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TypeOnline Course
Price$490 USD / 23500 INR.
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biopharmaceutical project management

Introduction

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Course Duration

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Eligibility

Who should attend

Certification

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About RA

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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-78

Course Title: Advance Certification in Biopharmaceutical Project Management (ACBPM)

Online distance learning course. Therefore the course can be accessed online across anywhere 24×7.

1 Month

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. 

Graduation in any discipline. Even the final year student can join the course.

  • 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.

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

  1. Attend the course 24×7 by login to your dashboard. So, you can attend lectures, simulation, self assessment tests and final certification examination.
  2. You will also eligible to receive the course study modules, which you can download by login to your course page.

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 5Current Trends in Biopharmaceutical Market
Lecture 6Dynamics of Biopharmaceutical Market
Lecture 7Challenges of Biopharmaceutical Industry
Lecture 8Biopharmaceutical Market Segmentation - Global Biologics Market – By Product
Lecture 9Market Share of Different Class of Biopharmaceutical
Lecture 10Blockbuster Biologic - Classifications,  Indications, Global Sales
Lecture 11Market Understanding: Leading Biosimilar Companies
Lecture 12Market Understanding: Top Leading Brands
Section 2Biopahrmaceutical Classification and study on each class
Lecture 13Recombinant protein
Lecture 14Monoclonal Antibodies Vs. Polyclonal Antibodies
Lecture 15Monoclonal Antibodies : Detailed Understanding
Lecture 16Synthetic Immunomodulator
Lecture 17Production of Monoclonal Antibodies
Lecture 18Cytokines
Lecture 19Interferon
Lecture 20Erythropoiesis-stimulating agent
Section 3Biopahramaceutical Regulatory Pathways
Lecture 21R&D Process & Introduction to discovery, development to commercialization process
Lecture 22Investigational New Drug Application (INDA)
Lecture 23New Drug Application (NDA) 
Lecture 24 Biological Licensing Application (BLA) 
Lecture 25Basic concept and understanding of the Generic Drug
Lecture 26Abbreviated New Drug Application (ANDA) 
Lecture 27Abbreviated Biosimilar Application - 351(k): Advance Strategic Planning Process : Originator Vs. Biosimilar Development and Regulatory Approval Process | Reference Biologic | Purple Book | Data Requirements
Lecture 28505(j) ANDA, 505(b)(2) NDA, 505(b)(1) NDA
Lecture 29Purple Book: Significance | Searching | Assignments
Lecture 30Nomenclature of biosimilars
Lecture 31Vaccine development and approval Process
Lecture 32REMS Strategic Planning 
Lecture 33PDUFA For Biologics
Lecture 34Clinical Trials Terminologies 
Lecture 35Advance Learning on 505B2 Pathway
Lecture 36FDA Forms and How to fill the resources
Lecture 37Chemistry, Manufacturing & Controls 
Lecture 38Strategic Discussion: PreIND, EOP1, EOP2 - What to expect !
Lecture 39Patent & Exclusivity - Strategic Understanding | Patent Restoration| Orphan Drug Exclusivity (ODE) 
Lecture 40USFDA expedited programs for Pharmaceuticals and Biopharmaceuticals
Section 4Bio-manufacturing
Lecture 41Biosimilar Development Process
Lecture 42Strategic Consideration for Biosimilar Development 
Lecture 43Important Considerations regarding Reference Biologics 
Lecture 44Bio-Manufacturing Process Information
Lecture 45Concept of Interchangeability in Biosimilar Development
Lecture 46Studies required for approval of biosimilar
Lecture 47Demonstrating Biosimilarity: A More Complex Task 
Lecture 48Fermentor | Bioreactor
Section 5Strategic Pathway for Biopharmaceuticals
Lecture 49Strategic Planning During Clinical Trials
Lecture 50LOE Strategies for Innovator Brands with case study
Lecture 51Evergreening - Patent Life Extension Strategies
Lecture 52Licensing - Advance Learning 
Lecture 53Drug Repurposing
Lecture 54Paediatric Exclusivity and Paediatric Study Plan Development
Lecture 55Compulsory Licensing
Lecture 56Licensing & Technology Transfer
Section 6Fundamental of Project Management
Lecture 57Introduction to Project Management
Lecture 58Difference between Project and Program
Lecture 59Role and Responsibility of Project Leader
Lecture 60Project Constraint & Effective management of Project Constraint | Role of Project Manager
Lecture 61Qualities of the Pharmaceutical Project Manager
Lecture 62Review Test
Lecture 63Introduction to Pharma Project Management  - PERT, CPM, Critical Path, Project Diagram and its components
Lecture 64Basic Finance for Pharma and Biopharma Project Manager
Lecture 65In-Licensing Vs. Outlicensing
Lecture 66Benchmarking | Benchmarking through consortium | How to use benchmarking for drug discovery development projects 
Section 7Advance Training in Biopharmaceutical Project Management
Lecture 67Introduction to Biopharmaceuticals and Biopharmaceutical Market
Lecture 68Portfolio Management Process | Portfolio Characteristics | Portfolio Analysis | Balancing the Portfolio | BD and Strategic Planning Department 
Lecture 69Identifying the corporate Need of business development | Objective – Strategy - Tactics | Portfolio constraints | SWOT | Numerical SWOT
Lecture 70Profiling and Searching | Objectives | Search Database | Creating Opportunity Anatomy for deal analysis | Mind Mapping | Searching Tools and Techniques - Web Search | Conference | Confidentaility - CDA | MTA
Lecture 71Current Trends in Biopharmaceutical Market
Lecture 72Modelling 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 73Market Size Determination - Market Share | Relative Market Share | Total Vs. Actual Vs. Penetrated Market
Lecture 74Forecasting : Tools and Techniques
Lecture 75Market Share of Different Class of Biopharmaceutical
Lecture 76Royalty Management - Royalty structuring | Royalty Calculation Method| Tiered Royalties | Terms | Royalty Reductions | Royalty Stacking - Concept and Calculation | Minimum Annual Royalties | Reach through royalties
Lecture 77Market Understanding: Leading Biosimilar Companies
Lecture 78Strategic Planning Process | Knowledge Area of Business Development | Lead targeting | Licensing term sheets 
Lecture 79Distribution Licensing | Geography | Indication Splitting | Execlusive and Non-Exclusive Licensing | Sub Licenses
Lecture 80Acquisition in Pharma  | Product Acquisition| Company Acquisitions| Steps in acquisition | Financing acquisition deals | Trademark Assignment Process
Lecture 81Indication Splitting | Concept | Implementation feasibility analysis 
Lecture 82Types of Deals from Discovery to Commercialization
Lecture 83Licensing Term Sheet | Content Structuring | Sample Term Sheet
Lecture 84Licensing Payment Scheduling: Different Types
Lecture 85Valuation Methods: DCF | rNPV | Sunk Cost Method | Comparables | Sum of Parts | Deterministic Vs. Probabilistic rNPV |  Peak Sales - Max-Min Approach
Lecture 86Valuation Methods: EBITDA method of valuation | Enterprise Value and Enterprise Multiple Calculation
Lecture 87Negotiation Skill Training for BD / Project Management Professionals
Lecture 88Business Development Simulation and Decision Making | Early Stage VS. Late Stage Valuation Methodology | Stair Step Model
Lecture 89Licensing Agreement : Confidentiality Agreement | MTA | A deed of Assignment | Exclusive | Non-Exclusive License | Sole License | Components - Terms - Duration - Key Considerations
Lecture 90Step By Step Implementation of Licensing Deal by Business Development Team 
Lecture 91
Lecture 92Due Diligence Activities in Pharmaceutical Licensing