Pharma Global Management

Introduction

Nature of course

Course Duration

Eligibility

Certification

Features

Related Courses

About Pharma Management

Add on Certification

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.

Course Code: RYD-080

Title: Executive PG Certification in Pharma Global Management (EPPGB)

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 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. Hence the course provides
The course provides orientation to job related practical aspects of the business development managers. Therefore, on completion of the course, the participants will develop the hands on understanding how Business Development Professional works.
One of the important feature of the course is real life simulation on critical decision making process. Hence, these simulations help to enhance the licensing and decision making skills which is the core aspects of the pharmaceutical management working.

Case Based Learning

Advance training on strategic management based on the various business regions.
Course covers regional business development requirements specific to 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

pharma global management course offer

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 / 3 Days certification course. One can choose the desire course from following course list.
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.

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

Section 6Pharma Global Brand Management

Lecture 173Marketing Orientation

Lecture 174Why Is Market Research Important in Pharmaceutical Business?

Lecture 175Market Research - Customer Engagement through feedback mechanism

Lecture 176Product Life cycle

Lecture 177Advance - Strategic Planning in Product Life cycle Management

Lecture 178Segmentation, Targeting and Positioning

Lecture 179A Pharmaceutical Segmentation outlook

Lecture 180Distribution Channel in Pharmaceutical Industry

Lecture 181Promotion in Pharmaceutical Industry : Communication Model, Effective promotional communication, Push Vs. Pull Strategy and Buying Decision Process

Lecture 182Practical understanding on Prescription Accelerating Materials used in pharmaceutical promotion

Lecture 183Method of Promotional Budgeting

Lecture 184Brand Recall | Brand Recognition |Top of mind - How to calculate brand recall value?

Lecture 185Advertising - Introduction | Objective | Types of Advertising

Lecture 186ATL, BTL & TTL Advertising

Lecture 187Advertising Agency - Understanding on various types of advertising agency

Lecture 188Selection of Advertising Agency

Lecture 189What is creative Briefing? How to Prepare !

Lecture 190Creative Briefing - Practical Simulation

Lecture 191Request for Proposal | Concepts in advertising

Lecture 192Advertising Message Strategy Development and Evaluation

Lecture 193Creative Approach and Styles

Lecture 194Steps of Development of Creatives

Lecture 195Advertisement Copy Development

Lecture 196How to prepare Ad Campaign Step By Step

Lecture 197Brand Name | Brand Logo | Designing of Brand Logo | Trademarking

Lecture 198Advance Understanding of Pharmaceutical Brand Logo Development

Lecture 199Component of Brand Logo

Lecture 200Brand Name and Trademark Registration Process

Lecture 201Trademark Searching Process | Hands on Practical Training

Lecture 202How to design an excellent brand logo : Tricks of the trade

Lecture 203Logo colour theme | Colour system | Colour coding | Significance of colour

Lecture 204Few Case Studies related to brand names and logos

Lecture 205Can one innovator company keep 2 or more brand name?

Lecture 206Traditional Vs. Non-Traditional trademark | Significance of Colour in Pharma Branding

Lecture 207Global Trademarking : Brand Protection Globally

Lecture 208Logo Rebranding - Reasons | Practical Examples | How to handle logo rebranding | Forced Rebranding

Lecture 209Brand Logo Development: Real Life Simulation

Lecture 210Tagline - Development, Finalization and Protection

Lecture 211Pharma Brand Name Generator

Lecture 212Fundamental of Pharma Marketing Plan

Lecture 213Basic Understanding how to launch a pharmaceutical product into the market

Lecture 214Practical Training on Marketing Plan Preparation with real life example

Lecture 215Marketing Campaign Development : Importance of Target Audience Segmentation for effective targeting

Lecture 216Sample Marketing Plan

Lecture 217Decide about brand USP -What to promote

Lecture 218How to prepare promotogram. Download sample Promotogram

Lecture 219Importance and Handling of Cycle Meeting and its importance

Lecture 220Sample Marketing Plan

Lecture 221Sample Marketing Plan

Lecture 222Sample Marketing Plan

Lecture 223CSR Campaign

Lecture 224Increase the brand reach with advance segmentation

Lecture 225Concept of uniform branding for better brand acceptability

Lecture 226Concept of Brand Differentiation

Lecture 227Introduction to visual aid designing | V3M Concept | Components of the visual aid page

Lecture 228Practical Training in visual aid designing | Step By Step Visual Aid Preparation | Creative Designing | Guideline on Proofing | USPs to differentiate the visual aid

Lecture 229Visual Aid Printing | Establishing Visual Aid Printing Specs for effective management of the vendors

Lecture 230Visual Aid Analysis with practical example

Lecture 231Guideline on visual aid development

Lecture 232Marketing Plan followed by Visual Aid Development

Lecture 233Visual Aid, Literature reference Sample

Lecture 234Interactive Visual Aid | E-detailing | Remote Detailing | Analysis of Animated Video based e-detailing visual aids

Lecture 235Visual aid detailing story writing

Lecture 236Artwork Development Process in PMT Department

Lecture 237Product List and Reminder card development

Lecture 238Catch Cover Development

Lecture 239Packaging Development

Lecture 240Prescribing Information and Patient Information Leaflet development

Lecture 241Pharma Packaging Case Studies

Lecture 242DHCP letter

Lecture 243Product Packshot Designing : Practical Knowledge

Lecture 244Creativity to develop brand essence

Lecture 245Advance Training on Pharmaceutical Packaging - Creative Packaging for Brand Differentiation

Lecture 246Unique identifier & anti-tampering device on outer packaging

Section 7Business Development | Licensing

Lecture 247Training on Basic Finance | Understanding Financial Statment | Income Statement | Balance Sheet | Cash Flow Statement

Lecture 248Moving Average | Moving Annual Total | YTD | How to calculate

Lecture 249Compound Annual Growth Rate | CAGR Calculation

Lecture 250Business Development Job Functionality | Strategic Planning Process | Knowledge Area of Business Development | Lead targeting | Licensing term sheets

Lecture 251Portfolio Management Process | Portfolio Characteristics | Portfolio Analysis | Balancing the Portfolio | BD and Strategic Planning Department

Lecture 252Identifying the corporate Need of business development | Objective – Strategy - Tactics | Portfolio constraints | SWOT | Numerical SWOT

Lecture 254Numerical SWOT Practical training

Lecture 256Market Size Determination - Market Share | Relative Market Share | Total Vs. Actual Vs. Penetrated Market

Lecture 257Forecasting : Tools and Techniques

Lecture 258Market Sizing & Forecasting Case Study

Lecture 260Average Royalty Rate

Lecture 261Factor affecting the Royalty Rate in Pharmaceutical and Biopharmaceutical Deal

Lecture 262Distribution Licensing | Geography | Indication Splitting | Exclusive and Non-Exclusive Licensing | Sub Licenses

Lecture 264Joint Ventures in Pharmaceutical and Biopharmaceutical Industry

Lecture 265SPECIAL PURPOSE VEHICLES (SPV)

Lecture 266Indication Splitting | Concept | Implementation feasibility analysis

Lecture 267Types of Deals from Discovery to Commercialization

Lecture 268What are the fundamental areas of business development

Lecture 269Licensing Term Sheet | Content Structuring | Sample Term Sheet

Lecture 270Licensing Payment Scheduling: Different Types

Lecture 272Valuation Methods: EBITDA method of valuation | Enterprise Value and Enterprise Multiple Calculation

Lecture 273Negotiation 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 274Business Development Simulation and Decision Making | Early Stage VS. Late Stage Valuation Methodology | Stair Step Model

Lecture 276Benchmarking | Benchmarking through consortium | How to use benchmarking for drug discovery development projects

Section 8Pharma Digital Marketing

Lecture 277Introduction to Digital Marketing

Lecture 278Inbound and outbound marketing in pharma | Types of inbound and outbound marketing

Lecture 280Digital 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 281Digital marketing strategy development | Planning process | E-Marketing Plan | Planning for MNC Vs. Start Up | Strategic Outcome measurement

Lecture 282Relationship marketing using digital platform | CRM | Concept of permission marketing | User Satisfaction and loyalty management | Feedback mechanism

Lecture 284Search Engine Optimization | Search Engine Marketing | Social Media Marketing

Lecture 285Web Host - Check the hosting details

Lecture 286Page Speed- importance and practical understanding | Check the web speed

Lecture 287Keyword | Keyword Planning for SEO and SEM | Keyword Planner

Lecture 288Mobile Responsive | Tracking the Site

Lecture 289HCP sites and Patient Site

Lecture 290Google Ad - Practical Training on Campaign Development and Execution

Lecture 291Digital Marketing Strategies for innovator brand | Pre launch - comuing soon, DSE Marketing | Launch activities - Day of approval (DOA) site | FDA Compliance | FDA 2253 Filing

Lecture 292Brand Portal Development

Lecture 293Relationship Marketing : KOL Management and Patient Advocacy Group

Lecture 294Public Relation - PR firm | PR Campaign | Press Release | Technical understanding of press release writing | Digital Press Release

Lecture 295Developing Ad - Pharmaceutical Prescription, OTC Vs FMCG Brands

Lecture 296Difference between FMCG and OTC Brand Ad

Lecture 297Digital Marketing Techniques

Lecture 298Video Marketing

Lecture 299Video Marketing Techniques For Small Business Owners

Lecture 300Promoting Brand through Article Advertising and Marketing

Section 9Regional Business Development : Africa

Lecture 301African Continent Overview - Brief introduction

Lecture 302African Pharma Market

Lecture 303Drug Registration - African medicines regulatory

Lecture 304Basic Export Requirement for African Countries

Lecture 305Export Documentations & Important Concepts

Lecture 306Nigeria - Drug Registration

Lecture 307Drug Registration in Algeria

Lecture 308Drug Registration in Ethiopia

Lecture 309Drug Registration in Kenya

Lecture 310Drug Registration in Egypt

Lecture 311Drug Registration in Ghana

Lecture 312Drug Registration in Botswana

Lecture 313Drug Registration in South Africa

Lecture 314Drug Registration in Zambia

Lecture 315Drug Registration in Namibia

Lecture 316Drug Registration in Tanzania

Lecture 317Drug Registration Senegal

Lecture 318Drug Registration in Zimbabwe

Lecture 319Drug Registration in Uganda

Lecture 320Drug Registration in Morocco

Lecture 321Drug Registration in Sudan

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

Lecture 322Middle East / MENA / GCC Countries Geographical Orientation

Lecture 323Middle East / MENA / GCC Countries National Regulatory Agencies

Lecture 324GCC Registration Procedure - Centralized and Decentralized Procedure | Detailed understanding on Centralized Registration Process

Lecture 325Drug Registration in Saudi Arabia

Lecture 326Drug Registration in UAE

Lecture 327Drug Registration and Regulatory Strategic Planning for Iran

Lecture 328Drug Registration and Regulatory Strategic Planning for Israel

Lecture 329Middle East Pharma Market

Lecture 330Drug Registration in Jordan

Lecture 331Drug Registration in Palestine

Section 11Regional Business Development : ASEAN

Lecture 332ASEAN - Region - Introduction

Lecture 333ASEAN Countries | Introduction | Geographical Overview

Lecture 334ASEAN countries drug regulatory bodies

Lecture 335ASEAN Common Technical Requirements (ACTRs)

Lecture 336The Pharmaceutical Inspection Co-operation Scheme

Lecture 337CPP Requirements for Drug Registration in ASEAN countries

Lecture 338Dossier Requirements - ACTD/CTD Acceptability

Lecture 339Pharmacopoeias Acceptability

Lecture 340Harmonization of Technical Guidelines

Lecture 341Stability Study requirements for drug registration in ASEAN countries

Lecture 342Product Labelling

Lecture 343Post Approval Changes (Variations) requirements in ASEAN countries

Lecture 344Pharmacovigilance and Risk Management Plan (RMP)

Lecture 345Timeline of Drug Registration Approval

Lecture 347Drug Registration and Regulation Singapore | Strategic Pathways for Marketing Authorization | Screening, Evaluation of MA applications | Variations Classifications and Management

Lecture 348Drug Registration and Regulation in Brunei

Lecture 349Drug Registration and Regulation in Cambodia

Section 12Regional Business Development : Latam

Lecture 350Introduction to Latam Region Pharma Business Development

Lecture 351Drug Registration and Regulation in Argentina

Lecture 352Drug Registration and Regulation in Bolivia

Lecture 353Drug Registration and Regulation in Brazil

Lecture 354Drug Registration and Regulation in Chile

Lecture 355Drug Registration and Regulation in Colombia

Lecture 356Drug Registration and Regulation in Mexico

Section 13Regional Business Development : China

Lecture 357Drug Registration and Regulation in China

Lecture 358NMPA's DDR and DMR update

Section 14References and Case Studies

Lecture 359Comparison of various requirement of drug registration

Lecture 360Comparison of Dossier requirements of US and EU

Lecture 361Comparison of DMF requirement of various regulatory bodies

Section 15Biopharmaceutical Management and Regulation

Lecture 362Introduction : Biopharmaceuticals

Lecture 363Classification of Biopharmaceutical

Lecture 364Important Concept regarding Biopharmaceuticals

Lecture 365Introduction to Biologics and Biosimilar | Key differences | Concept of Reference Product

Lecture 366Key features of Biologic | Differences in Chemical Drug Vs. Biologic Drugs

Lecture 367Principle of Naming of Biologic | Understanding on MAB naming system

Lecture 368Global Biopahrma Market Trends

Lecture 369Recombinant protein

Lecture 370Monoclonal Antibodies Vs. Polyclonal Antibodies

Lecture 371Monoclonal Antibodies

Lecture 372Synthetic Immunomodulators

Lecture 373Production of Monoclonal Antibodies

Lecture 374Cytokines

Lecture 375Interferon

Lecture 376Erythropoiesis-stimulating agent

Lecture 377Vaccine development and approval Process

Lecture 378Biosimilar Development Process

Lecture 379Strategic Consideration for Biosimilar Development

Lecture 380Bio-Manufacturing Process Information

Lecture 381Studies required for approval of biosimilar

Section 16Drug Registration and Regulation in Japan

Lecture 382Introduction to Japan Drug Regulatory Affairs

Lecture 383Drug Discovery Development to commercialization | PMDA functions | Consultation | Premarket to post market approval

Lecture 384Drug Approval System | GCP | PMDA requirements

Section 17Variation Filing : Marketing Authorization variation management

Lecture 385Introduction to Variation Management | Reasons for Variation | Working in Variation Department

Lecture 386Variation Classification | Basis of Classification | US and EU Variation Classification | Other region variation guideline.

Section 18Bioequivalence Study : Requirements

Lecture 387PKPD in Drug Discovery | PK-PD trial | Understanding PKPD from regulatory perspective in drug approval process

Lecture 388Bioequivalence Study | Study design | Different types of BE Studies

Lecture 390Biopharmaceutical Classification System (BCS) | Types | Biowaivers | BCS tool for drug development and regulatory submission

Lecture 391Bioequivalence Study - Discussion - Timeline of stability study and bioequivalence study

Lecture 392Bioequivalence Study - Discussion - Dissolution Testing

Lecture 393Bioequivalence Study - Generic Approval and Additives Labeling Requirements

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Pharma Global Management

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Introduction

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Certification

Features

Related Courses

About Pharma Management

Add on Certification

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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Introduction

Nature of course

Course Duration

Eligibility

Certification

Features

Related Courses

About Pharma Management

Add on Certification

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