KPE - C- 024 KPE's Executive Program in Pharmaceutical Global Business • NCK Pharma

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Course Description

Course Objective

Course duration

Features

Eligibility

Important URLs

Course Deliverable

Add on Certification

Related Courses

Executive Program in Pharmaceutical Global Business provides hands on training to enhance skill competency of middle and top level managers. This course suits for the working professionals of pharmaceutical and biopharmaceutical industry. In this self paced learning, one can experience the real life work simulations for pharma and biopharmaceutical industry. Skills which are most necessary for successful in the biopharmaceutical and pharmaceutical competitive landscape is covered in depth.

Code: KPE-C-024
Course Title: KPE’s Advance Diploma in Pharmaceutical Global Business
Type of the course: Self paced Online Course

Course Description

Executive Program in Pharma Global Business is little different from other other management business courses. Other Business Management courses concentrate narrowly on a diverse function or piece of the business—accounting, finance, marketing, production, human resources, or information systems, strategic management. But here it is strategic management
This course focus on the real life working on the whole spectrum of pharmaceutical and bio-pharmaceutical strategic business and management. The center of attention is the total pharma and biopharma enterprise–-the industry and competitive environment in which it operates, its long-term direction and strategy, its resources and competitive capabilities, and its prospects for success.

Key factor

Throughout the course, the spotlight will be trained on the foremost issue in running a pharmaceutical and biopharmaceutical business enterprise: “What must managers do, and do well, to make the pharmaceutical company a winner in the game of business?”

Strategic Orientation

The answer that emerges, and which becomes the theme of the course, is that good strategy-making and good strategy-execution are the key ingredients of company success and the most reliable signs of good management. The mission of the course is to explore why good strategic management leads to good business performance, to present the basic concepts and tools of strategic analysis, and to drill you in the methods of crafting a well-conceived strategy and executing it competently.

You’ll be called on to probe, question, and evaluate all aspects of a company’s external and internal strategic situation. You’ll grapple with sizing up a company’s standing in the marketplace and its ability to go head-to-head with rivals, learn to tell the difference between winning strategies and mediocre strategies, and become more skilled in spotting ways to improve a company’s strategy or its execution. In the midst of all this, another purpose is accomplished: to help you synthesize what you have learned in prior business courses.

KPE’s Executive Program in Pharmaceutical Global Business course in which you’ll see how the various pieces of the business puzzle fit together and why the different parts of a business need to be managed in strategic harmony for the organization to operate in winning fashion.

Objective of the course

The course helps participant to think strategically about a pharmaceutical and Biologic company, its present business position, its long-term direction, its resources and competitive capabilities, the caliber of its strategy, and its opportunities for gaining sustainable competitive advantage.
To develop clear cut understanding on drug discovery to development to commercialization process effectively, to strategise the pharmaceutical business in regulated, semi-regulated and unregulated market.
Executive Program in Pharmaceutical Global Business provides the skill training regarding branding activities and strategic analysis in a variety of competitive situations and, especially, to provide you with a stronger understanding of the competitive challenges of a global pharmaceutical business environment.
To give you hands-on experience in crafting pharmaceutical branding, business strategy, reasoning carefully about strategic options, using what-if analysis to evaluate action alternatives, and making sound strategic decisions.
This Global Pharma Business course helps one to acquaint with the managerial tasks associated with implementing and executing company growth strategies, drill in the range of actions managers can take to promote competent strategy execution, and give you some confidence in being able to function effectively as part of a company’s strategy-implementing team.
The course helps to develop the decision making skills for managers. Therefore, it helps one to learn how to assess business risk, and improve your ability to make sound decisions and achieve effective outcomes.

Course Duration

1 Year from the date of admission.

Features of the course

24×7 self paced online learning – learn at your convenience.
Courses can be accessed at your own convenient time.
Downloadable PDF study modules.
E-lectures for easy understanding of the concepts.
Self assessment concept checkers for each lecture.
Simulation to real life working.
Access to case studies.
Unique personalized course tracking page with course performance analytics.
Flexible online final examination (Computer Based Test by secure mode).
Course certification – Course completion and Course gradation certificate.

Minimum qualification for participation of this course is Graduation in any discipline with more than 24 months of work experience in middle and top management. Work Experience is mandatory for admission into this course.

Import URLs

Admission Process	Learn about the course admission procedure
Course FAQs	Frequently asked questions related to the course
Past performer	Prospect identification process – top performer in course since 2012

Course contains 34 study modules in the form of eBooks. Therefore, you can save the eBooks in your system.
You can download the study modules by login to your dashboard.
Immediately upon admission, course participant can instantly accessing the course.
Executive Program in Global Pharmaceutical Business is online 24×7 learning. Hence, course participants can access the lectures at their own convenience.
While attending lectures, course participant can also download the lecture handout and save for reference.

The participants of Global Business Registrant will get two add on certification.
Participant can choose add on courses of any 1 month or 1 week certification course.
Participant can activate the add on course anytime during 1 year active course duration.
On completion of add on course, participant will be issuing course certificate.
You can activate this add on course anytime during the active 1 year course tenure.

Strategic Management Courses

Course	Department / Functional Area
Pharma Global Business – Executive Program	Strategic Management, BD, Licensing, International Marketing, Product Management, Regulatory department,Top-Middle Management Corporate employees
Business Development and Licensing	Business Development and Licensing
Inlicensing and Outlicensing	BD, In and Outlicensing Department
Pharma Strategic Management	Strategic Management, BD, Licensing, International Marketing, Top-Middle Management Corporate employees
Biopharma Global Business	Biopharma Strategic Management, BD, Licensing, International Marketing, Product Management, Regulatory department, Top-Middle Management Corporate employees.
Market Access	Biopharma Strategic Management, Market Access.
Pharma International Business Management	Export, International Marketing, International Brand Management professionals

Market Access Courses

Course	Department / Functional Area
Market Access & Pricing	PM&A
Pharma Forecasting	PMT

Course Syllabus & Orientation:

Section 1Global Pharmaceutical R&D: Discovery to Development

Lecture 1Drug Regulation Fundamentals

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) Filing

Lecture 6Review on Drug Discovery and Development

Lecture 7Generic Drug User Fees Act (GDUFA)

Lecture 8Prescription Drug User Fees Act (PDUFA)

Lecture 9Handling of orange book

Lecture 10USFDA expedited programs

Lecture 11Practical Training on INDA, NDA, ANDA filing

Lecture 12505(j) ANDA, 505(b)(2) NDA, 505(b)(1) NDA

Lecture 13Authorized Generics: Key Understanding

Lecture 14Exploratory IND Vs. Traditional IND

Lecture 15Patents Vs. exclusivity

Lecture 17Orphan Drug & Orphan Drug Act

Lecture 18Clinical Research : Detailed Understanding

Lecture 19Clinical Trial Protocol Writing

Lecture 20Ethics in Clinical Research

Lecture 21FDA Forms and How to fill the resources

Lecture 22Strategic Discussion: PreIND, EOP1, EOP2 - What to expect !

Lecture 23Advance Learning on 505B2 Pathway

Lecture 24Importance and Significance of Phase 2b Clinical Trial

Lecture 25Informed Consent | Practical Training on Preparing ICF | Templates

Section 2Innovation Management in Pharmaceutical & Biopharmaceutical Industry

Lecture 26Introduction to intellectual Property Management

Lecture 27Introduction to Patent

Lecture 28Patent - Practical on search and filing - USPTO

Lecture 29Trademark - Practical on TM Search & Registration Process - USPTO

Lecture 30Trademark - Practical on TM Search USPTO

Lecture 31IPR - Patent Grant and Handling Process in India

Lecture 32Stages of Patent Grant Procedure

Lecture 33Patent search in Indian Patent Office

Lecture 34Differences in US and European Patent

Lecture 35Patent Claim | Types of Patent Claims

Lecture 36Patent Cliff | How to calculate the patent cliff

Lecture 37Terminologies related to patent, trademark, copyright and licensing

Lecture 38Patent Infringement

Lecture 39Introduction to Trademark | Trademark filing procedure

Lecture 40Trademark Searching Process | EUIPO Searching | USPTO Searching | IPINDIA Searching

Lecture 41Trademark Infringement | Passing off | Practical Cases

Lecture 42Trademark Classes | How to search the right trademark class for for filing trademark application

Section 3Global Strategic Management

Lecture 43Understanding of Regulatory Strategies

Lecture 44Advance study on Para IV Filing

Lecture 45Para IV Notices

Lecture 46Evergreening - Patent Life Extension Strategies

Lecture 47Pay For Delay Strategy

Lecture 48REMS Strategic Planning

Lecture 49Compulsory Licensing

Lecture 50Licensing & Technology Transfer

Lecture 51In-Licensing Vs. Outlicensing

Lecture 52LOE Strategies for Innovator Brands with case study

Lecture 53Paediatric Exclusivity and Paediatric Study Plan Development

Lecture 54Drug Repurposing

Lecture 55Licensing - Advance Learning

Lecture 56Detailed Understanding on 505(b)(2) VS. Suitability Petition : Case Based Learning

Lecture 57NCE Vs. 505b2 application - Case Based Learning

Lecture 58FTF - 180 Days Exclusivity - Case Based Learning

Lecture 59Classic case study of the 505b2 filing : Case Based Learning

Lecture 60Strategic Planning in Combating 30 months stay strategies of innovator company- Case Based Learning

Lecture 61Pipeline in a Molecule

Lecture 62Emergency Use Authorization (EUA)

Section 4Basic Fundamental of Pharma Production & Plant Management

Lecture 63Definition of GMP

Lecture 64Premises & Plant Layout Designing

Lecture 65Sanitation and Hygiene

Lecture 66Equipment Modules

Lecture 67Production Modules

Lecture 68Documentation

Lecture 69Quality Control

Lecture 70G7 Lecture Product Complaint

Lecture 71G8 Lecture Storage Module

Lecture 72ISO and ISO Audits

Lecture 73CAPA

Section 5Global Business : European Union - Regulatory & Strategic Planning

Lecture 74Introduction to EU Regulation

Lecture 75Orientation to European Countries and National Regulatory Bodies

Lecture 76Orientation to European Countries and National Regulatory Bodies

Lecture 77Overview of EU Regulation

Lecture 78EMA and EMA Authorisation Process

Lecture 79Summary of Product Characteristics

Lecture 80Compassionate Use

Lecture 81EU MA Strategic Planning: Full, Full-mixed, hybrid applications. Generic, Similar biologic application pathway, Well-established use application, Fixed combination application, Informed consent application

Lecture 82Validity 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 83Data Exclusivity and Market Protection - Supplementary Patent Protection, Exclusivity, 6/10 Rule, 8+2+1 Formulae

Lecture 84EU Orphan Medicinal Products Regulation

Lecture 85Conditional marketing authorisation | Marketing authorisation under exceptional circumstances

Lecture 86Paediatric use marketing authorisation (PUMA) & Paediatric Investigation Plan (PIP)

Lecture 87Summary of Product Characteristics

Lecture 88Compassionate Use

Lecture 89MHRA - UK Regulation

Lecture 90The 'sunset clause' for marketing authorisation of pharmaceuticals

Lecture 91EU variation - Types, Requirement & Planning - IA, IAIN, IB, II ; US FDA Variation AR, CBE-0, CBE-30, PAS - Strategic Discussion | Similarities & Differentiation

Lecture 92EU Prime Designation

Lecture 93Accelerated assessment by EMEA

Lecture 94EU Adaptive Pathway

Lecture 95European public assessment report (EPAR) - Importance, Component, Management, Updation

Lecture 96SPOR - Concept of Master Data Management

Section 6Biopharmaceutical - Regulatory and Strategic Management

Lecture 97Introduction : Biopharmaceuticals

Lecture 98Classification of Biopharmaceutical

Lecture 99Introduction to Biosimilar

Lecture 100Chemical Drugs Vs. Biologic Drugs

Lecture 101Principle of Naming of Biologics

Lecture 102Current Trends in Biopharmaceutical Market

Lecture 103Global Biologics Market – By Product

Lecture 104Market Share of Different Class of Biopharmaceuticals

Lecture 105Blockbuster Biologic - Classifications, Indications, Global Sales

Lecture 106Recombinant protein

Lecture 107Monoclonal Antibodies Vs. Polyclonal Antibodies

Lecture 108Monoclonal Antibodies

Lecture 109Synthetic Immunomodulators

Lecture 110Production of Monoclonal Antibodies

Lecture 111Cytokines

Lecture 112Interferon

Lecture 113Erythropoiesis-stimulating agent

Lecture 115Abbreviated Biosimilar Application - 351(k): Advance Strategic Planning Process : Originator Vs. Biosimilar Development and Regulatory Approval Process | Reference Biologic | Purple Book | Data Requirements

Lecture 116Purple Book: Significance | Searching | Assignments

Lecture 117Biosimilar Development Process

Lecture 118Strategic Consideration for Biosimilar Development

Lecture 119Bio-Manufacturing Process Information

Lecture 120Studies required for approval of biosimilar

Section 7Drug Registration Dossier

Lecture 121MA Submission Dossier Management

Lecture 122CMC Dossier & Compliance Management

Lecture 123Introduction to Electronic Common Technical Document (ECTD)

Lecture 124Advance Practical Training on Dossier Preparation focusing on drug registration in export countries

Lecture 125Modules on Stability Study 1

Lecture 126Importance of effective dossier management

Lecture 127Certificate of Analysis

Lecture 128Detailed Understanding on ANDA Submission Dossier

Lecture 129Prior Approval Submission

Lecture 130Detailed Understanding on ANDA Fees

Lecture 131Discussion on 85 common deficiency in CTD submission dossier

Lecture 132Key Consideration for Drug Master File Preparation and Submission

Lecture 133Practical Understanding on Drug Master File Preparation and Submission

Lecture 134Associated Learning: Site Master File - Detailed Understanding

Lecture 135DMF Completeness Assessment

Lecture 136Drug Master File - Fees

Lecture 137Drug Master File - Global Perspective [Across Different Regions]

Lecture 138Site Master File

Section 8Plant Inspection and Audit Handling

Lecture 139Data Integrity issues in Pharmaceutical Industry

Lecture 140Establishment Inspection Report | 483 Observations | USFDA Warning Letter | Handling of FDA inspection | Closing of Warning Letter

Lecture 141CAPA

Section 9Introduction to Pharma Brand Manager

Lecture 142Pharma Product Management

Lecture 143Detailed Understanding of Product Management Job

Lecture 144Classification of Doctors

Section 10Marketing Orientation for Business Manager

Lecture 145Marketing Orientation for Product Manager

Lecture 146Why Is Market Research Important in Pharmaceutical Business?

Lecture 147Product Life cycle

Lecture 148Advance - Strategic Planning in Product Life cycle Management

Lecture 149Segmentation

Lecture 150Pricing

Lecture 151Distribution Channel in Pharmaceutical Industry

Lecture 152A Pharmaceutical Segmentation outlook

Lecture 153Promotion in Pharmaceutical Industry : Communication Model, Effective promotional communication, Push Vs. Pull Strategy and Buying Decision Process

Lecture 154Practical understanding on Prescription Accelerating Materials used in pharmaceutical promotion

Lecture 155Setting and Quantifying Promotional Objectives

Lecture 156Break even analysis

Lecture 157Method of Promotional Budgeting

Lecture 158Basics of Advertising

Lecture 159The Advertising agency

Lecture 160Brand Recall | Brand Recognition |Top of mind - How to calculate brand recall value?

Lecture 161Advertising Planning - ATL, BTL, TTL activities

Lecture 162Target Audiences for Pharma Promotion : Types and Specialization

Lecture 163Business segments of Pharmaceutical Companies

Lecture 164Target Audience Selection Based on Products

Section 11Practical Training on Pharma Brand Logo Development

Lecture 165Brand Logo - Introduction

Lecture 166Purpose of Brand Logo

Lecture 167Component of Brand Logo

Lecture 168Trademark Registration

Lecture 169Trademark - Practical on TM Search

Lecture 170Trademark Search assignment

Lecture 171How to design excellent brand logo?

Lecture 172How to design excellent brand logo?

Lecture 173Color Systems - RGB & CMYK

Lecture 174Few Case Studies related to brand names and logos

Lecture 175Brand Logo - Simulation

Lecture 176Colour Trademarking in Pharma Branding

Lecture 177How to protect pharma brands globally?

Lecture 178Rebranding in Pharmaceuticals

Lecture 179Brand Logo Development: Real Life Simulation

Lecture 180Brand Tagline - Punchline

Lecture 181Pharma Brand Name Generator

Section 12Advance Pharma Brand Management - 1

Lecture 182Fundamental of Pharma Marketing Plan

Lecture 183Basic Understanding how to launch a pharmaceutical product into the market

Lecture 184Practical Training on Marketing Plan Preparation with real life example

Lecture 185Marketing Campaign Development : Importance of Target Audience Segmentation for effective targeting

Lecture 186New Product Launch Framework

Lecture 187Sectional Development of Marketing Plan

Lecture 188Decide about brand USP -What to promote

Lecture 189Sample Marketing Plan

Lecture 190How to prepare promotogram. Download sample Promotogram

Lecture 191Importance and Handling of Cycle Meeting and its importance

Lecture 192Brand Launch Case Study

Lecture 193Aristada - Launch Case Study

Lecture 194CSR Campaign

Lecture 195Cost Based Working for Sample Allocation

Lecture 196Increase the brand reach with advance segmentation

Lecture 197Concept of uniform branding for better brand acceptability

Lecture 198Concept of Brand Differentiation

Lecture 199Brand Plan to Marketing Campaign - Objective setting to effective execution

Section 13Digital Pharma Marketing

Lecture 200Pharma Packaging Case Studies

Lecture 201Inbound and outbound marketing in pharma | Types of inbound and outbound marketing

Lecture 203Digital 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 204Digital marketing strategy development | Planning process | E-Marketing Plan | Planning for MNC Vs. Start Up | Strategic Outcome measurement

Lecture 205Relationship marketing using digital platform | CRM | Concept of permission marketing | User Satisfaction and loyalty management | Feedback mechanism

Lecture 207Search Engine Optimization | Search Engine Marketing | Social Media Marketing

Lecture 208Web Analytics - Tool and Implementation

Lecture 209Web Host - Check the hosting details

Lecture 210Page Speed- importance and practical understanding | Check the web speed

Lecture 211Keyword | Keyword Planning for SEO and SEM | Keyword Planner

Lecture 212Mobile Responsive | Tracking the Site

Lecture 213HCP sites and Patient Site

Lecture 214Google Ad - Practical Training on Campaign Development and Execution

Lecture 215Digital Marketing Strategies for innovator brand | Pre launch - comuing soon, DSE Marketing | Launch activities - Day of approval (DOA) site | FDA Compliance | FDA 2253 Filing

Lecture 216Brand Portal Development

Lecture 217Relationship Marketing : KOL Management and Patient Advocacy Group

Lecture 218Public Relation - PR firm | PR Campaign | Press Release | Technical understanding of press release writing | Digital Press Release

Lecture 219Developing Ad - Pharmaceutical Prescription, OTC Vs FMCG Brands

Lecture 220Difference between FMCG and OTC Brand Ad

Lecture 221Digital Marketing Techniques

Lecture 222Video Marketing

Lecture 223Video Marketing Techniques For Small Business Owners

Lecture 224Promoting Brand through Article Advertising and Marketing

Section 14Analytics

Lecture 225Moving Average | Moving Annual Total | YTD | How to calculate

Lecture 226Compound Annual Growth Rate | CAGR Calculation

Lecture 227Analytical Approach in Determining Brand Potential with case study

Lecture 228Training on Basic Finance | Understanding Financial Statement | Income Statement | Balance Sheet | Cash Flow Statement

Section 15Export Documentations

Lecture 229Introduction to Pharmaceutical Export

Lecture 230Introduction of Export Documentation | Understanding of important terminologies

Lecture 231Proforma Invoice - Detailed understanding how to prepare Proforma Invoice

Lecture 232Export Contract | Importance | Considerations | Things to include in Export Contract

Lecture 233Commercial Invoice | Importance | Differences with Proforma Invoice

Lecture 234Custom House Agent | Role, Responsibilities, How they work | Freight Forwarder - Difference with CHA | Case Study

Lecture 236Bank Guarantee (BG) | How BG works | Differences between BG and LC | Applicability of BG

Lecture 237LC Discounting | How it works | How to calculate the LC discounting

Lecture 238Packing List | Importance | Things to include in packing list

Lecture 239Incoterms | 2020 Incoterms | Practical understanding on different types of Incoterms | Choosing the right incoterm

Lecture 240Logical selection of Incoterms | Landing in right incoterms for your business

Lecture 242Transport Documents | Bill of Lading | Different Types of Bill of Lading | Airway Bill

Section 16Project & Portfolio Management

Lecture 244Introduction: Project Management

Lecture 245Difference between Project and Program

Lecture 246Role and Responsibility of Project Leader

Lecture 247Project Constraint & Effective management of Project Constraint | Role of Project Manager

Lecture 248Key to Project Success

Lecture 249Review Test

Lecture 250PERT, CPM, Critical Path, Project Diagram and its components

Lecture 251Project Tracking in Drug Discovery Projects

Lecture 252Project Benchmarking through a Consortium

Lecture 253Cycle Times (Stage or phase lengths)

Lecture 254The proof of concept (POC) milestone in pharma Drug Development Projects

Lecture 255What is a milestone chart?

Lecture 256Project Termination and Project Reinitiation

Lecture 257Asset Tracking

Lecture 258Levels of Project and Portfolio Management

Lecture 259Functions of Portfolio Management Team

Lecture 260Importance of Periodic Portfolio Reviews

Lecture 261Portfolio Prioritization

Section 17Business Development Skill Training

Lecture 262Pharma Business Development Job Functionality | Strategic Planning Process | Knowledge Area of Business Development | Lead targeting | Licensing term sheets

Lecture 263Portfolio Management Process | Portfolio Characteristics | Portfolio Analysis | Balancing the Portfolio | BD and Strategic Planning Department

Lecture 264Identifying the corporate Need of business development | Objective – Strategy - Tactics | Portfolio constraints | SWOT | Numerical SWOT

Lecture 266Numerical SWOT Practical training

Lecture 268Market Size Determination - Market Share | Relative Market Share | Total Vs. Actual Vs. Penetrated Market

Lecture 269Forecasting : Tools and Techniques

Lecture 270Market Sizing & Forecasting Case Study

Lecture 272Average Royalty Rates

Lecture 273Factor affecting the Royalty Rate in Pharmaceutical and Biopharmaceutical Deal

Lecture 274Distribution Licensing | Geography | Indication Splitting | Execlusive and Non-Exclusive Licensing | Sub Licenses

Lecture 276Join Ventures in Pharmaceutical and Biopharmaceutical Industry

Lecture 277SPECIAL PURPOSE VEHICLES (SPV)

Lecture 278Indication Splitting | Concept | Implementation feasibility analysis

Lecture 279Types of Deals from Discovery to Commerialication

Lecture 280Review: What are the fundamental areas of business development

Lecture 281Licensing Term Sheet | Content Structuring | Sample Term Sheet

Lecture 282Licensing Payment Scheduling: Different Types

Lecture 284Valuation Methods: EBITDA method of valuation | Enterprise Value and Enterprise Multiple Calculation

Lecture 285Negotiation Skill Training for Business Development and Strategic Management Professionals

Lecture 286Business Development Simulation and Decision Making | Early Stage VS. Late Stage Valuation Methodology | Stair Step Model

Lecture 288Step By Step Implementation of Licensing Deal by Business Development Team

Lecture 289Due Diligence Activities in Pharmaceutical Licensing

Lecture 290Pharma Business Development - Competency Test. Check your competency

Lecture 291Co-promotion & Co-marketing strategy in pharma industry

Lecture 292Concept of Reverse co-promotion in pharma industry

Lecture 293Importance of Publications in Pharmaceutical Industry

Lecture 294Juxtapid Case Study

Lecture 295New Indication Approval Process and Promotion

Section 18GCC - Pharma Business

Lecture 296GCC Pharma Market

Lecture 297Export to GCC Market

Lecture 298Drug Registration in Saudi Arabia

Lecture 299Drug Registration in UAE

Lecture 300Drug Registration in Kuwait

Lecture 301Drug Registration in Bahrain

Lecture 302Drug Registration in Oman

Lecture 303Documentation Required for the GCC countries

Lecture 304Comparison of the GCC Registration Requirement with other Regulatory Agencies

Section 19Pharma Business Africa

Lecture 305African Continent Overview

Lecture 306African Pharma Market

Lecture 307Drug Registration - African medicines regulatory

Lecture 308Basic Export Requirement for African Countries

Lecture 309Export Documentations & Important Concepts

Lecture 310Nigeria - Drug Registration

Lecture 311Drug Registration in Algeria

Lecture 312Drug Registration in Ethiopia

Lecture 313Drug Registration in Kenya

Lecture 314Drug Registration in Egypt

Lecture 315Drug Registration in Ghana

Lecture 316Drug Registration in Botswana

Lecture 317Drug Registration in Uganda

Lecture 318Drug Registration in Sudan

Lecture 319Drug Registration in Morocco

Lecture 320Drug Registration and Regulation in Zimbabwe

Lecture 321Drug Registration and Regulation in Senegal

Lecture 322Drug Registration in Tanzania

Lecture 323Drug Registration in Namibia

Lecture 324Drug Registration in South Africa

Lecture 325Drug Registration in Zambia

Lecture 326Drug Registration in South Africa

Section 20Latam Pharma Market

Lecture 327Introduction to Latam

Lecture 328Drug Registration and Regulation in Argentina

Lecture 329Drug Registration and Regulation in Bolivia

Lecture 330Drug Registration and Regulation in Brazil

Lecture 331Drug Registration and Regulation in CHILE

Lecture 332Drug Registration and Regulation in Colombia

Lecture 333Drug Registration and Regulation in Mexico

Section 21ASEAN Pharma Market - BD & Regulatory Requirements

Lecture 334Introduction to ASEAN - Drug Regulatory Affairs

Lecture 335The ASEAN Region

Lecture 336ASEAN countries drug regulatory bodies

Lecture 337ACTRs | ACTD requirements | Other Key Factors specific to individual ASEAN countries

Lecture 338The Pharmaceutical Inspection Co-operation Scheme

Lecture 339CPP Requirements for Drug Registration in ASEAN countries

Lecture 340Dossier Requirements - ACTD/CTD Acceptability

Lecture 341Pharmacopoeias Acceptability

Lecture 342Harmonization of Technical Guidelines

Lecture 343Stability Study requirements for drug registration in ASEAN countries

Lecture 344Product Labelling

Lecture 345Post Approval Changes (Variations) requirements in ASEAN countries

Lecture 346Pharmacovigilance and Risk Management Plan (RMP)

Lecture 347Timeline of Drug Registration Approval

Lecture 349Drug Registration and Regulation Singapore | Strategic Pathways for Marketing Authorization | Screening, Evaluation of MA applications | Variations Classifications and Management

Lecture 350Drug Registration and Regulation in Cambodia

Lecture 351Drug Registration and Regulation in Brunei

Section 22Other Country and Business Region

Lecture 352Japan

Lecture 353India

Lecture 354China | ***Updated July 2020 DRR & DMR regulation

Lecture 355Australlia

Lecture 356Russsia

KPE – C- 024 KPE’s Executive Program in Pharmaceutical Global Business

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Admission Process

Our on demand courses

introduction

Course Description

Course Objective

Course duration

Features

Eligibility

Important URLs

Course Deliverable

Add on Certification

Related Courses

Course Description

Key factor

Strategic Orientation

Objective of the course

Course Duration

Features of the course

Import URLs

Strategic Management Courses

Market Access Courses

Course Syllabus & Orientation:

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Download Course Catalogue and Request for Demo Access

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Admission Process

Our on demand courses

introduction

Course Description

Course Objective

Course duration

Features

Eligibility

Important URLs

Course Deliverable

Add on Certification

Related Courses

Course Description

Key factor

Strategic Orientation

Objective of the course

Course Duration

Features of the course

Import URLs

Strategic Management Courses

Market Access Courses

Course Syllabus & Orientation: