InstructorRoyed Training
TypeOnline Course
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Price$590 / 41300 INR.
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pharma international business management course

Introduction

Who should attend

Features

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About Pharma International Business

Pharmaceutical International Business Management

This online Pharmaceutical International Business Management course provides an understanding of international business requirements of pharmaceuticals.

Advance Certification is designed to create an effective Pharmaceutical International Business Manager for Pharmaceutical and Biopharmaceutical Industry. Pharma International Business Manager’s training gives practical knowledge and real-life job simulation. Course focuses on how international marketing professionals work in the company and understanding of key responsibilities and job functions. pharma international business management course by royed training

This is a real-life learning course which is specially prepared and designed not only for beginners but also for those who are currently engaged in the activities of import & export but are not too conversant with their international business requirements for pharmaceuticals.

In this online self-paced module, participants will be understanding about the pharmaceutical regulation and commercialization process in detail. Therefore, it is easy and convenient to access. Courses can be accessed 24×7, across anywhere.

The course trains the candidate on skill set required pre-registration, registration and post registration business development and management process effectively.  Moreover, Course covers fundamental advanced learning on the drug registration process, regulation, and strategic management process for effective decision making. Above all, this course features a pharmaceutical export business documentation process.

Course snapshots:

  • Course Code: RYD-013
  • Title of the course : Advance Certification in Pharmaceutical International Business Management
  • Nature of the course: Online distance learning course. So, course can be accessed online across anywhere 24×7.
  • Duration of the course: 1 Month
  • Eligibility: Graduate in any discipline. Final year students can apply for the course. Anybody who wants to acquire pharmaceutical international business management competency should attend the course.
  • Course Certification: Certificate will be provided at the end of the successful completion of the course.

Who should attend this course? 

  • Those who are in pharmaceutical business development for international business.
  • Professionals who are involved in pharmaceutical international marketing operations.
  • Import – export professional who requires detailed understanding of the pharmaceutical export business management.
  • Fresher or beginners, those who want to make a career in international business.
  • MBAs who want to have a rewarding career in pharmaceutical international marketing.

Course Features

  • Orientation to job related practical aspects of the international managers is covered in this course extensively.
  • Simulation to real life decision making in the international business department. Therefore, it helps to enhance strategic decision making.
  • Advance training on pharmaceutical registration requirements for various regulatory bodies.
  • Access to Case Studies to learn about the pharmaceutical export documentation process.

pharma international management course syllabus

 

 

 

 

 

 

 

 

 

 

 

 

 

Career in Pharmaceutical International Business Management

A career in Pharmaceutical International Business Management is very challenging, but highly rewarding. In fact, it opens up a lot of opportunities for professionals. But the international business managers need to have the cross functional pharmaceutical domain knowledge for effectively performing the work. For instance, he should be involved with the decision making for pharmaceutical product’s regulatory submission, compliance directly. And at the same time, he should have the knowledge of the quality assurance, safety, vigilance process. Pharma International Business Management professionals should have a detailed understanding of the brand management aspects like brand plan preparation, brand logo designing, visual aid, other input designing etc. Lastly, they also should have the basic fundamental business development skills like lead finding, lead management techniques.

pharma international business management

Knowledge is the key in Pharmaceutical International Business

More knowledge, it will be more beneficial. In turn, it helps them to reach a greater height in organization hierarchy. In fact, international business provides fast growth for the individual, if the person is dynamic and having great knowledge from varieties of the discipline.

The global pharmaceutical business is growing at a rapid pace. But there is a rising concern over the safety and efficacy. Therefore, all countries are having their own drug registration process. Company needs to prepare the drug dossier as per the guidelines of the national drug regulatory authority. Further, the dossier will be submitted to the regulatory body for the approval. Hence, an international business manager should have a detailed understanding of the dossier preparation. Most of the time, international business managers need to monitor and coordinate with the regulatory team for effective submission of the dossier. Therefore, understanding the knowledge of dossiers is crucial for International business development activities.

In Pharmaceutical export, the export documentation requirements are evolving and changing every other day. Hence, international marketing professionals must have thorough knowledge about the updated export documentation requirements. Sound export documentation knowledge helps them to perform the export process without any errors.

Job Opportunities for Pharmaceutical International Business

Individual who undergoes Pharmaceutical International Business Management training and with required experience, can get work on the posts like:

  • Pharma Export managers and executives
  • International Business Development Manager
  • Pharmaceutical International Brand Manager
  • International Licensing Manager – Pharma
  • Pharma Global Business Manager
  • International Business Consultant – Pharma
  • International Logistic Manager – Pharma

Conclusion

To conclude, in pharmaceutical trade, international business is a dynamic field, but certainly very challenging. A person should have vast knowledge of different requirements like pre-export, during and post-export procedure. That is the reason, this course is effectively providing cross – functional pharmaceutical domain understanding for pharmaceutical international trade.

Section 1Fundamental Understanding on Discovery, Development and Commercialization Process of Pharmaceuticals
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 6Patent & Exclusivity - Strategic Understanding | Patent Restoration| Orphan Drug Exclusivity (ODE) | NCE & NCI Exclusivity | GAIN Exclusivity | Pediatric Exclusivity | 180 days exclusivity
Lecture 7Clinical Trials Terminologies 
Lecture 8Market Access Strategic Planning
Section 2Pharmaceutical International Business - Basic Know How
Lecture 9Introduction of Export Documentation | Understanding of important terminologies
Lecture 10Proforma Invoice - Detailed understanding how to prepare Proforma Invoice
Lecture 11Export Contract | Importance | Considerations | Things to include in Export Contract
Lecture 12Functions of Export Documentation
Lecture 13Custom House Agent | Role, Responsibilities, How they work | Freight Forwarder - Difference with CHA | Case Study
Lecture 14Letter of Credit | How it works | Different types of LC | LC terms and conditions | Sight LC | Case Studies
Lecture 15Bank Guarantee (BG) | How BG works | Differences between BG and LC | Applicability of BG
Lecture 16LC Discounting | How it works | How to calculate the LC discounting
Lecture 17Packing List | Importance | Things to include in packing list
Lecture 18Incoterms | 2020 Incoterms | Practical understanding on different types of Incoterms | Choosing the right incoterm
Lecture 19Logical selection of Incoterms | Landing in right incoterms for your business
Lecture 20Pre-shipment Certificate | COO |CVO| Fumigation Certificate | Preshipment Inspection Certificate | Certificate of Health
Lecture 21Transport Documents | Bill of Lading | Different Types of Bill of Lading | Airway Bill
Lecture 22Airfreight calculation | Gross Weight | Tare Weight | New Weight | Volumetric Calculation | Freight rate calculation
Lecture 23Difference between Proforma and Quotation
Lecture 24Bank Guarantee Cycle with Example
Lecture 25CHA and IFF Requirements - Roles and Conditions
Lecture 26CHA Pricing - Typical CHA Pricing Structure in Pharma Import–Export
Lecture 27Incoterm Understanding with case study
Section 3Certification required for International Business
Lecture 28Certification Pharmaceutical Companies / Plants
Lecture 29Introduction to Certificate of Pharmaceutical Product | Types of CoPP | List of Countries / Regulatory Authorities who requires CoPP | CoPP as a part of generic market expansion planning 
Lecture 30WHO-GMP Certification Scheme 
Lecture 31Template of Certificate of Pharmaceutical product | Key observations and points to note while working on CoPP
Lecture 32Certificate of Analysis
Lecture 33Certificate of Origin
Lecture 34Non-conviction certificate
Lecture 35ISO Certification
Lecture 36Pharma Export Process & Effective Documentation - Step By Step
Section 4Dossier Management Training
Lecture 37Introduction to Common Technical Document (CTD)
Lecture 38Advance Practical Training on Dossier Preparation focusing on drug registration in export countries 
Lecture 39Modules on Stability Study : Stability Study - Fundamental Understanding | Interchangebility | Reports | API & FPP Stability Study
Lecture 40Chemistry, Manufacturing & Controls 
Lecture 41Importance of effective dossier management
Lecture 42Discussion on 85 common deficiency in CTD submission dossier
Lecture 43Practical Understanding on Drug Master File Preparation and Submission
Lecture 44Detailed Understanding on ANDA Submission Dossier 
Lecture 45Prior Approval Submission 
Lecture 46Electronic Batch Record for effective compliance management | Key Understanding | Functionalities | Importance in managing data integrity
Lecture 47Data Integrity issues in Pharmaceutical Industry
Lecture 48Establishment Inspection Report | 483 Observations | USFDA Warning Letter | Handling of FDA inspection | Closing of Warning Letter 
Section 5Branding Training for Pharmaceutical International Business
Lecture 49Brand Logo | Brand Name Selection | Legal Search Technique | Brand Logo designing
Lecture 50Trademark Searching Process | Hands on Practical Training
Lecture 51How to design an excellent brand logo : Tricks of the trade
Lecture 52Logo colour theme | Colour system | Colour coding | Significance of colour
Lecture 53Simulation in Brand Name
Lecture 54Logo Rebranding - Reasons | Practical Examples | How to handle logo rebranding | Forced Rebranding 
Lecture 55Brand Logo Development: Real Life Simulation
Lecture 56Logo Rebranding - Reasons | Practical Examples | How to handle logo rebranding | Forced Rebranding 
Lecture 57Tagline - Development, Finalization and Protection
Lecture 58Pharma Brand Name Generator
Lecture 59Fundamental of Pharma Marketing Plan 
Lecture 60Basic Understanding how to launch a pharmaceutical product into the market 
Lecture 61Practical Training on Marketing Plan Preparation with real life example
Lecture 62Marketing Campaign Development : Importance of Target Audience Segmentation for effective targeting 
Lecture 63Decide about brand USP -What to promote 
Lecture 64How to prepare promotogram. Download sample Promotogram
Lecture 65Increase the brand reach with advance segmentation
Lecture 66Concept of uniform branding for better brand acceptability
Lecture 67Concept of Brand Differentiation
Lecture 68Introduction to visual aid designing  | V3M Concept | Components of the visual aid page | Component of Visual Aid designing
Lecture 69Practical Training in visual aid designing  | Step By Step Visual Aid Preparation | Creative Designing | Guideline on Proofing | USPs to differentiate the visual aid 
Lecture 70Visual Aid Printing  | Establishing Visual Aid Printing Specs for effective management of the vendors 
Lecture 71Visual Aid Analysis with practical example
Lecture 72Guideline on visual aid development
Lecture 73Interactive Visual Aid | E-detailing | Remote Detailing | Analysis of Animated Video based e-detailing visual aids 
Section 6International Business Development and Licensing
Lecture 74Business Development Job Functionality | Strategic Planning Process | Knowledge Area of Business Development | Lead targeting | Licensing term sheets
Lecture 75Portfolio Management Process | Portfolio Characteristics | Portfolio Analysis | Balancing the Portfolio | BD and Strategic Planning Department 
Lecture 76Identifying the corporate Need of business development | Objective – Strategy - Tactics | Portfolio constraints | SWOT | Numerical SWOT
Lecture 77Profiling and Searching | Objectives | Search Database | Creating Opportunity Anatomy for deal analysis | Mind Mapping | Searching Tools and Techniques - Web Search | Conference | Confidentaility - CDA | MTA
Lecture 78Modelling 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 79Market Size Determination - Market Share | Relative Market Share | Total Vs. Actual Vs. Penetrated Market
Lecture 80Forecasting : Tools and Techniques
Lecture 81Types 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 82Licensing and Technology Transfer
Lecture 83In-Licensing Vs. Outlicensing
Lecture 84Licensing - Advance Learning 
Lecture 85Distribution Licensing | Geography | Indication Splitting | Execlusive and Non-Exclusive Licensing | Sub Licenses
Lecture 86Acquisition in Pharma  | Product Acquisition| Company Acquisitions| Steps in acquisition | Financing acquisition deals | Trademark Assignment Process
Lecture 87Training on Basic Finance  |  Understanding Financial Statment | Income Statement | Balance Sheet | Cash Flow Statement
Lecture 88Training on Valuation Methods: DCF | rNPV | Sunk Cost Method | Comparables | Sum of Parts | Deterministic Vs. Probabilistic rNPV |  Peak Sales - Max-Min Approach
Lecture 89Valuation Methods: EBITDA method of valuation | Enterprise Value and Enterprise Multiple Calculation
Lecture 90Negotiation Skill Training
Lecture 91Business Development Simulation and Decision Making | Early Stage VS. Late Stage Valuation Methodology | Stair Step Model
Lecture 92Licensing Agreement : Confidentiality Agreement | MTA | A deed of Assignment | Exclusive | Non-Exclusive License | Sole License | Components - Terms - Duration - Key Considerations
Lecture 93Step By Step Implementation of Licensing Deal
Lecture 94Due Diligence Activities in Pharmaceutical Licensing
Section 7Final Certification Examination