InstructorRoyed Training
TypeOnline Course
Student Enrolled1
Price$590 USD / 29500 INR.
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biopharmaceutical project management



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biopharmaceutical project management

Biopharmaceutical Project Management course provides comprehensive training on advance tools and techniques of innovator and biosimilar portfolio management. Focus is on learning biopharmaceutical R&D, process development, manufacturing, regulatory and portfolio and pipeline management aspects. This comprehensive training program provides detailed understanding of both innovator biotech and biosimilar (similar biologic) in single course. This advance certification course utilizes interactive online learning tools to provide real life practical exposure. Therefore, participant will have real life understanding in the steps of the biopharmaceutical (biotech and biosimilar) R&D, process development and manufacturing, commercialization process related strategic planning.

The course can be completed at any pace, allowing the user to stop and start at their leisure. Hence, it is quite convenient to learn on the go.

  • Course Code: RYD-078
  • Course Title: Advance Certification in Biopharmaceutical Project Management (ACBPM)
  • Duration of the course: 1 Month
  • Nature of the training: Online distance learning course. Therefore the course can be accessed online across anywhere 24×7.
  • Eligibility: Graduation in any discipline. Even the final year student can join the course.
  • Course Certificate: Certificate will be provided at the end of the successful completion of the course.

This Biopharmaceutical Project Management online course utilizes interactive learning tools to guide each participant through to understand of the regulatory process of biopharmaceutical products. This online biopharmaceutical project management training course will focus on understanding different class of biopharmaceuticals, registration process and followed by biopharmaceutical project management and business development concepts. Hence, the course provides fundamental to advance understanding of the biopharmaceutical business and project management concepts.  Indeed, advance simulation in the course will challenge students to apply what they have learned from the course. In addition, there are advance learning tools like interactive exercises, reflection questions, expert live chat which makes the course very interesting.

Key features of the course

  • 24×7 Online Access. Therefore, access the course anytime from anywhere across globe.
  • Students can download the course materials from dashboard. Hence, it helps them to study offline even after completion of the course.
  • Access the e-lectures, case studies, self assessment modules and practical sessions through personalized web page.
  • Moreover, final examination is online. Hence student can attend the final examination own convenient date and time.

  • Those who want to know about the Biopharmaceutical Regulation and biopharmaceutical registration. Even freshers, for example biotechnology, micorbiology graduates who want to make a career in biopahrmceutical industry can join this course.
  • One want to enhance knowledge about the recent biopharmaceutical regulation, registration process of innovator biomolecules and biosimilar.
  • Those who want to enhance and acquire the biopharmaceutical project management skills.
  • Moreover, business Development, Regulatory Affairs, IPR, strategic management professionals who want to have the detailed understand strategic planning process for registration and regulation of the biopharmaceuticals and biosimilar.
  • The course provides hands on training on various aspects of the biopharmaceutical project management. Hence, this course is ideal for the pharmaceutical professionals who are going to work in biopharmaceutical projects.

Career in Biopharmaceutical Regulatory Affairs

The biopharma sector has seen high growth in last 10 years, and most importantly this high growth is going to sustain, even in next 15 years. Due to drying up drug (chemical) pipeline, patent expiry, traditional pharmaceutical companies, who are focussing on small molecules, are now looking for the strategic options to keep up their revenue projection.

Hence, a lot of pharmaceutical companies are diversifying to biopharmaceutical segment. Moreover, many patented biologics are going to expire in coming days, biosimilar is seen as a big scope for pharmaceutical and pharmaceutical companies. Way back in year 1990, total annual revenue of biopharmaceutical industry was has increased from about $4.4 billion. However, biopharma industry reached $275 billion. Most importantly, Biopharmaceutical industry is contributing more than 25 percent of the total pharmaceutical market.

So, there will be huge job demand in biopharmaceutical market. Therefore, biopharma industry seeks skilled person who knows about the basics of  biopharmaceuticals. In addition, advance knowledge about the biopharmaceutical regulation will be required for strategic management, business development and regulatory personnel.

What regulatory job involves?

A career in Biopharmaceutical and Bisomilar Regulatory Affairs is very challenging, but highly rewarding. It opens up lot of opportunities for professionals. But the regulatory job covers a variety of disciplines. Regulatory professional involved involved in regulatory submission, compliance, clinical trials, quality assurance, drug safety, pharmacovigilance.

Important Articles

Biopharma Basics

  • Introduction to Global biopharmaceutical Industry.
  • Biotech Drug Development Process. Overview of the development of a biotech product – clarify the difference between synthetic drugs, biologics and biotech products .
  • Biotech Drugs Classification. Important classes.
  • Detailed understanding on different types biologics. For example, Monoclonal Antibody, Interferon, Erythropoiesis Stimulating Agents and other important biologic.
  • Key Understanding on biotech regulation. Topics include understanding the differences in regulatory philosophy between small molecules and biotech product regulation.
  • Preclinical and Clinical Research Design.

Regulatory Pathway

  • Innovator biopharmaceutical regulation, registration process.
  • Biosimilar Development and regulation. Topics include Introduction to Biosimilar. Meaning of Biosimilar vs. Follow on biologics. Subsequently Difference between biosimilar and generic drugs. Key important issues in Biotech and biosimilar product manufacturing. Insight on biosimilar approval pathway.

Advance Strategic Management 

  • Topics include regulatory submission, approval, production, and the postmarket environment for both drugs and devices. Challenges surrounding the approval and naming of follow-on biologics are addressed. Above all, course discussion covers the stages of a drug pipeline and risk assessment at each marketing authorization stages.
  • Analytical techniques for the Biotech Drugs. Understand the need for using a range of analytical methods in the characterization of biotech product.
  • Global Biotechnology Business. Discussion also covers domestic and International business considerations and international regulatory requirements. Moreover, course provide the access to case studies related to biopharmaceutical strategic management.

Biopharmaceutical Project Management

  • Integrities of project management for innovator biopharmaceuticals and biosimilar products.
  • Fundamental to advance training on portfolio management. Topics cover are inlicensing, outlicnesing, licensing advance training, technology transfer, deal valuation, royalty management etc.
Section 1Fundamental Understanding on Biopahrmaceuticals and Biopahrmaceutical Market
Lecture 1Introduction to Biopharmaceuticals and Biopharmaceutical Market
Lecture 2Classification of Biopharmaceutical 
Lecture 3Chemical Drugs Vs. Biologic Drugs
Lecture 4Principle of Naming of Biologics
Lecture 5Biopharmaceutical Market Segmentation - Global Biologics Market – By Product
Lecture 6Introduction to Biopharma Market Access | Objectives | Various Key Terminologies | Steps of Market Access | Understanding on Pricing and Reimbursement
Lecture 7Biopharma Market Access Strategic Planning : Steps and Logical Sequencing for Market Access Strategy Development
Section 2Biopahrmaceutical Classification and study on each class
Lecture 8Recombinant protein
Lecture 9Monoclonal Antibodies Vs. Polyclonal Antibodies
Lecture 10Monoclonal Antibodies : Detailed Understanding
Lecture 11Synthetic Immunomodulator
Lecture 12Production of Monoclonal Antibodies
Lecture 13Cytokines
Lecture 14Interferon
Lecture 15Erythropoiesis-stimulating agent
Section 3Biopahramaceutical Regulatory Pathways
Lecture 16R&D Process & Introduction to discovery, development to commercialization process
Lecture 17Investigational New Drug Application (INDA)
Lecture 18New Drug Application (NDA) 
Lecture 19 Biological Licensing Application (BLA) 
Lecture 20Basic concept and understanding of the Generic Drug
Lecture 21Abbreviated New Drug Application (ANDA) 
Lecture 22Abbreviated Biosimilar Application - 351(k): Advance Strategic Planning Process : Originator Vs. Biosimilar Development and Regulatory Approval Process | Reference Biologic | Purple Book | Data Requirements
Lecture 23505(j) ANDA, 505(b)(2) NDA, 505(b)(1) NDA
Lecture 24Purple Book: Significance | Searching | Assignments
Lecture 25Nomenclature of biosimilars
Lecture 26Vaccine development and approval Process
Lecture 27REMS Strategic Planning 
Lecture 28PDUFA For Biologics
Lecture 29Clinical Trials Terminologies 
Lecture 30Advance Learning on 505B2 Pathway
Lecture 31FDA Forms and How to fill the resources
Lecture 32Chemistry, Manufacturing & Controls 
Lecture 33Strategic Discussion: PreIND, EOP1, EOP2 - What to expect !
Lecture 34Patent & Exclusivity - Strategic Understanding | Patent Restoration| Orphan Drug Exclusivity (ODE) 
Lecture 35USFDA expedited programs for Pharmaceuticals and Biopharmaceuticals
Section 4Bio-manufacturing
Lecture 36Biosimilar Development Process
Lecture 37Strategic Consideration for Biosimilar Development 
Lecture 38Important Considerations regarding Reference Biologics 
Lecture 39Bio-Manufacturing Process Information
Lecture 40Concept of Interchangeability in Biosimilar Development
Lecture 41Studies required for approval of biosimilar
Lecture 42Regulatory Requirements for Biosimilar | Stepwise evidence based development | Analytical Similarity | Clinical Study | PKPD study requirements | CMC expectation of Biosimilar
Lecture 43Comparability of Biologics | Different Categories of Comparability | General Principles 
Lecture 44CQA (Critical Quality Attribute) and CPP (Critical Process Parameter)
Section 5Strategic Pathway for Biopharmaceuticals
Lecture 45Strategic Planning During Clinical Trials
Lecture 46LOE Strategies for Innovator Brands with case study
Lecture 47Evergreening - Patent Life Extension Strategies
Lecture 48Licensing - Advance Learning 
Lecture 49Drug Repurposing
Lecture 50Paediatric Exclusivity and Paediatric Study Plan Development
Lecture 51Compulsory Licensing
Lecture 52Licensing & Technology Transfer
Section 6Fundamental of Project Management
Lecture 53Introduction to Project Management
Lecture 54Difference between Project and Program
Lecture 55Role and Responsibility of Project Leader
Lecture 56Project Constraint & Effective management of Project Constraint | Role of Project Manager
Lecture 57Qualities of the Pharmaceutical Project Manager
Lecture 58Review Test
Lecture 59Introduction to Pharma Project Management  - PERT, CPM, Critical Path, Project Diagram and its components
Lecture 60Basic Finance for Pharma and Biopharma Project Manager
Lecture 61In-Licensing Vs. Outlicensing
Lecture 62Benchmarking | Benchmarking through consortium | How to use benchmarking for drug discovery development projects 
Section 7Advance Training in Biopharmaceutical Project Management
Lecture 63Introduction to Biopharmaceuticals and Biopharmaceutical Market
Lecture 64Portfolio Management Process | Portfolio Characteristics | Portfolio Analysis | Balancing the Portfolio | BD and Strategic Planning Department 
Lecture 65Identifying the corporate Need of business development | Objective – Strategy - Tactics | Portfolio constraints | SWOT | Numerical SWOT
Lecture 66Profiling and Searching | Objectives | Search Database | Creating Opportunity Anatomy for deal analysis | Mind Mapping | Searching Tools and Techniques - Web Search | Conference | Confidentaility - CDA | MTA
Lecture 67Numerical SWOT Practical training
Lecture 68Modelling and Deal Valuation - Top Down Modeal | Epidemiology data method | Complex Model | Forecasting | Heuristic or ‘prophesy’ method | Different value perspectives | Deal Structuring Structuring the deal
Lecture 69Market Size Determination - Market Share | Relative Market Share | Total Vs. Actual Vs. Penetrated Market
Lecture 70Forecasting : Tools and Techniques
Lecture 71Market Share of Different Class of Biopharmaceutical
Lecture 72Royalty Management - Royalty structuring | Royalty Calculation Method| Tiered Royalties | Terms | Royalty Reductions | Royalty Stacking - Concept and Calculation | Minimum Annual Royalties | Reach through royalties
Lecture 73Market Understanding: Leading Biosimilar Companies
Lecture 74Strategic Planning Process | Knowledge Area of Business Development | Lead targeting | Licensing term sheets 
Lecture 75Distribution Licensing | Geography | Indication Splitting | Execlusive and Non-Exclusive Licensing | Sub Licenses
Lecture 76Acquisition in Pharma  | Product Acquisition| Company Acquisitions| Steps in acquisition | Financing acquisition deals | Trademark Assignment Process
Lecture 77Indication Splitting | Concept | Implementation feasibility analysis 
Lecture 78Types of Deals from Discovery to Commercialization
Lecture 79Licensing Term Sheet | Content Structuring | Sample Term Sheet
Lecture 80Licensing Payment Scheduling: Different Types
Lecture 81Valuation Methods: DCF | rNPV | Sunk Cost Method | Comparables | Sum of Parts | Deterministic Vs. Probabilistic rNPV |  Peak Sales - Max-Min Approach
Lecture 82Valuation Methods: EBITDA method of valuation | Enterprise Value and Enterprise Multiple Calculation
Lecture 83Negotiation Skill Training for BD / Project Management Professionals
Lecture 84Business Development Simulation and Decision Making | Early Stage VS. Late Stage Valuation Methodology | Stair Step Model
Lecture 85Licensing Agreement : Confidentiality Agreement | MTA | A deed of Assignment | Exclusive | Non-Exclusive License | Sole License | Components - Terms - Duration - Key Considerations
Lecture 86Step By Step Implementation of Licensing Deal by Business Development Team 
Lecture 87Due Diligence Activities in Pharmaceutical Licensing