Introduction
Course Type
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
At Royed Training, we also have dedicated Pharma Business Development training, specific to the regions. We have Middle East Pharma Business Development, Latam Business Development and MENA Pharma Business Development. Moreover, BD professionals who want only inlicensing and outlicensing knowledge can opt for 1 month certificate course in inlicensing and outlicensing.
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.
- 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.
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 7Handling of orange book
Lecture 8USFDAÂ 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. exclusivityÂ
Lecture 14Orphan Drug DesignationÂ
Lecture 15Advance Learning on 505B2 Pathway
Lecture 16Chemistry, Manufacturing & ControlsÂ
Lecture 17Patent & Exclusivity - Strategic Understanding | Patent Restoration| Orphan Drug Exclusivity (ODE) | NCE & NCI Exclusivity | GAIN Exclusivity | Pediatric Exclusivity | 180 days exclusivity
Lecture 18Clinical Trial : Detailed Understanding
Lecture 19Clinical Trial Protocol Writing
Lecture 20Ethics in Clinical Research
Lecture 21Informed Consent | Practical Training on preparing ICF | Ready Templates
Lecture 22FDA Forms and How to fill the resources
Lecture 23Strategic Discussion: PreIND, EOP1, EOP2 - What to expect !
Lecture 24Importance and Significance of Phase 2b Clinical TrialÂ
Lecture 25Regulatory Strategies in different phases of Clinical Trial
Lecture 26Para IV Filing - Strategic Insight
Lecture 27Para IV Notices
Lecture 28Evergreening - Patent Life Extension Strategies
Lecture 29Pay For Delay Strategy
Lecture 30REMS Strategic PlanningÂ
Lecture 31Compulsory Licensing
Lecture 32Licensing & Technology Transfer
Lecture 33In-Licensing Vs. Outlicensing
Lecture 34LOE Strategies for Innovator Brands with case study
Lecture 35Pediatric Exclusivity and Pediatric Study Plan Development
Lecture 36Drug Repurposing
Lecture 37Advance understanding of the portfolio ManagementÂ
Lecture 38New Indication Approval Process and PromotionÂ
Lecture 39OTC SwitchÂ
Lecture 40Detailed Understanding on 505(b)(2) VS. Suitability Petition : Case Based Learning
Lecture 41NCE Vs. 505b2 application - Case Based LearningÂ
Lecture 42FTF - 180 Days Exclusivity - Case Based Learning
Lecture 43Classic case study of the 505b2 filing : Case Based Learning
Lecture 44Strategic Planning in Combating 30 months stay strategies of innovator company- Case Based Learning
Lecture 45What is meaning of 'Pipeline in a Molecule'?
Lecture 46USFDA Emergency Use Authorization (EUA)
Lecture 47Target product profile (TPP) | Quality Target product profile (QTPP) | Critical Quality Attributes (CQAs) | Quality By Design (QbD)
Section 2Strategic Business Management - European Market
Lecture 48Introduction to EU RegulationÂ
Lecture 49Orientation to European Countries and National Regulatory Bodies
Lecture 50EU Drug Discovery Development to Commercialization (Step By Step)
Lecture 51Overview of EU RegulationÂ
Lecture 52EMA and EMA Authorisation Process
Lecture 53EU MA Application Types and Strategic Planning
Lecture 54EU MA Procedure - Centralised, Decentralised, Mutual Recognition, National ProcedureÂ
Lecture 55EU MA Strategic Planning: Full, Full-mixed, hybrid applications. Generic, Similar biologic application pathway, Well-established use application, Fixed combination application, Informed consent application
Lecture 56Validity 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 57Data Exclusivity and Market Protection - Supplementary Patent Protection, Exclusivity, 6/10 Rule, 8+2+1 Formulae
Lecture 58EU Orphan Medicinal Products Regulation
Lecture 59Conditional marketing authorisation | Marketing authorisation under exceptional circumstances
Lecture 60Summary of Product CharacteristicsÂ
Lecture 61Compassionate Use
Lecture 62MHRA - UK RegulationÂ
Lecture 63The 'sunset clause' for marketing authorisation of pharmaceuticals
Lecture 64Paediatric use marketing authorisation (PUMA) & Paediatric Investigation Plan (PIP) - EU Requirments
Lecture 65EU Prime Designation
Lecture 66Accelerated assessment by EMEA
Lecture 67EU Adaptive Pathway
Lecture 68European public assessment report (EPAR) - Importance, Component, Management, UpdationÂ
Lecture 69SPOR - Concept of Master Data Management Â
Section 3Pharma International Business - Product Registration, Plant Certification, Dossier Preparation and Export Documentation
Lecture 70Introduction to Pharmaceutical Export
Lecture 71Types of Export DocumentsÂ
Lecture 72Freight Forwarder
Lecture 73Benefit of Export Documentation
Lecture 74Functions of Export Documentation
Lecture 75Export Documents and Terminologies
Lecture 76Proforma Invoice
Lecture 77Commercial Invoice
Lecture 78Custom House Agent (CHA)
Lecture 79Packing ListÂ
Lecture 80Certificate of Origin
Lecture 81Transport Documents
Lecture 82Documents Required for Payments
Lecture 83Air Freight Calculation Methodologies
Lecture 84Certification Pharmaceutical Companies / Plants
Lecture 85GMP Certificate
Lecture 86Manufacturing License
Lecture 87Free Sale Certificate
Lecture 88CPP (Certificate of Pharmaceutical Product)
Lecture 89Certificate of Analysis
Lecture 90Certificate of Origin (COO)
Lecture 91Non-conviction certificate
Lecture 92ISO Certification
Lecture 93Common Technical Document (CTD)
Lecture 94Electronic Common Technical Document (ECTD)
Lecture 95Dossier Preparation focusing on drug registration in export countriesÂ
Lecture 96Modules on Stability Study : Stability Study - Fundamental Understanding | Interchangebility | Reports | API & FPP Stability Study
Lecture 97Importance of effective dossier management
Lecture 98Detailed Understanding on ANDA Submission DossierÂ
Lecture 99Prior Approval SubmissionÂ
Lecture 100Detailed Understanding on ANDA Fees
Lecture 101Discussion on 85 common deficiency in CTD submission dossier
Section 4Biopharmaceutical Management and Regulation
Lecture 102Introduction : Biopharmaceuticals
Lecture 103Classification of BiopharmaceuticalÂ
Lecture 104Important Concept regarding Biopharmaceuticals
Lecture 105Principle of Naming of Biologics
Lecture 106Global Biologics Market
Lecture 107Recombinant protein
Lecture 108Monoclonal Antibodies Vs. Polyclonal Antibodies
Lecture 109Monoclonal Antibodies
Lecture 110Synthetic Immunomodulators
Lecture 111Production of Monoclonal Antibodies
Lecture 112Cytokines
Lecture 113Interferon
Lecture 114Erythropoiesis-stimulating agent
Lecture 115Biological Licensing Application (BLA)Â
Lecture 116Abbreviated Biosimilar Application - 351(k): Advance Strategic Planning Process : Originator Vs. Biosimilar Development and Regulatory Approval Process | Reference Biologic | Purple Book | Data Requirements
Lecture 117Purple Book: Significance | Searching | Assignments
Lecture 118Vaccine development and approval Process
Lecture 119PDUFA For Biologics
Lecture 120Biosimilar Development Process
Lecture 121Strategic Consideration for Biosimilar DevelopmentÂ
Lecture 122Bio-Manufacturing Process Information
Lecture 123Studies required for approval of biosimilar
Section 5Business Development | Licensing
Lecture 124Training on Basic Finance | Understanding Financial Statment | Income Statement | Balance Sheet | Cash Flow Statement
Lecture 125Moving Average | Moving Annual Total | YTD | How to calculateÂ
Lecture 126Compound Annual Growth Rate | CAGR Calculation
Lecture 127Business Development Job Functionality | Strategic Planning Process | Knowledge Area of Business Development | Lead targeting | Licensing term sheets
Lecture 128Portfolio Management Process | Portfolio Characteristics | Portfolio Analysis | Balancing the Portfolio | BD and Strategic Planning DepartmentÂ
Lecture 129Identifying the corporate Need of business development | Objective – Strategy - Tactics | Portfolio constraints | SWOT | Numerical SWOT
Lecture 130Profiling and Searching | Objectives | Search Database | Creating Opportunity Anatomy for deal analysis | Mind Mapping | Searching Tools and Techniques - Web Search | Conference | Confidentaility - CDA | MTA
Lecture 131Numerical SWOT Practical training
Lecture 132Modelling 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 133Market Size Determination - Market Share | Relative Market Share | Total Vs. Actual Vs. Penetrated Market
Lecture 134Forecasting : Tools and Techniques
Lecture 135Market Sizing & Forecasting Case Study
Lecture 136Royalty Management - Royalty structuring | Royalty Calculation Method| Tiered Royalties | Terms | Royalty Reductions | Royalty Stacking - Concept and Calculation | Minimum Annual Royalties | Reach through royalties
Lecture 137Average Royalty Rate
Lecture 138Factor affecting the Royalty Rate in Pharmaceutical and Biopharmaceutical Deal
Lecture 139Distribution Licensing | Geography | Indication Splitting | Exclusive and Non-Exclusive Licensing | Sub Licenses
Lecture 140Acquisition in Pharma | Product Acquisition| Company Acquisitions| Steps in acquisition | Financing acquisition deals | Trademark Assignment Process
Lecture 141Joint Ventures in Pharmaceutical and Biopharmaceutical Industry
Lecture 142SPECIAL PURPOSE VEHICLES (SPV)
Lecture 143Indication Splitting | Concept | Implementation feasibility analysisÂ
Lecture 144Types of Deals from Discovery to Commercialization
Lecture 145What are the fundamental areas of business development
Lecture 146Licensing Term Sheet | Content Structuring | Sample Term Sheet
Lecture 147Licensing Payment Scheduling: Different Types
Lecture 148Valuation Methods: DCF | rNPV | Sunk Cost Method | Comparables | Sum of Parts | Deterministic Vs. Probabilistic rNPV |Â Peak Sales - Max-Min Approach
Lecture 149Valuation Methods: EBITDA method of valuation | Enterprise Value and Enterprise Multiple Calculation
Lecture 150Negotiation 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 151Business Development Simulation and Decision Making | Early Stage VS. Late Stage Valuation Methodology | Stair Step Model
Lecture 152Types 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 153Benchmarking | Benchmarking through consortium | How to use benchmarking for drug discovery development projectsÂ
Lecture 154Value Share Principle | Discounting of licensing deal | Discount RateÂ
Section 6Pharma Digital Marketing
Lecture 155Introduction to Digital MarketingÂ
Lecture 156Inbound and outbound marketing in pharma | Types of inbound and outbound marketingÂ
Lecture 157Digital 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 158Digital 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 159Digital marketing strategy development | Planning process | E-Marketing Plan | Planning for MNC Vs. Start Up | Strategic Outcome measurement
Lecture 160Relationship marketing using digital platform | CRM | Concept of permission marketing | User Satisfaction and loyalty management | Feedback mechanism
Lecture 161Campaign 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 162Search Engine Optimization | Search Engine Marketing | Social Media Marketing
Lecture 163Web Host - Check the hosting detailsÂ
Lecture 164Page Speed- importance and practical understanding | Check the web speedÂ
Lecture 165Keyword | Keyword Planning for SEO and SEM | Keyword Planner
Lecture 166Mobile Responsive | Tracking the SiteÂ
Lecture 167HCP sites and Patient Site
Lecture 168Google Ad - Practical Training on Campaign Development and Execution
Lecture 169Digital Marketing Strategies for innovator brand | Pre launch - comuing soon, DSE Marketing | Launch activities - Day of approval (DOA) site | FDA Compliance | FDA 2253 Filing
Lecture 170Brand Portal Development
Lecture 171Relationship Marketing : KOL Management and Patient Advocacy GroupÂ
Lecture 172Public Relation - PR firm | PR Campaign | Press Release | Technical understanding of press release writing | Digital Press Release
Lecture 173Developing Ad - Pharmaceutical Prescription, OTC Vs FMCG Brands
Lecture 174Difference between FMCG and OTC Brand Ad
Lecture 175Digital Marketing Techniques
Lecture 176Video Marketing
Lecture 177Video Marketing Techniques For Small Business Owners
Lecture 178Promoting Brand through Article Advertising and Marketing
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