Pharma Global Management

Introduction

Eligibility

Features

Related Courses

About Pharma Management

Add on Course

pharma global management

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

⭐ 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 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 4Plant Management and Certification | Quality Management

Lecture 114Premises & Plant Layout Designing

Lecture 115Sanitation and Hygiene

Lecture 116Equipment Modules

Lecture 117Production Modules

Lecture 118Documentation

Lecture 119Quality Control

Lecture 120Product Complaint

Lecture 121Storage Module

Lecture 122Pharmaceutical SOPs Management from regulatory perspective

Lecture 123Establishment Inspection Report | 483 Observations | USFDA Warning Letter | Handling of FDA inspection | Closing of Warning Letter

Lecture 124Data Integrity issues in Pharmaceutical Industry

Lecture 125Electronic Batch Record for effective compliance management | Key Understanding | Functionalities | Importance in managing data integrity

Lecture 126Quality Risk Management | ICH Q9 | ISO 14971 | Principle of Risk Management

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

Lecture 127Introduction to Market Access | Objectives | Various Key Terminologies | Steps of Market Access | Understanding on Pricing and Reimbursement

Lecture 128Market Access Functions : Role and Responsibilities | Key Job Areas | Understanding Job Description

Lecture 129Introduction to Health Economics | Key terminologies related to health economics.

Lecture 130HEOR Application in Pharmaceutical and Biopharmaceutical Industry

Lecture 132Economic Evaluation Methods | Various methods | Importance of perspective in health economics | Discounting | Uncertainty

Lecture 137Patient Based Forecasting Model | Applying more filters and variables

Lecture 138QALY | How to calculate QALY | Importance and Significance

Lecture 139ICER | How to calculate ICER | Importance and Significance | Incremental Effectiveness determination

Lecture 140CER and PCOR

Lecture 141Market Access Strategic Planning : Steps and Logical Sequencing for Market Access Strategy Development

Lecture 142Indication Sequencing | Indication Prioritization | Development of Indication Timeline | Indication Matrix | Value Based Indication Prioritization

Lecture 143Market Access Value Dossier : What it is | Significance | Components | What to include

Lecture 144AMCP Market Access Dossier Preparation

Lecture 145Target product profile (TPP) | Quality Target product profile (QTPP) | Critical Quality Attributes (CQAs) | Quality By Design (QbD)

Lecture 146Drug Pricing Methodologies - I

Lecture 147Drug Pricing Methodologies - II

Lecture 149Pharma Market Access Pricing Case Study: interchangeable Pricing

Lecture 150Sales Forecasting in Life Science Industry

Lecture 151New Product Forecast Algorithm

Lecture 152Patient Based Forecasting Model | Applying more filters and variables

Lecture 153Prescription Based Forecasting Model | Differences between Patient Based and Prescription Based Forecasting Model | Which model to use and when?

Lecture 154Prevalence Vs. Incidence Model

Lecture 155EPI Based Forecasting | Sales Based Forecasting | When and where to apply which forecasting model

Lecture 156Sales Forecasting Tools | New Product Forecasting | In Market Forecasting

Lecture 157Market Size Assignment 1 [Oncology Brand] - Applying sales forecasting tools to carry out next 6 years sales forecast | Excel Based Model

Lecture 158Market Size Assignment 2 [Asthma Brand] - Applying sales forecasting tools to carry out multiple years sales forecast | Excel Based Model

Lecture 159Patient Based Model Vs. Patient Flow Model | Critical Differences in Model | Concept of Black Box in Patient Flow Model | Application of both model

Lecture 160Concomitancy and polypharmacy | How it alter the basic forecasting algorithm | Practical Working | Comorbidity

Lecture 162Bottom-up or Top-down Forecasting | LRx | Significance of LRx data analysis

Lecture 163Simulation on Bottom-up forecasting

Lecture 164Assessment on Bottom-up forecasting

Lecture 165Oncology Brand Forecasting

Lecture 166Revenue Forecasting Case Study - Novel Antihypertensive

Lecture 167Portfolio Based Forecasting | Forecasting Model Development in Excel

Lecture 168Evidence Based Decision Making | Combine evidences for decision making | Do we need more evidence?

Lecture 169RWD and RWE | Potential sources of RWE | Traditional RCTs vs. RWE | Case Study - RWE Programs | Influencing HCP decision-making

Lecture 170RWD and RWE in Product Lifecycle Management

Lecture 171RWD and RWE - Fit to use | Assessment

Lecture 172RWD data sources | Different types | Detailed understanding of each class

Lecture 173First-in-class | Best-in-class | Market Access Strategic Decision Making

Lecture 174Forecasting Biosimilar | Key Factors to consider

Lecture 175Consensus Meeting

Lecture 176One Number Vs. Multi Number Forecasting

Lecture 177Active Vs. Passive Cannibalization | Impact on forecasting | Case Study

Lecture 178Rebates | Importance | Factors affecting Rebates | Deductibles and Rebates

Lecture 180Treatment Algorithm and Forecasting : Case Based Learning

Lecture 181Chronic and Acute Segment | Forecasting on Chronic and Acute Segment Drugs

Lecture 182Prescription Value Calculation

Lecture 183Practical Training on Value Dossier Preparation | Sample Value Dossier with each section with data | Key points to consider while preparing value dossier

Lecture 184Clinical Data in Value Dossier | Understanding in different types of clinical study with rationale | Case based example on clinical study section writing

Lecture 187Case Study : Pharma Pricing and Reimbursement Planning for new launches | Reimbursement Rate Calculation

Lecture 188HCPCS and CPT Codes | Importance | Significance and Characteristics | Differences between HCPCS and CPT Codes

Section 6Pharma Global Brand Management

Lecture 189Marketing Orientation

Lecture 190Why Is Market Research Important in Pharmaceutical Business?

Lecture 191Market Research - Customer Engagement through feedback mechanism

Lecture 192Product Life cycle

Lecture 193Advance - Strategic Planning in Product Life cycle Management

Lecture 194Segmentation, Targeting and Positioning

Lecture 195A Pharmaceutical Segmentation outlook

Lecture 196Distribution Channel in Pharmaceutical Industry

Lecture 197Promotion in Pharmaceutical Industry : Communication Model, Effective promotional communication, Push Vs. Pull Strategy and Buying Decision Process

Lecture 198Practical understanding on Prescription Accelerating Materials used in pharmaceutical promotion

Lecture 199Method of Promotional Budgeting

Lecture 200Brand Recall | Brand Recognition |Top of mind - How to calculate brand recall value?

Lecture 201Advertising - Introduction | Objective | Types of Advertising

Lecture 202ATL, BTL & TTL Advertising

Lecture 203Advertising Agency - Understanding on various types of advertising agency

Lecture 204Selection of Advertising Agency

Lecture 205What is creative Briefing? How to Prepare !

Lecture 206Creative Briefing - Practical Simulation

Lecture 207Request for Proposal | Concepts in advertising

Lecture 208Advertising Message Strategy Development and Evaluation

Lecture 209Creative Approach and Styles

Lecture 210Steps of Development of Creatives

Lecture 211Advertisement Copy Development

Lecture 212How to prepare Ad Campaign Step By Step

Lecture 213Brand Name | Brand Logo | Designing of Brand Logo | Trademarking

Lecture 214Advance Understanding of Pharmaceutical Brand Logo Development

Lecture 215Component of Brand Logo

Lecture 216Brand Name and Trademark Registration Process

Lecture 217Trademark Searching Process | Hands on Practical Training

Lecture 218How to design an excellent brand logo : Tricks of the trade

Lecture 219Logo colour theme | Colour system | Colour coding | Significance of colour

Lecture 220Few Case Studies related to brand names and logos

Lecture 221Can one innovator company keep 2 or more brand name?

Lecture 222Traditional Vs. Non-Traditional trademark | Significance of Colour in Pharma Branding

Lecture 223Global Trademarking : Brand Protection Globally

Lecture 224Logo Rebranding - Reasons | Practical Examples | How to handle logo rebranding | Forced Rebranding

Lecture 225Brand Logo Development: Real Life Simulation

Lecture 226Tagline - Development, Finalization and Protection

Lecture 227Pharma Brand Name Generator

Lecture 228Fundamental of Pharma Marketing Plan

Lecture 229Basic Understanding how to launch a pharmaceutical product into the market

Lecture 230Practical Training on Marketing Plan Preparation with real life example

Lecture 231Marketing Campaign Development : Importance of Target Audience Segmentation for effective targeting

Lecture 232Sample Marketing Plan

Lecture 233Decide about brand USP -What to promote

Lecture 234How to prepare promotogram. Download sample Promotogram

Lecture 235Importance and Handling of Cycle Meeting and its importance

Lecture 236Sample Marketing Plan

Lecture 237Sample Marketing Plan

Lecture 238Sample Marketing Plan

Lecture 239CSR Campaign

Lecture 240Increase the brand reach with advance segmentation

Lecture 241Concept of uniform branding for better brand acceptability

Lecture 242Concept of Brand Differentiation

Lecture 243Introduction to visual aid designing | V3M Concept | Components of the visual aid page

Lecture 244Practical Training in visual aid designing | Step By Step Visual Aid Preparation | Creative Designing | Guideline on Proofing | USPs to differentiate the visual aid

Lecture 245Visual Aid Printing | Establishing Visual Aid Printing Specs for effective management of the vendors

Lecture 246Visual Aid Analysis with practical example

Lecture 247Guideline on visual aid development

Lecture 248Marketing Plan followed by Visual Aid Development

Lecture 249Visual Aid, Literature reference Sample

Lecture 250Interactive Visual Aid | E-detailing | Remote Detailing | Analysis of Animated Video based e-detailing visual aids

Lecture 251Visual aid detailing story writing

Lecture 252Artwork Development Process in PMT Department

Lecture 253Product List and Reminder card development

Lecture 254Catch Cover Development

Lecture 255Packaging Development

Lecture 256Prescribing Information and Patient Information Leaflet development

Lecture 257Pharma Packaging Case Studies

Lecture 258DHCP letter

Lecture 259Product Packshot Designing : Practical Knowledge

Lecture 260Creativity to develop brand essence

Lecture 261Advance Training on Pharmaceutical Packaging - Creative Packaging for Brand Differentiation

Lecture 262Fundamental Training on Disease Awareness Campaign | Case Based Analysis | Comprehensive Module

Lecture 263DAC Campaign Planning and Execution : Case Based Analysis

Lecture 264DAC Do’s and Don’ts + Case Based Simulation

Lecture 265DAC Thumb Rules

Section 7Business Development | Licensing

Lecture 266Training on Basic Finance | Understanding Financial Statment | Income Statement | Balance Sheet | Cash Flow Statement

Lecture 267Moving Average | Moving Annual Total | YTD | How to calculate

Lecture 268Compound Annual Growth Rate | CAGR Calculation

Lecture 269Business Development Job Functionality | Strategic Planning Process | Knowledge Area of Business Development | Lead targeting | Licensing term sheets

Lecture 270Portfolio Management Process | Portfolio Characteristics | Portfolio Analysis | Balancing the Portfolio | BD and Strategic Planning Department

Lecture 271Identifying the corporate Need of business development | Objective – Strategy - Tactics | Portfolio constraints | SWOT | Numerical SWOT

Lecture 273Numerical SWOT Practical training

Lecture 275Market Size Determination - Market Share | Relative Market Share | Total Vs. Actual Vs. Penetrated Market

Lecture 276Forecasting : Tools and Techniques

Lecture 277Market Sizing & Forecasting Case Study

Lecture 279Average Royalty Rate

Lecture 280Factor affecting the Royalty Rate in Pharmaceutical and Biopharmaceutical Deal

Lecture 281Distribution Licensing | Geography | Indication Splitting | Exclusive and Non-Exclusive Licensing | Sub Licenses

Lecture 283SPECIAL PURPOSE VEHICLES (SPV)

Lecture 284Indication Splitting | Concept | Implementation feasibility analysis

Lecture 285Types of Deals from Discovery to Commercialization

Lecture 286What are the fundamental areas of business development

Lecture 287Licensing Term Sheet | Content Structuring | Sample Term Sheet

Lecture 288Licensing Payment Scheduling: Different Types

Lecture 290Valuation Methods: EBITDA method of valuation | Enterprise Value and Enterprise Multiple Calculation

Lecture 291Negotiation 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 292Business Development Simulation and Decision Making | Early Stage VS. Late Stage Valuation Methodology | Stair Step Model

Lecture 294Benchmarking | Benchmarking through consortium | How to use benchmarking for drug discovery development projects

Lecture 295DCF Calculation : Concept and Calculation - Step by step understanding

Lecture 296Net Present Value (NPV) method : Calculation

Lecture 297Risk-Adjusted Discount Rate Method - Calculation | Concept of Risk Premium

Lecture 298Valuation Metric - P/E Ratio and EPS : Calculation

Lecture 299Comparable Company Analysis method : Calculation

Lecture 301Pipeline Benchmarking | Significance and Importance in Bio Pharma BD&L | Analyzing sample portfolio | Comparative outcome in business development

Lecture 302Comparative pipeline benchmarking analysis | Level of Benchmarking | Primary - Secondary - Tertiary Benchmarking Metrics | Case Based Analysis of three companies comparative pipeline benchmarking

Lecture 303Pipeline Diversity Scores | Significance | How to Calculate | Comparative Study of Pipeline Diversity Scores

Lecture 304Design, Analysis, Assessment and Feedback on Real Time Portfolio Tracker

Lecture 305Research Productivity Index | Concept | Significance | Calculation Methodology | Comparative RPI benchmarking Exercise

Lecture 306WACC in Biopharma Valuation | Significance | WACC benchmarking

Lecture 307WACC Calculation | Step by Step Calculation | Insight on WACC components

Lecture 308rNPV Model | Step by Step Calculation | Insight on Probability and Cumulative Probability | Factoring WACC for Discounting

Lecture 309Probability and Cumulative Probability | Calculation | Benchmarking | Factoring for WACC and rNPV

Lecture 310Real 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 311ROV Scenario Based Case Study

Lecture 312Biotech Decision Tree Model with Decision Reasoning

Section 8Pharma Digital Marketing & Omnichannel Marketing

Lecture 313Introduction to Digital Marketing

Lecture 314Inbound and outbound marketing in pharma | Types of inbound and outbound marketing

Lecture 316Digital 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 317Digital marketing strategy development | Planning process | E-Marketing Plan | Planning for MNC Vs. Start Up | Strategic Outcome measurement

Lecture 318Relationship marketing using digital platform | CRM | Concept of permission marketing | User Satisfaction and loyalty management | Feedback mechanism

Lecture 320Search Engine Optimization | Search Engine Marketing | Social Media Marketing

Lecture 321Web Host - Check the hosting details

Lecture 322Page Speed- importance and practical understanding | Check the web speed

Lecture 323Keyword | Keyword Planning for SEO and SEM | Keyword Planner

Lecture 324Mobile Responsive | Tracking the Site

Lecture 325HCP sites and Patient Site

Lecture 326Google Ad - Practical Training on Campaign Development and Execution

Lecture 327Digital Marketing Strategies for innovator brand | Pre launch - comuing soon, DSE Marketing | Launch activities - Day of approval (DOA) site | FDA Compliance | FDA 2253 Filing

Lecture 328Brand Portal Development

Lecture 329Relationship Marketing : KOL Management and Patient Advocacy Group

Lecture 330Public Relation - PR firm | PR Campaign | Press Release | Technical understanding of press release writing | Digital Press Release

Lecture 331Developing Ad - Pharmaceutical Prescription, OTC Vs FMCG Brands

Lecture 332Difference between FMCG and OTC Brand Ad

Lecture 333Digital Marketing Techniques

Lecture 334Video Marketing

Lecture 335Video Marketing Techniques For Small Business Owners

Lecture 336Promoting Brand through Article Advertising and Marketing

Lecture 337Introduction to Omnichannel Marketing | Importance | Significance | Implementation outcome of Omnichannel Marketing

Lecture 338OMM Implementation Framework | Step By Step | Key Activities in each step | 3 Case Study on OMM

Lecture 339Download OMM Implementation Framework Checklist

Lecture 340OMM terminologies | Explanation of important digital marketing terms

Lecture 341OM Brand Plan Development | Practical Brand Plan with different sections with touchpoints

Section 9Regional Business Development : Africa

Lecture 342African Continent Overview - Brief introduction

Lecture 343African Pharma Market

Lecture 344Drug Registration - African medicines regulatory

Lecture 345Basic Export Requirement for African Countries

Lecture 346Export Documentations & Important Concepts

Lecture 347Nigeria - Drug Registration

Lecture 348Drug Registration in Algeria

Lecture 349Drug Registration in Ethiopia

Lecture 350Drug Registration in Kenya

Lecture 351Drug Registration in Egypt

Lecture 352Drug Registration in Ghana

Lecture 353Drug Registration in Botswana

Lecture 354Drug Registration in South Africa

Lecture 355Drug Registration in Zambia

Lecture 356Drug Registration in Namibia

Lecture 357Drug Registration in Tanzania

Lecture 358Drug Registration Senegal

Lecture 359Drug Registration in Zimbabwe

Lecture 360Drug Registration in Uganda

Lecture 361Drug Registration in Morocco

Lecture 362Drug Registration in Sudan

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

Lecture 363Middle East / MENA / GCC Countries Geographical Orientation

Lecture 364Middle East / MENA / GCC Countries National Regulatory Agencies

Lecture 365GCC Registration Procedure - Centralized and Decentralized Procedure | Detailed understanding on Centralized Registration Process

Lecture 366Drug Registration in Saudi Arabia

Lecture 367Drug Registration in UAE

Lecture 368Drug Registration and Regulatory Strategic Planning for Iran

Lecture 369Drug Registration and Regulatory Strategic Planning for Israel

Lecture 370Middle East Pharma Market

Lecture 371Drug Registration in Jordan

Lecture 372Drug Registration in Palestine

Section 11Regional Business Development : ASEAN

Lecture 373ASEAN - Region - Introduction

Lecture 374ASEAN Countries | Introduction | Geographical Overview

Lecture 375ASEAN countries drug regulatory bodies

Lecture 376ASEAN Common Technical Requirements (ACTRs)

Lecture 377The Pharmaceutical Inspection Co-operation Scheme

Lecture 378CPP Requirements for Drug Registration in ASEAN countries

Lecture 379Dossier Requirements - ACTD/CTD Acceptability

Lecture 380Pharmacopoeias Acceptability

Lecture 381Harmonization of Technical Guidelines

Lecture 382Stability Study requirements for drug registration in ASEAN countries

Lecture 383Product Labelling

Lecture 384Post Approval Changes (Variations) requirements in ASEAN countries

Lecture 385Pharmacovigilance and Risk Management Plan (RMP)

Lecture 386Timeline of Drug Registration Approval

Lecture 388Drug Registration and Regulation Singapore | Strategic Pathways for Marketing Authorization | Screening, Evaluation of MA applications | Variations Classifications and Management

Lecture 389Drug Registration and Regulation in Brunei

Lecture 390Drug Registration and Regulation in Cambodia

Section 12Regional Business Development : Latam

Lecture 391Introduction to Latam Region Pharma Business Development

Lecture 392Drug Registration and Regulation in Argentina

Lecture 393Drug Registration and Regulation in Bolivia

Lecture 394Drug Registration and Regulation in Brazil

Lecture 395Drug Registration and Regulation in Chile

Lecture 396Drug Registration and Regulation in Colombia

Lecture 397Drug Registration and Regulation in Mexico

Lecture 398Drug regulation and registration in Peru

Lecture 399Drug regulation and registration in El Salvador

Lecture 400Central America Drug Regulatory Affairs | Panama, Costa Rica, Guatemala, El Salvador, Honduras, Dominican Republic | RTCA guideline [2022]

Section 13Regional Business Development : China

Lecture 401Drug Registration and Regulation in China

Lecture 402NMPA's DDR and DMR update

Section 14Biopharmaceutical Management and Regulation

Lecture 403Introduction : Biopharmaceuticals

Lecture 404Classification of Biopharmaceutical

Lecture 405Important Concept regarding Biopharmaceuticals

Lecture 406Introduction to Biologics and Biosimilar | Key differences | Concept of Reference Product

Lecture 407Key features of Biologic | Differences in Chemical Drug Vs. Biologic Drugs

Lecture 408Principle of Naming of Biologic | Understanding on MAB naming system

Lecture 409Global Biopahrma Market Trends

Lecture 410Recombinant protein

Lecture 411Monoclonal Antibodies Vs. Polyclonal Antibodies

Lecture 412Monoclonal Antibodies

Lecture 413Synthetic Immunomodulators

Lecture 414Production of Monoclonal Antibodies

Lecture 415Cytokines

Lecture 416Interferon

Lecture 417Erythropoiesis-stimulating agent

Lecture 418Vaccine development and approval Process

Lecture 419Biosimilar Development Process

Lecture 420Strategic Consideration for Biosimilar Development

Lecture 421Bio-Manufacturing Process Information

Lecture 422Studies required for approval of biosimilar

Lecture 423ATMPs | Types and Classification | Regulatory Mechanism

Lecture 424Biosimilar Approval and Patent Management | Strategic Pathway of Patent Negotiation and Litigation in Biosimilar Approval | Patent Dance | FAQs on Biologic Patent Management

Lecture 425Biosimilar launch case study | Patent Dance Framework

Lecture 426Biosimilar Launch Framework

Lecture 427Biosimilar 180 Day Notice

Lecture 4283(A) List | Significance | Importance | How to interpret

Lecture 429Steps to win over innovator patents | Step wise planning

Lecture 430Biosimilar Launch Project Roadmap with defined stages of project

Lecture 431Timing of Biosimilar Submission and Approvals | Two Scenario based timeline assessments

Lecture 432Hands on Training on Reference Biologic Patent | Classify RPS Biologic Patents | Case Simulation

Lecture 433How to work on RPS’s Patent | Walkthrough | Case Study

Lecture 434Biosimilar Launch Project With Milestones

Lecture 435Analysis of Biologic Patents | Work Assignments

Lecture 436Biologic Patent Insight Worksheet

Lecture 437Patent Thickets | Concept | Implication | Case Based Learning

Section 15Drug Registration and Regulation in Japan

Lecture 440Introduction to Japan Drug Regulatory Affairs

Lecture 441Drug Discovery Development to commercialization | PMDA functions | Consultation | Premarket to post market approval

Lecture 442Drug Approval System | GCP | PMDA requirements

Lecture 443New Drug Application | Requirements | Review Process

Lecture 444Generic Drug Application Review and Approval

Lecture 445Marketing Authorization Process for registration of pharmaceutical in Japan

Lecture 446API Registration in Japan | Step By Step Process

Lecture 448Priority Review Application | Criteria | Review Process | Timeline

Lecture 449Orphan Drug Designation in Japan

Lecture 450Japan DMF System | MF filing Process | Key points

Lecture 451Strategic Approval Pathway - Formulation Approval Quoting MF

Lecture 452SAKIGAKE designation

Section 16Variation Filing : Marketing Authorization variation management

Lecture 453Introduction to Variation Management | Reasons for Variation | Working in Variation Department

Lecture 454Variation Classification | Basis of Classification | US and EU Variation Classification | Other region variation guideline.

Section 17Bioequivalence Study : Requirements

Lecture 455PKPD in Drug Discovery | PK-PD trial | Understanding PKPD from regulatory perspective in drug approval process

Lecture 456Bioequivalence Study | Study design | Different types of BE Studies

Lecture 458Biopharmaceutical Classification System (BCS) | Types | Biowaivers | BCS tool for drug development and regulatory submission

Lecture 459Bioequivalence Study - Discussion - Timeline of stability study and bioequivalence study

Lecture 460Bioequivalence Study - Discussion - Dissolution Testing

Lecture 461Bioequivalence Study - Generic Approval and Additives Labeling Requirements

Lecture 462IVIVC - Basis | Importance | Case Based Determination of IVIVC

Lecture 463Setting Dissolution Specification for Generic Products | Regulatory Expectations

Section 18CIS - EAEU Regulatory Affairs

Lecture 464Drug Registration and Submission Strategic Planning for Russia and EAEU region

Lecture 465GMP requirements in Russia

Section 19Drug Registration and Regulation in India

Lecture 467Medicine Export Criteria from India

Lecture 468Documents for conducting BE Study for Export

Lecture 469New Drug Approval in DCGI

Lecture 470Line Extension New Strength Approval

Section 20Data Visualization in Pharma Market Access and Forecasting

Lecture 471Line Chart vs. Spline Chart

Lecture 472Basic Area Charts

Lecture 473Stacked Area Chart

Lecture 474Basic Bar Charts

Lecture 475Stacked Bar Charts

Lecture 476Basic Column Charts

Lecture 477Stacked Column Charts

Lecture 478Pie Chart

Lecture 479Donut Chart

Lecture 480Scatter Plot

Lecture 481Case Study: New Oncology Drug Launch Forecasting

Lecture 482Treemap Plot

Lecture 483Spiderweb chart

Lecture 484Polar Chart

Lecture 4853D Funnel Chart

Lecture 486Heatmap Chart

Section 21Pharma Forecasting and Market Access Related Case Studies

Lecture 487Case Study: Forecasting DMD Drug

Lecture 488Case Study: Forecasting the Uptake of a New Cancer Drug After Launch in a Specific Region

Lecture 489Case Study: Forecasting Demand for a New Cancer Treatment Expected to Generate Billions in Sales Globally

Lecture 490Generic Drug Forecasting - Post Patent Expiry

Lecture 491Case Study: Estimating the Market Uptake of a Generic Version of a Popular Cholesterol-Lowering Drug

Lecture 492Data-Driven Forecasting Case Study: Market Share Forecast for a New Hypertension Drug

Lecture 493Forecasting During Early Stage of Development

Lecture 494Case Simulation : Demographic-Based Forecasting

Lecture 495Forecasting and Valuation for Weight Loss Drugs | Forecasting Model | Model Assumptions | Data Inputs | Projected Revenue Calculations

Lecture 496Forecasting Assignment

Section 22Certification Request | Course Certificate

pharma global business, pharma global management

Pharma Global Management

Download All Course Catalogue

Your form has been submitted

Request for Course Demo Session

Your form has been submitted

Introduction

Eligibility

Features

Related Courses

About Pharma Management

Add on Course

Who should attend this course?

Key details about the course:

Features of Pharma Global Management Course

Case Based Learning

Few of the similar courses

Career in pharma global management

Knowledge of the various business regions is important

Royed Training

Pharma Global Management

Please sign in first

Not a member?

Download All Course Catalogue

Your form has been submitted

Request for Course Demo Session

Your form has been submitted

Introduction

Eligibility

Features

Related Courses

About Pharma Management

Add on Course

Who should attend this course?

Key details about the course:

Features of Pharma Global Management Course

Case Based Learning

Few of the similar courses

Career in pharma global management

Knowledge of the various business regions is important