vs. Non-Traditional trademark | Significance of Colour in Pharma Branding

Lecture 309Global Trademarking : Brand Protection Globally

Lecture 310Logo Rebranding - Reasons | Practical Examples | How to handle logo rebranding | Forced Rebranding

Lecture 311Brand Logo Development: Real Life Simulation

Lecture 312Tagline - Development, Finalization and Protection

Lecture 313Pharma Brand Name Generator

Lecture 314Fundamental of Pharma Marketing Plan

Lecture 315Basic Understanding how to launch a pharmaceutical product into the market

Lecture 316Practical Training on Marketing Plan Preparation with real life example

Lecture 317Marketing Campaign Development : Importance of Target Audience Segmentation for effective targeting

Lecture 318Sample Marketing Plan

Lecture 319Decide about brand USP -What to promote

Lecture 320How to prepare promotogram. Download sample Promotogram

Lecture 321Importance and Handling of Cycle Meeting and its importance

Lecture 322Sample Marketing Plan

Lecture 323Sample Marketing Plan

Lecture 324Sample Marketing Plan

Lecture 325CSR Campaign

Lecture 326Increase the brand reach with advance segmentation

Lecture 327Concept of uniform branding for better brand acceptability

Lecture 328Concept of Brand Differentiation

Lecture 329Introduction to visual aid designing | V3M Concept | Components of the visual aid page

Lecture 330Practical Training in visual aid designing | Step By Step Visual Aid Preparation | Creative Designing | Guideline on Proofing | USPs to differentiate the visual aid

Lecture 331Visual Aid Printing | Establishing Visual Aid Printing Specs for effective management of the vendors

Lecture 332Visual Aid Analysis with practical example

Lecture 333Guideline on visual aid development

Lecture 334Marketing Plan followed by Visual Aid Development

Lecture 335Visual Aid, Literature reference Sample

Lecture 336Interactive Visual Aid | E-detailing | Remote Detailing | Analysis of Animated Video based e-detailing visual aids

Lecture 337Visual aid detailing story writing

Lecture 338Artwork Development Process in PMT Department

Lecture 339Product List and Reminder card development

Lecture 340Catch Cover Development

Lecture 341Packaging Development

Lecture 342Prescribing Information and Patient Information Leaflet development

Lecture 343Pharma Packaging Case Studies

Lecture 344DHCP letter

Lecture 345Product Packshot Designing : Practical Knowledge

Lecture 346Creativity to develop brand essence

Lecture 347Advance Training on Pharmaceutical Packaging - Creative Packaging for Brand Differentiation

Lecture 348Fundamental Training on Disease Awareness Campaign | Case Based Analysis | Comprehensive Module

Lecture 349DAC Campaign Planning and Execution : Case Based Analysis

Lecture 350DAC Do’s and Don’ts + Case Based Simulation

Lecture 351DAC Thumb Rules

Section 12Digital Marketing & Omnichannel Marketing

Lecture 352Introduction to Digital Marketing

Lecture 353Inbound and outbound marketing in pharma | Types of inbound and outbound marketing

Lecture 355Digital 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 356Digital marketing strategy development | Planning process | E-Marketing Plan | Planning for MNC Vs. Start Up | Strategic Outcome measurement

Lecture 357Relationship marketing using digital platform | CRM | Concept of permission marketing | User Satisfaction and loyalty management | Feedback mechanism

Lecture 359Search Engine Optimization | Search Engine Marketing | Social Media Marketing

Lecture 360Web Host - Check the hosting details

Lecture 361Page Speed- importance and practical understanding | Check the web speed

Lecture 362Keyword | Keyword Planning for SEO and SEM | Keyword Planner

Lecture 363Mobile Responsive | Tracking the Site

Lecture 364HCP sites and Patient Site

Lecture 365Google Ad - Practical Training on Campaign Development and Execution

Lecture 366Digital Marketing Strategies for innovator brand | Pre launch - comuing soon, DSE Marketing | Launch activities - Day of approval (DOA) site | FDA Compliance | FDA 2253 Filing

Lecture 367Brand Portal Development

Lecture 368Relationship Marketing : KOL Management and Patient Advocacy Group

Lecture 369Public Relation - PR firm | PR Campaign | Press Release | Technical understanding of press release writing | Digital Press Release

Lecture 370Developing Ad - Pharmaceutical Prescription, OTC Vs FMCG Brands

Lecture 371Difference between FMCG and OTC Brand Ad

Lecture 372Introduction to Omnichannel Marketing | Importance | Significance | Implementation outcome of Omnichannel Marketing

Lecture 373OMM Implementation Framework | Step By Step | Key Activities in each step | 3 Case Study on OMM

Lecture 374Download OMM Implementation Framework Checklist

Lecture 375OMM terminologies | Explanation of important digital marketing terms

Lecture 376OM Brand Plan Development | Practical Brand Plan with different sections with touchpoints

Section 13Biologic Market Access | Product Class Training | Market Access Strategic Planning

Lecture 377Introduction : Biopharmaceuticals

Lecture 378Classification of Biopharmaceutical

Lecture 379Important Concept regarding Biopharmaceuticals

Lecture 380Introduction to Biologics and Biosimilar | Key differences | Concept of Reference Product

Lecture 381Key features of Biologic | Differences in Chemical Drug Vs. Biologic Drugs

Lecture 382Principle of Naming of Biologic | Understanding on MAB naming system

Lecture 383Global Biopharma Market Trends | Strategic Insight

Lecture 384Recombinant protein

Lecture 385Monoclonal Antibodies Vs. Polyclonal Antibodies

Lecture 386Monoclonal Antibodies

Lecture 387Synthetic Immunomodulators

Lecture 388Production of Monoclonal Antibodies

Lecture 389Cytokines

Lecture 390Interferon

Lecture 391Erythropoiesis-stimulating agent

Lecture 392Vaccine development and approval Process

Lecture 393Biosimilar Development Process

Lecture 394Strategic Consideration for Biosimilar Development

Lecture 395Bio-Manufacturing Process Information

Lecture 396Studies required for approval of biosimilar

Lecture 397ATMPs | Types and Classification | Regulatory Mechanism

Lecture 398Biosimilar Approval and Patent Management | Strategic Pathway of Patent Negotiation and Litigation in Biosimilar Approval | Patent Dance | FAQs on Biologic Patent Management

Lecture 399Biosimilar launch case study | Patent Dance Framework

Lecture 400Biosimilar Launch Framework

Lecture 401Biosimilar 180 Day Notice

Lecture 4023(A) List | Significance | Importance | How to interpret

Lecture 403Steps to win over innovator patents | Step wise planning

Lecture 404Biosimilar Launch Project Roadmap with defined stages of project

Lecture 405Timing of Biosimilar Submission and Approvals | Two Scenario based timeline assessments

Lecture 406Hands on Training on Reference Biologic Patent | Classify RPS Biologic Patents | Case Simulation

Lecture 407How to work on RPS’s Patent | Walkthrough | Case Study

Lecture 408Biosimilar Launch Project With Milestones

Lecture 409Analysis of Biologic Patents | Work Assignments

Lecture 410Biologic Patent Insight Worksheet

Lecture 411Patent Thickets | Concept | Implication | Case Based Learning

Section 14Market Access of Pharmaceuticals in Japan

Lecture 412Introduction to Japan Drug Regulatory Affairs

Lecture 413Drug Discovery Development to commercialization | PMDA functions | Consultation | Premarket to post market approval

Lecture 414Drug Approval System | GCP | PMDA requirements

Lecture 415New Drug Application | Requirements | Review Process

Lecture 416Generic Drug Application Review and Approval

Lecture 417Marketing Authorization Process for registration of pharmaceutical in Japan

Lecture 418API Registration in Japan | Step By Step Process

Lecture 420Priority Review Application | Criteria | Review Process | Timeline

Lecture 421Orphan Drug Designation in Japan

Lecture 422Japan DMF System | MF filing Process | Key points

Lecture 423Strategic Approval Pathway - Formulation Approval Quoting MF

Lecture 424SAKIGAKE designation

Section 15Variation Filing : Marketing Authorization variation management

Lecture 425Introduction to Variation Management | Reasons for Variation | Working in Variation Department

Lecture 426Variation Classification | Basis of Classification | US and EU Variation Classification | Other region variation guideline.

Section 16Bioequivalence Study : Requirements

Lecture 427PKPD in Drug Discovery | PK-PD trial | Understanding PKPD from regulatory perspective in drug approval process

Lecture 428Bioequivalence Study | Study design | Different types of BE Studies

Lecture 430Biopharmaceutical Classification System (BCS) | Types | Biowaivers | BCS tool for drug development and regulatory submission

Lecture 431Bioequivalence Study - Discussion - Timeline of stability study and bioequivalence study

Lecture 432Bioequivalence Study - Discussion - Dissolution Testing

Lecture 433Bioequivalence Study - Generic Approval and Additives Labeling Requirements

Lecture 434IVIVC - Basis | Importance | Case Based Determination of IVIVC

Lecture 435Setting Dissolution Specification for Generic Products | Regulatory Expectations

Section 17CIS - EAEU Market Access

Lecture 436Drug Registration and Submission Strategic Planning for Russia and EAEU region

Lecture 437GMP requirements in Russia

Section 18Market Access Planning for India

Lecture 439Medicine Export Criteria from India

Lecture 440Documents for conducting BE Study for Export

Lecture 441New Drug Approval in DCGI

Lecture 442Line Extension New Strength Approval

Section 19Regional Business Development : Latam

Lecture 443Introduction to Latam Region Pharma Business Development

Lecture 444Drug Registration and Regulation in Argentina

Lecture 445Drug Registration and Regulation in Bolivia

Lecture 446Drug Registration and Regulation in Brazil

Lecture 447Drug Registration and Regulation in Chile

Lecture 448Drug Registration and Regulation in Colombia

Lecture 449Drug Registration and Regulation in Mexico

Section 20Regional Business Development : Latam

Lecture 450Introduction to Latam Region Pharma Business Development

Lecture 451Drug Registration and Regulation in Argentina

Lecture 452Drug Registration and Regulation in Bolivia

Lecture 453Drug Registration and Regulation in Brazil

Lecture 454Drug Registration and Regulation in Chile

Lecture 455Drug Registration and Regulation in Colombia

Lecture 456Drug Registration and Regulation in Mexico

Section 21Regional Business Development : GCC, Middle East and MENA

Lecture 457Middle East / MENA / GCC Countries Geographical Orientation

Lecture 458Middle East / MENA / GCC Countries National Regulatory Agencies

Lecture 459GCC Registration Procedure - Centralized and Decentralized Procedure | Detailed understanding on Centralized Registration Process

Lecture 460Drug Registration in Saudi Arabia

Lecture 461Drug Registration in UAE

Lecture 462Drug Registration and Regulatory Strategic Planning for Iran

Lecture 463Drug Registration and Regulatory Strategic Planning for Israel

Lecture 464Middle East Pharma Market

Lecture 465Drug Registration in Jordan

Lecture 466Drug Registration in Palestine

Section 22Regional Business Development : ASEAN

Lecture 467ASEAN - Region - Introduction

Lecture 468ASEAN Countries | Introduction | Geographical Overview

Lecture 469ASEAN countries drug regulatory bodies

Lecture 470ASEAN Common Technical Requirements (ACTRs)

Lecture 471The Pharmaceutical Inspection Co-operation Scheme

Lecture 472CPP Requirements for Drug Registration in ASEAN countries

Lecture 473Dossier Requirements - ACTD/CTD Acceptability

Lecture 474Pharmacopoeias Acceptability

Lecture 475Harmonization of Technical Guidelines

Lecture 476Stability Study requirements for drug registration in ASEAN countries

Lecture 477Product Labelling

Lecture 478Post Approval Changes (Variations) requirements in ASEAN countries

Lecture 479Pharmacovigilance and Risk Management Plan (RMP)

Lecture 480Timeline of Drug Registration Approval

Lecture 482Drug Registration and Regulation Singapore | Strategic Pathways for Marketing Authorization | Screening, Evaluation of MA applications | Variations Classifications and Management

Lecture 483Drug Registration and Regulation in Brunei

Lecture 484Drug Registration and Regulation in Cambodia

Section 23Regional Business Development : Africa

Lecture 485African Continent Overview - Brief introduction

Lecture 486African Pharma Market

Lecture 487Drug Registration - African medicines regulatory

Lecture 488Basic Export Requirement for African Countries

Lecture 489Export Documentations & Important Concepts

Lecture 490Nigeria - Drug Registration

Lecture 491Drug Registration in Algeria

Lecture 492Drug Registration in Ethiopia

Lecture 493Drug Registration in Kenya

Lecture 494Drug Registration in Egypt

Lecture 495Drug Registration in Ghana

Lecture 496Drug Registration in Botswana

Lecture 497Drug Registration in South Africa

Lecture 498Drug Registration in Zambia

Lecture 499Drug Registration in Namibia

Lecture 500Drug Registration in Tanzania

Lecture 501Drug Registration Senegal

Lecture 502Drug Registration in Zimbabwe

Lecture 503Drug Registration in Uganda

Lecture 504Drug Registration in Morocco

Lecture 505Drug Registration in Sudan

Section 24Regional Business Development : China

Lecture 506Drug Registration and Regulation in China

Lecture 507NMPA's DDR and DMR update

Section 25Swiss Regulation and Market Access

Lecture 509Swiss Regulatory System | Simulations

Lecture 510Swiss and EU MRA | 2 Case Simulation | 5 Scenario Based assessments

Lecture 511Switzerland - International Agreement and Treaties

Lecture 512Swiss Pharma Regulatory Pathways | Types of Pathways | Case Based Simulations | Checklist File

life science management, Lifesceience business, Lifesceience consultant, Lifesceience consulting, Lifesceience consulting management

Life Science Global Management

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Introduction

Target Audience

Features

Related Courses

Career in Life Science

Add on Course

Key details about the course:

Professionals in the Life Science Sector

Regulatory Affairs Specialists

Quality Assurance and Quality Control Professionals

Product Development and R&D Professionals

Marketing and Business Development Professionals

Entrepreneurs and Start-up Founders

Consultants and Advisors

Students and Researchers

Professionals Transitioning to the Life Science Industry

Features of Life Science Global Management Course

Case Based Learning

Few of the similar courses

Career in Life Science Company

Research and Development (R&D):

Market Access

Strategic Management

Manufacturing and Operations:

Quality Assurance (QA) and Quality Control (QC):

Sales and Marketing:

Medical Affairs:

Business Development and Licensing:

Compliance and Legal Affairs:

Clinical Operations and Project Management:

Royed Training

Life Science Global Management

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Download All Course Catalogue

Your form has been submitted

Request for Course Demo Session

Your form has been submitted

Introduction

Target Audience

Features

Related Courses

Career in Life Science

Add on Course

Key details about the course:

Professionals in the Life Science Sector

Regulatory Affairs Specialists

Quality Assurance and Quality Control Professionals

Product Development and R&D Professionals

Marketing and Business Development Professionals

Entrepreneurs and Start-up Founders

Consultants and Advisors

Students and Researchers

Professionals Transitioning to the Life Science Industry

Features of Life Science Global Management Course

Case Based Learning

Few of the similar courses

Career in Life Science Company

Research and Development (R&D):

Market Access

Strategic Management

Manufacturing and Operations:

Quality Assurance (QA) and Quality Control (QC):

Sales and Marketing:

Medical Affairs:

Business Development and Licensing:

Compliance and Legal Affairs:

Clinical Operations and Project Management: