Pharma Strategic Management [PG Certification]

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About strategic management

pharma strategic management course

This online training provide understanding of pharma strategic business management skills which are commonly applied in the pharma and biotech companies. The course is designed to create the new-edged Strategic Business Manager for pharma and biotech industry. Course focuses on how pharma and biotech strategic business manager works and their key responsibilities and job functions.

Course Code: RYD-005
Title of the course: PG Certification in Pharma Strategic Management
Nature of the course: Online Self Paced Learning
Duration: 1 Year
Certification: Certificate will be provided at the end of the successful completion of the course.

Key Learning Area for the course

Drug Development to Commercialization. R&D Fundamentals.
Pharmacoeconomics / Health Economics.
Clinical research, real world data and real world evidence.
Market Access strategic planning.
Pricing, Reimbursement.
Forecasting.
Portfolio Management.
Pharma Marketing Strategic Planning.
Generic Drug Strategic Planning.
Biologic and Biosimilar Strategic Planning.
Managing pharmaceutical SBU (strategic business unit) revenue model.
Region specific pharma business strategies.
Inlicensing and outlicensing.
Deals and deal management in pharmaceutical and bio pharmaceutical industry.
Deal valuation tools and techniques.
Pharmaceutical Business Audit – Due diligence.
Financial Planning and Management for pharma strategic management professionals.
Branding Training – Brand plan preparation, advertisement management, marketing campaign planning.

Understanding on pharma strategic business management principles involved from drug discovery development to commercialization. Therefore fundamental to advance R&D management process training is included.
Additionally, the course provide pharma portfolio management skill training.
Advance Simulation provide to real life learning experience. Hence it helps to improve the decision making skills of the participants.
Biotech, biosimilar products strategic management is also part of the course.
Above all, course participants are exposed to Global Pharma Business Case Studies.
24×7 access of the course. Hence you can attend the course at your own preferred date and time.

Related courses

Pharmaceutical Brand management Course >> Click here
Pharma marketing course >> Click here
Sales Management Training >> Click here
Biopharma Business Management >> Click here
Brand valuation >> Click here
Pharma Product Management >> Click here

What is strategic management in pharma and biotech industry?

Strategic management is the process of planning, monitoring, analysis and assessment of all what is must for an organization to meet its goals and objectives. Because of this, in all leading pharma and biotech companies, there is a separate division called strategic management cell. They work on planning organization’s strategy.
Pharma strategic management professionals involve in changes in organization’s business process. As a result, they bring the success to organization.
Today pharma and biotech organization are looking for trained professionals who understand all aspects of strategic planning. However, there is a lack of professionals who understand complex pharma and biotech business environment.

What skill Pharma Strategic Manager should have?

Firstly, Pharma Strategic Manager should be master of the drug discovery, development to commercialization process. They should have excellent and updated regulatory knowledge. Secondly, professionals should have the fundamental understanding on portfolio management process. Thirdly, they should have strategic business skills, acumen and competency. Last but not the least, they should have basic financial management skills. Most importantly, the course covers deal valuation tools and techniques.

To summarize, strategic management professionals should have overall pharma business functional understanding.

Do the course cover both pharmaceutical and biopharmaceutical strategic management?

Yes. It’s cover the both pharmaceutical and biopharmaceutical industry.

Section 1R&D Fundamental | Discovery Development to Commercialization

Lecture 1Introduction to R&D Process & drug discovery

Lecture 2Investigational New Drug Application

Lecture 3New Drug Application (NDA)

Lecture 4Basic concept and understanding of the Generic Drug

Lecture 5Abbreviated New Drug Application (ANDA)

Lecture 6Review on Drug Discovery and Development

Lecture 7Handling of orange book

Lecture 8USFDA expedited programs

Lecture 9Practical Training on INDA, NDA, ANDA filing

Lecture 10505(j) ANDA, 505(b)(2) NDA, 505(b)(1) NDA

Lecture 11Authorized Generics: Key Understanding

Lecture 12Exploratory IND Vs. Traditional IND

Lecture 13Patents Vs. exclusivity

Lecture 14Orphan Drug Designation

Lecture 15Advance Learning on 505B2 Pathway

Lecture 16Chemistry, Manufacturing & Controls

Lecture 18Introduction to Health Economics | Key terminologies related to health economics

Lecture 19HEOR Application in Pharmaceutical and Biopharmaceutical Industry

Lecture 21Economic Evaluation Methods | Various methods | Importance of perspective in health economics | Discounting | Uncertainty

Lecture 23QALY | How to calculate QALY | Importance and Significance

Lecture 24ICER | How to calculate ICER | Importance and Significance | Incremental Effectiveness determination

Lecture 28Pharmaco-economic evaluation – analysis and results | Different Types of Models | Understanding Decision Tree - Components with practical Example | Markov model

Lecture 29CER and PCOR

Section 2CLINICAL RESEARCH - PHARMA R&D STRATEGIC ORIENTATION

Lecture 30Clinical Trial Terminologies

Lecture 31Clinical Trial Protocol Writing

Lecture 32Ethics in Clinical Research

Lecture 33Informed Consent | Practical Training on preparing ICF | Ready Templates

Lecture 34Strategic Discussion: PreIND, EOP1, EOP2 - What to expect !

Lecture 35FDA Forms and How to fill the resources

Lecture 36Strategic Discussion: PreIND, EOP1, EOP2 - What to expect !

Lecture 37Importance and Significance of Phase 2b Clinical Trial

Lecture 38Evidence Based Decision Making | Combine evidences for decision making | Do we need more evidence?

Lecture 39RWD and RWE | Potential sources of RWE | Traditional RCTs vs. RWE | Case Study - RWE Programs | Influencing HCP decision-making

Lecture 40RWD and RWE - Fit to use | Assessment

Lecture 41RWD data sources | Different types | Detailed understanding of each class

Section 3Portfolio Management, Market Access. Pricing, Forecasting

Lecture 42Regulatory Strategies in different phases of Clinical Trial

Lecture 43Para IV Filing

Lecture 44Para IV Notices

Lecture 45Evergreening - Patent Life Extension Strategies

Lecture 46Pay For Delay Strategy

Lecture 47REMS Strategic Planning

Lecture 48Compulsory Licensing

Lecture 49Licensing & Technology Transfer

Lecture 50In-Licensing Vs. Outlicensing

Lecture 51LOE Strategies for Innovator Brands with case study

Lecture 52Paediatric Exclusivity and Paediatric Study Plan Development

Lecture 53Drug Repurposing

Lecture 54Advance understanding of the portfolio Management

Lecture 55New Indication Approval Process and Promotion

Lecture 56OTC Switch

Lecture 57Detailed Understanding on 505(b)(2) VS. Suitability Petition : Case Based Learning

Lecture 58NCE Vs. 505b2 application - Case Based Learning

Lecture 59FTF - 180 Days Exclusivity - Case Based Learning

Lecture 60Classic case study of the 505b2 filing : Case Based Learning

Lecture 61Strategic Planning in Combating 30 months stay strategies of innovator company- Case Based Learning

Lecture 62Pipeline in a Molecule

Lecture 63USFDA Emergency Use Authorization (EUA)

Lecture 64Target product profile (TPP) | Quality Target product profile (QTPP) | Critical Quality Attributes (CQAs) | Quality By Design (QbD)

Lecture 65Introduction to Market Access | Objectives | Various Key Terminologies | Steps of Market Access | Understanding on Pricing and Reimbursement

Lecture 66Market Access Functions : Role and Responsibilities | Key Job Areas | Understanding Job Description

Lecture 67Market Access Strategic Planning : Steps and Logical Sequencing for Market Access Strategy Development

Lecture 68Indication Sequencing | Indication Prioritization | Development of Indication Timeline | Indication Matrix | Value Based Indication Prioritization

Lecture 69Indication Prioritization Case Study

Lecture 70Market Access Value Dossier : What it is | Significance | Components | What to include

Lecture 71AMCP Market Access Dossier Preparation

Lecture 72Drug Pricing Methodologies

Lecture 73Drug Pricing Methodologies

Lecture 75Pharma Market Access Pricing Case Study : Lantus interchangeable Pricing

Lecture 76Sales Forecasting in Life Science Industry

Lecture 77New Product Forecast Algorithm

Lecture 78Patient Based Forecasting Model | Applying more filters and variables

Lecture 79Prescription Based Forecasting Model | Differences between Patient Based and Prescription Based Forecasting Model | Which model to use and when?

Lecture 80Prevalence Vs. Incidence Model

Lecture 81EPI Based Forecasting | Sales Based Forecasting | When and where to apply which forecasting model

Lecture 82Sales Forecasting Tools | New Product Forecasting | In Market Forecasting

Lecture 83Market Size Assignment 1 [Oncology Brand] - Applying sales forecasting tools to carry out next 6 years sales forecast | Excel Based Model

Lecture 84Market Size Assignment 2 [Asthma Brand] - Applying sales forecasting tools to carry out multiple years sales forecast | Excel Based Model

Lecture 85Patient Based Model Vs. Patient Flow Model | Critical Differences in Model | Concept of Black Box in Patient Flow Model | Application of both model

Lecture 86Concomitancy and polypharmacy | How it alter the basic forecasting algorithm | Practical Working | Comorbidity

Lecture 88Bottom-up or Top-down Forecasting | LRx | Significance of LRx data analysis

Lecture 89Simulation on Bottom-up forecasting

Lecture 90Assessment on Bottom-up forecasting

Lecture 91Oncology Brand Forecasting

Lecture 92Revenue Forecasting Case Study - Novel Antihypertensive

Lecture 93Portfolio Based Forecasting | Forecasting Model Development in Excel

Section 4Pharma Marketing and Brand Management

Lecture 94 Introduction to Pharma Marketing

Lecture 95Market Research in Pharma Business

Lecture 96 Consumer buying behavior

Lecture 97Product Life cycle - Basic Understanding

Lecture 98 STP - Strategic Positioning and Brand Differentiation

Lecture 99 Pricing Strategies

Lecture 100Distribution and Logistics

Lecture 101 Pharmaceutical Distribution

Lecture 102Promotion Management Process in a Pharmaceutical Company

Lecture 103 Setting and Quantifying Promotional Objectives

Lecture 104Promotional Budget Setting : Tools and Techniques

Lecture 105Basics of Advertising : Introduction

Lecture 106 Classifications of Advertising

Lecture 107 The Advertising agency

Lecture 108Classification of Doctors

Lecture 109 Moving Annual Total (MAT)

Lecture 110 CAGR

Lecture 111 Brand Potential

Section 5PHARMA BRAND STRATEGY MANAGEMENT

Lecture 112PRATICAL TRAINING SESSION : BRAND NAME, BRAND LOGO, TRADEMARKING

Lecture 113 Purpose of Pharma Brand Logo

Lecture 114Component of brand logo

Lecture 115Brand Name and TM Registration Process

Lecture 116How to design excellent brand logo?

Lecture 117Case study in brand name finalization

Lecture 118Brand Name Simulation

Lecture 119 Traditional Vs. Non-Traditional trademark

Lecture 120 Global Protection of the Pharma Brand

Lecture 121Rebranding in Pharmaceuticals

Lecture 122Brand Logo Development: Real Life Simulation

Lecture 123 Fundamental of Pharma Marketing Plan

Lecture 124Basic Know-How: Marketing Campaign Development

Lecture 125How to prepare a Pharma Brand Plan

Lecture 126 Decide about brand USP -What to promote

Lecture 127 How to prepare promotogram. Download sample Promotogram

Lecture 128Sample Allocation

Lecture 129 Importance of Visual Aid in Pharmaceutical Industry

Lecture 130BUYING SIGNAL

Lecture 131 Indications for Drugs: Approved vs. Non-approved

Lecture 132Case Study : Indication approval to extend the usage of the brands (molecule)

Lecture 133Step By Step Visual Aid Designing

Lecture 134 Guideline of Visual Aid Designin

Lecture 135Practical Sample to understand visual aid contents and effective placement of the texts

Lecture 136 VISUAL AID PRINTING

Lecture 137 Detailing and e-detailing

Lecture 138 Marketing Plan followed by Visual Aid Development

Lecture 139Visual Aid, Literature reference Sample

Lecture 140 Creativity to develop brand essence

Lecture 141 Increase the brand reach with advance segmentation

Lecture 142 Concept of uniform branding for better brand acceptability

Lecture 143Concept of Brand Differentiation

Section 6BIOPHARMACEUTICALS AND BIOSIMILAR DEVELOPMENT PROCESS

Lecture 144Introduction : Biopharmaceuticals

Lecture 145 Classification of Biopharmaceutical

Lecture 146Introduction to Biosimilar

Lecture 147 Chemical Drugs Vs. Biologic Drugs

Lecture 148 Current Trends in Biopharmaceutical Market

Lecture 149Complexity of biopharma supply chain and operations

Lecture 150Biopharma - Market Segmentation

Lecture 151Blockbuster Biologic - Classifications, Indications, Global Sales

Lecture 152Recombinant protein

Lecture 153Monoclonal Antibodies Vs. Polyclonal Antibodies

Lecture 154Monoclonal Antibodies

Lecture 155Synthetic Immunomodulators

Lecture 1561Production of Monoclonal Antibodies

Lecture 157Cytokines

Lecture 158Interferon

Lecture 159Erythropoiesis-stimulating agent

Lecture 160Biological Licensing Application (BLA)

Lecture 161Biosimilar Approval process

Lecture 162Difference : Drugs Vs. Biopharmaceutical Approval process

Lecture 163Pricing and cost effectiveness of biosimilars

Lecture 164Exclusivity Protections for Biopharmaceuticals

Lecture 165REMS Strategic Planning

Lecture 166Review : 351(a) vs. 351(k) pathway

Section 7STRATEGIC ORIENTATION IN PHARMA AND BIOPHARMA INDUSTRY

Lecture 167Licensing Vs. Outlicensing in Pharma / Biopharma Industry

Lecture 168Licensing - Advance Strategic Learning

Lecture 169Terms / Duration of License

Lecture 170Are improvements licensed

Lecture 171Financial of Licensing Deals

Lecture 172Milestone Payment

Lecture 173How are royalties structured in a licensing deal?

Lecture 174What accounts, inspection and audit provisions are in a license?

Lecture 175How is patenting dealt with in a license?

Lecture 176What warranties are in a license?

Lecture 177What competition law issues are there in licensing?

Lecture 178Co-development and co-marketing agreements in Pharmaceutical Strategic Management

Lecture 179Due Diligence Activities in Pharmaceutical Licensing

Lecture 180Detailed in-depth strategic understanding on Technology Transfer

Lecture 181Overview of contractual agreements in Technology Transfer

Lecture 182Confidentiality agreements

Lecture 183Material Transfer Agreements

Lecture 184Deeds of assignment or assignment deeds

Pharma Strategic Management [PG Certification]

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Introduction

Learning Areas

Features

Related Courses

About strategic management

Key Learning Area for the course

What is strategic management in pharma and biotech industry?

What skill Pharma Strategic Manager should have?

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Download Course Catalogue

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Introduction

Learning Areas

Features

Related Courses

About strategic management

Key Learning Area for the course

What is strategic management in pharma and biotech industry?

What skill Pharma Strategic Manager should have?