Pharma Global Management

Introduction

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About Pharma Management

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Pharma global management course provides hands on training to enhance skill competency of pharmaceutical middle and top level managers. This course ideal for the working professionals of pharmaceutical and biopharmaceutical industry. This comprehensive pharma global management 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 business skills.

In these online self-paced modules, participants understands 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 regulatory affairs and related department.
Professionals from strategic management.
Those who are in business development and licensing department.
This pharma global management course is ideal for the senior management professionals working in pharmaceutical and biopharmaceutical project management.
Anyone requiring an overview and detail understanding on working of pharmaceutical management.
Fresher or beginners, Those who want to make a career in the management in pharmaceutical and biopharmaceutical company.

Key details about the course:

Course Code: RYD-080
Title: Executive PG Certification in Pharma Global Management (EPPGM)
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

Any body who wants to acquire pharma strategic management competency should attend the course.

Features of Pharma Global Management Course

This pharma global management covers all aspects of the strategic management from drug discovery development, regulatory, commercialization, marketing, branding, business development and sales.
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

Advance training on strategic management based on the various business regions.
Course covers regional business development 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 pharma global management

A career in pharma management is very challenging, but highly rewarding. But at the same time, it opens up lot of opportunities for trained professionals. Companies always look for the trained professionals with relevant experience for the pharma management department. This is because, the strategic management job covers a variety of disciplines. Hence, pharma management professional involved in drug development, discovery, regulatory submission, compliance, clinical trials, quality assurance, drug safety, pharmacovigilance, branding, business development and licensing. So, person who want to be successful in pharma management should have 360 degree knowledge in various domain of pharma business.

Knowledge of the various business regions is important

The pharmaceutical industry is growing at a rapid pace. But there is a rising concern over the safety and efficacy. Hence, the major objective of the pharma management professionals to learn various regional regulatory knowledge. In fact, regional regulatory knowledge will help them to become successful in international business management. Moreover, pharma regulations are evolving and changing every other day. Pharma Management Professionals must have thorough knowledge about the updated regulations. Sound regulatory knowledge helps them to take strategic decision effectively. Therefore, this course is ideal choice for the pharma management course which covers various domain.

About regulatory affairs job>> Learn here

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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 47Pipeline in a molecule | Case Study

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

Lecture 109Difference between Proforma and Quotation

Lecture 110Bank Guarantee Cycle with Example

Lecture 111CHA and IFF Requirements - Roles and Conditions

Lecture 112CHA Pricing - Typical CHA Pricing Structure in Pharma Import–Export

Lecture 113Incoterm Understanding with case study

Section 4IP and Innovation Management Strategic Planning [Pharma and Biopharma]

Lecture 114General Introduction to intellectual Property Management

Lecture 115Introduction to Intellectual Property in Life Sciences | Types of IP | Introduction to Patent Portfolio Strategy

Lecture 116Introduction to Patent

Lecture 117Global Pharmaceutical Patent Landscape | Strategic Overview of Global Patent Filing and Protection

Lecture 118Understanding on Patent System

Lecture 119Patent Grant and Managing Patent Filing Procedure

Lecture 120Scope of Patentability

Lecture 121Stages of Patent Grant Procedure

Lecture 122Patent search in Indian Patent Office

Lecture 123Global Pharmaceutical Patent Filing Strategy

Lecture 124PCT Patent Filing Flow

Lecture 125Patentability Criteria in Pharmaceuticals | Practical Case Study

Lecture 126Patent Law Framework for Pharmaceuticals

Lecture 127Understanding and Decoding Section 3(d) of the Indian Patent Act | Case Based Analysis

Lecture 128Evergreening vs Genuine Innovation in Pharmaceutical Patents | Evergreening and Genuine Innovation Evaluation

Lecture 129Pharmaceutical Patent Lifecycle - Integrated Layer Strategy

Lecture 130Blockbuster Drug Patent Thicket Strategy

Lecture 131Types of Pharmaceutical Patents | Patent Layering StrategiesTypes of Pharmaceutical Patents

Lecture 132Understanding Patent Searching Process

Lecture 133IPC and CPC - Importance and Significance in Patent Search

Lecture 134IPC Structures for Pharmaceutical Patents

Lecture 135Freedom-to-Operate (FTO) | FTO Risk Assessment | Strategic Management

Lecture 136FTO Decision Tree – Generic Drug Launch Strategy

Lecture 137Fundamental of Pharmaceutical Patent Drafting | Structure | Component | Claim Anatomy | Effective Claim Writing

Lecture 138Pharmaceutical Patent Risk Management Framework

Lecture 139Patent Claim Coverage - Practical Example

Lecture 140Pharmaceutical Patent Filing Procedure and Global Filing Strategy | PCT Filing | Timeline

Lecture 141Advanced Understanding on Patent Opposition and Patent Litigation in Pharmaceutical Domain

Lecture 142Patent Prosecution and Handling Examiner Objections

Lecture 143Pharmaceutical Patent Portfolio Management | How to build and manage pharma patent portfolio

Lecture 144Pharmaceutical Patent Valuation and Licensing

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

Lecture 145Introduction to Market Access | Objectives | Various Key Terminologies | Steps of Market Access | Understanding on Pricing and Reimbursement

Lecture 146Market Access Functions : Role and Responsibilities | Key Job Areas | Understanding Job Description

Lecture 147Introduction to Health Economics | Key terminologies related to health economics.

Lecture 148HEOR Application in Pharmaceutical and Biopharmaceutical Industry

Lecture 150Economic Evaluation Methods | Various methods | Importance of perspective in health economics | Discounting | Uncertainty

Lecture 155Patient Based Forecasting Model | Applying more filters and variables

Lecture 156QALY | How to calculate QALY | Importance and Significance

Lecture 157ICER | How to calculate ICER | Importance and Significance | Incremental Effectiveness determination

Lecture 158CER and PCOR

Lecture 159Market Access Strategic Planning : Steps and Logical Sequencing for Market Access Strategy Development

Lecture 160Indication Sequencing | Indication Prioritization | Development of Indication Timeline | Indication Matrix | Value Based Indication Prioritization

Lecture 161Market Access Value Dossier : What it is | Significance | Components | What to include

Lecture 162AMCP Market Access Dossier Preparation

Lecture 163Target product profile (TPP) | Quality Target product profile (QTPP) | Critical Quality Attributes (CQAs) | Quality By Design (QbD)

Lecture 164Drug Pricing Methodologies - I

Lecture 165Drug Pricing Methodologies - II

Lecture 167Pharma Market Access Pricing Case Study: interchangeable Pricing

Lecture 168Sales Forecasting in Life Science Industry

Lecture 169New Product Forecast Algorithm

Lecture 170Patient Based Forecasting Model | Applying more filters and variables

Lecture 171Prescription Based Forecasting Model | Differences between Patient Based and Prescription Based Forecasting Model | Which model to use and when?

Lecture 172Prevalence Vs. Incidence Model

Lecture 173EPI Based Forecasting | Sales Based Forecasting | When and where to apply which forecasting model

Lecture 174Sales Forecasting Tools | New Product Forecasting | In Market Forecasting

Lecture 175Market Size Assignment 1 [Oncology Brand] - Applying sales forecasting tools to carry out next 6 years sales forecast | Excel Based Model

Lecture 176Market Size Assignment 2 [Asthma Brand] - Applying sales forecasting tools to carry out multiple years sales forecast | Excel Based Model

Lecture 177Patient Based Model Vs. Patient Flow Model | Critical Differences in Model | Concept of Black Box in Patient Flow Model | Application of both model

Lecture 178Concomitancy and polypharmacy | How it alter the basic forecasting algorithm | Practical Working | Comorbidity

Lecture 180Bottom-up or Top-down Forecasting | LRx | Significance of LRx data analysis

Lecture 181Simulation on Bottom-up forecasting

Lecture 182Assessment on Bottom-up forecasting

Lecture 183Oncology Brand Forecasting

Lecture 184Revenue Forecasting Case Study - Novel Antihypertensive

Lecture 185Portfolio Based Forecasting | Forecasting Model Development in Excel

Lecture 186Evidence Based Decision Making | Combine evidences for decision making | Do we need more evidence?

Lecture 187RWD and RWE | Potential sources of RWE | Traditional RCTs vs. RWE | Case Study - RWE Programs | Influencing HCP decision-making

Lecture 188RWD and RWE in Product Lifecycle Management

Lecture 189RWD and RWE - Fit to use | Assessment

Lecture 190RWD data sources | Different types | Detailed understanding of each class

Lecture 191First-in-class | Best-in-class | Market Access Strategic Decision Making

Lecture 192Forecasting Biosimilar | Key Factors to consider

Lecture 193Consensus Meeting

Lecture 194One Number Vs. Multi Number Forecasting

Lecture 195Active Vs. Passive Cannibalization | Impact on forecasting | Case Study

Lecture 196Rebates | Importance | Factors affecting Rebates | Deductibles and Rebates

Lecture 198Treatment Algorithm and Forecasting : Case Based Learning

Lecture 199Chronic and Acute Segment | Forecasting on Chronic and Acute Segment Drugs

Lecture 200Prescription Value Calculation

Lecture 201Practical Training on Value Dossier Preparation | Sample Value Dossier with each section with data | Key points to consider while preparing value dossier

Lecture 202Clinical Data in Value Dossier | Understanding in different types of clinical study with rationale | Case based example on clinical study section writing

Lecture 205Case Study : Pharma Pricing and Reimbursement Planning for new launches | Reimbursement Rate Calculation

Lecture 206HCPCS and CPT Codes | Importance | Significance and Characteristics | Differences between HCPCS and CPT Codes

Section 6Pharma Global Brand Management

Lecture 207Marketing Orientation

Lecture 208Why Is Market Research Important in Pharmaceutical Business?

Lecture 209Market Research - Customer Engagement through feedback mechanism

Lecture 210Product Life cycle

Lecture 211Advance - Strategic Planning in Product Life cycle Management

Lecture 212Segmentation, Targeting and Positioning

Lecture 213A Pharmaceutical Segmentation outlook

Lecture 214Distribution Channel in Pharmaceutical Industry

Lecture 215Promotion in Pharmaceutical Industry : Communication Model, Effective promotional communication, Push Vs. Pull Strategy and Buying Decision Process

Lecture 216Practical understanding on Prescription Accelerating Materials used in pharmaceutical promotion

Lecture 217Method of Promotional Budgeting

Lecture 218Brand Recall | Brand Recognition |Top of mind - How to calculate brand recall value?

Lecture 219Advertising - Introduction | Objective | Types of Advertising

Lecture 220ATL, BTL & TTL Advertising

Lecture 221Advertising Agency - Understanding on various types of advertising agency

Lecture 222Selection of Advertising Agency

Lecture 223What is creative Briefing? How to Prepare !

Lecture 224Creative Briefing - Practical Simulation

Lecture 225Request for Proposal | Concepts in advertising

Lecture 226Advertising Message Strategy Development and Evaluation

Lecture 227Creative Approach and Styles

Lecture 228Steps of Development of Creatives

Lecture 229Advertisement Copy Development

Lecture 230How to prepare Ad Campaign Step By Step

Lecture 231Brand Name | Brand Logo | Designing of Brand Logo | Trademarking

Lecture 232Advance Understanding of Pharmaceutical Brand Logo Development

Lecture 233Component of Brand Logo

Lecture 234Brand Name and Trademark Registration Process

Lecture 235Trademark Searching Process | Hands on Practical Training

Lecture 236How to design an excellent brand logo : Tricks of the trade

Lecture 237Logo colour theme | Colour system | Colour coding | Significance of colour

Lecture 238Few Case Studies related to brand names and logos

Lecture 239Can one innovator company keep 2 or more brand name?

Lecture 240Traditional Vs. Non-Traditional trademark | Significance of Colour in Pharma Branding

Lecture 241Global Trademarking : Brand Protection Globally

Lecture 242Logo Rebranding - Reasons | Practical Examples | How to handle logo rebranding | Forced Rebranding

Lecture 243Brand Logo Development: Real Life Simulation

Lecture 244Tagline - Development, Finalization and Protection

Lecture 245Pharma Brand Name Generator

Lecture 246Fundamental of Pharma Marketing Plan

Lecture 247Basic Understanding how to launch a pharmaceutical product into the market

Lecture 248Practical Training on Marketing Plan Preparation with real life example

Lecture 249Marketing Campaign Development : Importance of Target Audience Segmentation for effective targeting

Lecture 250Sample Marketing Plan

Lecture 251Decide about brand USP -What to promote

Lecture 252How to prepare promotogram. Download sample Promotogram

Lecture 253Importance and Handling of Cycle Meeting and its importance

Lecture 254Sample Marketing Plan

Lecture 255Sample Marketing Plan

Lecture 256Sample Marketing Plan

Lecture 257CSR Campaign

Lecture 258Increase the brand reach with advance segmentation

Lecture 259Concept of uniform branding for better brand acceptability

Lecture 260Concept of Brand Differentiation

Lecture 261Introduction to visual aid designing | V3M Concept | Components of the visual aid page

Lecture 262Practical Training in visual aid designing | Step By Step Visual Aid Preparation | Creative Designing | Guideline on Proofing | USPs to differentiate the visual aid

Lecture 263Visual Aid Printing | Establishing Visual Aid Printing Specs for effective management of the vendors

Lecture 264Visual Aid Analysis with practical example

Lecture 265Guideline on visual aid development

Lecture 266Marketing Plan followed by Visual Aid Development

Lecture 267Visual Aid, Literature reference Sample

Lecture 268Interactive Visual Aid | E-detailing | Remote Detailing | Analysis of Animated Video based e-detailing visual aids

Lecture 269Visual aid detailing story writing

Lecture 270Artwork Development Process in PMT Department

Lecture 271Product List and Reminder card development

Lecture 272Catch Cover Development

Lecture 273Packaging Development

Lecture 274Prescribing Information and Patient Information Leaflet development

Lecture 275Pharma Packaging Case Studies

Lecture 276DHCP letter

Lecture 277Product Packshot Designing : Practical Knowledge

Lecture 278Creativity to develop brand essence

Lecture 279Advance Training on Pharmaceutical Packaging - Creative Packaging for Brand Differentiation

Lecture 280Fundamental Training on Disease Awareness Campaign | Case Based Analysis | Comprehensive Module

Lecture 281DAC Campaign Planning and Execution : Case Based Analysis

Lecture 282DAC Do’s and Don’ts + Case Based Simulation

Lecture 283DAC Thumb Rules

Section 7Business Development | Licensing

Lecture 284Training on Basic Finance | Understanding Financial Statment | Income Statement | Balance Sheet | Cash Flow Statement

Lecture 285Moving Average | Moving Annual Total | YTD | How to calculate

Lecture 286Compound Annual Growth Rate | CAGR Calculation

Lecture 287Business Development Job Functionality | Strategic Planning Process | Knowledge Area of Business Development | Lead targeting | Licensing term sheets

Lecture 288Portfolio Management Process | Portfolio Characteristics | Portfolio Analysis | Balancing the Portfolio | BD and Strategic Planning Department

Lecture 289Identifying the corporate Need of business development | Objective – Strategy - Tactics | Portfolio constraints | SWOT | Numerical SWOT

Lecture 291Numerical SWOT Practical training

Lecture 293Market Size Determination - Market Share | Relative Market Share | Total Vs. Actual Vs. Penetrated Market

Lecture 294Forecasting : Tools and Techniques

Lecture 295Market Sizing & Forecasting Case Study

Lecture 297Average Royalty Rate

Lecture 298Factor affecting the Royalty Rate in Pharmaceutical and Biopharmaceutical Deal

Lecture 299Distribution Licensing | Geography | Indication Splitting | Exclusive and Non-Exclusive Licensing | Sub Licenses

Lecture 301SPECIAL PURPOSE VEHICLES (SPV)

Lecture 302Indication Splitting | Concept | Implementation feasibility analysis

Lecture 303Types of Deals from Discovery to Commercialization

Lecture 304What are the fundamental areas of business development

Lecture 305Licensing Term Sheet | Content Structuring | Sample Term Sheet

Lecture 306Licensing Payment Scheduling: Different Types

Lecture 308Valuation Methods: EBITDA method of valuation | Enterprise Value and Enterprise Multiple Calculation

Lecture 309Negotiation 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 310Business Development Simulation and Decision Making | Early Stage VS. Late Stage Valuation Methodology | Stair Step Model

Lecture 312Benchmarking | Benchmarking through consortium | How to use benchmarking for drug discovery development projects

Lecture 313DCF Calculation : Concept and Calculation - Step by step understanding

Lecture 314Net Present Value (NPV) method : Calculation

Lecture 315Risk-Adjusted Discount Rate Method - Calculation | Concept of Risk Premium

Lecture 316Valuation Metric - P/E Ratio and EPS : Calculation

Lecture 317Comparable Company Analysis method : Calculation

Lecture 319Pipeline Benchmarking | Significance and Importance in Bio Pharma BD&L | Analyzing sample portfolio | Comparative outcome in business development

Lecture 320Comparative pipeline benchmarking analysis | Level of Benchmarking | Primary - Secondary - Tertiary Benchmarking Metrics | Case Based Analysis of three companies comparative pipeline benchmarking

Lecture 321Pipeline Diversity Scores | Significance | How to Calculate | Comparative Study of Pipeline Diversity Scores

Lecture 322Design, Analysis, Assessment and Feedback on Real Time Portfolio Tracker

Lecture 323Research Productivity Index | Concept | Significance | Calculation Methodology | Comparative RPI benchmarking Exercise

Lecture 324WACC in Biopharma Valuation | Significance | WACC benchmarking

Lecture 325WACC Calculation | Step by Step Calculation | Insight on WACC components

Lecture 326rNPV Model | Step by Step Calculation | Insight on Probability and Cumulative Probability | Factoring WACC for Discounting

Lecture 327Probability and Cumulative Probability | Calculation | Benchmarking | Factoring for WACC and rNPV

Lecture 328Real 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 329ROV Scenario Based Case Study

Lecture 330Biotech Decision Tree Model with Decision Reasoning

Section 8Pharma Digital Marketing & Omnichannel Marketing

Lecture 331Introduction to Digital Marketing

Lecture 332Inbound and outbound marketing in pharma | Types of inbound and outbound marketing

Lecture 334Digital 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 335Digital marketing strategy development | Planning process | E-Marketing Plan | Planning for MNC Vs. Start Up | Strategic Outcome measurement

Lecture 336Relationship marketing using digital platform | CRM | Concept of permission marketing | User Satisfaction and loyalty management | Feedback mechanism

Lecture 338Search Engine Optimization | Search Engine Marketing | Social Media Marketing

Lecture 339Web Host - Check the hosting details

Lecture 340Page Speed- importance and practical understanding | Check the web speed

Lecture 341Keyword | Keyword Planning for SEO and SEM | Keyword Planner

Lecture 342Mobile Responsive | Tracking the Site

Lecture 343HCP sites and Patient Site

Lecture 344Google Ad - Practical Training on Campaign Development and Execution

Lecture 345Digital Marketing Strategies for innovator brand | Pre launch - comuing soon, DSE Marketing | Launch activities - Day of approval (DOA) site | FDA Compliance | FDA 2253 Filing

Lecture 346Brand Portal Development

Lecture 347Relationship Marketing : KOL Management and Patient Advocacy Group

Lecture 348Public Relation - PR firm | PR Campaign | Press Release | Technical understanding of press release writing | Digital Press Release

Lecture 349Developing Ad - Pharmaceutical Prescription, OTC Vs FMCG Brands

Lecture 350Difference between FMCG and OTC Brand Ad

Lecture 351Digital Marketing Techniques

Lecture 352Video Marketing

Lecture 353Video Marketing Techniques For Small Business Owners

Lecture 354Promoting Brand through Article Advertising and Marketing

Lecture 355Introduction to Omnichannel Marketing | Importance | Significance | Implementation outcome of Omnichannel Marketing

Lecture 356OMM Implementation Framework | Step By Step | Key Activities in each step | 3 Case Study on OMM

Lecture 357Download OMM Implementation Framework Checklist

Lecture 358OMM terminologies | Explanation of important digital marketing terms

Lecture 359OM Brand Plan Development | Practical Brand Plan with different sections with touchpoints

Section 9Regional Business Development : Africa

Lecture 360African Continent Overview - Brief introduction

Lecture 361African Pharma Market

Lecture 362Drug Registration - African medicines regulatory

Lecture 363Basic Export Requirement for African Countries

Lecture 364Export Documentations & Important Concepts

Lecture 365Nigeria - Drug Registration

Lecture 366Drug Registration in Algeria

Lecture 367Drug Registration in Ethiopia

Lecture 368Drug Registration in Kenya

Lecture 369Drug Registration in Egypt

Lecture 370Drug Registration in Ghana

Lecture 371Drug Registration in Botswana

Lecture 372Drug Registration in South Africa

Lecture 373Drug Registration in Zambia

Lecture 374Drug Registration in Namibia

Lecture 375Drug Registration in Tanzania

Lecture 376Drug Registration Senegal

Lecture 377Drug Registration in Zimbabwe

Lecture 378Drug Registration in Uganda

Lecture 379Drug Registration in Morocco

Lecture 380Drug Registration in Sudan

Section 10Regional Business Development : GCC, Middle East and MENA

Lecture 381Middle East / MENA / GCC Countries Geographical Orientation

Lecture 382Middle East / MENA / GCC Countries National Regulatory Agencies

Lecture 383GCC Registration Procedure - Centralized and Decentralized Procedure | Detailed understanding on Centralized Registration Process

Lecture 384Drug Registration in Saudi Arabia

Lecture 385Drug Registration in UAE

Lecture 386Drug Registration and Regulatory Strategic Planning for Iran

Lecture 387Drug Registration and Regulatory Strategic Planning for Israel

Lecture 388Middle East Pharma Market

Lecture 389Drug Registration in Jordan

Lecture 390Drug Registration in Palestine

Section 11Regional Business Development : ASEAN

Lecture 391ASEAN - Region - Introduction

Lecture 392ASEAN Countries | Introduction | Geographical Overview

Lecture 393ASEAN countries drug regulatory bodies

Lecture 394ASEAN Common Technical Requirements (ACTRs)

Lecture 395The Pharmaceutical Inspection Co-operation Scheme

Lecture 396CPP Requirements for Drug Registration in ASEAN countries

Lecture 397Dossier Requirements - ACTD/CTD Acceptability

Lecture 398Pharmacopoeias Acceptability

Lecture 399Harmonization of Technical Guidelines

Lecture 400Stability Study requirements for drug registration in ASEAN countries

Lecture 401Product Labelling

Lecture 402Post Approval Changes (Variations) requirements in ASEAN countries

Lecture 403Pharmacovigilance and Risk Management Plan (RMP)

Lecture 404Timeline of Drug Registration Approval

Lecture 406Drug Registration and Regulation Singapore | Strategic Pathways for Marketing Authorization | Screening, Evaluation of MA applications | Variations Classifications and Management

Lecture 407Drug Registration and Regulation in Brunei

Lecture 408Drug Registration and Regulation in Cambodia

Section 12Regional Business Development : Latam

Lecture 409Introduction to Latam Region Pharma Business Development

Lecture 410Drug Registration and Regulation in Argentina

Lecture 411Drug Registration and Regulation in Bolivia

Lecture 412Drug Registration and Regulation in Brazil

Lecture 413Drug Registration and Regulation in Chile

Lecture 414Drug Registration and Regulation in Colombia

Lecture 415Drug Registration and Regulation in Mexico

Lecture 416Drug regulation and registration in Peru

Lecture 417Drug regulation and registration in El Salvador

Lecture 418Central America Drug Regulatory Affairs | Panama, Costa Rica, Guatemala, El Salvador, Honduras, Dominican Republic | RTCA guideline [2022]

Section 13Regional Business Development : China

Lecture 419Drug Registration and Regulation in China

Lecture 420NMPA's DDR and DMR update

Section 14Biopharmaceutical Management and Regulation

Lecture 421Introduction : Biopharmaceuticals

Lecture 422Classification of Biopharmaceutical

Lecture 423Important Concept regarding Biopharmaceuticals

Lecture 424Introduction to Biologics and Biosimilar | Key differences | Concept of Reference Product

Lecture 425Key features of Biologic | Differences in Chemical Drug Vs. Biologic Drugs

Lecture 426Principle of Naming of Biologic | Understanding on MAB naming system

Lecture 427Global Biopahrma Market Trends

Lecture 428Recombinant protein

Lecture 429Monoclonal Antibodies Vs. Polyclonal Antibodies

Lecture 430Monoclonal Antibodies

Lecture 431Synthetic Immunomodulators

Lecture 432Production of Monoclonal Antibodies

Lecture 433Cytokines

Lecture 434Interferon

Lecture 435Erythropoiesis-stimulating agent

Lecture 436Vaccine development and approval Process

Lecture 437Biosimilar Development Process

Lecture 438Strategic Consideration for Biosimilar Development

Lecture 439Bio-Manufacturing Process Information

Lecture 440Studies required for approval of biosimilar

Lecture 441ATMPs | Types and Classification | Regulatory Mechanism

Lecture 442Biosimilar Approval and Patent Management | Strategic Pathway of Patent Negotiation and Litigation in Biosimilar Approval | Patent Dance | FAQs on Biologic Patent Management

Lecture 443Biosimilar launch case study | Patent Dance Framework

Lecture 444Biosimilar Launch Framework

Lecture 445Biosimilar 180 Day Notice

Lecture 4463(A) List | Significance | Importance | How to interpret

Lecture 447Steps to win over innovator patents | Step wise planning

Lecture 448Biosimilar Launch Project Roadmap with defined stages of project

Lecture 449Timing of Biosimilar Submission and Approvals | Two Scenario based timeline assessments

Lecture 450Hands on Training on Reference Biologic Patent | Classify RPS Biologic Patents | Case Simulation

Lecture 451How to work on RPS’s Patent | Walkthrough | Case Study

Lecture 452Biosimilar Launch Project With Milestones

Lecture 453Analysis of Biologic Patents | Work Assignments

Lecture 454Biologic Patent Insight Worksheet

Lecture 455Patent Thickets | Concept | Implication | Case Based Learning

Section 15Drug Registration and Regulation in Japan

Lecture 458Introduction to Japan Drug Regulatory Affairs

Lecture 459Drug Discovery Development to commercialization | PMDA functions | Consultation | Premarket to post market approval

Lecture 460Drug Approval System | GCP | PMDA requirements

Lecture 461New Drug Application | Requirements | Review Process

Lecture 462Generic Drug Application Review and Approval

Lecture 463Marketing Authorization Process for registration of pharmaceutical in Japan

Lecture 464API Registration in Japan | Step By Step Process

Lecture 466Priority Review Application | Criteria | Review Process | Timeline

Lecture 467Orphan Drug Designation in Japan

Lecture 468Japan DMF System | MF filing Process | Key points

Lecture 469Strategic Approval Pathway - Formulation Approval Quoting MF

Lecture 470SAKIGAKE designation

Section 16Variation Filing : Marketing Authorization variation management

Lecture 471Introduction to Variation Management | Reasons for Variation | Working in Variation Department

Lecture 472Variation Classification | Basis of Classification | US and EU Variation Classification | Other region variation guideline.

Section 17Bioequivalence Study : Requirements

Lecture 473PKPD in Drug Discovery | PK-PD trial | Understanding PKPD from regulatory perspective in drug approval process

Lecture 474Bioequivalence Study | Study design | Different types of BE Studies

Lecture 476Biopharmaceutical Classification System (BCS) | Types | Biowaivers | BCS tool for drug development and regulatory submission

Lecture 477Bioequivalence Study - Discussion - Timeline of stability study and bioequivalence study

Lecture 478Bioequivalence Study - Discussion - Dissolution Testing

Lecture 479Bioequivalence Study - Generic Approval and Additives Labeling Requirements

Lecture 480IVIVC - Basis | Importance | Case Based Determination of IVIVC

Lecture 481Setting Dissolution Specification for Generic Products | Regulatory Expectations

Section 18CIS - EAEU Regulatory Affairs

Lecture 482Drug Registration and Submission Strategic Planning for Russia and EAEU region

Lecture 483GMP requirements in Russia

Section 19Drug Registration and Regulation in India

Lecture 485Medicine Export Criteria from India

Lecture 486Documents for conducting BE Study for Export

Lecture 487New Drug Approval in DCGI

Lecture 488Line Extension New Strength Approval

Section 20Data Visualization in Pharma Market Access and Forecasting

Lecture 489Line Chart vs. Spline Chart

Lecture 490Basic Area Charts

Lecture 491Stacked Area Chart

Lecture 492Basic Bar Charts

Lecture 493Stacked Bar Charts

Lecture 494Basic Column Charts

Lecture 495Stacked Column Charts

Lecture 496Pie Chart

Lecture 497Donut Chart

Lecture 498Scatter Plot

Lecture 499Case Study: New Oncology Drug Launch Forecasting

Lecture 500Treemap Plot

Lecture 501Spiderweb chart

Lecture 502Polar Chart

Lecture 5033D Funnel Chart

Lecture 504Heatmap Chart

Section 21Pharma Forecasting and Market Access Related Case Studies

Lecture 505Case Study: Forecasting DMD Drug

Lecture 506Case Study: Forecasting the Uptake of a New Cancer Drug After Launch in a Specific Region

Lecture 507Case Study: Forecasting Demand for a New Cancer Treatment Expected to Generate Billions in Sales Globally

Lecture 508Generic Drug Forecasting - Post Patent Expiry

Lecture 509Case Study: Estimating the Market Uptake of a Generic Version of a Popular Cholesterol-Lowering Drug

Lecture 510Data-Driven Forecasting Case Study: Market Share Forecast for a New Hypertension Drug

Lecture 511Forecasting During Early Stage of Development

Lecture 512Case Simulation : Demographic-Based Forecasting

Lecture 513Forecasting and Valuation for Weight Loss Drugs | Forecasting Model | Model Assumptions | Data Inputs | Projected Revenue Calculations

Lecture 514Forecasting Assignment

Section 22Certification Request | Course Certificate

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Introduction

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Case Based Learning

Few of the similar courses

Career in pharma global management

Knowledge of the various business regions is important