InstructorRoyed Training
TypeOnline Course
Student Enrolled3
Price$790 / 55300 INR.
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Global API business development

Introduction

Who should attend

Learning Domain

Features

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Global API Business Development

The Global API Business Development Online Certification Course offered by Royed Training is a comprehensive online certification course to provide professionals with in-depth knowledge of the rapidly growing Active Pharmaceutical Ingredients (API) industry.

This Global API Business Development course covers key areas such as market trends, pricing strategies, sourcing, supply chain management, and regulatory frameworks. Learners will explore API sourcing techniques, international regulations, and strategies for market access. Moreover, the participant will learn how to design and develop the key market strategies. Above all, this Global API Business Development course provides hands on training on risk management, supplier evaluation, and negotiation tactics. By the end of the course, learners will be equipped with the skills to drive successful API sourcing, negotiate effectively, and make informed business decisions in the pharmaceutical sector. Ideal for pharmaceutical business development professionals, regulatory affairs experts. This course is perfect for professionals in pharma business development, regulatory affairs, and supply chain management.

Key learning areas: Market trends in the Pharma API industry, API sourcing and supplier evaluation, Regulatory frameworks for APIs (FDA, EMA, ICH), Pricing strategies and cost structures, Supply chain management in API business, Market access and entry strategies, Risk management in the API sector, Negotiation tactics for API partnerships, International API regulations and compliance, Business development strategies for API markets.

Key details about the course:

  • Course Code: RYD-125
  • Title: Executive PG Certification in Global API Business Development (EPG-API-BD)
  • Type of the course: Self paced Online Course. Hence, this course can be accessed online across anywhere 24×7. Moreover, you can attend the course at your convenience in your flexible time. For example, you want to attend the session at your 11 pm at night, you can do that.
  • Duration of the course: 1 Year. Course can completed within 1 year based on own speed of access.
  • Course Certificate: Certificate will be provided at the end of the successful completion of the course

Who Should Attend:

  • Pharmaceutical Business Development Managers looking to expand their knowledge of the API market and enhance their strategic decision-making.
  • API Business Development professionals to enrich knowledge base.
  • Regulatory Affairs Professionals who want to understand the global API market regulations and their impact on business strategies.
  • Pharma Entrepreneurs & Startups seeking a competitive edge in API sourcing, partnerships, and business development.
  • Supply Chain Managers in the pharma sector who need to better understand API supply chain dynamics and cost management.
  • Graduates & Professionals aspiring to enter the pharmaceutical industry, particularly in the API management / API Business Development domain.

Learning Domain in Global API Business Development Course

  • Introduction to Pharma API Market: Overview of the pharmaceutical API market, its global trends, and the dynamics of API business development.
  • API Development and Manufacturing : Key process development techniques, milestones, stages and different manufacturing processes. Course covers in-depth certification requirements for API business.
  • API Sourcing & Supply Chain Management: Explore sourcing strategies, supplier relationships, and supply chain dynamics critical to API business success.
  • Regulatory Frameworks: Learn about international regulatory requirements for APIs, including FDA, EMA, and ICH guidelines, and how they impact business decisions.
  • Regional Regulatory, Business Development, and Market Access : Learn API specific market access requirements in US EU GCC Middle East Africa Japan China India Russia and ROW market.
  • API Pricing Strategies: Understand cost structures, pricing models, and how to develop competitive pricing strategies in the API market.
  • Licensing and Business Expansion Strategies: Master strategies for entering new markets, including local regulations, partnerships, Licensing and establishing a brand presence.
  • Risk Management & Negotiation: Learn how to assess risks in the API sector, including geopolitical, financial, and regulatory risks, and effective negotiation strategies.
  • Case Studies & Practical Applications: Review real-life examples and case studies on API business development and market access.

Course Features of Global API Business Development

  • Comprehensive Learning Modules: In-depth exploration of key aspects of Active Pharmaceutical Ingredients (API) business development, including market trends, pricing strategies, regulatory guidelines, and supply chain management.
  • Industry Insights: Learn from industry experts with real-world case studies, examples, and practical insights into API sourcing and partnerships.
  • Interactive Learning: Engaging multimedia content, quizzes, and assignments to reinforce learning and encourage practical application.
  • Flexible Access: Learn at your own pace, also with full access to course materials for 1 year.
  • Certification: Gain a globally recognized certification in Pharma API Business Development.

How this course become useful resource for pharma api business development managers?

The Global API Business Development Online Certification Course is an invaluable resource for Pharma API Business Development Managers. It equips them with the critical knowledge needed to navigate the complex landscape of the API industry, helping them stay ahead in a competitive market. In fact, managers will gain expertise in sourcing strategies and supplier evaluation, allowing them to make informed decisions when selecting partners and optimizing the supply chain. The course also covers essential regulatory frameworks, ensuring that managers can successfully navigate compliance requirements across different global markets.

Furthermore, the course delves into pricing strategies and market access tactics, enabling business development managers to craft competitive API pricing models and identify profitable market opportunities. Hence, by learning effective risk management techniques, managers will be better prepared to handle challenges related to geopolitical, regulatory, and financial risks. Moreover, the practical insights and real-life case studies provided will help managers apply the learned concepts directly to their business strategies, enhancing their ability to drive growth, negotiate favorable contracts, and lead successful API development initiatives. Overall, this course will boost their leadership skills and strategic thinking, making them key contributors to their organization’s success in the API business development space.

Section 1API Market Insight | Manufacturing | Development | Strategic Framework
Lecture 1API Market Insight | Global API Market | Key Drivers and Challenges 
Lecture 2Case Insight: Evolution of China and India as dominant API Player 
Lecture 3Post Covid-19 API Era: How API industry impacted | Changes observed in post covid-19 era
Lecture 4API Production Trends | API Outsourcing Strategic Planning | Key Strategies and Trends in API Outsourcing
Lecture 5API Industry Key Trend Metrics | Case Based Assessment on Dual Sourcing 
Lecture 6API Manufacturing and Development | Understanding critical steps in manufacturing and development of API 
Lecture 7Key Milestones and Stages of API Development | API Process Research | API Scale Up | Risk Management | QbD 
Lecture 8API Registration Pathways | Requirements from Different regions | Focus on API Regulatory Framework | API pathways for US EU Japan and China
Lecture 9General Framework for API Registration | Two case study on API registration and framework
Lecture 10CAS Number | Importance of API Sourcing | Case study
Lecture 11API Sourcing | Checklist Development | How to work step by step in API sourcing?
Lecture 12API BD Tool Training 1 | Case Based Analysis | How to work on the tool 
Lecture 13Leading API Sourcing Platforms / Tools
Lecture 14Strategic Alliances in API Business | Types of Alliances | Case studies 
Lecture 15Licensing Model in API Industry
Lecture 16Co-development | Co-marketing model in API industry
Lecture 17API Supply Agreements and Distribution Strategies | API Distribution Models | Simulations 
Lecture 18API Classification | Commodity API | Speciality API | Strategic Insight on Specialty API | Case Based Analysis 
Lecture 19API Pricing Model | Strategic Insight on each model | 3 Case Study  
Lecture 20API Market Entry Strategic Planning for EU Market | Strategic Framework 
Lecture 21API Monograph | Importance | Regulatory Requirements for API registration | Vendor Management
Lecture 22Monographs | Characteristics and Usage
Lecture 23Certificate of Suitability (CEP) | Significance | Importance | Understanding Regulatory Compliance and Submission Process | Walkthrough
Lecture 24ASMF Filing - Preparation | Documentation and Management | Key Components 
Lecture 25API Global Trade-off Simulation 
Lecture 26API Review Test | Check your API Business Competency | Difficulty Level - Easy 
Lecture 27CEP Dossier DMF - Differences
Lecture 28Key differences in API regulatory approval pathways for APIs (Active Pharmaceutical Ingredients) across the US, EU, and emerging markets
Lecture 29Precision in API Weighting | Importance | How effectively Plan and Monitor API weight | API Weight Calculation Methods | Vendor Management
Section 2US API R&D Regulation and Strategic Management
Lecture 30R&D Process & Introduction to drug discovery
Lecture 31Investigational New Drug Application (INDA)
Lecture 32New Drug Application (NDA) 
Lecture 33Basic concept and understanding of the Generic Drug
Lecture 34Abbreviated New Drug Application (ANDA) 
Lecture 35Biological Licensing Application (BLA)  | 351(a) application | Form 356h | Differentiation with NDA | Timeline | Handling FDA queries
Lecture 36Abbreviated Biosimilar Application - 351(k): Advance Strategic Planning Process : Originator Vs. Biosimilar Development and Regulatory Approval Process | Reference Biologic | Purple Book | Data Requirements
Lecture 37Purple Book: Significance | Searching | Assignments
Lecture 38Handling of orange book
Lecture 39USFDA expedited programs
Lecture 40Practical Training on INDA, NDA, ANDA filing
Lecture 41505(j) ANDA, 505(b)(2) NDA, 505(b)(1) NDA
Lecture 42Authorized Generics: Key Understanding
Lecture 43Exploratory IND Vs. Traditional IND
Lecture 44Patents Vs. exclusivity 
Lecture 45Orphan Drug Designation 
Lecture 46Advance Learning on 505B2 Pathway
Lecture 47Chemistry, Manufacturing & Controls 
Lecture 48Patent & Exclusivity - Strategic Understanding | Patent Restoration| Orphan Drug Exclusivity (ODE) | NCE & NCI Exclusivity | GAIN Exclusivity | Pediatric Exclusivity | 180 days exclusivity
Lecture 49Clinical Research | Terminologies and definition in Clinical Research | Phases |Expanded access trial | Observational Study |Randomized controlled and Placebo controlled study | Active comparator study
Lecture 50Clinical Trial Protocol Writing
Lecture 51Ethics in Clinical Research
Lecture 52Informed Consent | Practical Training on preparing ICF | Ready Templates
Lecture 53FDA Forms and How to fill the resources
Lecture 54Strategic Discussion: PreIND, EOP1, EOP2 - What to expect !
Lecture 55Importance and Significance of Phase 2b Clinical Trial 
Lecture 56Regulatory Strategies in different phases of Clinical Trial
Lecture 57Para IV Filing - Strategic Insight
Lecture 58Para IV Notices
Lecture 59Evergreening - Patent Life Extension Strategies
Lecture 60Pay For Delay Strategy
Lecture 61REMS Strategic Planning 
Lecture 62Compulsory Licensing
Lecture 63Licensing & Technology Transfer
Lecture 64In-Licensing Vs. Outlicensing
Lecture 65LOE Strategies for Innovator Brands with case study
Lecture 66Pediatric Exclusivity and Pediatric Study Plan Development
Lecture 67Drug Repurposing
Lecture 68Advance understanding of the portfolio Management 
Lecture 69New Indication Approval Process and Promotion 
Lecture 70OTC Switch 
Lecture 71Detailed Understanding on 505(b)(2) VS. Suitability Petition : Case Based Learning
Lecture 72NCE Vs. 505b2 application - Case Based Learning 
Lecture 73FTF - 180 Days Exclusivity - Case Based Learning
Lecture 74Classic case study of the 505b2 filing : Case Based Learning
Lecture 75Strategic Planning in Combating 30 months stay strategies of innovator company- Case Based Learning
Lecture 76Pipeline in a molecule | Case Study 
Lecture 77USFDA Emergency Use Authorization (EUA)
Lecture 78Target product profile (TPP) | Quality Target product profile (QTPP) | Critical Quality Attributes (CQAs) | Quality By Design (QbD)
Lecture 79Fundamental of CMC | Detailed understanding of CMC section writing | Important Points regarding CMC | Drug Product and Drug Substance | Excipient, FP, Analysis and Stability Study Requirements
Lecture 80Review on Drug Discovery and Development 
Section 3EU API Business and Strategic Management
Lecture 81Introduction to EU Regulation 
Lecture 82Orientation to European Countries and National Regulatory Bodies
Lecture 83EU Drug Discovery Development to Commercialization (Step By Step)
Lecture 84Overview of EU Regulation 
Lecture 85EMA and EMA Authorisation Process
Lecture 86EU MA Application Types and Strategic Planning
Lecture 87EU MA Procedure - Centralised, Decentralised, Mutual Recognition, National Procedure 
Lecture 88EU MA Strategic Planning: Full, Full-mixed, hybrid applications. Generic, Similar biologic application pathway, Well-established use application, Fixed combination application, Informed consent application
Lecture 89Validity of the EU MA  - Renewal steps, Cessation of the marketing authorisation, Significance of "Placed in Union Market", Suspension or withdrawal & EU MA for licensed products
Lecture 90Data Exclusivity and Market Protection - Supplementary Patent Protection, Exclusivity, 6/10 Rule, 8+2+1 Formulae
Lecture 91EU Orphan Medicinal Products Regulation
Lecture 92Conditional marketing authorisation | Marketing authorisation under exceptional circumstances
Lecture 93Summary of Product Characteristics 
Lecture 94Compassionate Use
Lecture 95MHRA - UK Regulation 
Lecture 96The 'sunset clause' for marketing authorisation of pharmaceuticals
Lecture 97Paediatric use marketing authorisation (PUMA) & Paediatric Investigation Plan (PIP) - EU Requirments
Lecture 98EU Prime Designation
Lecture 99Accelerated assessment by EMEA
Lecture 100EU Adaptive Pathway
Lecture 101European public assessment report (EPAR) - Importance, Component, Management, Updation 
Lecture 102SPOR  - Concept of Master Data Management  
Lecture 103Policy 0070 |  RPDP Submission and Management timeline | Anonymisation Report (AnR) - Significance | AnR in FRDP 
Section 4API Plant Management and Certification | Quality Management
Lecture 104Premises & Plant Layout Designing
Lecture 105Sanitation and Hygiene
Lecture 106Equipment Modules
Lecture 107Production Modules
Lecture 108Documentation
Lecture 109Quality Control
Lecture 110Product Complaint
Lecture 111Storage Module
Lecture 112Pharmaceutical SOPs Management from regulatory perspective
Lecture 113Establishment Inspection Report | 483 Observations | USFDA Warning Letter | Handling of FDA inspection | Closing of Warning Letter 
Lecture 114Data Integrity issues in Pharmaceutical Industry
Lecture 115Electronic Batch Record for effective compliance management | Key Understanding | Functionalities | Importance in managing data integrity
Lecture 116Quality Risk Management | ICH Q9 | ISO 14971 | Principle of Risk Management 
Section 5API Documentation - Submission Management
Lecture 117Introduction to Common Technical Document (CTD)
Lecture 118CMC Dossier & Compliance Management
Lecture 119Introduction to Electronic Common Technical Document (ECTD)
Lecture 120Advance Practical Training on Dossier Preparation focusing on drug registration in export countries 
Lecture 121Modules on Stability Study : Stability Study - Fundamental Understanding | Interchangebility | Reports | API & FPP Stability Study
Lecture 122Key Consideration for Drug Master File Preparation and Submission 
Lecture 123Practical Understanding on Drug Master File Preparation and Submission
Lecture 124Associated Learning: Site Master File - Detailed Understanding 
Lecture 125DMF Completeness Assessment
Lecture 126Drug Master File - Fees
Lecture 127Drug Master File - Global Perspective [Across Different Regions]
Lecture 128Importance of effective dossier management
Lecture 129Discussion on 85 common deficiencies in CTD submission dossier
Lecture 130Certificate of Analysis
Lecture 131Detailed Understanding on ANDA Submission Dossier 
Section 6Japan API Registration and Strategic Management
Lecture 132Introduction to Japan Drug Regulatory Affairs 
Lecture 133Drug Discovery Development to commercialization | PMDA functions | Consultation | Premarket to post market approval 
Lecture 134Drug Approval System | GCP | PMDA requirements 
Lecture 135New Drug Application | Requirements | Review Process
Lecture 136Generic Drug Application Review and Approval 
Lecture 137Marketing Authorization Process for registration of pharmaceutical in Japan
Lecture 138API Registration in Japan | Step By Step Process
Lecture 139Generic Registration | Patent - Patent Term Extension | Exclusivity | Re-examination System | Pediatric Designation |  Patent Term Extension Case Studies
Lecture 140Priority Review Application | Criteria | Review Process | Timeline
Lecture 141Orphan Drug Designation in Japan
Lecture 142Japan DMF System | MF filing Process | Key points 
Lecture 143Strategic Approval Pathway - Formulation Approval Quoting MF
Lecture 144SAKIGAKE designation 
Section 7API Business : Latam
Lecture 145Introduction to Latam Region Pharma Business Development
Lecture 146Drug Registration and Regulation in Argentina 
Lecture 147Drug Registration and Regulation in Bolivia
Lecture 148Drug Registration and Regulation in Brazil
Lecture 149Drug Registration and Regulation in Chile
Lecture 150Drug Registration and Regulation in Colombia
Lecture 151Drug Registration and Regulation in Mexico
Lecture 152Drug regulation and registration in Peru
Lecture 153Drug regulation and registration in El Salvador
Lecture 154Central America Drug Regulatory Affairs | Panama, Costa Rica, Guatemala, El Salvador, Honduras, Dominican Republic | RTCA guideline [2022]
Section 8API Business : Africa
Lecture 155African Continent Overview - Brief introduction
Lecture 156African Pharma Market
Lecture 157Drug Registration - African medicines regulatory
Lecture 158Basic Export Requirement for African Countries
Lecture 159Export Documentations & Important Concepts
Lecture 160Nigeria  - Drug Registration
Lecture 161Drug Registration in Algeria
Lecture 162Drug Registration in Ethiopia
Lecture 163Drug Registration in Kenya
Lecture 164Drug Registration in Egypt
Lecture 165Drug Registration in Ghana
Lecture 166Drug Registration in Botswana
Lecture 167Drug Registration in South Africa
Lecture 168Drug Registration in Zambia
Lecture 169Drug Registration in Namibia
Lecture 170Drug Registration in Tanzania
Lecture 171Drug Registration Senegal
Lecture 172Drug Registration in Zimbabwe
Lecture 173Drug Registration in Uganda
Lecture 174Drug Registration in Morocco
Lecture 175Drug Registration in Sudan
Section 9API Business : GCC, Middle East and MENA
Lecture 176Middle East / MENA / GCC Countries Geographical Orientation 
Lecture 177Middle East / MENA / GCC Countries National Regulatory Agencies
Lecture 178GCC Registration Procedure - Centralized and Decentralized Procedure | Detailed understanding on Centralized Registration Process
Lecture 179Drug Registration in Saudi Arabia
Lecture 180Drug Registration in UAE
Lecture 181Drug Registration and Regulatory Strategic Planning for Iran
Lecture 182Drug Registration and Regulatory Strategic Planning for Israel
Lecture 183Middle East Pharma Market
Lecture 184Drug Registration in Jordan
Lecture 185Drug Registration in Palestine
Section 10API Business : ASEAN
Lecture 186ASEAN - Region - Introduction
Lecture 187ASEAN Countries | Introduction | Geographical Overview 
Lecture 188ASEAN countries drug regulatory bodies
Lecture 189ASEAN Common Technical Requirements (ACTRs)
Lecture 190The Pharmaceutical Inspection Co-operation Scheme
Lecture 191CPP Requirements for Drug Registration in ASEAN countries
Lecture 192Dossier Requirements - ACTD/CTD Acceptability
Lecture 193Pharmacopoeias Acceptability
Lecture 194Harmonization of Technical Guidelines 
Lecture 195Stability Study requirements for drug registration in ASEAN countries
Lecture 196Product Labelling
Lecture 197Post Approval Changes (Variations) requirements in ASEAN countries
Lecture 198Pharmacovigilance and Risk Management Plan (RMP)
Lecture 199Timeline of Drug Registration Approval
Lecture 200ASEAN Drug Regulations : Comparison Study | Guidelines | Pharmaceutical products Regulatory Submissions | Pharmacopoeia Requirements | stability requirements | Pharmacovigilance | Product labeling | Drug variation information
Lecture 201Drug Registration and Regulation Singapore | Strategic Pathways for Marketing Authorization | Screening, Evaluation of MA applications | Variations Classifications and Management
Lecture 202Drug Registration and Regulation in Brunei
Lecture 203Drug Registration and Regulation in Cambodia
Section 11API Business - CIS - EAEU | Russia
Lecture 204Drug Registration and Submission Strategic Planning for Russia and EAEU region
Lecture 205GMP requirements in Russia 
Section 12API Business : China
Lecture 206Drug Registration and Regulation in China
Lecture 207NMPA's DDR and DMR update
Section 13API Business - India
Lecture 208Drug Registration and Regulation in India - Prime Session | CDSCO - Organization Regulatory Functions - Central and State | Import License | Registration Certificate | Inspection, Fees and Process | Export from India | Step by Step Guidance
Lecture 209Medicine Export Criteria from India
Lecture 210Documents for conducting BE Study for Export
Lecture 211New Drug Approval in DCGI
Lecture 212Line Extension New Strength Approval
Section 14API Business - CIS - EAEU | Russia
Lecture 213Drug Registration and Submission Strategic Planning for Russia and EAEU region
Lecture 214GMP requirements in Russia 
Section 15Bioequivalence Study : Requirements
Lecture 215PKPD in Drug Discovery | PK-PD trial | Understanding PKPD from regulatory perspective in drug approval process
Lecture 216Bioequivalence Study | Study design | Different types of BE Studies
Lecture 217Bioequivalence Study | Study design | Parallel Study | Crossover study design | Other alternative study designs | Blood Sampling Planning  | Analyte | Bioanalytical Methods Validation  | Statistical Model  | Ln Transformation  | Dose normalisation | Confidence interval acceptance criteria
Lecture 218Biopharmaceutical Classification System (BCS) | Types | Biowaivers | BCS tool for drug development and regulatory submission 
Lecture 219Bioequivalence Study - Discussion - Timeline of stability study and bioequivalence study 
Lecture 220Bioequivalence Study - Discussion - Dissolution Testing
Lecture 221Bioequivalence Study - Generic Approval and Additives Labeling Requirements 
Lecture 222IVIVC  - Basis | Importance | Case Based Determination of IVIVC 
Lecture 223Setting Dissolution Specification for Generic Products | Regulatory Expectations
Section 16Variation Filing : Marketing Authorization variation management
Lecture 224Introduction to Variation Management | Reasons for Variation | Working in Variation Department 
Lecture 225Variation Classification | Basis of Classification | US and EU Variation Classification | Other region variation guideline.
Section 17Biologic API | Understanding Class | Specific Registration Requirements | Strategic Planning
Lecture 226Introduction : Biopharmaceuticals
Lecture 227Classification of Biopharmaceutical 
Lecture 228Important Concept regarding Biopharmaceuticals
Lecture 229Introduction to Biologics and Biosimilar | Key differences | Concept of Reference Product
Lecture 230Key features of Biologic | Differences in Chemical Drug Vs. Biologic Drugs
Lecture 231Principle of Naming of Biologic | Understanding on MAB naming system
Lecture 232Global Biopahrma Market Trends
Lecture 233Recombinant protein
Lecture 234Monoclonal Antibodies Vs. Polyclonal Antibodies
Lecture 235Monoclonal Antibodies
Lecture 236Synthetic Immunomodulators
Lecture 237Production of Monoclonal Antibodies
Lecture 238Cytokines
Lecture 239Interferon
Lecture 240Erythropoiesis-stimulating agent
Lecture 241Vaccine development and approval Process
Lecture 242Biosimilar Development Process
Lecture 243Strategic Consideration for Biosimilar Development 
Lecture 244Bio-Manufacturing Process Information
Lecture 245Studies required for approval of biosimilar
Lecture 246ATMPs | Types and Classification | Regulatory Mechanism 
Section 18API Export Procedure | Export Business Requirement handling | Pre - During - Post Export Procedure
Lecture 247Introduction of Export Documentation | Understanding of important terminologies
Lecture 248Proforma Invoice - Detailed understanding how to prepare Proforma Invoice
Lecture 249Export Contract | Importance | Considerations | Things to include in Export Contract
Lecture 250Commercial Invoice | Importance | Differences with Proforma Invoice 
Lecture 251Custom House Agent | Role, Responsibilities, How they work | Freight Forwarder - Difference with CHA | Case Study
Lecture 252Letter of Credit | How it works | Different types of LC | LC terms and conditions | Sight LC | Case Studies
Lecture 253Bank Guarantee (BG) | How BG works | Differences between BG and LC | Applicability of BG
Lecture 254LC Discounting | How it works | How to calculate the LC discounting
Lecture 255Packing List | Importance | Things to include in packing list
Lecture 256Incoterms | 2020 Incoterms | Practical understanding on different types of Incoterms | Choosing the right incoterm
Lecture 257Logical selection of Incoterms | Landing in right incoterms for your business
Lecture 258Pre-shipment Certificate | COO |CVO| Fumigation Certificate | Preshipment Inspection Certificate | Certificate of Health
Lecture 259Transport Documents | Bill of Lading | Different Types of Bill of Lading | Airway Bill
Lecture 260Airfreight calculation | Gross Weight | Tare Weight | New Weight | Volumetric Calculation | Freight rate calculation
Section 19Business Development | Licensing
Lecture 261Training on Basic Finance  |  Understanding Financial Statment | Income Statement | Balance Sheet | Cash Flow Statement
Lecture 262Moving Average | Moving Annual Total | YTD | How to calculate 
Lecture 263Compound Annual Growth Rate | CAGR Calculation
Lecture 264Business Development Job Functionality | Strategic Planning Process | Knowledge Area of Business Development | Lead targeting | Licensing term sheets
Lecture 265Portfolio Management Process | Portfolio Characteristics | Portfolio Analysis | Balancing the Portfolio | BD and Strategic Planning Department 
Lecture 266Identifying the corporate Need of business development | Objective – Strategy - Tactics | Portfolio constraints | SWOT | Numerical SWOT
Lecture 267Profiling and Searching | Objectives | Search Database | Creating Opportunity Anatomy for deal analysis | Mind Mapping | Searching Tools and Techniques - Web Search | Conference | Confidentaility - CDA | MTA
Lecture 268Numerical SWOT Practical training
Lecture 269Modelling 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 270Market Size Determination - Market Share | Relative Market Share | Total Vs. Actual Vs. Penetrated Market
Lecture 271Forecasting : Tools and Techniques
Lecture 272Market Sizing & Forecasting Case Study
Lecture 273Royalty Management - Royalty structuring | Royalty Calculation Method| Tiered Royalties | Terms | Royalty Reductions | Royalty Stacking - Concept and Calculation | Minimum Annual Royalties | Reach through royalties
Lecture 274Average Royalty Rate
Lecture 275Factor affecting the Royalty Rate in Pharmaceutical and Biopharmaceutical Deal
Lecture 276Distribution Licensing | Geography | Indication Splitting | Exclusive and Non-Exclusive Licensing | Sub Licenses
Lecture 277Acquisition in Pharma  | Product Acquisition| Company Acquisitions| Steps in acquisition | Financing acquisition deals | Trademark Assignment Process
Lecture 278Joint Ventures in Pharmaceutical and Biopharmaceutical Industry
Lecture 279SPECIAL PURPOSE VEHICLES (SPV)
Lecture 280Indication Splitting | Concept | Implementation feasibility analysis 
Lecture 281Types of Deals from Discovery to Commercialization
Lecture 282What are the fundamental areas of business development
Lecture 283Licensing Term Sheet | Content Structuring | Sample Term Sheet
Lecture 284Licensing Payment Scheduling: Different Types
Lecture 285Valuation Methods: DCF | rNPV | Sunk Cost Method | Comparables | Sum of Parts | Deterministic Vs. Probabilistic rNPV |  Peak Sales - Max-Min Approach
Lecture 286Valuation Methods: EBITDA method of valuation | Enterprise Value and Enterprise Multiple Calculation
Lecture 287Negotiation 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 288Business Development Simulation and Decision Making | Early Stage VS. Late Stage Valuation Methodology | Stair Step Model
Lecture 289Types 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 firms 
Lecture 290Benchmarking | Benchmarking through consortium | How to use benchmarking for drug discovery development projects 
Lecture 291DCF Calculation : Concept and Calculation - Step by step understanding
Lecture 292Net Present Value (NPV) method : Calculation
Lecture 293Risk-Adjusted Discount Rate Method - Calculation | Concept of Risk Premium 
Lecture 294Valuation Metric - P/E Ratio and EPS : Calculation
Lecture 295Comparable Company Analysis method : Calculation
Lecture 296EBITDA Multiples | Importance in Pharma Biopharma BD&L | Calculation | Benchmarking EBITDA multiplies | Sourcing EBITDA multiples | Decoding EBITDA multiples value in different types of pharma and biopharma organizations
Lecture 297Pipeline Benchmarking | Significance and Importance in Bio Pharma BD&L | Analyzing sample portfolio | Comparative outcome in business development 
Lecture 298Comparative pipeline benchmarking analysis | Level of Benchmarking | Primary - Secondary - Tertiary Benchmarking Metrics | Case Based Analysis of three companies comparative pipeline benchmarking
Lecture 299Pipeline Diversity Scores | Significance | How to Calculate | Comparative Study of Pipeline Diversity Scores
Lecture 300Design, Analysis, Assessment and Feedback on Real Time Portfolio Tracker
Lecture 301Research Productivity Index | Concept | Significance | Calculation Methodology | Comparative RPI benchmarking Exercise  
Section 20References and Case Studies
Lecture 302Comparison of various requirement of drug registration
Lecture 303Comparison of Dossier requirements of US and EU
Lecture 304Comparison of DMF requirement of various regulatory bodies