InstructorRoyed Training
TypeOnline Course
Price$690 USD / 34500 INR.
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pharma strategic management course

Introduction

Learning Areas

Features

Eligibility

Certification

Related Courses

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

Key Learning Area for the course

  • Drug Development to Commercialization.
  • Innovation Management in pharmaceutical industry.
  • Pharma Marketing Strategic Planning.
  • Generic Drug Strategic Planning.
  • Managing pharmaceutical SBU (strategic business unit) revenue model.
  • Region specific pharma business strategies.
  • International Marketing strategic planning in pharmaceutical.
  • 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.
  • Advance soft skill training for pharma strategic management professionals.
  • 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.

Minimum qualification Graduation in any discipline.

Certificate will be provided at the end of the successful completion of the course.

Related courses

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.

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Section 1INTRODUCTION TO PHARMACEUTICAL STRATEGIC MANAGEMENT
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 17Patent & Exclusivity - Strategic Understanding | Patent Restoration| Orphan Drug Exclusivity (ODE) | NCE & NCI Exclusivity | GAIN Exclusivity | Pediatric Exclusivity | 180 days exclusivity
Section 2CLINICAL RESEARCH - PHARMA R&D STRATEGIC ORIENTATION
Lecture 18Clinical Trial Terminologies
Lecture 19Clinical Trial Protocol Writing
Lecture 20Ethics in Clinical Research
Lecture 21Informed Consent | Practical Training on preparing ICF | Ready Templates
Lecture 22Strategic Discussion: PreIND, EOP1, EOP2 - What to expect !
Lecture 23FDA Forms and How to fill the resources
Lecture 24Strategic Discussion: PreIND, EOP1, EOP2 - What to expect !
Lecture 25Importance and Significance of Phase 2b Clinical Trial 
Section 3Strategic Planning and Management
Lecture 26Regulatory Strategies in different phases of Clinical Trial
Lecture 27Para IV Filing
Lecture 28Para IV Notices
Lecture 29Evergreening - Patent Life Extension Strategies
Lecture 30Pay For Delay Strategy
Lecture 31REMS Strategic Planning 
Lecture 32Compulsory Licensing
Lecture 33Licensing & Technology Transfer
Lecture 34In-Licensing Vs. Outlicensing
Lecture 35LOE Strategies for Innovator Brands with case study
Lecture 36Paediatric Exclusivity and Paediatric Study Plan Development
Lecture 37Drug Repurposing
Lecture 38Advance understanding of the portfolio Management 
Lecture 39New Indication Approval Process and Promotion 
Lecture 40OTC Switch 
Lecture 41Detailed Understanding on 505(b)(2) VS. Suitability Petition : Case Based Learning
Lecture 42NCE Vs. 505b2 application - Case Based Learning 
Lecture 43FTF - 180 Days Exclusivity - Case Based Learning
Lecture 44Classic case study of the 505b2 filing : Case Based Learning
Lecture 45Strategic Planning in Combating 30 months stay strategies of innovator company- Case Based Learning
Lecture 46Pipeline in a Molecule
Lecture 47USFDA Emergency Use Authorization (EUA)
Lecture 48Target product profile (TPP) | Quality Target product profile (QTPP) | Critical Quality Attributes (CQAs) | Quality By Design (QbD)
Section 4PHARMA MARKETING - BRAND MANAGEMENT
Lecture 49 Introduction to Pharma Marketing
Lecture 50Market Research in Pharma Business
Lecture 51 Consumer buying behavior
Lecture 52Product Life cycle - Basic Understanding
Lecture 53 STP - Strategic Positioning and Brand Differentiation
Lecture 54 Pricing Strategies
Lecture 55Distribution and Logistics
Lecture 56 Pharmaceutical Distribution
Lecture 57Promotion Management Process in a Pharmaceutical Company
Lecture 58 Setting and Quantifying Promotional Objectives
Lecture 59Promotional Budget Setting : Tools and Techniques
Lecture 60Basics of Advertising : Introduction
Lecture 61 Classifications of Advertising
Lecture 62 The Advertising agency
Lecture 63Classification of Doctors
Lecture 64 Moving Annual Total (MAT)
Lecture 65 CAGR
Lecture 66 Brand Potential
Section 5PHARMA BRAND STRATEGY MANAGEMENT
Lecture 67PRATICAL TRAINING SESSION : BRAND NAME, BRAND LOGO, TRADEMARKING
Lecture 68 Purpose of Pharma Brand Logo
Lecture 69Component of brand logo
Lecture 70Brand Name and TM Registration Process
Lecture 71How to design excellent brand logo?
Lecture 72Case study in brand name finalization
Lecture 73Brand Name Simulation
Lecture 74 Traditional Vs. Non-Traditional trademark
Lecture 75 Global Protection of the Pharma Brand
Lecture 76Rebranding in Pharmaceuticals
Lecture 77Brand Logo Development: Real Life Simulation
Lecture 78 Fundamental of Pharma Marketing Plan
Lecture 79Basic Know-How: Marketing Campaign Development
Lecture 80How to prepare a Pharma Brand Plan
Lecture 81 Decide about brand USP -What to promote
Lecture 82 How to prepare promotogram. Download sample Promotogram
Lecture 83Sample Allocation
Lecture 84 Importance of Visual Aid in Pharmaceutical Industry
Lecture 85BUYING SIGNAL
Lecture 86 Indications for Drugs: Approved vs. Non-approved
Lecture 87Case Study : Indication approval to extend the usage of the brands (molecule)
Lecture 88Step By Step Visual Aid Designing
Lecture 89 Guideline of Visual Aid Designin
Lecture 90Practical Sample to understand visual aid contents and effective placement of the texts
Lecture 91 VISUAL AID PRINTING
Lecture 92 Detailing and e-detailing
Lecture 93 Marketing Plan followed by Visual Aid Development
Lecture 94Visual Aid, Literature reference Sample
Lecture 95 Creativity to develop brand essence
Lecture 96 Increase the brand reach with advance segmentation
Lecture 97 Concept of uniform branding for better brand acceptability
Lecture 98Concept of Brand Differentiation
Section 6BIOPHARMACEUTICALS AND BIOSIMILAR DEVELOPMENT PROCESS
Lecture 99Introduction : Biopharmaceuticals
Lecture 100 Classification of Biopharmaceutical
Lecture 101Introduction to Biosimilar
Lecture 102 Chemical Drugs Vs. Biologic Drugs
Lecture 103 Current Trends in Biopharmaceutical Market
Lecture 104Complexity of biopharma supply chain and operations
Lecture 105Biopharma - Market Segmentation
Lecture 106Blockbuster Biologic - Classifications, Indications, Global Sales
Lecture 107Recombinant protein
Lecture 108Monoclonal Antibodies Vs. Polyclonal Antibodies
Lecture 109Monoclonal Antibodies
Lecture 110Synthetic Immunomodulators
Lecture 1111Production of Monoclonal Antibodies
Lecture 112Cytokines
Lecture 113Interferon
Lecture 114Erythropoiesis-stimulating agent
Lecture 115Biological Licensing Application (BLA)
Lecture 116Biosimilar Approval process
Lecture 117Difference : Drugs Vs. Biopharmaceutical Approval process
Lecture 118Pricing and cost effectiveness of biosimilars
Lecture 119Exclusivity Protections for Biopharmaceuticals
Lecture 120REMS Strategic Planning
Lecture 121Review : 351(a) vs. 351(k) pathway
Section 7STRATEGIC ORIENTATION IN PHARMA AND BIOPHARMA INDUSTRY
Lecture 122Licensing Vs. Outlicensing in Pharma / Biopharma Industry
Lecture 123Licensing - Advance Strategic Learning
Lecture 124Terms / Duration of License
Lecture 125Are improvements licensed
Lecture 126Financial of Licensing Deals
Lecture 127Milestone Payment
Lecture 128How are royalties structured in a licensing deal?
Lecture 129What accounts, inspection and audit provisions are in a license?
Lecture 130How is patenting dealt with in a license?
Lecture 131What warranties are in a license?
Lecture 132What competition law issues are there in licensing?
Lecture 133Co-development and co-marketing agreements in Pharmaceutical Strategic Management
Lecture 134Due Diligence Activities in Pharmaceutical Licensing
Lecture 135Detailed in-depth strategic understanding on Technology Transfer
Lecture 136Overview of contractual agreements in Technology Transfer
Lecture 137Confidentiality agreements
Lecture 138Material Transfer Agreements
Lecture 139Deeds of assignment or assignment deeds
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