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mena pharma business development

Introduction

Nature of course

Course Duration

Eligibility

Certification

Features

Related Courses

About MENA Pharma Market

MENA pharma business development

Pharma International Business Development & Licensing training focus on international business requirements in MENA region. 

The MENA (Middle East and North Africa) pharmaceutical market is a growing industry that has been expanding rapidly over the past decade. The region encompasses over 20 countries, including the Gulf Cooperation Council (GCC) countries, Egypt, Iran, Iraq, Jordan, Lebanon, Morocco, and Tunisia. This course will provide hands on training on MENA pharmaceutical market.

This course ideal for the working professionals of pharmaceutical and biopharmaceutical industry. In fact this comprehensive MENA region business development  training involves the real life job simulation on specific to middle east business. Hence, the course provides practical knowledge. 

Who should attend this course? 

  • This course is ideal choice for those who are working in MENA business development projects.
  • Moreover, this course will be natural choice for professionals working on MENA pharmaceutical companies in regulatory affairs, international marketing and related department.
  • Most importantly this online certification course will be valuable tool to enhance skills those working in portfolio management, business development, strategic marketing and inlicensing department.
  • Above all this course will provide great opportunity to master the business skills required for middle east pharma market. Therefore, anyone who requires an overview and detail understanding on MENA pharma market and business development skills should undergo this course. 
  • Lastly, Fresher or beginners too can opt this program who want to make a career in the management in pharmaceutical and biopharmaceutical company. 

Course Code: RYD-091

Title: Executive PG Certification in MENA Pharma Business Development (PGMENABD)

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.
  • Above all the course provides hands on training on drug registration process in each and every MENA countries.

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.

MENA Pharma Market – Overview

The MENA (Middle East and North Africa) pharma market is a rapidly growing market, with a current estimated value of approximately $60 billion USD. The market is expected to continue growing, driven by factors such as an increasing demand for healthcare services, rising populations, and the prevalence of chronic diseases.

Some of the largest markets within the MENA region include Saudi Arabia, Iran, and Egypt. However, other countries such as the UAE, Turkey, and Morocco are also experiencing significant growth in their pharmaceutical sectors.

Countries in MENA

The MENA (Middle East and North Africa) region consists of a diverse group of countries with different cultural, economic, and political backgrounds. The countries typically included in the MENA region are:

  1. Algeria
  2. Bahrain
  3. Djibouti
  4. Egypt
  5. Iran
  6. Iraq
  7. Israel
  8. Jordan
  9. Kuwait
  10. Lebanon
  11. Libya
  12. Malta
  13. Morocco
  14. Oman
  15. Palestine
  16. Qatar
  17. Saudi Arabia
  18. Syria
  19. Tunisia
  20. United Arab Emirates (UAE)
  21. Yemen

It is worth noting that the definition of the MENA region can vary depending on the context and purpose of the analysis. Some definitions may include additional countries, such as Cyprus or Turkey, while others may exclude some of the countries listed above.

 

Characteristics of MENA pharmaceutical Market

The MENA region is also characterized by a large number of domestic pharmaceutical manufacturers, as well as a growing number of multinational companies that are expanding their presence in the region. Governments within the region have also taken steps to encourage the growth of the pharma sector, such as through the implementation of regulatory frameworks and investment in healthcare infrastructure.

The market is dominated by generic drugs, which make up over 70% of total pharmaceutical sales in the region. However, there is an increasing demand for innovative and specialty drugs, particularly in the areas of oncology, immunology, and rare diseases.

Some of the major multinational pharmaceutical companies, including Pfizer, Sanofi, and Novartis, have a strong presence in the MENA region. Local pharmaceutical companies are also emerging and expanding, particularly in countries such as Egypt, Saudi Arabia, and the United Arab Emirates.

The MENA pharmaceutical market faces some challenges, such as regulatory barriers, intellectual property protection, and pricing pressures. However, the market presents significant growth opportunities, driven by increasing healthcare spending, a growing population, and an increasing demand for innovative and specialty drugs.

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 3Regional Business Development : GCC, Middle East and MENA
Lecture 69Middle East / MENA / GCC Countries Geographical Orientation 
Lecture 70GCC Registration Procedure - Centralized and Decentralized Procedure
Lecture 71GCC Registration Procedure - Centralized and Decentralized Procedure | Detailed understanding on Centralized Registration Process
Lecture 72Drug Registration in Saudi Arabia
Lecture 73Drug Registration in UAE
Lecture 74Drug Registration in Bahrain
Lecture 75Drug Registration and Regulatory Strategic Planning for Israel
Lecture 76Drug Registration and Regulatory Strategic Planning for Jordan
Lecture 77Drug Registration and Regulatory Strategic Planning for Iraq
Lecture 78Drug Registration and Regulatory Strategic Planning for Israel
Lecture 79Bahrain Pharmaceutical Market
Lecture 80Palestine Pharma Market
Lecture 81Syria Pharma Market | Regulation | Registration | Key Strategic Facts
Lecture 82Oman Pharmaceutical Market | Drug Registration Process | Strategic Keynotes
Section 4Pharma Market Access & Pricing - Forecasting - Formulary Placement of brands
Lecture 83Introduction to Market Access | Objectives | Various Key Terminologies | Steps of Market Access | Understanding on Pricing and Reimbursement
Lecture 84Market Access Functions : Role and Responsibilities | Key Job Areas | Understanding Job Description
Lecture 85Market Access Strategic Planning
Lecture 86Indication Sequencing | Indication Prioritization | Development of Indication Timeline | Indication Matrix | Value Based Indication Prioritization
Lecture 87Indication Prioritization Case Study
Lecture 88Market Access Value Dossier : What it is | Significance | Components | What to include
Lecture 89AMCP Market Access Value Dossier Preparation
Lecture 90Drug Pricing Methodologies
Lecture 91Sales Forecasting in Life Science Industry
Lecture 92New Product Forecast Algorithm
Lecture 93Patient Based Forecasting Model | Applying more filters and variables
Lecture 94Prescription Based Forecasting Model | Differences between Patient Based and Prescription Based Forecasting Model | Which model to use and when?
Lecture 95Prevalence Vs. Incidence Model
Lecture 96EPI Based Forecasting | Sales Based Forecasting | When and where to apply which forecasting model
Lecture 97Sales Forecasting Tools | New Product Forecasting | In Market Forecasting
Lecture 98Market Size Assignment 1 [Oncology Brand] - Applying sales forecasting tools to carry out next 6 years sales forecast | Excel Based Model
Lecture 99Market Size Assignment 2 [Asthma Brand] - Applying sales forecasting tools to carry out multiple years sales forecast | Excel Based Model
Lecture 100Formulary Placement | Different Tiers | How to classify the medication in different tiers | Formulary negotiation process | Rebates | Copay differential | Step-edits | Case Simulations - teasers
Lecture 101Patient Based Model Vs. Patient Flow Model | Critical Differences in Model | Concept of Black Box in Patient Flow Model | Application of both model
Lecture 102Concomitancy and polypharmacy | How it alter the basic forecasting algorithm | Practical Working | Comorbidity
Lecture 103Forecasting Techniques | Simple Conjoint-type Models | Zipf's Law | Simple Elasticity Model | The Bass Model |Simple Extrapolation
Lecture 104Simulation on Bottom-up forecasting
Lecture 105Assessment on Bottom-up forecasting
Lecture 106Oncology Brand Forecasting
Lecture 107Target product profile (TPP) | Quality Target product profile (QTPP) | Critical Quality Attributes (CQAs) | Quality By Design (QbD)
Lecture 108What is meaning of 'Pipeline in a Molecule'?
Section 5Business Development | Licensing
Lecture 109Training on Basic Finance  |  Understanding Financial Statment | Income Statement | Balance Sheet | Cash Flow Statement
Lecture 110Moving Average | Moving Annual Total | YTD | How to calculate 
Lecture 111Compound Annual Growth Rate | CAGR Calculation
Lecture 112Business Development Job Functionality | Strategic Planning Process | Knowledge Area of Business Development | Lead targeting | Licensing term sheets
Lecture 113Portfolio Management Process | Portfolio Characteristics | Portfolio Analysis | Balancing the Portfolio | BD and Strategic Planning Department 
Lecture 114Identifying the corporate Need of business development | Objective – Strategy - Tactics | Portfolio constraints | SWOT | Numerical SWOT
Lecture 115Profiling and Searching | Objectives | Search Database | Creating Opportunity Anatomy for deal analysis | Mind Mapping | Searching Tools and Techniques - Web Search | Conference | Confidentaility - CDA | MTA
Lecture 116Numerical SWOT Practical training
Lecture 117Modelling 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 118Market Size Determination - Market Share | Relative Market Share | Total Vs. Actual Vs. Penetrated Market
Lecture 119Forecasting : Tools and Techniques
Lecture 120Market Sizing & Forecasting Case Study
Lecture 121Royalty Management - Royalty structuring | Royalty Calculation Method| Tiered Royalties | Terms | Royalty Reductions | Royalty Stacking - Concept and Calculation | Minimum Annual Royalties | Reach through royalties
Lecture 122Average Royalty Rate
Lecture 123Factor affecting the Royalty Rate in Pharmaceutical and Biopharmaceutical Deal
Lecture 124Distribution Licensing | Geography | Indication Splitting | Exclusive and Non-Exclusive Licensing | Sub Licenses
Lecture 125Acquisition in Pharma  | Product Acquisition| Company Acquisitions| Steps in acquisition | Financing acquisition deals | Trademark Assignment Process
Lecture 126Joint Ventures in Pharmaceutical and Biopharmaceutical Industry
Lecture 127SPECIAL PURPOSE VEHICLES (SPV)
Lecture 128Indication Splitting | Concept | Implementation feasibility analysis 
Lecture 129Types of Deals from Discovery to Commercialization
Lecture 130What are the fundamental areas of business development
Lecture 131Licensing Term Sheet | Content Structuring | Sample Term Sheet
Lecture 132Licensing Payment Scheduling: Different Types
Lecture 133Valuation Methods: DCF | rNPV | Sunk Cost Method | Comparables | Sum of Parts | Deterministic Vs. Probabilistic rNPV |  Peak Sales - Max-Min Approach
Lecture 134Valuation Methods: EBITDA method of valuation | Enterprise Value and Enterprise Multiple Calculation
Lecture 135Negotiation 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 136Business Development Simulation and Decision Making | Early Stage VS. Late Stage Valuation Methodology | Stair Step Model
Lecture 137Types 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 138Benchmarking | Benchmarking through consortium | How to use benchmarking for drug discovery development projects 
Section 6Pharma Business Development in North Africa
Lecture 139African Continent Overview - Brief introduction
Lecture 140African Pharma Market
Lecture 141Drug Registration - African medicines regulatory
Lecture 142Basic Export Requirement for African Countries
Lecture 143Export Documentations & Important Concepts
Lecture 144Drug Registration in Algeria
Lecture 145Drug Registration in Egypt
Lecture 146Drug Registration in Morocco
Lecture 147Drug Registration in Sudan
Section 7Pharma Brand Management for BD professionals
Lecture 148Marketing Orientation for Product Manager
Lecture 149Why Is Market Research Important in Pharmaceutical Business?
Lecture 150Market Research - Customer Engagement through feedback mechanism 
Lecture 151Product Life cycle 
Lecture 152Advance - Strategic Planning in Product Life cycle Management
Lecture 153Segmentation, Targeting and Positioning
Lecture 154Pricing
Lecture 155A Pharmaceutical Segmentation outlook
Lecture 156Distribution Channel in Pharmaceutical Industry
Lecture 157Promotion in Pharmaceutical Industry : Communication Model, Effective promotional communication, Push Vs. Pull Strategy and Buying Decision Process
Lecture 158Practical understanding on Prescription Accelerating Materials used in pharmaceutical promotion
Lecture 159Method of Promotional Budgeting
Lecture 160Brand Recall | Brand Recognition |Top of mind - How to calculate brand recall value?
Lecture 161Advertising - Introduction | Objective | Types of Advertising 
Lecture 162ATL, BTL & TTL Advertising
Lecture 163Advertising Agency - Understanding on various types of advertising agency
Lecture 164Selection of Advertising Agency
Lecture 165What is creative Briefing? How to Prepare !
Lecture 166Creative Briefing - Practical Simulation
Lecture 167Request for Proposal | Concepts in advertising
Lecture 168Advertising Message Strategy Development and Evaluation
Lecture 169Creative Approach and Styles
Lecture 170Steps of Development of Creatives
Lecture 171Advertisement Copy Development
Lecture 172How to prepare Ad Campaign Step By Step
Lecture 173BRAND NAME,  BRAND LOGO, TRADEMARKING 
Lecture 174Advance Understanding of Pharmaceutical Brand Logo Development 
Lecture 175Trademark Searching Process | Hands on Practical Training
Lecture 176How to design an excellent brand logo : Tricks of the trade
Lecture 177Logo colour theme | Colour system | Colour coding | Significance of colour
Lecture 178Few Case Studies related to brand names and logos
Lecture 179Simulation: Can one innovator company keep 2 or more brand name?
Lecture 180Traditional Vs. Non-Traditional trademark | Significance of Colour in Pharma Branding 
Lecture 181Global Trademarking : Brand Protection Globally 
Lecture 182Logo Rebranding - Reasons | Practical Examples | How to handle logo rebranding | Forced Rebranding 
Lecture 183Brand Logo Development: Real Life Simulation
Lecture 184Tagline - Development, Finalization and Protection
Lecture 185Pharma Brand Name Generator
Lecture 186Fundamental of Pharma Marketing Plan 
Lecture 187Basic Understanding how to launch a pharmaceutical product into the market 
Lecture 188Practical Training on Marketing Plan Preparation with real life example
Lecture 189Marketing Campaign Development : Importance of Target Audience Segmentation for effective targeting 
Lecture 190Sample Marketing Plan 
Lecture 191Decide about brand USP -What to promote
Lecture 192How to prepare promotogram. Download sample Promotogram
Lecture 193Importance and Handling of Cycle Meeting and its importance 
Lecture 194Sample Marketing Plan
Lecture 195Sample Marketing Plan
Lecture 196Sample Marketing Plan
Lecture 197CSR Campaign 
Lecture 198Increase the brand reach with advance segmentation
Lecture 199Concept of uniform branding for better brand acceptability
Lecture 200Concept of Brand Differentiation
Lecture 201Introduction to visual aid designing  | V3M Concept | Components of the visual aid page
Lecture 202Practical Training in visual aid designing  | Step By Step Visual Aid Preparation | Creative Designing | Guideline on Proofing | USPs to differentiate the visual aid 
Lecture 203Visual Aid Printing  | Establishing Visual Aid Printing Specs for effective management of the vendors 
Lecture 204Visual Aid Analysis with practical example
Lecture 205Guideline on visual aid development
Lecture 206Marketing Plan followed by Visual Aid Development
Lecture 207Visual Aid, Literature reference Sample
Lecture 208Interactive Visual Aid | E-detailing | Remote Detailing | Analysis of Animated Video based e-detailing visual aids 
Lecture 209Visual aid detailing story writing
Lecture 210Artwork Development Process in PMT Departmen
Lecture 211Product List and Reminder card development
Lecture 212Catch Cover Development
Lecture 213Packaging Development 
Lecture 214Prescribing Information and Patient Information Leaflet development
Lecture 215Product Packshot Designing : Practical Knowledge
Lecture 216Creativity to develop brand essence
Lecture 217Advance Training on Pharmaceutical Packaging -  Creative Packaging for Brand Differentiation 
Section 8Pharma Digital Marketing Skill Training for Pharma BD Manager
Lecture 218Introduction to Digital Marketing 
Lecture 219Inbound and outbound marketing in pharma | Types of inbound and outbound marketing 
Lecture 220Digital 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 221Digital 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 222Digital marketing strategy development | Planning process | E-Marketing Plan | Planning for MNC Vs. Start Up | Strategic Outcome measurement
Lecture 223Relationship marketing using digital platform | CRM | Concept of permission marketing | User Satisfaction and loyalty management | Feedback mechanism
Lecture 224Campaign 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 225Search Engine Optimization | Search Engine Marketing | Social Media Marketing
Lecture 226Web Host - Check the hosting details 
Lecture 227Page Speed- importance and practical understanding | Check the web speed 
Lecture 228Keyword | Keyword Planning for SEO and SEM | Keyword Planner
Lecture 229Mobile Responsive | Tracking the Site 
Lecture 230HCP sites and Patient Site
Lecture 231Google Ad - Practical Training on Campaign Development and Execution
Lecture 232Digital Marketing Strategies for innovator brand | Pre launch - comuing soon, DSE Marketing | Launch activities - Day of approval (DOA) site | FDA Compliance | FDA 2253 Filing
Lecture 233Brand Portal Development
Lecture 234Relationship Marketing : KOL Management and Patient Advocacy Group 
Lecture 235Public Relation - PR firm | PR Campaign | Press Release | Technical understanding of press release writing | Digital Press Release
Lecture 236Developing Ad - Pharmaceutical Prescription, OTC Vs FMCG Brands
Lecture 237Difference between FMCG and OTC Brand Ad
Lecture 238Digital Marketing Techniques
Lecture 239Video Marketing
Lecture 240Video Marketing Techniques For Small Business Owners
Lecture 241Promoting Brand through Article Advertising and Marketing