InstructorRoyed Training
TypeOnline Course
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MENA pharma business development


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MENA pharma business development

Pharma International Business Development & Licensing training focus on international business requirements in MENA region. Middle East and North Africa is witnessing good growth in recent time. Consisting of approximately 22 countries and with over 350 million inhabitants, the MENA pharmaceutical market was worth $36 billion in 2016, which represented 2% of the global market. This relatively low starting base is now seeing projected growth of 10%, vastly outstripping the current global growth rate of 4-6% – even surpassing the traditional “pharmemerging” economies such as Brazil and China. 

This course purely provides hands on training to enhance skill competency of pharmaceutical middle and top level managers working on the MENA business region. 

This course provides 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. 

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. Hence, the course covers fundamentals to advance learning on various skill areas. 

Who should attend this course? 

  • Those who are working on MENA business
  • Those who are in the regulatory affairs and related department.
  • Professionals from strategic management. 
  • Those who are in business development and licensing department.
  • 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 pharmaceutical management. 
  • Fresher or beginners, Those who want to make a career in the management in pharmaceutical and biopharmaceutical company. 

Course Code: RYD-091

Title: Executive PG Certification in Pharma International Business Development & Licensing [MENA region]

Type of the course: Self paced Online Course

Online distance learning 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.

1 Year

Any body who wants to acquire drug regulatory affairs competency should attend the course.

Certificate will be provided at the end of the successful completion of the course

Features of Pharma International Business Development & Licensing [MENA region]

  • This pharma global management covers all aspects of the strategic management from drug discovery development, regulatory, commercialization, marketing, branding, business development and sales. Hence the course provides
  • The course provides orientation to job related practical aspects of the business development managers. Therefore, on completion of the course, the participants will develop the hands on understanding how Business Development Professional works.
  • One of the important feature of the course is real life simulation on critical decision making process. Hence, these simulations help to enhance the licensing and  decision making skills which is the core aspects of the pharmaceutical management working.

Case Based Learning

  • Advance training on strategic management based on the various business regions.
  • Course covers regional business development requirements specific to MENA region.
  • Access to Case Studies to learn about the drug commercialization steps. Hence, participants will develop advanced competency on strategic portfolio management.
Section 1Pharma R&D Management- General Understanding
Lecture 1R&D Process & Introduction to drug discovery
Lecture 2Investigational New Drug Application (INDA)
Lecture 3New Drug Application (NDA) 
Lecture 4Basic concept and understanding of the Generic Drug
Lecture 5Abbreviated New Drug Application (ANDA) 
Lecture 6Review on Drug Discovery and Development 
Lecture 7Handling of orange book
Lecture 8USFDA 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 12Advance Learning on 505B2 Pathway
Lecture 13Chemistry, Manufacturing & Controls 
Lecture 14Patent & Exclusivity - Strategic Understanding | Patent Restoration| Orphan Drug Exclusivity (ODE) | NCE & NCI Exclusivity | GAIN Exclusivity | Pediatric Exclusivity | 180 days exclusivity
Lecture 15Clinical Trial : Detailed Understanding
Lecture 16Clinical Trial Protocol Writing
Lecture 17Ethics in Clinical Research
Lecture 18Informed Consent | Practical Training on preparing ICF | Ready Templates
Lecture 19FDA Forms and How to fill the resources
Lecture 20Strategic Discussion: PreIND, EOP1, EOP2 - What to expect !
Lecture 21Importance and Significance of Phase 2b Clinical Trial 
Lecture 22Regulatory Strategies in different phases of Clinical Trial
Lecture 23Para IV Filing - Strategic Insight
Lecture 24Para IV Notices
Lecture 25Evergreening - Patent Life Extension Strategies
Lecture 26Pay For Delay Strategy
Lecture 27Compulsory Licensing
Lecture 28Licensing & Technology Transfer
Lecture 29In-Licensing Vs. Outlicensing
Lecture 30LOE Strategies for Innovator Brands with case study
Lecture 31Drug Repurposing
Section 2Pharma International Business - Product Registration, Plant Certification, Dossier Preparation and Export Documentation
Lecture 32Introduction to Pharmaceutical Export
Lecture 33Introduction of Export Documentation | Understanding of important terminologies
Lecture 34Proforma Invoice - Detailed understanding how to prepare Proforma Invoice
Lecture 35Export Contract | Importance | Considerations | Things to include in Export Contract
Lecture 36Commercial Invoice | Importance | Differences with Proforma Invoice 
Lecture 37Custom House Agent | Role, Responsibilities, How they work | Freight Forwarder - Difference with CHA | Case Study
Lecture 38Letter of Credit | How it works | Different types of LC | LC terms and conditions | Sight LC | Case Studies
Lecture 39Bank Guarantee (BG) | How BG works | Differences between BG and LC | Applicability of BG
Lecture 40LC Discounting | How it works | How to calculate the LC discounting
Lecture 41Packing List | Importance | Things to include in packing list
Lecture 42Incoterms | 2020 Incoterms | Practical understanding on different types of Incoterms | Choosing the right incoterm
Lecture 43Logical selection of Incoterms | Landing in right incoterms for your business
Lecture 44Pre-shipment Certificate | COO |CVO| Fumigation Certificate | Preshipment Inspection Certificate | Certificate of Health
Lecture 45Transport Documents | Bill of Lading | Different Types of Bill of Lading | Airway Bill
Lecture 46Certification Pharmaceutical Companies / Plants
Lecture 47Airfreight calculation | Gross Weight | Tare Weight | New Weight | Volumetric Calculation | Freight rate calculation
Lecture 48Manufacturing License
Lecture 49Free Sale Certificate
Lecture 50CPP (Certificate of Pharmaceutical Product)
Lecture 51Certificate of Analysis
Lecture 52Certificate of Origin (COO)
Lecture 53Non-conviction certificate
Lecture 54ISO Certification
Lecture 55Common Technical Document (CTD)
Lecture 56Electronic Common Technical Document (ECTD)
Lecture 57Dossier Preparation focusing on drug registration in export countries 
Lecture 58Modules on Stability Study : Stability Study - Fundamental Understanding | Interchangebility | Reports | API & FPP Stability Study
Lecture 59Importance of effective dossier management
Lecture 60Detailed Understanding on ANDA Submission Dossier 
Lecture 61Prior Approval Submission 
Lecture 62Detailed Understanding on ANDA Fees
Lecture 63Discussion on 85 common deficiency in CTD submission dossier
Lecture 64Detailed Understanding on 505(b)(2) VS. Suitability Petition : Case Based Learning
Lecture 65NCE Vs. 505b2 application - Case Based Learning 
Lecture 66FTF - 180 Days Exclusivity - Case Based Learning
Lecture 67Classic case study of the 505b2 filing : Case Based Learning
Lecture 68Strategic Planning in Combating 30 months stay strategies of innovator company- Case Based Learning
Section 3Plant Management and Certification | Quality Management
Lecture 69Premises & Plant Layout Designing
Lecture 70Sanitation and Hygiene
Lecture 71Equipment Modules
Lecture 72Production Modules
Lecture 73Documentation
Lecture 74Quality Control
Lecture 75Product Complaint
Lecture 76Storage Module
Lecture 77Pharmaceutical SOPs Management from regulatory perspective
Lecture 78Establishment Inspection Report | 483 Observations | USFDA Warning Letter | Handling of FDA inspection | Closing of Warning Letter 
Lecture 79Data Integrity issues in Pharmaceutical Industry
Lecture 80Electronic Batch Record for effective compliance management | Key Understanding | Functionalities | Importance in managing data integrity
Section 4Pharma Market Access & Pricing - Forecasting - Formulary Placement of brands
Lecture 81Introduction to Market Access | Objectives | Various Key Terminologies | Steps of Market Access | Understanding on Pricing and Reimbursement
Lecture 82Market Access Functions : Role and Responsibilities | Key Job Areas | Understanding Job Description
Lecture 83Market Access Strategic Planning
Lecture 84Indication Sequencing | Indication Prioritization | Development of Indication Timeline | Indication Matrix | Value Based Indication Prioritization
Lecture 85Indication Prioritization Case Study
Lecture 86Market Access Value Dossier : What it is | Significance | Components | What to include
Lecture 87AMCP Market Access Value Dossier Preparation
Lecture 88Drug Pricing Methodologies
Lecture 89Sales Forecasting in Life Science Industry
Lecture 90New Product Forecast Algorithm
Lecture 91Patient Based Forecasting Model | Applying more filters and variables
Lecture 92Prescription Based Forecasting Model | Differences between Patient Based and Prescription Based Forecasting Model | Which model to use and when?
Lecture 93Prevalence Vs. Incidence Model
Lecture 94EPI Based Forecasting | Sales Based Forecasting | When and where to apply which forecasting model
Lecture 95Sales Forecasting Tools | New Product Forecasting | In Market Forecasting
Lecture 96Market Size Assignment 1 [Oncology Brand] - Applying sales forecasting tools to carry out next 6 years sales forecast | Excel Based Model
Lecture 97Market Size Assignment 2 [Asthma Brand] - Applying sales forecasting tools to carry out multiple years sales forecast | Excel Based Model
Lecture 98Formulary Placement | Different Tiers | How to classify the medication in different tiers | Formulary negotiation process | Rebates | Copay differential | Step-edits | Case Simulations - teasers
Lecture 99Patient Based Model Vs. Patient Flow Model | Critical Differences in Model | Concept of Black Box in Patient Flow Model | Application of both model
Lecture 100Concomitancy and polypharmacy | How it alter the basic forecasting algorithm | Practical Working | Comorbidity
Lecture 101Forecasting Techniques | Simple Conjoint-type Models | Zipf's Law | Simple Elasticity Model | The Bass Model |Simple Extrapolation
Lecture 102Simulation on Bottom-up forecasting
Lecture 103Assessment on Bottom-up forecasting
Lecture 104Oncology Brand Forecasting
Lecture 105Target product profile (TPP) | Quality Target product profile (QTPP) | Critical Quality Attributes (CQAs) | Quality By Design (QbD)
Lecture 106What is meaning of 'Pipeline in a Molecule'?
Section 5Business Development | Licensing
Lecture 107Training on Basic Finance  |  Understanding Financial Statment | Income Statement | Balance Sheet | Cash Flow Statement
Lecture 108Moving Average | Moving Annual Total | YTD | How to calculate 
Lecture 109Compound Annual Growth Rate | CAGR Calculation
Lecture 110Business Development Job Functionality | Strategic Planning Process | Knowledge Area of Business Development | Lead targeting | Licensing term sheets
Lecture 111Portfolio Management Process | Portfolio Characteristics | Portfolio Analysis | Balancing the Portfolio | BD and Strategic Planning Department 
Lecture 112Identifying the corporate Need of business development | Objective – Strategy - Tactics | Portfolio constraints | SWOT | Numerical SWOT
Lecture 113Profiling and Searching | Objectives | Search Database | Creating Opportunity Anatomy for deal analysis | Mind Mapping | Searching Tools and Techniques - Web Search | Conference | Confidentaility - CDA | MTA
Lecture 114Numerical SWOT Practical training
Lecture 115Modelling 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 116Market Size Determination - Market Share | Relative Market Share | Total Vs. Actual Vs. Penetrated Market
Lecture 117Forecasting : Tools and Techniques
Lecture 118Market Sizing & Forecasting Case Study
Lecture 119Royalty Management - Royalty structuring | Royalty Calculation Method| Tiered Royalties | Terms | Royalty Reductions | Royalty Stacking - Concept and Calculation | Minimum Annual Royalties | Reach through royalties
Lecture 120Average Royalty Rate
Lecture 121Factor affecting the Royalty Rate in Pharmaceutical and Biopharmaceutical Deal
Lecture 122Distribution Licensing | Geography | Indication Splitting | Exclusive and Non-Exclusive Licensing | Sub Licenses
Lecture 123Acquisition in Pharma  | Product Acquisition| Company Acquisitions| Steps in acquisition | Financing acquisition deals | Trademark Assignment Process
Lecture 124Joint Ventures in Pharmaceutical and Biopharmaceutical Industry
Lecture 126Indication Splitting | Concept | Implementation feasibility analysis 
Lecture 127Types of Deals from Discovery to Commercialization
Lecture 128What are the fundamental areas of business development
Lecture 129Licensing Term Sheet | Content Structuring | Sample Term Sheet
Lecture 130Licensing Payment Scheduling: Different Types
Lecture 131Valuation Methods: DCF | rNPV | Sunk Cost Method | Comparables | Sum of Parts | Deterministic Vs. Probabilistic rNPV |  Peak Sales - Max-Min Approach
Lecture 132Valuation Methods: EBITDA method of valuation | Enterprise Value and Enterprise Multiple Calculation
Lecture 133Negotiation 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 134Business Development Simulation and Decision Making | Early Stage VS. Late Stage Valuation Methodology | Stair Step Model
Lecture 135Types 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 136Benchmarking | Benchmarking through consortium | How to use benchmarking for drug discovery development projects 
Section 6Pharma Business Development in North Africa
Lecture 137African Continent Overview - Brief introduction
Lecture 138African Pharma Market
Lecture 139Drug Registration - African medicines regulatory
Lecture 140Basic Export Requirement for African Countries
Lecture 141Export Documentations & Important Concepts
Lecture 142Drug Registration in Algeria
Lecture 143Drug Registration in Egypt
Lecture 144Drug Registration in Morocco
Lecture 145Drug Registration in Sudan
Section 7Regional Business Development : GCC, Middle East and MENA
Lecture 146GCC Pharmaceutical Market
Lecture 147GCC Registration Procedure - Centralized and Decentralized Procedure
Lecture 148Drug Registration in Saudi Arabia
Lecture 149Drug Registration in UAE
Lecture 150Drug Registration in Kuwait
Lecture 151Drug Registration in Bahrain
Lecture 152Drug Registration in Oman
Lecture 153Middle East Pharma Market
Lecture 154Drug Registration in Jordan
Lecture 155Drug Registration in Palestine
Lecture 156Drug Registration in Israel
Lecture 157Drug Registration in Syria
Lecture 158Drug Registration in Iran
Lecture 159Drug Registration in Iraq