Pharma Global Management

Introduction

Eligibility

Features

Related Courses

About Pharma Management

pharma global management

Pharma global management course provides hands on training to enhance skill competency of pharmaceutical middle and top level managers. This course ideal for the working professionals of pharmaceutical and biopharmaceutical industry. This comprehensive pharma global management training involves the real life job simulation. Hence, the course provides practical knowledge. Moreover, this course focuses 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 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.

Key details about the course:

Course Code: RYD-080
Title: Executive PG Certification in Pharma Global Management (EPPGM)
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

Any body who wants to acquire pharma strategic management competency should attend the course.

Features of Pharma Global Management Course

This pharma global management covers all aspects of the strategic management from drug discovery development, regulatory, commercialization, marketing, branding, business development and sales.
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 US, EU, Middle East, GCC, MENA, African, ASEAN, Latam, China, Japan, India etc.
Access to Case Studies to learn about the drug commercialization steps. Hence, participants will develop advanced competency on strategic portfolio management.

Few of the similar courses

Career in pharma global management

A career in pharma management is very challenging, but highly rewarding. But at the same time, it opens up lot of opportunities for trained professionals. Companies always look for the trained professionals with relevant experience for the pharma management department. This is because, the strategic management job covers a variety of disciplines. Hence, pharma management professional involved in drug development, discovery, regulatory submission, compliance, clinical trials, quality assurance, drug safety, pharmacovigilance, branding, business development and licensing. So, person who want to be successful in pharma management should have 360 degree knowledge in various domain of pharma business.

Knowledge of the various business regions is important

The pharmaceutical industry is growing at a rapid pace. But there is a rising concern over the safety and efficacy. Hence, the major objective of the pharma management professionals to learn various regional regulatory knowledge. In fact, regional regulatory knowledge will help them to become successful in international business management. Moreover, pharma regulations are evolving and changing every other day. Pharma Management Professionals must have thorough knowledge about the updated regulations. Sound regulatory knowledge helps them to take strategic decision effectively. Therefore, this course is ideal choice for the pharma management course which covers various domain.

About regulatory affairs job>> Learn here

Section 1Pharma R&D Management- Discovery to Development | Strategic Management for US Market

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 7Abbreviated Biosimilar Application - 351(k): Advance Strategic Planning Process : Originator Vs. Biosimilar Development and Regulatory Approval Process | Reference Biologic | Purple Book | Data Requirements

Lecture 8Purple Book: Significance | Searching | Assignments

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 16Orphan Drug Designation

Lecture 17Advance Learning on 505B2 Pathway

Lecture 18Chemistry, Manufacturing & Controls

Lecture 21Clinical Trial Protocol Writing

Lecture 22Ethics in Clinical Research

Lecture 23Informed Consent | Practical Training on preparing ICF | Ready Templates

Lecture 24FDA Forms and How to fill the resources

Lecture 25Strategic Discussion: PreIND, EOP1, EOP2 - What to expect !

Lecture 26Importance and Significance of Phase 2b Clinical Trial

Lecture 27Regulatory Strategies in different phases of Clinical Trial

Lecture 28Para IV Filing - Strategic Insight

Lecture 29Para IV Notices

Lecture 30Evergreening - Patent Life Extension Strategies

Lecture 31Pay For Delay Strategy

Lecture 32REMS Strategic Planning

Lecture 33Compulsory Licensing

Lecture 34Licensing & Technology Transfer

Lecture 35In-Licensing Vs. Outlicensing

Lecture 36LOE Strategies for Innovator Brands with case study

Lecture 37Pediatric Exclusivity and Pediatric Study Plan Development

Lecture 38Drug Repurposing

Lecture 39Advance understanding of the portfolio Management

Lecture 40New Indication Approval Process and Promotion

Lecture 41OTC Switch

Lecture 42Detailed Understanding on 505(b)(2) VS. Suitability Petition : Case Based Learning

Lecture 43NCE Vs. 505b2 application - Case Based Learning

Lecture 44FTF - 180 Days Exclusivity - Case Based Learning

Lecture 45Classic case study of the 505b2 filing : Case Based Learning

Lecture 46Strategic Planning in Combating 30 months stay strategies of innovator company- Case Based Learning

Lecture 47What is meaning of 'Pipeline in a Molecule'?

Lecture 48USFDA Emergency Use Authorization (EUA)

Lecture 49Target product profile (TPP) | Quality Target product profile (QTPP) | Critical Quality Attributes (CQAs) | Quality By Design (QbD)

Lecture 50Fundamental 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 51Review on Drug Discovery and Development

Section 2Strategic Business Management - European Market

Lecture 52Introduction to EU Regulation

Lecture 53Orientation to European Countries and National Regulatory Bodies

Lecture 54EU Drug Discovery Development to Commercialization (Step By Step)

Lecture 55Overview of EU Regulation

Lecture 56EMA and EMA Authorisation Process

Lecture 57EU MA Application Types and Strategic Planning

Lecture 58EU MA Procedure - Centralised, Decentralised, Mutual Recognition, National Procedure

Lecture 59EU MA Strategic Planning: Full, Full-mixed, hybrid applications. Generic, Similar biologic application pathway, Well-established use application, Fixed combination application, Informed consent application

Lecture 60Validity 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 61Data Exclusivity and Market Protection - Supplementary Patent Protection, Exclusivity, 6/10 Rule, 8+2+1 Formulae

Lecture 62EU Orphan Medicinal Products Regulation

Lecture 63Conditional marketing authorisation | Marketing authorisation under exceptional circumstances

Lecture 64Summary of Product Characteristics

Lecture 65Compassionate Use

Lecture 66MHRA - UK Regulation

Lecture 67The 'sunset clause' for marketing authorisation of pharmaceuticals

Lecture 68Paediatric use marketing authorisation (PUMA) & Paediatric Investigation Plan (PIP) - EU Requirments

Lecture 69EU Prime Designation

Lecture 70Accelerated assessment by EMEA

Lecture 71EU Adaptive Pathway

Lecture 72European public assessment report (EPAR) - Importance, Component, Management, Updation

Lecture 73SPOR - Concept of Master Data Management

Section 3Pharma International Business - Product Registration, Plant Certification, Dossier Preparation and Export Documentation

Lecture 74Introduction to Pharmaceutical Export

Lecture 75Introduction of Export Documentation | Understanding of important terminologies

Lecture 76Proforma Invoice - Detailed understanding how to prepare Proforma Invoice

Lecture 77Export Contract | Importance | Considerations | Things to include in Export Contract

Lecture 78Commercial Invoice | Importance | Differences with Proforma Invoice

Lecture 79Custom House Agent | Role, Responsibilities, How they work | Freight Forwarder - Difference with CHA | Case Study

Lecture 81Bank Guarantee (BG) | How BG works | Differences between BG and LC | Applicability of BG

Lecture 82LC Discounting | How it works | How to calculate the LC discounting

Lecture 83Packing List | Importance | Things to include in packing list

Lecture 84Incoterms | 2020 Incoterms | Practical understanding on different types of Incoterms | Choosing the right incoterm

Lecture 85Logical selection of Incoterms | Landing in right incoterms for your business

Lecture 87Transport Documents | Bill of Lading | Different Types of Bill of Lading | Airway Bill

Lecture 88Certification Pharmaceutical Companies / Plants

Lecture 90Introduction 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 91WHO-GMP Certification Scheme

Lecture 92Template of Certificate of Pharmaceutical product | Key observations and points to note while working on CoPP

Lecture 93Certificate of Analysis

Lecture 94Certificate of Origin (COO)

Lecture 95Non-conviction certificate

Lecture 96ISO Certification

Lecture 97Common Technical Document (CTD)

Lecture 98Electronic Common Technical Document (ECTD)

Lecture 99Dossier Preparation focusing on drug registration in export countries

Lecture 100Modules on Stability Study : Stability Study - Fundamental Understanding | Interchangebility | Reports | API & FPP Stability Study

Lecture 101Importance of effective dossier management

Lecture 102Detailed Understanding on ANDA Submission Dossier

Lecture 103Prior Approval Submission

Lecture 104Detailed Understanding on ANDA Fees

Lecture 105Discussion on 85 common deficiency in CTD submission dossier

Lecture 106Introduction 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 107WHO-GMP Certification Scheme

Lecture 108Template of Certificate of Pharmaceutical product | Key observations and points to note while working on CoPP

Section 4Plant Management and Certification | Quality Management

Lecture 109Premises & Plant Layout Designing

Lecture 110Sanitation and Hygiene

Lecture 111Equipment Modules

Lecture 112Production Modules

Lecture 113Documentation

Lecture 114Quality Control

Lecture 115Product Complaint

Lecture 116Storage Module

Lecture 117Pharmaceutical SOPs Management from regulatory perspective

Lecture 118Establishment Inspection Report | 483 Observations | USFDA Warning Letter | Handling of FDA inspection | Closing of Warning Letter

Lecture 119Data Integrity issues in Pharmaceutical Industry

Lecture 120Electronic Batch Record for effective compliance management | Key Understanding | Functionalities | Importance in managing data integrity

Lecture 121Quality Risk Management | ICH Q9 | ISO 14971 | Principle of Risk Management

Section 5HEOR, Market Access & Pricing, Reimbursement, Forecasting

Lecture 122Introduction to Market Access | Objectives | Various Key Terminologies | Steps of Market Access | Understanding on Pricing and Reimbursement

Lecture 123Market Access Functions : Role and Responsibilities | Key Job Areas | Understanding Job Description

Lecture 124Introduction to Health Economics | Key terminologies related to health economics.

Lecture 125HEOR Application in Pharmaceutical and Biopharmaceutical Industry

Lecture 127Economic Evaluation Methods | Various methods | Importance of perspective in health economics | Discounting | Uncertainty

Lecture 132Patient Based Forecasting Model | Applying more filters and variables

Lecture 133QALY | How to calculate QALY | Importance and Significance

Lecture 134ICER | How to calculate ICER | Importance and Significance | Incremental Effectiveness determination

Lecture 135CER and PCOR

Lecture 136Market Access Strategic Planning : Steps and Logical Sequencing for Market Access Strategy Development

Lecture 137Indication Sequencing | Indication Prioritization | Development of Indication Timeline | Indication Matrix | Value Based Indication Prioritization

Lecture 138Market Access Value Dossier : What it is | Significance | Components | What to include

Lecture 139AMCP Market Access Dossier Preparation

Lecture 140Target product profile (TPP) | Quality Target product profile (QTPP) | Critical Quality Attributes (CQAs) | Quality By Design (QbD)

Lecture 141Drug Pricing Methodologies - I

Lecture 142Drug Pricing Methodologies - II

Lecture 144Pharma Market Access Pricing Case Study: interchangeable Pricing

Lecture 145Sales Forecasting in Life Science Industry

Lecture 146New Product Forecast Algorithm

Lecture 147Patient Based Forecasting Model | Applying more filters and variables

Lecture 148Prescription Based Forecasting Model | Differences between Patient Based and Prescription Based Forecasting Model | Which model to use and when?

Lecture 149Prevalence Vs. Incidence Model

Lecture 150EPI Based Forecasting | Sales Based Forecasting | When and where to apply which forecasting model

Lecture 151Sales Forecasting Tools | New Product Forecasting | In Market Forecasting

Lecture 152Market Size Assignment 1 [Oncology Brand] - Applying sales forecasting tools to carry out next 6 years sales forecast | Excel Based Model

Lecture 153Market Size Assignment 2 [Asthma Brand] - Applying sales forecasting tools to carry out multiple years sales forecast | Excel Based Model

Lecture 154Patient Based Model Vs. Patient Flow Model | Critical Differences in Model | Concept of Black Box in Patient Flow Model | Application of both model

Lecture 155Concomitancy and polypharmacy | How it alter the basic forecasting algorithm | Practical Working | Comorbidity

Lecture 157Bottom-up or Top-down Forecasting | LRx | Significance of LRx data analysis

Lecture 158Simulation on Bottom-up forecasting

Lecture 159Assessment on Bottom-up forecasting

Lecture 160Oncology Brand Forecasting

Lecture 161Revenue Forecasting Case Study - Novel Antihypertensive

Lecture 162Portfolio Based Forecasting | Forecasting Model Development in Excel

Lecture 163Evidence Based Decision Making | Combine evidences for decision making | Do we need more evidence?

Lecture 164RWD and RWE | Potential sources of RWE | Traditional RCTs vs. RWE | Case Study - RWE Programs | Influencing HCP decision-making

Lecture 165RWD and RWE in Product Lifecycle Management

Lecture 166RWD and RWE - Fit to use | Assessment

Lecture 167RWD data sources | Different types | Detailed understanding of each class

Lecture 168First-in-class | Best-in-class | Market Access Strategic Decision Making

Lecture 169Forecasting Biosimilar | Key Factors to consider

Lecture 170Consensus Meeting

Lecture 171One Number Vs. Multi Number Forecasting

Lecture 172Active Vs. Passive Cannibalization | Impact on forecasting | Case Study

Lecture 173Rebates | Importance | Factors affecting Rebates | Deductibles and Rebates

Lecture 175Treatment Algorithm and Forecasting : Case Based Learning

Lecture 176Chronic and Acute Segment | Forecasting on Chronic and Acute Segment Drugs

Lecture 177Prescription Value Calculation

Section 6Pharma Global Brand Management

Lecture 178Marketing Orientation

Lecture 179Why Is Market Research Important in Pharmaceutical Business?

Lecture 180Market Research - Customer Engagement through feedback mechanism

Lecture 181Product Life cycle

Lecture 182Advance - Strategic Planning in Product Life cycle Management

Lecture 183Segmentation, Targeting and Positioning

Lecture 184A Pharmaceutical Segmentation outlook

Lecture 185Distribution Channel in Pharmaceutical Industry

Lecture 186Promotion in Pharmaceutical Industry : Communication Model, Effective promotional communication, Push Vs. Pull Strategy and Buying Decision Process

Lecture 187Practical understanding on Prescription Accelerating Materials used in pharmaceutical promotion

Lecture 188Method of Promotional Budgeting

Lecture 189Brand Recall | Brand Recognition |Top of mind - How to calculate brand recall value?

Lecture 190Advertising - Introduction | Objective | Types of Advertising

Lecture 191ATL, BTL & TTL Advertising

Lecture 192Advertising Agency - Understanding on various types of advertising agency

Lecture 193Selection of Advertising Agency

Lecture 194What is creative Briefing? How to Prepare !

Lecture 195Creative Briefing - Practical Simulation

Lecture 196Request for Proposal | Concepts in advertising

Lecture 197Advertising Message Strategy Development and Evaluation

Lecture 198Creative Approach and Styles

Lecture 199Steps of Development of Creatives

Lecture 200Advertisement Copy Development

Lecture 201How to prepare Ad Campaign Step By Step

Lecture 202Brand Name | Brand Logo | Designing of Brand Logo | Trademarking

Lecture 203Advance Understanding of Pharmaceutical Brand Logo Development

Lecture 204Component of Brand Logo

Lecture 205Brand Name and Trademark Registration Process

Lecture 206Trademark Searching Process | Hands on Practical Training

Lecture 207How to design an excellent brand logo : Tricks of the trade

Lecture 208Logo colour theme | Colour system | Colour coding | Significance of colour

Lecture 209Few Case Studies related to brand names and logos

Lecture 210Can one innovator company keep 2 or more brand name?

Lecture 211Traditional Vs. Non-Traditional trademark | Significance of Colour in Pharma Branding

Lecture 212Global Trademarking : Brand Protection Globally

Lecture 213Logo Rebranding - Reasons | Practical Examples | How to handle logo rebranding | Forced Rebranding

Lecture 214Brand Logo Development: Real Life Simulation

Lecture 215Tagline - Development, Finalization and Protection

Lecture 216Pharma Brand Name Generator

Lecture 217Fundamental of Pharma Marketing Plan

Lecture 218Basic Understanding how to launch a pharmaceutical product into the market

Lecture 219Practical Training on Marketing Plan Preparation with real life example

Lecture 220Marketing Campaign Development : Importance of Target Audience Segmentation for effective targeting

Lecture 221Sample Marketing Plan

Lecture 222Decide about brand USP -What to promote

Lecture 223How to prepare promotogram. Download sample Promotogram

Lecture 224Importance and Handling of Cycle Meeting and its importance

Lecture 225Sample Marketing Plan

Lecture 226Sample Marketing Plan

Lecture 227Sample Marketing Plan

Lecture 228CSR Campaign

Lecture 229Increase the brand reach with advance segmentation

Lecture 230Concept of uniform branding for better brand acceptability

Lecture 231Concept of Brand Differentiation

Lecture 232Introduction to visual aid designing | V3M Concept | Components of the visual aid page

Lecture 233Practical Training in visual aid designing | Step By Step Visual Aid Preparation | Creative Designing | Guideline on Proofing | USPs to differentiate the visual aid

Lecture 234Visual Aid Printing | Establishing Visual Aid Printing Specs for effective management of the vendors

Lecture 235Visual Aid Analysis with practical example

Lecture 236Guideline on visual aid development

Lecture 237Marketing Plan followed by Visual Aid Development

Lecture 238Visual Aid, Literature reference Sample

Lecture 239Interactive Visual Aid | E-detailing | Remote Detailing | Analysis of Animated Video based e-detailing visual aids

Lecture 240Visual aid detailing story writing

Lecture 241Artwork Development Process in PMT Department

Lecture 242Product List and Reminder card development

Lecture 243Catch Cover Development

Lecture 244Packaging Development

Lecture 245Prescribing Information and Patient Information Leaflet development

Lecture 246Pharma Packaging Case Studies

Lecture 247DHCP letter

Lecture 248Product Packshot Designing : Practical Knowledge

Lecture 249Creativity to develop brand essence

Lecture 250Advance Training on Pharmaceutical Packaging - Creative Packaging for Brand Differentiation

Lecture 251Unique identifier & anti-tampering device on outer packaging

Section 7Business Development | Licensing

Lecture 252Training on Basic Finance | Understanding Financial Statment | Income Statement | Balance Sheet | Cash Flow Statement

Lecture 253Moving Average | Moving Annual Total | YTD | How to calculate

Lecture 254Compound Annual Growth Rate | CAGR Calculation

Lecture 255Business Development Job Functionality | Strategic Planning Process | Knowledge Area of Business Development | Lead targeting | Licensing term sheets

Lecture 256Portfolio Management Process | Portfolio Characteristics | Portfolio Analysis | Balancing the Portfolio | BD and Strategic Planning Department

Lecture 257Identifying the corporate Need of business development | Objective – Strategy - Tactics | Portfolio constraints | SWOT | Numerical SWOT

Lecture 259Numerical SWOT Practical training

Lecture 261Market Size Determination - Market Share | Relative Market Share | Total Vs. Actual Vs. Penetrated Market

Lecture 262Forecasting : Tools and Techniques

Lecture 263Market Sizing & Forecasting Case Study

Lecture 265Average Royalty Rate

Lecture 266Factor affecting the Royalty Rate in Pharmaceutical and Biopharmaceutical Deal

Lecture 267Distribution Licensing | Geography | Indication Splitting | Exclusive and Non-Exclusive Licensing | Sub Licenses

Lecture 269Joint Ventures in Pharmaceutical and Biopharmaceutical Industry

Lecture 270SPECIAL PURPOSE VEHICLES (SPV)

Lecture 271Indication Splitting | Concept | Implementation feasibility analysis

Lecture 272Types of Deals from Discovery to Commercialization

Lecture 273What are the fundamental areas of business development

Lecture 274Licensing Term Sheet | Content Structuring | Sample Term Sheet

Lecture 275Licensing Payment Scheduling: Different Types

Lecture 277Valuation Methods: EBITDA method of valuation | Enterprise Value and Enterprise Multiple Calculation

Lecture 278Negotiation 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 279Business Development Simulation and Decision Making | Early Stage VS. Late Stage Valuation Methodology | Stair Step Model

Lecture 281Benchmarking | Benchmarking through consortium | How to use benchmarking for drug discovery development projects

Section 8Pharma Digital Marketing

Lecture 282Introduction to Digital Marketing

Lecture 283Inbound and outbound marketing in pharma | Types of inbound and outbound marketing

Lecture 285Digital 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 286Digital marketing strategy development | Planning process | E-Marketing Plan | Planning for MNC Vs. Start Up | Strategic Outcome measurement

Lecture 287Relationship marketing using digital platform | CRM | Concept of permission marketing | User Satisfaction and loyalty management | Feedback mechanism

Lecture 289Search Engine Optimization | Search Engine Marketing | Social Media Marketing

Lecture 290Web Host - Check the hosting details

Lecture 291Page Speed- importance and practical understanding | Check the web speed

Lecture 292Keyword | Keyword Planning for SEO and SEM | Keyword Planner

Lecture 293Mobile Responsive | Tracking the Site

Lecture 294HCP sites and Patient Site

Lecture 295Google Ad - Practical Training on Campaign Development and Execution

Lecture 296Digital Marketing Strategies for innovator brand | Pre launch - comuing soon, DSE Marketing | Launch activities - Day of approval (DOA) site | FDA Compliance | FDA 2253 Filing

Lecture 297Brand Portal Development

Lecture 298Relationship Marketing : KOL Management and Patient Advocacy Group

Lecture 299Public Relation - PR firm | PR Campaign | Press Release | Technical understanding of press release writing | Digital Press Release

Lecture 300Developing Ad - Pharmaceutical Prescription, OTC Vs FMCG Brands

Lecture 301Difference between FMCG and OTC Brand Ad

Lecture 302Digital Marketing Techniques

Lecture 303Video Marketing

Lecture 304Video Marketing Techniques For Small Business Owners

Lecture 305Promoting Brand through Article Advertising and Marketing

Section 9Regional Business Development : Africa

Lecture 306African Continent Overview - Brief introduction

Lecture 307African Pharma Market

Lecture 308Drug Registration - African medicines regulatory

Lecture 309Basic Export Requirement for African Countries

Lecture 310Export Documentations & Important Concepts

Lecture 311Nigeria - Drug Registration

Lecture 312Drug Registration in Algeria

Lecture 313Drug Registration in Ethiopia

Lecture 314Drug Registration in Kenya

Lecture 315Drug Registration in Egypt

Lecture 316Drug Registration in Ghana

Lecture 317Drug Registration in Botswana

Lecture 318Drug Registration in South Africa

Lecture 319Drug Registration in Zambia

Lecture 320Drug Registration in Namibia

Lecture 321Drug Registration in Tanzania

Lecture 322Drug Registration Senegal

Lecture 323Drug Registration in Zimbabwe

Lecture 324Drug Registration in Uganda

Lecture 325Drug Registration in Morocco

Lecture 326Drug Registration in Sudan

Section 10Regional Business Development : GCC, Middle East and MENA

Lecture 327Middle East / MENA / GCC Countries Geographical Orientation

Lecture 328Middle East / MENA / GCC Countries National Regulatory Agencies

Lecture 329GCC Registration Procedure - Centralized and Decentralized Procedure | Detailed understanding on Centralized Registration Process

Lecture 330Drug Registration in Saudi Arabia

Lecture 331Drug Registration in UAE

Lecture 332Drug Registration and Regulatory Strategic Planning for Iran

Lecture 333Drug Registration and Regulatory Strategic Planning for Israel

Lecture 334Middle East Pharma Market

Lecture 335Drug Registration in Jordan

Lecture 336Drug Registration in Palestine

Section 11Regional Business Development : ASEAN

Lecture 337ASEAN - Region - Introduction

Lecture 338ASEAN Countries | Introduction | Geographical Overview

Lecture 339ASEAN countries drug regulatory bodies

Lecture 340ASEAN Common Technical Requirements (ACTRs)

Lecture 341The Pharmaceutical Inspection Co-operation Scheme

Lecture 342CPP Requirements for Drug Registration in ASEAN countries

Lecture 343Dossier Requirements - ACTD/CTD Acceptability

Lecture 344Pharmacopoeias Acceptability

Lecture 345Harmonization of Technical Guidelines

Lecture 346Stability Study requirements for drug registration in ASEAN countries

Lecture 347Product Labelling

Lecture 348Post Approval Changes (Variations) requirements in ASEAN countries

Lecture 349Pharmacovigilance and Risk Management Plan (RMP)

Lecture 350Timeline of Drug Registration Approval

Lecture 352Drug Registration and Regulation Singapore | Strategic Pathways for Marketing Authorization | Screening, Evaluation of MA applications | Variations Classifications and Management

Lecture 353Drug Registration and Regulation in Brunei

Lecture 354Drug Registration and Regulation in Cambodia

Section 12Regional Business Development : Latam

Lecture 355Introduction to Latam Region Pharma Business Development

Lecture 356Drug Registration and Regulation in Argentina

Lecture 357Drug Registration and Regulation in Bolivia

Lecture 358Drug Registration and Regulation in Brazil

Lecture 359Drug Registration and Regulation in Chile

Lecture 360Drug Registration and Regulation in Colombia

Lecture 361Drug Registration and Regulation in Mexico

Section 13Regional Business Development : China

Lecture 362Drug Registration and Regulation in China

Lecture 363NMPA's DDR and DMR update

Section 14References and Case Studies

Lecture 364Comparison of various requirement of drug registration

Lecture 365Comparison of Dossier requirements of US and EU

Lecture 366Comparison of DMF requirement of various regulatory bodies

Section 15Biopharmaceutical Management and Regulation

Lecture 367Introduction : Biopharmaceuticals

Lecture 368Classification of Biopharmaceutical

Lecture 369Important Concept regarding Biopharmaceuticals

Lecture 370Introduction to Biologics and Biosimilar | Key differences | Concept of Reference Product

Lecture 371Key features of Biologic | Differences in Chemical Drug Vs. Biologic Drugs

Lecture 372Principle of Naming of Biologic | Understanding on MAB naming system

Lecture 373Global Biopahrma Market Trends

Lecture 374Recombinant protein

Lecture 375Monoclonal Antibodies Vs. Polyclonal Antibodies

Lecture 376Monoclonal Antibodies

Lecture 377Synthetic Immunomodulators

Lecture 378Production of Monoclonal Antibodies

Lecture 379Cytokines

Lecture 380Interferon

Lecture 381Erythropoiesis-stimulating agent

Lecture 382Vaccine development and approval Process

Lecture 383Biosimilar Development Process

Lecture 384Strategic Consideration for Biosimilar Development

Lecture 385Bio-Manufacturing Process Information

Lecture 386Studies required for approval of biosimilar

Section 16Drug Registration and Regulation in Japan

Lecture 387Introduction to Japan Drug Regulatory Affairs

Lecture 388Drug Discovery Development to commercialization | PMDA functions | Consultation | Premarket to post market approval

Lecture 389Drug Approval System | GCP | PMDA requirements

Section 17Variation Filing : Marketing Authorization variation management

Lecture 390Introduction to Variation Management | Reasons for Variation | Working in Variation Department

Lecture 391Variation Classification | Basis of Classification | US and EU Variation Classification | Other region variation guideline.

Section 18Bioequivalence Study : Requirements

Lecture 392PKPD in Drug Discovery | PK-PD trial | Understanding PKPD from regulatory perspective in drug approval process

Lecture 393Bioequivalence Study | Study design | Different types of BE Studies

Lecture 395Biopharmaceutical Classification System (BCS) | Types | Biowaivers | BCS tool for drug development and regulatory submission

Lecture 396Bioequivalence Study - Discussion - Timeline of stability study and bioequivalence study

Lecture 397Bioequivalence Study - Discussion - Dissolution Testing

Lecture 398Bioequivalence Study - Generic Approval and Additives Labeling Requirements

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Pharma Global Management

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Introduction

Eligibility

Features

Related Courses

About Pharma Management

Who should attend this course?

Key details about the course:

Features of Pharma Global Management Course

Case Based Learning

Few of the similar courses

Career in pharma global management

Knowledge of the various business regions is important

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Download Course Catalogue

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Introduction

Eligibility

Features

Related Courses

About Pharma Management

Who should attend this course?

Key details about the course:

Features of Pharma Global Management Course

Case Based Learning

Few of the similar courses

Career in pharma global management

Knowledge of the various business regions is important