Pharmaceutical Project Management

pharma project management course by royed training

Introduction

Feature

Who should attend

Key learning area

Related Courses

Pharmaceutical Project Maangement Course by Royed Training

In the dynamic landscape of the pharmaceutical industry, effective project management is paramount for success. Royed Training’s Advanced Certification in Pharmaceutical Project Management offers a comprehensive and advanced curriculum designed to equip professionals with the specialized skills and knowledge. In fact this course is ideal for those who want to excel in managing complex projects within the pharmaceutical sector. This intensive program dives deep into the intricacies of pharmaceutical project management, covering key concepts, methodologies, and best practices essential for navigating the unique challenges of this rapidly evolving industry.

This course provides training on the pharma and biopharma R&D discovery, development and commercialization pipeline, project and portfolio management.

This online Pharmaceutical and Biopharmaceutical Project Management training course utilizes interactive learning tools to guide each participant through the steps of the project management process which takes place in the pharmaceutical, biotech keeping in view both in innovative and generic industry.

The course is designed to challenge students to apply what they have learned through the use of interactive exercises, reflection questions, expert live chat and a final assessment at the end of the course. The course can be completed at any pace, allowing the user to stop and start at their leisure.

Course Title: Advance Certification in Pharmaceutical Project Management
Course Code: RYD-047
Nature of the course: Online distance learning course. Course can be accessed online across anywhere 24×7.
Duration of the course: 1 Month
Eligibility: Graduation in any discipline.
Course Certificates: Certificate will be provided at the end of the successful completion of the course.
Deliverables: Attend the course 24×7 by login to your dashboard. You can attend lectures, simulation, self assessment tests and final certification examination. You will also eligible to receive the course study modules, which you can download by login to your course page.

Features of Pharma Project Management Course

This pharma project management covers all aspects of the project and portfolio management from drug discovery development, regulatory, commercialization of the innovator drugs, innovator biologics, generics and biosimilars.
The course provides orientation to job related practical aspects of the pharmaceutical project managers. Therefore, on completion of the course, the participants will develop the hands on understanding how Project Management Professionals works in pharmaceutical and biopharmaceutical company..
One of the important feature of the course is real life simulation on project related critical decision making process. Hence, these simulations help to enhance the decision making skills which is the core aspects of the pharmaceutical project manager’s working.

Who should attend this course?

Professionals already working in pharmaceutical and biopharmaceutical company.
Project managers seeking to specialize in pharmaceutical projects.
Those who moving into pharmaceutical project management from different functional areas.
Pharmaceutical R&D scientist, Regulatory Affairs Professionals, market access and strategic management professionals.

Key Area I

Drug Development to Commercialization – R&D management and related strategic planning.
Basics of Biopharmaceutical – Development to commercialization
Advanced training on various classes of biopharmaceuticals.
Understanding on the biopharmaceutical regulatory affairs, registration requirements.
Biopharma strategic management training
Biopharma market access | Market sizing | Forecasting | Valuation | Pricing | Reimbursement
Strategic Planning Process | Knowledge Area of Business Development | Lead targeting | Licensing term sheets Portfolio Management Process | Portfolio Characteristics | Portfolio Analysis | Balancing the Portfolio
Objective – Strategy – Tactics | Portfolio constraints | SWOT | Numerical SWOT Profiling and Searching | Objectives | Search Database | Creating Opportunity Anatomy for deal analysis | Mind Mapping | Searching Tools and Techniques – Web Search | Conference | Confidentiality – CDA | MTA
Life cycle extension / Loss of Exclusivity – LOE strategies.
Pharma Marketing and branding Strategic Planning
Generic Drug Strategic Planning
Strategic Pathways for marketing authorization of the pharmaceutical and – biopharmaceutical products
Exclusive training on Biopharmaceutical and biosimilar management.
In depth training on Licensing in the pharmaceutical industry – In Licensing Vs. Out licensing, Co-development, co-marketing, Co-promotion, Reverse Copromotion

Key Area II

Financial Planning and Management for pharma strategic management professionals
Modelling and Deal Valuation – Top Down Model | Epidemiology data method | Complex Model | Forecasting | Heuristic or ‘prophesy’ method | Different value perspectives | Deal Structuring Structuring the deal
Royalty Management – Royalty structuring | Royalty Calculation Method| Tiered Royalties | Terms | Royalty Reductions | Royalty Stacking – Concept and Calculation | Minimum Annual Royalties | Reach through royalties
Distribution Licensing | Geography | Indication Splitting | Exclusive and Non-Exclusive Licensing | Sub Licenses.
Acquisition in Pharma | Product Acquisition| Company Acquisitions| Steps in acquisition | Financing acquisition deals | Trademark Assignment Process.
Valuation Methods: DCF | rNPV | Sunk Cost Method | Comparables | Sum of Parts | Deterministic Vs. Probabilistic rNPV | Peak Sales – Max-Min Approach.
EBITDA method of valuation | Enterprise Value and Enterprise Multiple Calculation | EBITDA Multiples
Comparative pipeline benchmarking analysis | Level of Benchmarking | Primary – Secondary – Tertiary Benchmarking Metrics | Case Based Analysis of three companies comparative pipeline benchmarking
Pipeline Diversity Scores | Significance | How to Calculate | Comparative Study of Pipeline Diversity Scores

Related Courses

Section 1Fundamental Understanding of Project Management

Lecture 1Importance of Project Management in Pharmaceutical and Biopharmaceutical Industry

Lecture 2Traditional Project Management Vs. Pharma Project Management | Key Differences | Different Parameters

Lecture 3Key Comparison of Traditional and Pharma Project Management

Lecture 4Regulatory Influences on Project Timelines and Deliverables

Lecture 5Case Study: Managing a New Drug Development Project with Strict Regulatory Timelines

Lecture 6Core Identified Phases of the Pharmaceutical Project Lifecycle

Lecture 7Pharma Project Management Terminologies

Lecture 8Project Tracking

Lecture 9Asset Tracking

Lecture 10Regulatory Influences on Project Timelines and Deliverables

Lecture 11Role and Responsibility of Project Leader

Lecture 12Project Constraint & Effective management of Project Constraint | Role of Project Manager

Lecture 13Critical Success Factor in Drug Development Projects

Lecture 14Project Management Case Study | Exploring the Project Tools Used in real life project

Section 2Pharma and Biopharma R&D Project and Portfolio Management

Lecture 15Fundamental of Pharma R&D - Discovery to Commercialization Process

Lecture 16Investigational New Drug Application (INDA)

Lecture 17New Drug Application (NDA)

Lecture 19Basic concept and understanding of the Generic Drug

Lecture 20Abbreviated Biosimilar Application - 351(k): Advance Strategic Planning Process : Originator Vs. Biosimilar Development and Regulatory Approval Process | Reference Biologic | Purple Book | Data Requirements

Lecture 21Handling of orange book

Lecture 22Purple Book: Significance | Searching | Assignments

Lecture 23USFDA expedited programs

Lecture 24505(j) ANDA, 505(b)(2) NDA, 505(b)(1) NDA

Lecture 25Advance Learning on 505B2 Pathway

Lecture 26Benchmarking | Benchmarking through consortium | How to use benchmarking for drug discovery development projects

Lecture 27Project Terminations

Lecture 28Market Access - Understanding key terminologies and various key steps in market access

Lecture 29Market Access Strategic Planning : Steps and Logical Sequencing for Market Access Strategy Development

Lecture 30Indication Sequencing | Indication Prioritization | Development of Indication Timeline | Indication Matrix | Value Based Indication Prioritization

Lecture 31Indication Prioritization Case Study

Lecture 32Market Access Value Dossier : What it is | Significance | Components | What to include

Lecture 33Target product profile (TPP) | Quality Target product profile (QTPP) | Critical Quality Attributes (CQAs) | Quality By Design (QbD)

Lecture 34Cycle Times (Stage or phase lengths)

Lecture 35Importance of The proof of concept (POC) milestone in pharma Drug Development Projects

Lecture 36Milestone chart

Lecture 37Levels of Project and Portfolio Management

Lecture 38Types of deal from discovery to commercialization

Lecture 39First-in-class | Best-in-class | Market Access Strategic Decision Making

Lecture 40Introduction to Health Economics | Key terminologies related to health economics

Lecture 41HEOR Application in Pharmaceutical and Biopharmaceutical Industry

Lecture 43Economic Evaluation Methods | Various methods | Importance of perspective in health economics | Discounting | Uncertainty

Lecture 48Pharmaco-economic evaluation – analysis and results | Different Types of Models | Understanding Decision Tree - Components with practical Example | Markov model

Lecture 49CER and PCOR

Lecture 50QALY | How to calculate QALY | Importance and Significance

Lecture 51ICER | How to calculate ICER | Importance and Significance | Incremental Effectiveness determination

Section 3Concepts related Portfolio Management

Lecture 52Strategic Planning During Clinical Trials

Lecture 53LOE Strategies for Innovator Brands with case study

Lecture 54Evergreening - Patent Life Extension Strategies

Lecture 55Fundamental Understanding of Patent, Trademark Licensing, Project Management and related terminology

Lecture 56In-Licensing Vs. Outlicensing

Lecture 57Licensing - Advance Learning

Lecture 58Drug Repurposing

Lecture 59Advance study on Para IV Filing

Lecture 60Para IV Notices

Lecture 61Pay For Delay Strategy

Lecture 62REMS Strategic Planning

Lecture 63Compulsory Licensing

Lecture 64Licensing & Technology Transfer

Lecture 65Pipeline in a Molecule

Lecture 66Patent Cliff

Lecture 67Due Diligence Activities in Pharmaceutical Licensing

Lecture 68Paediatric Exclusivity and Paediatric Study Plan Development

Section 4Strategic Project Planning and Portfolio Management

Lecture 69Strategic Planning Process | Knowledge Area of Business Development | Lead targeting | Licensing term sheets

Lecture 70Portfolio Management Process | Portfolio Characteristics | Portfolio Analysis | Balancing the Portfolio | BD and Strategic Planning Department

Lecture 71Identifying the corporate Need of business development | Objective – Strategy - Tactics | Portfolio constraints | SWOT | Numerical SWOT

Lecture 73Numerical SWOT Practical training

Lecture 75Distribution Licensing | Geography | Indication Splitting | Execlusive and Non-Exclusive Licensing | Sub Licenses

Lecture 77Licensing Term Sheet | Content Structuring | Sample Term Sheet

Lecture 78Negotiation Skill Training for Project Management Professionals

Lecture 80Step By Step Implementation of Licensing Deal by Business Development Team

Section 5Forecasting, Market Sizing, Market Potential Analysis

Lecture 82Sales Forecasting in Life Science Industry

Lecture 83New Product Forecast Algorithm

Lecture 84Patient Based Forecasting Model | Applying more filters and variables

Lecture 85Prescription Based Forecasting Model | Differences between Patient Based and Prescription Based Forecasting Model | Which model to use and when?

Lecture 86Prevalence Vs. Incidence Model

Lecture 87EPI Based Forecasting | Sales Based Forecasting | When and where to apply which forecasting model

Lecture 88Sales Forecasting Tools | New Product Forecasting | In Market Forecasting

Lecture 89Market Size Assignment 1 [Oncology Brand] - Applying sales forecasting tools to carry out next 6 years sales forecast | Excel Based Model

Lecture 90Market Size Assignment 2 [Asthma Brand] - Applying sales forecasting tools to carry out multiple years sales forecast | Excel Based Model

Lecture 91Patient Based Model Vs. Patient Flow Model | Critical Differences in Model | Concept of Black Box in Patient Flow Model | Application of both model

Lecture 92Bottom-up or Top-down Forecasting | LRx | Significance of LRx data analysis

Lecture 93Market Sizing & Forecasting Case Study

Lecture 94Market Size Determination - Market Share | Relative Market Share | Total Vs. Actual Vs. Penetrated Market

Lecture 95Forecasting : Tools and Techniques

Section 6Royalty Management

Lecture 97Average Royalty Rates

Lecture 98Factors affecting Royalty Rates

Section 7Finance and Valuation Management

Lecture 99Training on Basic Finance | Understanding Financial Statement | Income Statement | Balance Sheet | Cash Flow Statement

Lecture 101Valuation Methods: EBITDA method of valuation | Enterprise Value and Enterprise Multiple Calculation

Lecture 102Early Stage VS. Late Stage Valuation Methodology | Stair Step Model

Lecture 103Licensing Payment Schedule | Case Study

Lecture 104Licensing Term Sheet | Importance | Significance | Content of the Term Sheet | Sample Predesigned Term Sheet of Pharma Licensing Deal

Lecture 105Value Share Principle | Discounting of licensing deal | Discount Rate

Lecture 106DCF Calculation : Concept and Calculation - Step by step understanding

Lecture 107Net Present Value (NPV) method : Calculation

Lecture 108Risk-Adjusted Discount Rate Method - Calculation | Concept of Risk Premium

Lecture 109Valuation Metric - P/E Ratio and EPS : Calculation

Lecture 110Comparable Company Analysis method : Calculation

Lecture 112WACC in Biopharma Valuation | Significance | WACC benchmarking

Lecture 113WACC Calculation | Step by Step Calculation | Insight on WACC components

Lecture 114rNPV Model | Step by Step Calculation | Insight on Probability and Cumulative Probability | Factoring WACC for Discounting

Lecture 115Probability and Cumulative Probability | Calculation | Benchmarking | Factoring for WACC and rNPV

Lecture 116Real 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 117ROV Scenario Based Case Study

Lecture 118Biotech Decision Tree Model with Decision Reasoning

Section 8Evidence based decision making | Real World Data (RWD) | Real World Evidence (RWE)

Lecture 119Evidence Based Decision Making | Combine evidences for decision making | Do we need more evidence?

Lecture 120RWD and RWE | Potential sources of RWE | Traditional RCTs vs. RWE | Case Study - RWE Programs | Influencing HCP decision-making

Lecture 121RWD and RWE in Product Lifecycle Management

Lecture 122RWD and RWE - Fit to use | Assessment

Lecture 123RWD data sources | Different types | Detailed understanding of each class

Section 9Portfolio Benchmarking

Lecture 124Benchmarking | Benchmarking through consortium | How to use benchmarking for drug discovery development projects

Lecture 125Pipeline Benchmarking | Significance and Importance in Bio Pharma BD&L | Analyzing sample portfolio | Comparative outcome in business development

Lecture 126Comparative pipeline benchmarking analysis | Level of Benchmarking | Primary - Secondary - Tertiary Benchmarking Metrics | Case Based Analysis of three companies comparative pipeline benchmarking

Lecture 127Pipeline Diversity Scores | Significance | How to Calculate | Comparative Study of Pipeline Diversity Scores

Lecture 128Design, Analysis, Assessment and Feedback on Real Time Portfolio Tracker

Lecture 129Research Productivity Index | Concept | Significance | Calculation Methodology | Comparative RPI benchmarking Exercise

Section 10Request for course certificate