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TypeOnline Course
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Price$890 / 41830 INR.
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pharma global management


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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.

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

  • 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 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 16Orphan Drug Designation 
Lecture 17Advance Learning on 505B2 Pathway
Lecture 18Chemistry, Manufacturing & Controls 
Lecture 19Patent & Exclusivity - Strategic Understanding | Patent Restoration| Orphan Drug Exclusivity (ODE) | NCE & NCI Exclusivity | GAIN Exclusivity | Pediatric Exclusivity | 180 days exclusivity
Lecture 20Clinical Trial : Detailed Understanding
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
Section 2Strategic Business Management - European Market
Lecture 51Introduction to EU Regulation 
Lecture 52Orientation to European Countries and National Regulatory Bodies
Lecture 53EU Drug Discovery Development to Commercialization (Step By Step)
Lecture 54Overview of EU Regulation 
Lecture 55EMA and EMA Authorisation Process
Lecture 56EU MA Application Types and Strategic Planning
Lecture 57EU MA Procedure - Centralised, Decentralised, Mutual Recognition, National Procedure 
Lecture 58EU MA Strategic Planning: Full, Full-mixed, hybrid applications. Generic, Similar biologic application pathway, Well-established use application, Fixed combination application, Informed consent application
Lecture 59Validity 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 60Data Exclusivity and Market Protection - Supplementary Patent Protection, Exclusivity, 6/10 Rule, 8+2+1 Formulae
Lecture 61EU Orphan Medicinal Products Regulation
Lecture 62Conditional marketing authorisation | Marketing authorisation under exceptional circumstances
Lecture 63Summary of Product Characteristics 
Lecture 64Compassionate Use
Lecture 65MHRA - UK Regulation 
Lecture 66The 'sunset clause' for marketing authorisation of pharmaceuticals
Lecture 67Paediatric use marketing authorisation (PUMA) & Paediatric Investigation Plan (PIP) - EU Requirments
Lecture 68EU Prime Designation
Lecture 69Accelerated assessment by EMEA
Lecture 70EU Adaptive Pathway
Lecture 71European public assessment report (EPAR) - Importance, Component, Management, Updation 
Lecture 72SPOR  - Concept of Master Data Management  
Section 3Pharma International Business - Product Registration, Plant Certification, Dossier Preparation and Export Documentation
Lecture 73Introduction to Pharmaceutical Export
Lecture 74Introduction of Export Documentation | Understanding of important terminologies
Lecture 75Proforma Invoice - Detailed understanding how to prepare Proforma Invoice
Lecture 76Export Contract | Importance | Considerations | Things to include in Export Contract
Lecture 77Commercial Invoice | Importance | Differences with Proforma Invoice 
Lecture 78Custom House Agent | Role, Responsibilities, How they work | Freight Forwarder - Difference with CHA | Case Study
Lecture 79Letter of Credit | How it works | Different types of LC | LC terms and conditions | Sight LC | Case Studies
Lecture 80Bank Guarantee (BG) | How BG works | Differences between BG and LC | Applicability of BG
Lecture 81LC Discounting | How it works | How to calculate the LC discounting
Lecture 82Packing List | Importance | Things to include in packing list
Lecture 83Incoterms | 2020 Incoterms | Practical understanding on different types of Incoterms | Choosing the right incoterm
Lecture 84Logical selection of Incoterms | Landing in right incoterms for your business
Lecture 85Pre-shipment Certificate | COO |CVO| Fumigation Certificate | Preshipment Inspection Certificate | Certificate of Health
Lecture 86Transport Documents | Bill of Lading | Different Types of Bill of Lading | Airway Bill
Lecture 87Certification Pharmaceutical Companies / Plants
Lecture 88Airfreight calculation | Gross Weight | Tare Weight | New Weight | Volumetric Calculation | Freight rate calculation
Lecture 89Introduction 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 90WHO-GMP Certification Scheme 
Lecture 91Template of Certificate of Pharmaceutical product | Key observations and points to note while working on CoPP
Lecture 92Certificate of Analysis
Lecture 93Certificate of Origin (COO)
Lecture 94Non-conviction certificate
Lecture 95ISO Certification
Lecture 96Common Technical Document (CTD)
Lecture 97Electronic Common Technical Document (ECTD)
Lecture 98Dossier Preparation focusing on drug registration in export countries 
Lecture 99Modules on Stability Study : Stability Study - Fundamental Understanding | Interchangebility | Reports | API & FPP Stability Study
Lecture 100Importance of effective dossier management
Lecture 101Detailed Understanding on ANDA Submission Dossier 
Lecture 102Prior Approval Submission 
Lecture 103Detailed Understanding on ANDA Fees
Lecture 104Discussion on 85 common deficiency in CTD submission dossier
Lecture 105Introduction 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 106WHO-GMP Certification Scheme 
Lecture 107Template of Certificate of Pharmaceutical product | Key observations and points to note while working on CoPP
Section 4Plant Management and Certification | Quality Management
Lecture 108Premises & Plant Layout Designing
Lecture 109Sanitation and Hygiene
Lecture 110Equipment Modules
Lecture 111Production Modules
Lecture 112Documentation
Lecture 113Quality Control
Lecture 114Product Complaint
Lecture 115Storage Module
Lecture 116Pharmaceutical SOPs Management from regulatory perspective
Lecture 117Establishment Inspection Report | 483 Observations | USFDA Warning Letter | Handling of FDA inspection | Closing of Warning Letter 
Lecture 118Data Integrity issues in Pharmaceutical Industry
Lecture 119Electronic Batch Record for effective compliance management | Key Understanding | Functionalities | Importance in managing data integrity
Lecture 120Quality Risk Management | ICH Q9 | ISO 14971 | Principle of Risk Management 
Section 5Pharma Market Access & Pricing - Forecasting - Formulary Placement of brands
Lecture 121Introduction to Market Access | Objectives | Various Key Terminologies | Steps of Market Access | Understanding on Pricing and Reimbursement
Lecture 122Market Access Functions : Role and Responsibilities | Key Job Areas | Understanding Job Description
Lecture 123Market Access Strategic Planning
Lecture 124Indication Sequencing | Indication Prioritization | Development of Indication Timeline | Indication Matrix | Value Based Indication Prioritization
Lecture 125Indication Prioritization Case Study
Lecture 126Market Access Value Dossier : What it is | Significance | Components | What to include
Lecture 127AMCP Market Access Value Dossier Preparation
Lecture 128Drug Pricing Methodologies
Lecture 129Sales Forecasting in Life Science Industry
Lecture 130New Product Forecast Algorithm
Lecture 131Patient Based Forecasting Model | Applying more filters and variables
Lecture 132Prescription Based Forecasting Model | Differences between Patient Based and Prescription Based Forecasting Model | Which model to use and when?
Lecture 133Prevalence Vs. Incidence Model
Lecture 134EPI Based Forecasting | Sales Based Forecasting | When and where to apply which forecasting model
Lecture 135Sales Forecasting Tools | New Product Forecasting | In Market Forecasting
Lecture 136Market Size Assignment 1 [Oncology Brand] - Applying sales forecasting tools to carry out next 6 years sales forecast | Excel Based Model
Lecture 137Market Size Assignment 2 [Asthma Brand] - Applying sales forecasting tools to carry out multiple years sales forecast | Excel Based Model
Lecture 138Formulary Placement | Different Tiers | How to classify the medication in different tiers | Formulary negotiation process | Rebates | Copay differential | Step-edits | Case Simulations - teasers
Lecture 139Patient Based Model Vs. Patient Flow Model | Critical Differences in Model | Concept of Black Box in Patient Flow Model | Application of both model
Lecture 140Concomitancy and polypharmacy | How it alter the basic forecasting algorithm | Practical Working | Comorbidity
Lecture 141Forecasting Techniques | Simple Conjoint-type Models | Zipf's Law | Simple Elasticity Model | The Bass Model |Simple Extrapolation
Lecture 142Simulation on Bottom-up forecasting
Lecture 143Assessment on Bottom-up forecasting
Lecture 144Oncology Brand Forecasting
Section 6Pharma Global Brand Management
Lecture 145Marketing Orientation
Lecture 146Why Is Market Research Important in Pharmaceutical Business?
Lecture 147Market Research - Customer Engagement through feedback mechanism 
Lecture 148Product Life cycle 
Lecture 149Advance - Strategic Planning in Product Life cycle Management
Lecture 150Segmentation, Targeting and Positioning
Lecture 151Pricing
Lecture 152A Pharmaceutical Segmentation outlook
Lecture 153Distribution Channel in Pharmaceutical Industry 
Lecture 154Promotion in Pharmaceutical Industry : Communication Model, Effective promotional communication, Push Vs. Pull Strategy and Buying Decision Process
Lecture 155Practical understanding on Prescription Accelerating Materials used in pharmaceutical promotion
Lecture 156Method of Promotional Budgeting
Lecture 157Brand Recall | Brand Recognition |Top of mind - How to calculate brand recall value?
Lecture 158Advertising - Introduction | Objective | Types of Advertising 
Lecture 159ATL, BTL & TTL Advertising
Lecture 160Advertising Agency - Understanding on various types of advertising agency
Lecture 161Selection of Advertising Agency
Lecture 162What is creative Briefing? How to Prepare !
Lecture 163Creative Briefing - Practical Simulation
Lecture 164Request for Proposal | Concepts in advertising
Lecture 165Advertising Message Strategy Development and Evaluation
Lecture 166Creative Approach and Styles
Lecture 167Steps of Development of Creatives
Lecture 168Advertisement Copy Development
Lecture 169How to prepare Ad Campaign Step By Step
Lecture 170Brand Name | Brand Logo | Designing of Brand Logo | Trademarking
Lecture 171Advance Understanding of Pharmaceutical Brand Logo Development 
Lecture 172Component of Brand Logo
Lecture 173Brand Name and Trademark Registration Process
Lecture 174Trademark Searching Process | Hands on Practical Training
Lecture 175How to design an excellent brand logo : Tricks of the trade
Lecture 176Logo colour theme | Colour system | Colour coding | Significance of colour
Lecture 177Few Case Studies related to brand names and logos
Lecture 178Can one innovator company keep 2 or more brand name?
Lecture 179Traditional Vs. Non-Traditional trademark | Significance of Colour in Pharma Branding 
Lecture 180Global Trademarking : Brand Protection Globally 
Lecture 181Logo Rebranding - Reasons | Practical Examples | How to handle logo rebranding | Forced Rebranding 
Lecture 182Brand Logo Development: Real Life Simulation
Lecture 183Tagline - Development, Finalization and Protection
Lecture 184Pharma Brand Name Generator
Lecture 185Fundamental of Pharma Marketing Plan 
Lecture 186Basic Understanding how to launch a pharmaceutical product into the market
Lecture 187Practical Training on Marketing Plan Preparation with real life example
Lecture 188Marketing Campaign Development : Importance of Target Audience Segmentation for effective targeting 
Lecture 189Sample Marketing Plan 
Lecture 190Decide about brand USP -What to promote 
Lecture 191How to prepare promotogram. Download sample Promotogram
Lecture 192Importance and Handling of Cycle Meeting and its importance 
Lecture 193Sample Marketing Plan
Lecture 194Sample Marketing Plan
Lecture 195Sample Marketing Plan
Lecture 196CSR Campaign 
Lecture 197Increase the brand reach with advance segmentation
Lecture 198Concept of uniform branding for better brand acceptability
Lecture 199Concept of Brand Differentiation
Lecture 200Introduction to visual aid designing  | V3M Concept | Components of the visual aid page
Lecture 201Practical Training in visual aid designing  | Step By Step Visual Aid Preparation | Creative Designing | Guideline on Proofing | USPs to differentiate the visual aid 
Lecture 202Visual Aid Printing  | Establishing Visual Aid Printing Specs for effective management of the vendors 
Lecture 203Visual Aid Analysis with practical example
Lecture 204Guideline on visual aid development
Lecture 205Marketing Plan followed by Visual Aid Development
Lecture 206Visual Aid, Literature reference Sample
Lecture 207Interactive Visual Aid | E-detailing | Remote Detailing | Analysis of Animated Video based e-detailing visual aids 
Lecture 208Visual aid detailing story writing
Lecture 209Artwork Development Process in PMT Department
Lecture 210Product List and Reminder card development
Lecture 211Catch Cover Development
Lecture 212Packaging Development 
Lecture 213Prescribing Information and Patient Information Leaflet development
Lecture 214Pharma Packaging Case Studies
Lecture 215DHCP letter
Lecture 216Product Packshot Designing : Practical Knowledge
Lecture 217Creativity to develop brand essence
Lecture 218Advance Training on Pharmaceutical Packaging -  Creative Packaging for Brand Differentiation 
Lecture 219Unique identifier & anti-tampering device on outer packaging
Section 7Business Development | Licensing
Lecture 220Training on Basic Finance  |  Understanding Financial Statment | Income Statement | Balance Sheet | Cash Flow Statement
Lecture 221Moving Average | Moving Annual Total | YTD | How to calculate 
Lecture 222Compound Annual Growth Rate | CAGR Calculation
Lecture 223Business Development Job Functionality | Strategic Planning Process | Knowledge Area of Business Development | Lead targeting | Licensing term sheets
Lecture 224Portfolio Management Process | Portfolio Characteristics | Portfolio Analysis | Balancing the Portfolio | BD and Strategic Planning Department 
Lecture 225Identifying the corporate Need of business development | Objective – Strategy - Tactics | Portfolio constraints | SWOT | Numerical SWOT
Lecture 226Profiling and Searching | Objectives | Search Database | Creating Opportunity Anatomy for deal analysis | Mind Mapping | Searching Tools and Techniques - Web Search | Conference | Confidentaility - CDA | MTA
Lecture 227Numerical SWOT Practical training
Lecture 228Modelling and Deal Valuation - Top Down Model | Epidemiology data method | Complex Model | Forecasting | Heuristic or ‘prophesy’ method | Different value perspectives | Deal Structuring Structuring the deal
Lecture 229Market Size Determination - Market Share | Relative Market Share | Total Vs. Actual Vs. Penetrated Market
Lecture 230Forecasting : Tools and Techniques
Lecture 231Market Sizing & Forecasting Case Study
Lecture 232Royalty Management - Royalty structuring | Royalty Calculation Method| Tiered Royalties | Terms | Royalty Reductions | Royalty Stacking - Concept and Calculation | Minimum Annual Royalties | Reach through royalties
Lecture 233Average Royalty Rate
Lecture 234Factor affecting the Royalty Rate in Pharmaceutical and Biopharmaceutical Deal
Lecture 235Distribution Licensing | Geography | Indication Splitting | Exclusive and Non-Exclusive Licensing | Sub Licenses
Lecture 236Acquisition in Pharma  | Product Acquisition| Company Acquisitions| Steps in acquisition | Financing acquisition deals | Trademark Assignment Process
Lecture 237Joint Ventures in Pharmaceutical and Biopharmaceutical Industry
Lecture 239Indication Splitting | Concept | Implementation feasibility analysis 
Lecture 240Types of Deals from Discovery to Commercialization
Lecture 241What are the fundamental areas of business development
Lecture 242Licensing Term Sheet | Content Structuring | Sample Term Sheet
Lecture 243Licensing Payment Scheduling: Different Types
Lecture 244Valuation Methods: DCF | rNPV | Sunk Cost Method | Comparables | Sum of Parts | Deterministic Vs. Probabilistic rNPV |  Peak Sales - Max-Min Approach
Lecture 245Valuation Methods: EBITDA method of valuation | Enterprise Value and Enterprise Multiple Calculation
Lecture 246Negotiation 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 247Business Development Simulation and Decision Making | Early Stage VS. Late Stage Valuation Methodology | Stair Step Model
Lecture 248Types of Strategic Alliances: Unilateral technology licensing | Cross technology licensing | R&D contracts | R&D collaborations | Minority-equity-based R&D alliances | JV | Manufacturing and marketing agreements | big pharma firms with dedicated biotechnology firms 
Lecture 249Benchmarking | Benchmarking through consortium | How to use benchmarking for drug discovery development projects 
Section 8Pharma Digital Marketing
Lecture 250Introduction to Digital Marketing 
Lecture 251Inbound and outbound marketing in pharma | Types of inbound and outbound marketing 
Lecture 252Digital Media Marketing Macro-Environment Analysis | Mapping of online market place | Internet marketing conversion process | Conversion Process Digital VS. Traditional | Publisher revenue model | Affiliate revenue model
Lecture 253Digital 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 254Digital marketing strategy development | Planning process | E-Marketing Plan | Planning for MNC Vs. Start Up | Strategic Outcome measurement
Lecture 255Relationship marketing using digital platform | CRM | Concept of permission marketing | User Satisfaction and loyalty management | Feedback mechanism
Lecture 256Campaign planning for digital media | Goal setting | Tracking | Campaign insight | Segmentation and targeting | Message Development | Media Mix Selection | Media scheduling | Practical understanding to campaign performance matrics | CPC | CPA | PPC | ROI | CPS
Lecture 257Search Engine Optimization | Search Engine Marketing | Social Media Marketing
Lecture 258Web Host - Check the hosting details 
Lecture 259Page Speed- importance and practical understanding | Check the web speed 
Lecture 260Keyword | Keyword Planning for SEO and SEM | Keyword Planner
Lecture 261Mobile Responsive | Tracking the Site 
Lecture 262HCP sites and Patient Site
Lecture 263Google Ad - Practical Training on Campaign Development and Execution
Lecture 264Digital Marketing Strategies for innovator brand | Pre launch - comuing soon, DSE Marketing | Launch activities - Day of approval (DOA) site | FDA Compliance | FDA 2253 Filing
Lecture 265Brand Portal Development
Lecture 266Relationship Marketing : KOL Management and Patient Advocacy Group 
Lecture 267Public Relation - PR firm | PR Campaign | Press Release | Technical understanding of press release writing | Digital Press Release
Lecture 268Developing Ad - Pharmaceutical Prescription, OTC Vs FMCG Brands
Lecture 269Difference between FMCG and OTC Brand Ad
Lecture 270Digital Marketing Techniques
Lecture 271Video Marketing
Lecture 272Video Marketing Techniques For Small Business Owners
Lecture 273Promoting Brand through Article Advertising and Marketing
Section 9Regional Business Development : Africa
Lecture 274African Continent Overview - Brief introduction
Lecture 275African Pharma Market
Lecture 276Drug Registration - African medicines regulatory
Lecture 277Basic Export Requirement for African Countries
Lecture 278Export Documentations & Important Concepts
Lecture 279Nigeria  - Drug Registration
Lecture 280Drug Registration in Algeria
Lecture 281Drug Registration in Ethiopia
Lecture 282Drug Registration in Kenya
Lecture 283Drug Registration in Egypt
Lecture 284Drug Registration in Ghana
Lecture 285Drug Registration in Botswana
Lecture 286Drug Registration in South Africa
Lecture 287Drug Registration in Zambia
Lecture 288Drug Registration in Namibia
Lecture 289Drug Registration in Tanzania
Lecture 290Drug Registration Senegal
Lecture 291Drug Registration in Zimbabwe
Lecture 292Drug Registration in Uganda
Lecture 293Drug Registration in Morocco
Lecture 294Drug Registration in Sudan
Section 10Regional Business Development : GCC, Middle East and MENA
Lecture 295GCC Pharmaceutical Market
Lecture 296GCC Registration Procedure - Centralized and Decentralized Procedure
Lecture 297Drug Registration in Saudi Arabia
Lecture 298Drug Registration in UAE
Lecture 299Drug Registration in Kuwait
Lecture 300Drug Registration in Bahrain
Lecture 301Drug Registration in Oman
Lecture 302Middle East Pharma Market
Lecture 303Drug Registration in Jordan
Lecture 304Drug Registration in Palestine
Lecture 305Drug Registration in Israel
Lecture 306Drug Registration in Syria
Lecture 307Drug Registration in Iran
Lecture 308Drug Registration in Iraq
Section 11Regional Business Development : ASEAN
Lecture 309ASEAN Drug Regulatory Affairs
Lecture 310Asean Geography 
Lecture 311Drug Registration in Brunei 
Lecture 312Drug Registration in Malaysia 
Lecture 313Drug Registration in Cambodia 
Lecture 314Drug Registration in Mayanmar 
Lecture 315Drug Registration in Philippines 
Lecture 316Drug Registration in Singapore 
Lecture 317Asean Common Technical Document (ACTD) 
Section 12Regional Business Development : Latam
Lecture 318Introduction to Latam Region Pharma Business Development
Lecture 319Drug Registration and Regulation in Argentina 
Lecture 320Drug Registration and Regulation in Bolivia
Lecture 321Drug Registration and Regulation in Brazil
Lecture 322Drug Registration and Regulation in Chile
Lecture 323Drug Registration and Regulation in Colombia
Lecture 324Drug Registration and Regulation in Mexico
Section 13Regional Business Development : China
Lecture 325Drug Registration and Regulation in China
Lecture 326NMPA's DDR and DMR update
Section 14References and Case Studies
Lecture 327Comparison of various requirement of drug registration
Lecture 328Comparison of Dossier requirements of US and EU
Lecture 329Comparison of DMF requirement of various regulatory bodies
Section 15Biopharmaceutical Management and Regulation
Lecture 330Introduction : Biopharmaceuticals
Lecture 331Classification of Biopharmaceutical 
Lecture 332Important Concept regarding Biopharmaceuticals
Lecture 333Introduction to Biologics and Biosimilar | Key differences | Concept of Reference Product
Lecture 334Key features of Biologic | Differences in Chemical Drug Vs. Biologic Drugs
Lecture 335Principle of Naming of Biologic | Understanding on MAB naming system
Lecture 336Global Biopahrma Market Trends
Lecture 337Recombinant protein
Lecture 338Monoclonal Antibodies Vs. Polyclonal Antibodies
Lecture 339Monoclonal Antibodies
Lecture 340Synthetic Immunomodulators
Lecture 341Production of Monoclonal Antibodies
Lecture 342Cytokines
Lecture 343Interferon
Lecture 344Erythropoiesis-stimulating agent
Lecture 345Vaccine development and approval Process
Lecture 346Biosimilar Development Process
Lecture 347Strategic Consideration for Biosimilar Development 
Lecture 348Bio-Manufacturing Process Information
Lecture 349Studies required for approval of biosimilar
Section 16Drug Registration and Regulation in Japan
Lecture 350Introduction to Japan Drug Regulatory Affairs 
Lecture 351Drug Discovery Development to commercialization | PMDA functions | Consultation | Premarket to post market approval 
Lecture 352Drug Approval System | GCP | PMDA requirements 
Section 17Variation Filing : Marketing Authorization variation management
Lecture 353Introduction to Variation Management | Reasons for Variation | Working in Variation Department 
Lecture 354Variation Classification | Basis of Classification | US and EU Variation Classification | Other region variation guideline.
Section 18Bioequivalence Study : Requirements
Lecture 355PKPD in Drug Discovery | PK-PD trial | Understanding PKPD from regulatory perspective in drug approval process
Lecture 356Bioequivalence Study | Study design | Different types of BE Studies
Lecture 357Bioequivalence Study | Study design | Parallel Study | Crossover study design | Other alternative study designs | Blood Sampling Planning  | Analyte | Bioanalytical Methods Validation  | Statistical Model  | Ln Transformation  | Dose normalisation | Confidence interval acceptance criteria
Lecture 358Biopharmaceutical Classification System (BCS) | Types | Biowaivers | BCS tool for drug development and regulatory submission 
Lecture 359Bioequivalence Study - Discussion - Timeline of stability study and bioequivalence study 
Lecture 360Bioequivalence Study - Discussion - Dissolution Testing
Lecture 361Bioequivalence Study - Generic Approval and Additives Labeling Requirements