Global API Business Development

Introduction

Who should attend

Learning Domain

Features

Related Courses

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.

Few of the similar courses

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 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 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 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]

Lecture 155LATAM Country Clusters &Comparative Regulatory Logic | Wave Filing Strategy

Lecture 156Strategic Understanding on Delta Documentation

Lecture 157Marketing Authorization Framework Across LATAM

Lecture 158LATAM Dossier Structure Differences Matrix

Lecture 159Language Requirements for Latam Filing

Lecture 160ANVISA Regulatory Submission | Delta Packages | CMC | Stability Decision Tree | Case Study

Lecture 161Case Study - ANVISA Submission for generic pharmaceutical | Critical Steps | Pathways | Risk Analysis and Mitigation Strategy

Lecture 162COFEPRIS (Mexico) Regulatory Submission | NCE Pathways | NOM-177 Requirements

Lecture 163Stability Requirements for Pharmaceutical Products in Mexico (COFEPRIS)

Lecture 164LATAM Stability Requirement Comparison (Brazil vs Mexico vs Argentina vs Chile)

Lecture 165Global Stability Program Supporting LATAM Registrations

Lecture 166LATAM Review Test | Check your competency

Lecture 167LATAM Marketing Authorization Simulation

Section 8API Business : Africa

Lecture 168African Continent Overview - Brief introduction

Lecture 169African Pharma Market

Lecture 170Drug Registration - African medicines regulatory

Lecture 171Basic Export Requirement for African Countries

Lecture 172Export Documentations & Important Concepts

Lecture 173Nigeria - Drug Registration

Lecture 174Drug Registration in Algeria

Lecture 175Drug Registration in Ethiopia

Lecture 176Drug Registration in Kenya

Lecture 177Drug Registration in Egypt

Lecture 178Drug Registration in Ghana

Lecture 179Drug Registration in Botswana

Lecture 180Drug Registration in South Africa

Lecture 181Drug Registration in Zambia

Lecture 182Drug Registration in Namibia

Lecture 183Drug Registration in Tanzania

Lecture 184Drug Registration Senegal

Lecture 185Drug Registration in Zimbabwe

Lecture 186Drug Registration in Uganda

Lecture 187Drug Registration in Morocco

Lecture 188Drug Registration in Sudan

Section 9API Business : GCC, Middle East and MENA

Lecture 189Middle East / MENA / GCC Countries Geographical Orientation

Lecture 190Middle East / MENA / GCC Countries National Regulatory Agencies

Lecture 191GCC Registration Procedure - Centralized and Decentralized Procedure | Detailed understanding on Centralized Registration Process

Lecture 192Drug Registration in Saudi Arabia

Lecture 193Drug Registration in UAE

Lecture 194Drug Registration and Regulatory Strategic Planning for Iran

Lecture 195Drug Registration and Regulatory Strategic Planning for Israel

Lecture 196Middle East Pharma Market

Lecture 197Drug Registration in Jordan

Lecture 198Drug Registration in Palestine

Section 10API Business : ASEAN

Lecture 199ASEAN - Region - Introduction

Lecture 200ASEAN Countries | Introduction | Geographical Overview

Lecture 201ASEAN countries drug regulatory bodies

Lecture 202ASEAN Common Technical Requirements (ACTRs)

Lecture 203The Pharmaceutical Inspection Co-operation Scheme

Lecture 204CPP Requirements for Drug Registration in ASEAN countries

Lecture 205Dossier Requirements - ACTD/CTD Acceptability

Lecture 206Pharmacopoeias Acceptability

Lecture 207Harmonization of Technical Guidelines

Lecture 208Stability Study requirements for drug registration in ASEAN countries

Lecture 209Product Labelling

Lecture 210Post Approval Changes (Variations) requirements in ASEAN countries

Lecture 211Pharmacovigilance and Risk Management Plan (RMP)

Lecture 212Timeline of Drug Registration Approval

Lecture 214Drug Registration and Regulation Singapore | Strategic Pathways for Marketing Authorization | Screening, Evaluation of MA applications | Variations Classifications and Management

Lecture 215Drug Registration and Regulation in Brunei

Lecture 216Drug Registration and Regulation in Cambodia

Section 11API Business - CIS - EAEU | Russia

Lecture 217Drug Registration and Submission Strategic Planning for Russia and EAEU region

Lecture 218GMP requirements in Russia

Section 12API Business : China

Lecture 219Drug Registration and Regulation in China

Lecture 220NMPA's DDR and DMR update

Section 13API Business - India

Lecture 222Medicine Export Criteria from India

Lecture 223Documents for conducting BE Study for Export

Lecture 224New Drug Approval in DCGI

Lecture 225Line Extension New Strength Approval

Section 14API Business - CIS - EAEU | Russia

Lecture 226Drug Registration and Submission Strategic Planning for Russia and EAEU region

Lecture 227GMP requirements in Russia

Section 15Bioequivalence Study : Requirements

Lecture 228PKPD in Drug Discovery | PK-PD trial | Understanding PKPD from regulatory perspective in drug approval process

Lecture 229Bioequivalence Study | Study design | Different types of BE Studies

Lecture 231Biopharmaceutical Classification System (BCS) | Types | Biowaivers | BCS tool for drug development and regulatory submission

Lecture 232Bioequivalence Study - Discussion - Timeline of stability study and bioequivalence study

Lecture 233Bioequivalence Study - Discussion - Dissolution Testing

Lecture 234Bioequivalence Study - Generic Approval and Additives Labeling Requirements

Lecture 235IVIVC - Basis | Importance | Case Based Determination of IVIVC

Lecture 236Setting Dissolution Specification for Generic Products | Regulatory Expectations

Section 16Variation Filing : Marketing Authorization variation management

Lecture 237Introduction to Variation Management | Reasons for Variation | Working in Variation Department

Lecture 238Variation Classification | Basis of Classification | US and EU Variation Classification | Other region variation guideline.

Section 17Biologic API | Understanding Class | Specific Registration Requirements | Strategic Planning

Lecture 239Introduction : Biopharmaceuticals

Lecture 240Classification of Biopharmaceutical

Lecture 241Important Concept regarding Biopharmaceuticals

Lecture 242Introduction to Biologics and Biosimilar | Key differences | Concept of Reference Product

Lecture 243Key features of Biologic | Differences in Chemical Drug Vs. Biologic Drugs

Lecture 244Principle of Naming of Biologic | Understanding on MAB naming system

Lecture 245Global Biopahrma Market Trends

Lecture 246Recombinant protein

Lecture 247Monoclonal Antibodies Vs. Polyclonal Antibodies

Lecture 248Monoclonal Antibodies

Lecture 249Synthetic Immunomodulators

Lecture 250Production of Monoclonal Antibodies

Lecture 251Cytokines

Lecture 252Interferon

Lecture 253Erythropoiesis-stimulating agent

Lecture 254Vaccine development and approval Process

Lecture 255Biosimilar Development Process

Lecture 256Strategic Consideration for Biosimilar Development

Lecture 257Bio-Manufacturing Process Information

Lecture 258Studies required for approval of biosimilar

Lecture 259ATMPs | Types and Classification | Regulatory Mechanism

Section 18API Export Procedure | Export Business Requirement handling | Pre - During - Post Export Procedure

Lecture 260Introduction of Export Documentation | Understanding of important terminologies

Lecture 261Proforma Invoice - Detailed understanding how to prepare Proforma Invoice

Lecture 262Export Contract | Importance | Considerations | Things to include in Export Contract

Lecture 263Commercial Invoice | Importance | Differences with Proforma Invoice

Lecture 264Custom House Agent | Role, Responsibilities, How they work | Freight Forwarder - Difference with CHA | Case Study

Lecture 266Bank Guarantee (BG) | How BG works | Differences between BG and LC | Applicability of BG

Lecture 267LC Discounting | How it works | How to calculate the LC discounting

Lecture 268Packing List | Importance | Things to include in packing list

Lecture 269Incoterms | 2020 Incoterms | Practical understanding on different types of Incoterms | Choosing the right incoterm

Lecture 270Logical selection of Incoterms | Landing in right incoterms for your business

Lecture 272Transport Documents | Bill of Lading | Different Types of Bill of Lading | Airway Bill

Section 19Business Development | Licensing

Lecture 274Training on Basic Finance | Understanding Financial Statment | Income Statement | Balance Sheet | Cash Flow Statement

Lecture 275Moving Average | Moving Annual Total | YTD | How to calculate

Lecture 276Compound Annual Growth Rate | CAGR Calculation

Lecture 277Business Development Job Functionality | Strategic Planning Process | Knowledge Area of Business Development | Lead targeting | Licensing term sheets

Lecture 278Portfolio Management Process | Portfolio Characteristics | Portfolio Analysis | Balancing the Portfolio | BD and Strategic Planning Department

Lecture 279Identifying the corporate Need of business development | Objective – Strategy - Tactics | Portfolio constraints | SWOT | Numerical SWOT

Lecture 281Numerical SWOT Practical training

Lecture 283Market Size Determination - Market Share | Relative Market Share | Total Vs. Actual Vs. Penetrated Market

Lecture 284Forecasting : Tools and Techniques

Lecture 285Market Sizing & Forecasting Case Study

Lecture 287Average Royalty Rate

Lecture 288Factor affecting the Royalty Rate in Pharmaceutical and Biopharmaceutical Deal

Lecture 289Distribution Licensing | Geography | Indication Splitting | Exclusive and Non-Exclusive Licensing | Sub Licenses

Lecture 291Joint Ventures in Pharmaceutical and Biopharmaceutical Industry

Lecture 292SPECIAL PURPOSE VEHICLES (SPV)

Lecture 293Indication Splitting | Concept | Implementation feasibility analysis

Lecture 294Types of Deals from Discovery to Commercialization

Lecture 295What are the fundamental areas of business development

Lecture 296Licensing Term Sheet | Content Structuring | Sample Term Sheet

Lecture 297Licensing Payment Scheduling: Different Types

Lecture 299Valuation Methods: EBITDA method of valuation | Enterprise Value and Enterprise Multiple Calculation

Lecture 300Negotiation 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 301Business Development Simulation and Decision Making | Early Stage VS. Late Stage Valuation Methodology | Stair Step Model

Lecture 303Benchmarking | Benchmarking through consortium | How to use benchmarking for drug discovery development projects

Lecture 304DCF Calculation : Concept and Calculation - Step by step understanding

Lecture 305Net Present Value (NPV) method : Calculation

Lecture 306Risk-Adjusted Discount Rate Method - Calculation | Concept of Risk Premium

Lecture 307Valuation Metric - P/E Ratio and EPS : Calculation

Lecture 308Comparable Company Analysis method : Calculation

Lecture 310Pipeline Benchmarking | Significance and Importance in Bio Pharma BD&L | Analyzing sample portfolio | Comparative outcome in business development

Lecture 311Comparative pipeline benchmarking analysis | Level of Benchmarking | Primary - Secondary - Tertiary Benchmarking Metrics | Case Based Analysis of three companies comparative pipeline benchmarking

Lecture 312Pipeline Diversity Scores | Significance | How to Calculate | Comparative Study of Pipeline Diversity Scores

Lecture 313Design, Analysis, Assessment and Feedback on Real Time Portfolio Tracker

Lecture 314Research Productivity Index | Concept | Significance | Calculation Methodology | Comparative RPI benchmarking Exercise

Section 20Innovation and IP Management in API industry

Lecture 315Comparison of various requirement of drug registration

Lecture 316General Introduction to intellectual Property Management

Lecture 317Introduction to Intellectual Property in Life Sciences | Types of IP | Introduction to Patent Portfolio Strategy

Lecture 318Introduction to Patent

Lecture 319Global Pharmaceutical Patent Landscape | Strategic Overview of Global Patent Filing and Protection

Lecture 320Understanding on Patent System

Lecture 321Patent Grant and Managing Patent Filing Procedure

Lecture 322Scope of Patentability

Lecture 323Stages of Patent Grant Procedure

Lecture 324Patent search in Indian Patent Office

Lecture 325Global Pharmaceutical Patent Filing Strategy

Lecture 326PCT Patent Filing Flow

Lecture 327Patentability Criteria in Pharmaceuticals | Practical Case Study

Lecture 328Patent Law Framework for Pharmaceuticals

Lecture 329Understanding and Decoding Section 3(d) of the Indian Patent Act | Case Based Analysis

Lecture 330Evergreening vs Genuine Innovation in Pharmaceutical Patents | Evergreening and Genuine Innovation Evaluation

Lecture 331Pharmaceutical Patent Lifecycle - Integrated Layer Strategy

Lecture 332Blockbuster Drug Patent Thicket Strategy

Lecture 333Types of Pharmaceutical Patents | Patent Layering StrategiesTypes of Pharmaceutical Patents

Lecture 334Understanding Patent Searching Process

Lecture 335IPC and CPC - Importance and Significance in Patent Search

Lecture 336IPC Structures for Pharmaceutical Patents

Lecture 337Freedom-to-Operate (FTO) | FTO Risk Assessment | Strategic Management

Lecture 338FTO Decision Tree – Generic Drug Launch Strategy

Lecture 339Fundamental of Pharmaceutical Patent Drafting | Structure | Component | Claim Anatomy | Effective Claim Writing

Lecture 340Pharmaceutical Patent Risk Management Framework

Lecture 341Patent Claim Coverage - Practical Example

Lecture 342Pharmaceutical Patent Filing Procedure and Global Filing Strategy | PCT Filing | Timeline

Lecture 343Advanced Understanding on Patent Opposition and Patent Litigation in Pharmaceutical Domain

Lecture 344Patent Prosecution and Handling Examiner Objections

Lecture 345Pharmaceutical Patent Portfolio Management | How to build and manage pharma patent portfolio

Lecture 346Pharmaceutical Patent Valuation and Licensing

Section 21API Labelling and Artwork Management

Lecture 347Introduction to Labelling | Regulatory vs Commercial Perspective of Labelling | Labelling Compliance Function

Lecture 348Types of Labels

Lecture 349Artwork & Packaging Lifecycle | Artwork Management Lifecycle Workflow

Lecture 350Global Artwork Labelling Framework | 5 Case Simulation

Lecture 351Country-Specific Labelling Requirements

Lecture 352Summary of Product Characteristics (SmPC)

Lecture 353Patient Information Leaflet (PIL)

Lecture 354Summary of Product Characteristics (SmPC) – Review Checklist

Lecture 355Patient Information Leaflet (PIL) – Review Checklist

Lecture 356US Prescribing Information (PI) | Differences with EU SmPC

Lecture 357US Prescribing Information (PI) - Review Checklist

Lecture 358Fundamental Understanding on Medication Guide

Lecture 359Regulatory Decision Flow: When Is a Medication Guide Required? - Step Based Decision Making

Lecture 360Medication Guide - Review Checklist | Inspection Checklist

Lecture 361PI Vs. Medication Guide Comparison

Lecture 362Patient Information Leaflet (PIL) vs Medication Guide

Lecture 363Label Components | Key considerations for effective designing of label

Lecture 364Label Review Checklist

Lecture 365Pharmaceutical Artwork Design Specification Worksheet - Complete Tracker

Lecture 366CCDS Management

Lecture 367CCDS Management Tools - Native, AI Plus | Key Functionalities

Lecture 368AI Augmented Labelling Compliance System

Lecture 369Label Drift in CCDS Management | Simulation Case Study | AI Based Workflow in Label Drift detection and management

Lecture 370AI Review of Labels, PI and SMPC with help of the Case Based Simulation | 4 Case Simulations

Lecture 371CCDS Management Case Study | Pregnancy Warning Upgrade Case Study

Lecture 372CCDS Management Case Study | Dosage Section Conflict | Case Based Analysis

Lecture 373Centralized Artwork Operation | Mechanism | Operation Step Planning

Lecture 374Case Study on Centralized Artwork Operation [Recall Management]

Lecture 375Artwork Management Terms | Key Understanding on Terminologies | Usage in Artwork Cases

Lecture 376Source Documents | Artwork Brief

Lecture 377Creating and Reviewing Label Content | Stakeholders of Labelling and Artwork Management | Case Studies

Lecture 378Change control process for labels | Types of changes | Impact Assessment | Concept of Greyzone Changes

Lecture 379Label Impact Assessment Checklist

Lecture 381Labelling Management System (LMS) | Understanding of Popular LMS Softwares | Workflow Management | Workflow Automation & Version Tracking | Best Practices

Section 22Download Master Modules

Lecture 382Download Master | Module How to Sell APIs to International Clients : Strategies for Global Success in the API Business

Lecture 383Global API & DMF Regulatory Requirements across different regions and countries

Lecture 384Global API / DMF Requirement Matrix - 195 sovereign states (Look Up File)

Section 23Final Certification - Request for Course Certification

Global API Business Development

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Introduction

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Learning Domain in Global API Business Development Course

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Global API Business Development

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Download All Course Catalogue

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Request for Course Demo Session

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Introduction

Who should attend

Learning Domain

Features

Related Courses

Key details about the course:

Who Should Attend:

Learning Domain in Global API Business Development Course

Course Features of Global API Business Development

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

Few of the similar courses