Introduction
Course Type
Course Duration
Feature
Eligibility
Duration
Who should attend
Certification
Course Deliverable
Certification
Related Courses
Pharma Business Development and Licensing course is designed to train the practical working knowledge and skill-set of Business Development. This course provides comprehensive skill training for business development managers working in pharmaceutical and biopharmaceutical industry. Pharma BD course covers important areas of the skill areas where a pharma business development manager should have the competency.
In these online self-paced modules, participants understands about the development to commercialization process in detail. In other words, you will understand portfolio strategic management. Moreover, this course focuses on how pharma business development, strategic management, regulatory and licensing professionals working in the company. Therefore, it helps advance professionals to acquire cutting edged business skills. Hence, the course covers fundamentals to advance learning on pharma business development process. Â
Self Paced Learning
This pharma business development course utilizes interactive learning tools to guide participant to understand of the Business Development working in a pharma company. The course will focus on understanding business development skills which is required for effective functioning as BD personnel in business development department. This online training will adopt a practical and interactive approach that will enable you to apply what you have learned to your daily work. The steps of approval process in details. The course will challenge the students to apply what they have learned through the use of interactive exercises, reflection questions, simulation and a final assessment at the end of the course.
This bio pharmaceutical business development course provide detailed training on biopharma valuation tools and techniques.
The course can be completed at any pace, allowing the user to stop and start at their leisure.
Course Code: RYD-081
Title: PG Certification in Pharma Business Development and Licensing (PGPBDL)
Type of the course: Self paced Online Course
Who should attend this course?Â
- This course is ideal for those who are working in business development and licensing department.
- Professionals from strategic management. Those working in strategic management department in pharmaceutical and biopharmaceutical company.Â
- Those who are in the regulatory affairs and related department, and looking for chnage into business development department.Â
- This pharma global management course is ideal for the senior management professionals working in pharmaceutical and biopharmaceutical project management.
- Anyone requiring an overview and detail understanding on working of IPR, Licensing and Technology Transfer Department.Â
Online distance learning course. Course can be accessed online across anywhere 24×7.
1 Month
- 24×7 Online Access – Access anytime from anywhere across globe.
- Prinatable booklet provided to all course participants.Â
- Access the e-lectures, case studies, self assessment modules and practical sessions through personalized web page.Â
- Flexible online final examination (Computer Based Test by secure mode)
- Real life Case Study module will be provided along with the course, material.Â
Graduation in any discipline.
1 Year from the date of initiation of the course.
- Biopharma business development professionals seeking to improve their skills.
- Those who are working on biopharma strategic business deals and want detailed understanding on strategic processing.
- Anyone wishing to update their knowledge on strategic valuation and various valuation tools and techniques.
- This course is ideal for the biopharma strategic portfolio management tools and techniques and licensing techniques.
 Certificate will be provided at the end of the successful completion of the course
- 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.
Certificate will be provided at the end of the successful completion of the course.
Some of the related courses
- Biopharma business development >> Click here
- pharmaceutical strategic management >> Click here
- Inlicensing and outlicensing >> Click here
- Biopharma Valuation >> View Course
- Basics of Biopharma >> View Course
Section 1Pharma R&D Management- Discovery to Development | Strategic Management for US Market
Lecture 1R&D Process & Introduction to drug discovery
Lecture 2Investigational New Drug Application (INDA)
Lecture 3New Drug Application (NDA)Â
Lecture 4Basic concept and understanding of the Generic Drug
Lecture 5Abbreviated New Drug Application (ANDA)Â
Lecture 6Review on Drug Discovery and DevelopmentÂ
Lecture 7Generic Drug User Fees Act (GDUFA)
Lecture 8Prescription Drug User Fees Act (PDUFA)
Lecture 9Handling of orange book
Lecture 10USFDAÂ expedited programs
Lecture 11Practical Training on INDA, NDA, ANDA filing
Lecture 12505(j) ANDA, 505(b)(2) NDA, 505(b)(1) NDA
Lecture 13Authorized Generics: Key Understanding
Lecture 14Exploratory IND Vs. Traditional IND
Lecture 15Patents Vs. exclusivityÂ
Lecture 16Orphan Drug DesignationÂ
Lecture 17Advance Learning on 505B2 Pathway
Lecture 18Chemistry, Manufacturing & ControlsÂ
Lecture 19Patent & Exclusivity - Strategic Understanding | Patent Restoration| Orphan Drug Exclusivity (ODE) | NCE & NCI Exclusivity | GAIN Exclusivity | Pediatric Exclusivity | 180 days exclusivity
Lecture 20Clinical Trial : Detailed Understanding
Lecture 21Clinical Trial Protocol Writing
Lecture 22Ethics in Clinical Research
Lecture 23Informed Consent | Practical Training on preparing ICF | Ready Templates
Lecture 24FDA Forms and How to fill the resources
Lecture 25Strategic Discussion: PreIND, EOP1, EOP2 - What to expect !
Lecture 26Importance and Significance of Phase 2b Clinical TrialÂ
Lecture 27Regulatory Strategies in different phases of Clinical Trial
Lecture 28Para IV Filing - Strategic Insight
Lecture 29Para IV Notices
Lecture 30Evergreening - Patent Life Extension Strategies
Lecture 31Pay For Delay Strategy
Lecture 32REMS Strategic PlanningÂ
Lecture 33Compulsory Licensing
Lecture 34Licensing & Technology Transfer
Lecture 35In-Licensing Vs. Outlicensing
Lecture 36LOE Strategies for Innovator Brands with case study
Lecture 37Pediatric Exclusivity and Pediatric Study Plan Development
Lecture 38Drug Repurposing
Lecture 39Advance understanding of the portfolio ManagementÂ
Lecture 40New Indication Approval Process and PromotionÂ
Lecture 41OTC SwitchÂ
Lecture 42Detailed Understanding on 505(b)(2) VS. Suitability Petition : Case Based Learning
Lecture 43NCE Vs. 505b2 application - Case Based LearningÂ
Lecture 44FTF - 180 Days Exclusivity - Case Based Learning
Lecture 45Classic case study of the 505b2 filing : Case Based Learning
Lecture 46Strategic Planning in Combating 30 months stay strategies of innovator company- Case Based Learning
Lecture 47What is meaning of 'Pipeline in a Molecule'?
Lecture 48USFDA Emergency Use Authorization (EUA)
Lecture 49Target product profile (TPP) | Quality Target product profile (QTPP) | Critical Quality Attributes (CQAs) | Quality By Design (QbD)
Section 2Strategic Business Management - European Market
Lecture 50Introduction to EU RegulationÂ
Lecture 51Orientation to European Countries and National Regulatory Bodies
Lecture 52EU Drug Discovery Development to Commercialization (Step By Step)
Lecture 53Overview of EU RegulationÂ
Lecture 54EMA and EMA Authorisation Process
Lecture 55EU MA Application Types and Strategic Planning
Lecture 56EU MA Procedure - Centralised, Decentralised, Mutual Recognition, National ProcedureÂ
Lecture 57EU MA Strategic Planning: Full, Full-mixed, hybrid applications. Generic, Similar biologic application pathway, Well-established use application, Fixed combination application, Informed consent application
Lecture 58Validity of the EU MAÂ - Renewal steps, Cessation of the marketing authorisation, Significance of "Placed in Union Market", Suspension or withdrawal & EU MA for licensed products
Lecture 59Data Exclusivity and Market Protection - Supplementary Patent Protection, Exclusivity, 6/10 Rule, 8+2+1 Formulae
Lecture 60EU Orphan Medicinal Products Regulation
Lecture 61Conditional marketing authorisation | Marketing authorisation under exceptional circumstances
Lecture 62Summary of Product CharacteristicsÂ
Lecture 63Compassionate Use
Lecture 64MHRA - UK RegulationÂ
Lecture 65The 'sunset clause' for marketing authorisation of pharmaceuticals
Lecture 66Paediatric use marketing authorisation (PUMA) & Paediatric Investigation Plan (PIP) - EU Requirments
Lecture 67EU Prime Designation
Lecture 68Accelerated assessment by EMEA
Lecture 69EU Adaptive Pathway
Lecture 70European public assessment report (EPAR) - Importance, Component, Management, UpdationÂ
Lecture 71SPOR - Concept of Master Data Management Â
Section 3Pharma International Business - Product Registration, Plant Certification, Dossier Preparation and Export Documentation
Lecture 72Introduction to Pharmaceutical Export
Lecture 73Types of Export DocumentsÂ
Lecture 74Freight Forwarder
Lecture 75Benefit of Export Documentation
Lecture 76Functions of Export Documentation
Lecture 77Export Documents and Terminologies
Lecture 78Proforma Invoice
Lecture 79Commercial Invoice
Lecture 80Custom House Agent (CHA)
Lecture 81Packing ListÂ
Lecture 82Certificate of Origin
Lecture 83Transport Documents
Lecture 84Documents Required for Payments
Lecture 85Air Freight Calculation Methodologies
Lecture 86Certification Pharmaceutical Companies / Plants
Lecture 87GMP Certificate
Lecture 88Manufacturing License
Lecture 89Free Sale Certificate
Lecture 90CPP (Certificate of Pharmaceutical Product)
Lecture 91Certificate of Analysis
Lecture 92Certificate of Origin (COO)
Lecture 93Non-conviction certificate
Lecture 94ISO Certification
Lecture 95Common Technical Document (CTD)
Lecture 96Electronic Common Technical Document (ECTD)
Lecture 97Dossier Preparation focusing on drug registration in export countriesÂ
Lecture 98Modules on Stability Study : Stability Study - Fundamental Understanding | Interchangebility | Reports | API & FPP Stability Study
Lecture 99Importance of effective dossier management
Lecture 100Detailed Understanding on ANDA Submission DossierÂ
Lecture 101Prior Approval SubmissionÂ
Lecture 102Detailed Understanding on ANDA Fees
Lecture 103Discussion on 85 common deficiency in CTD submission dossier
Section 4Biopharmaceutical Management and Regulation
Lecture 104Introduction : Biopharmaceuticals
Lecture 105Classification of BiopharmaceuticalÂ
Lecture 106Important Concept regarding Biopharmaceuticals
Lecture 107Principle of Naming of Biologics
Lecture 108Global Biologics Market
Lecture 109Recombinant protein
Lecture 110Monoclonal Antibodies Vs. Polyclonal Antibodies
Lecture 111Monoclonal Antibodies
Lecture 112Synthetic Immunomodulators
Lecture 113Production of Monoclonal Antibodies
Lecture 114Cytokines
Lecture 115Interferon
Lecture 116Erythropoiesis-stimulating agent
Lecture 117Biological Licensing Application (BLA)Â
Lecture 118Abbreviated Biosimilar Application - 351(k): Advance Strategic Planning Process : Originator Vs. Biosimilar Development and Regulatory Approval Process | Reference Biologic | Purple Book | Data Requirements
Lecture 119Purple Book: Significance | Searching | Assignments
Lecture 120Vaccine development and approval Process
Lecture 121PDUFA For Biologics
Lecture 122Biosimilar Development Process
Lecture 123Strategic Consideration for Biosimilar DevelopmentÂ
Lecture 124Bio-Manufacturing Process Information
Lecture 125Studies required for approval of biosimilar
Section 5Business Development | Licensing
Lecture 126Training on Basic Finance | Understanding Financial Statment | Income Statement | Balance Sheet | Cash Flow Statement
Lecture 127Moving Average | Moving Annual Total | YTD | How to calculateÂ
Lecture 128Compound Annual Growth Rate | CAGR Calculation
Lecture 129Business Development Job Functionality | Strategic Planning Process | Knowledge Area of Business Development | Lead targeting | Licensing term sheets
Lecture 130Portfolio Management Process | Portfolio Characteristics | Portfolio Analysis | Balancing the Portfolio | BD and Strategic Planning DepartmentÂ
Lecture 131Identifying the corporate Need of business development | Objective – Strategy - Tactics | Portfolio constraints | SWOT | Numerical SWOT
Lecture 132Profiling and Searching | Objectives | Search Database | Creating Opportunity Anatomy for deal analysis | Mind Mapping | Searching Tools and Techniques - Web Search | Conference | Confidentaility - CDA | MTA
Lecture 133Numerical SWOT Practical training
Lecture 134Modelling and Deal Valuation - Top Down Model | Epidemiology data method | Complex Model | Forecasting | Heuristic or ‘prophesy’ method | Different value perspectives | Deal Structuring Structuring the deal
Lecture 135Market Size Determination - Market Share | Relative Market Share | Total Vs. Actual Vs. Penetrated Market
Lecture 136Forecasting : Tools and Techniques
Lecture 137Market Sizing & Forecasting Case Study
Lecture 138Royalty Management - Royalty structuring | Royalty Calculation Method| Tiered Royalties | Terms | Royalty Reductions | Royalty Stacking - Concept and Calculation | Minimum Annual Royalties | Reach through royalties
Lecture 139Average Royalty Rate
Lecture 140Factor affecting the Royalty Rate in Pharmaceutical and Biopharmaceutical Deal
Lecture 141Distribution Licensing | Geography | Indication Splitting | Exclusive and Non-Exclusive Licensing | Sub Licenses
Lecture 142Acquisition in Pharma | Product Acquisition| Company Acquisitions| Steps in acquisition | Financing acquisition deals | Trademark Assignment Process
Lecture 143Joint Ventures in Pharmaceutical and Biopharmaceutical Industry
Lecture 144SPECIAL PURPOSE VEHICLES (SPV)
Lecture 145Indication Splitting | Concept | Implementation feasibility analysisÂ
Lecture 146Types of Deals from Discovery to Commercialization
Lecture 147What are the fundamental areas of business development
Lecture 148Licensing Term Sheet | Content Structuring | Sample Term Sheet
Lecture 149Licensing Payment Scheduling: Different Types
Lecture 150Valuation Methods: DCF | rNPV | Sunk Cost Method | Comparables | Sum of Parts | Deterministic Vs. Probabilistic rNPV |Â Peak Sales - Max-Min Approach
Lecture 151Valuation Methods: EBITDA method of valuation | Enterprise Value and Enterprise Multiple Calculation
Lecture 152Negotiation Skill Training for BD personnel | Mind Mapping Tools | Practical Case Based Learning | Do and Don’ts in Pharma Business development Negotiations | Role of Scribes
Lecture 153Business Development Simulation and Decision Making | Early Stage VS. Late Stage Valuation Methodology | Stair Step Model
Lecture 154Types of Strategic Alliances: Unilateral technology licensing | Cross technology licensing | R&D contracts | R&D collaborations | Minority-equity-based R&D alliances | JV | Manufacturing and marketing agreements | big pharma firms with dedicated biotechnology firmsÂ
Lecture 155Benchmarking | Benchmarking through consortium | How to use benchmarking for drug discovery development projectsÂ
Section 6Pharma Digital Marketing
Lecture 156Introduction to Digital MarketingÂ
Lecture 157Inbound and outbound marketing in pharma | Types of inbound and outbound marketingÂ
Lecture 158Digital Media Marketing Macro-Environment Analysis | Mapping of online market place | Internet marketing conversion process | Conversion Process Digital VS. Traditional | Publisher revenue model | Affiliate revenue model
Lecture 159Digital Media Marketing Micro - Environment Analysis | Web server | Web browser | http vs. https - Significance and hands on understanding | Privacy and ethical issues in internet marketing
Lecture 160Digital marketing strategy development | Planning process | E-Marketing Plan | Planning for MNC Vs. Start Up | Strategic Outcome measurement
Lecture 161Relationship marketing using digital platform | CRM | Concept of permission marketing | User Satisfaction and loyalty management | Feedback mechanism
Lecture 162Campaign planning for digital media | Goal setting | Tracking | Campaign insight | Segmentation and targeting | Message Development | Media Mix Selection | Media scheduling | Practical understanding to campaign performance matrics | CPC | CPA | PPC | ROI | CPS
Lecture 163Search Engine Optimization | Search Engine Marketing | Social Media Marketing
Lecture 164Web Host - Check the hosting detailsÂ
Lecture 165Page Speed- importance and practical understanding | Check the web speedÂ
Lecture 166Keyword | Keyword Planning for SEO and SEM | Keyword Planner
Lecture 167Mobile Responsive | Tracking the SiteÂ
Lecture 168HCP sites and Patient Site
Lecture 169Google Ad - Practical Training on Campaign Development and Execution
Lecture 170Digital Marketing Strategies for innovator brand | Pre launch - comuing soon, DSE Marketing | Launch activities - Day of approval (DOA) site | FDA Compliance | FDA 2253 Filing
Lecture 171Brand Portal Development
Lecture 172Relationship Marketing : KOL Management and Patient Advocacy GroupÂ
Lecture 173Public Relation - PR firm | PR Campaign | Press Release | Technical understanding of press release writing | Digital Press Release
Lecture 174Developing Ad - Pharmaceutical Prescription, OTC Vs FMCG Brands
Lecture 175Difference between FMCG and OTC Brand Ad
Lecture 176Digital Marketing Techniques
Lecture 177Video Marketing
Lecture 178Video Marketing Techniques For Small Business Owners
Lecture 179Promoting Brand through Article Advertising and Marketing
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