Section 1Fundamental of Drug Discovery and Development | US Regulatory Affairs
Lecture 1Introduction to R&D Process & drug discovery
Lecture 2Investigational New Drug Application
Lecture 3New Drug Application (NDA)
Lecture 4Basic concept and understanding of the Generic Drug
Lecture 5Abbreviated New Drug Application (ANDA)
Lecture 6Regulatory Requirements for Non-clinical Studies | Types of Non-clinical studiesÂ
Lecture 7Types and Timing of Non-clinical StudiesÂ
Lecture 8USFDA Expedited Programs (Detailed Understanding)
Lecture 9505(j) ANDA, 505(b)(2) NDA, 505(b)(1) NDA
Lecture 10Concept of Authorized Generics: Key Understanding
Lecture 11Concept of Exploratory IND
Lecture 12Patent & Exclusivity - Strategic Understanding | Patent Restoration| Orphan Drug Exclusivity (ODE) | NCE & NCI Exclusivity | GAIN Exclusivity | Pediatric Exclusivity | 180 days exclusivity
Lecture 13Orphan Drug Designation
Lecture 14Advance Learning on 505B2 Pathway
Lecture 15Chemistry, Manufacturing & Controls - Fundamental Understanding
Lecture 16Review on Drug Discovery and DevelopmentÂ
Lecture 17Complete Response Letter | Key understanding | Management and Action Plan
Lecture 18Handling of orange book
Lecture 19Review on Drug Discovery and DevelopmentÂ
Lecture 20Understanding on Clinical Trials and Clinical ResearchÂ
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 26Preformulation Study in Drug DevelopmentÂ
Lecture 27Regulatory Requirements for Preformulation StudyÂ
Lecture 28Logical Sequence of Preformulation Study | Case Insights | Strategies for preformulation studies Â
Lecture 29Introduction to ICH | Members | GuidelinesÂ
Lecture 30ICH Q1 : Stability Guideline | Matrixing | Bracketing
Lecture 31ICH Q2 : Analytical ValidationÂ
Lecture 32ICH Q3 : Impurities
Lecture 33Rest of ICH Q Family Guidelines
Lecture 34Emergency Use Authorization (EUA) | EUA Pathways | Criteria | Justification | Early Discussion with FDA | LOA | FactsheetsÂ
Lecture 35Fundamental 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 2European Drug Regulatory Affairs
Lecture 36Orientation to European Countries and National Regulatory Bodies
Lecture 37EU Drug Discovery Development to Commercialization (Step By Step)
Lecture 38Overview of EU RegulationÂ
Lecture 39EMA and EMA Authorisation Process
Lecture 40EU MA Application Types and Strategic Planning
Lecture 41EU MA Procedure - Centralised, Decentralised, Mutual Recognition, National ProcedureÂ
Lecture 42EU MA Strategic Planning: Full, Full-mixed, hybrid applications. Generic, Similar biologic application pathway, Well-established use application, Fixed combination application, Informed consent application
Lecture 43Validity of the EU MAÂ - Renewal steps, Cessation of the marketing authorisation, Significance of "Placed in Union Market", Suspension or withdrawal & EU MA for licensed products
Lecture 44Data Exclusivity and Market Protection - Supplementary Patent Protection, Exclusivity, 6/10 Rule, 8+2+1 Formulae
Lecture 45EU Orphan Medicinal Products Regulation
Lecture 46EU variation -Types, Requirement & Planning - IA, IAIN, IB, II ; US FDA Variation AR, CBE-0, CBE-30, PAS - Strategic Discussion | Similarities &Â Differentiation
Lecture 47Conditional marketing authorisation | Marketing authorisation under exceptional circumstances
Lecture 48Summary of Product CharacteristicsÂ
Lecture 49Compassionate Use
Lecture 50IMPD | Significance | Format of IMPD | Differences with CTA, IB, IND
Lecture 51Investigator’s Brochure | Significance | Format of IB | Preparing different sections of IB
Lecture 52Paediatric use marketing authorisation (PUMA) & Paediatric Investigation Plan (PIP)
Lecture 53EU Prime DesignationÂ
Lecture 54Accelerated assessment by EMEA
Lecture 55EU Adaptive Pathway
Lecture 56European public assessment report (EPAR) - Importance, Component, Management, UpdationÂ
Lecture 57SPOR - Concept of Master Data Management Â
Lecture 58MHRA - UK RegulationÂ
Lecture 59The 'sunset clause' for marketing authorisation of pharmaceuticals
Section 3 Regulatory Strategic Management and planning
Lecture 60Regulatory Strategies in different phases of Clinical Trial
Lecture 61Advance study on Para IV Filing
Lecture 62Para IV Notice
Lecture 63Evergreening - Patent Life Extension Strategies
Lecture 64Pay For Delay Strategy
Lecture 65REMS Strategic Planning
Lecture 66Compulsory Licensing
Lecture 67Licensing & Technology Transfer
Lecture 68In-Licensing Vs. Outlicensing
Lecture 69LOE Strategies for Innovator Brands with case study
Lecture 70Paediatric Exclusivity and Paediatric Study Plan Development
Lecture 71Drug Re-purposing
Lecture 72Practical Queries on different USFDA application and Filing
Lecture 73Publication Management from Regulatory perspective
Lecture 74Juxtapid Case Study
Lecture 75New Indication Approval Process and Promotion
Lecture 76OTC Switch
Section 4Good Manufacturing Practices
Lecture 77Certification Pharmaceutical Companies / Plants
Lecture 78Premises & Plant Layout Designing
Lecture 79Sanitation and Hygiene
Lecture 80Equipment
Lecture 81Production Modules
Lecture 82GMP Documentation
Lecture 83Quality Control
Lecture 84Handling of Product Complaint
Lecture 85GMP Storage
Lecture 86ISO and ISO Audits
Lecture 87Pharmaceutical SOPs
Lecture 88SOP Automation
Section 5 Submission Dossier : CTD | ACTD | DMF - SMF-ANDA | 505(b)(2) | NCE | Petittion| Prior Approval Submission
Lecture 89Advance Practical Training on Dossier Preparation focusing on drug registration in export countries
Lecture 90CMC Dossier & Compliance Management
Lecture 91Electronic Common Technical Document (ECTD)
Lecture 92Advance Practical Training on Dossier Preparation focusing on drug registration in export countriesÂ
Lecture 93Key Consideration for Drug Master File Preparation and SubmissionÂ
Lecture 94Practical Understanding on Drug Master File Preparation and Submission
Lecture 95Site Master File - Detailed UnderstandingÂ
Lecture 96DMF Completeness Assessment
Lecture 97Drug Master File - Fees
Lecture 98Drug Master File - Global Perspective [Across Different Regions]
Lecture 99Importance of effective dossier management
Lecture 100Common deficiencies in CTD submission dossier
Lecture 101Certificate of Analysis
Lecture 102Detailed Understanding on ANDA Fees
Lecture 103Prior Approval SubmissionÂ
Lecture 104Detailed Understanding on ANDA Fees
Lecture 105Detailed Understanding on 505(b)(2) VS. Suitability Petition : Case Based Learning
Lecture 106NCE Vs. 505b2 application - Case Based LearningÂ
Lecture 107FTF - 180 Days Exclusivity - Case Based Learning
Lecture 108Classic case study of the 505b2 filing : Case Based Learning
Lecture 109Strategic Planning in Combating 30 months stay strategies of innovator company- Case Based Learning
Lecture 110Discussion on 85 common deficiency in CTD submission dossier
Lecture 111Asean Common Technical Document (ACTD)Â
Section 6Quality issues, Warning Letter, CAPA and Data Integrity
Lecture 112Data Integrity issues in Pharmaceutical Industry
Lecture 113Establishment Inspection Report | 483 Observations | USFDA Warning Letter | Handling of FDA inspection | Closing of Warning LetterÂ
Lecture 114Electronic Batch Record for effective compliance management | Key Understanding | Functionalities | Importance in managing data integrity
Lecture 115RTQs | Response to Queries | How to handle Regulatory Queries Â
Section 7Bioequivalence Study
Lecture 116PKPD in Drug Discovery | PK-PD trial | Understanding PKPD from regulatory perspective in drug approval process
Lecture 117Bioequivalence Study | Study design | Different types of BE Studies
Lecture 118Bioequivalence 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 119Biopharmaceutical Classification System (BCS) | Types | Biowaivers | BCS tool for drug development and regulatory submissionÂ
Lecture 120Bioequivalence Study - Discussion - Timeline of stability study and bioequivalence studyÂ
Lecture 121Bioequivalence Study - Discussion - Dissolution Testing
Lecture 122Bioequivalence Study - Generic Approval and Additives Labeling RequirementsÂ
Section 8Variation Management
Lecture 123Introduction to Variation Management | Reasons for Variation | Working in Variation DepartmentÂ
Lecture 124Variation Classification | Basis of Classification | US and EU Variation Classification | Other region variation guideline.
Section 9Stability Study
Lecture 125Modules on Stability Study : Stability Study - Fundamental Understanding | Interchangebility | Reports | API & FPP Stability Study
Lecture 126Climate Zone
Lecture 127Stability Zone Finder
Lecture 128Stability Studies : Case discussions
Lecture 129Stability Data for Zone IV countries
Lecture 130Accelerated and intermediate testing conditions
Lecture 131Long Term Stability Testing Requirements
Lecture 132Stability Study Protocol Development - Dosage form: Capsule
Lecture 133Stability Data Sheet
Lecture 134Dossier Stability Test
Lecture 135Testing Frequency
Lecture 136Bracketing
Lecture 137Matrixing
Section 10Biopharmaceutical Regulatory Affairs (Innovative Biologics and Biosimilars / Similar Biologics)
Lecture 138Introduction to Biopharmaceuticals
Lecture 139Classification of BiopharmaceuticalÂ
Lecture 140Chemical Drugs Vs. Biologic Drugs
Lecture 141Principle of Naming of Biologic | Understanding on MAB naming systemÂ
Lecture 142Global Biologics Market – By Product
Lecture 143Recombinant protein
Lecture 144Monoclonal Antibodies Vs. Polyclonal Antibodies
Lecture 145Monoclonal Antibodies
Lecture 146Synthetic Immunomodulators
Lecture 147Production of Monoclonal Antibodies
Lecture 148Cytokines
Lecture 149Interferon
Lecture 150Erythropoiesis-stimulating agent
Lecture 151Biological Licensing Application (BLA)Â
Lecture 152Abbreviated Biosimilar Application - 351(k): Advance Strategic Planning Process : Originator Vs. Biosimilar Development and Regulatory Approval Process | Reference Biologic | Purple Book | Data Requirements
Lecture 153Purple Book: Significance | Searching | Assignments
Lecture 154Vaccine development and approval Process
Lecture 155Biosimilar Development Process
Lecture 156Strategic Consideration for Biosimilar DevelopmentÂ
Lecture 157Bio-Manufacturing Process Information
Lecture 158Studies required for approval of biosimilar
Section 11Fundamental of Pharma Product Management
Lecture 159Introduction to Pharma Product Management | Career in Pharma PMT | Job profile of Pharma Product Manager
Lecture 160Lecture Session: Classification of Doctors
Lecture 161Job Description of Pharmaceutical Product ManagerÂ
Lecture 162How to start work as pharma product manager in a pharma company
Lecture 163On-the-field and Off-the-field activity of the pharma product managers
Lecture 164Key Knowledge Area of Pharma Product Managers
Lecture 165Marketing Orientation for Product Manager
Lecture 166Market Research Pharmaceutical Brand Management
Lecture 167Market Research - Customer Engagement through feedback mechanismÂ
Lecture 168Fundamental Training of Product Life cycleÂ
Lecture 169Advance - Strategic Planning in Product Life cycle Management
Lecture 170Segmentation, Targeting and Positioning
Lecture 171Pricing
Lecture 172A Pharmaceutical Segmentation outlook
Lecture 173Distribution Channel in Pharmaceutical IndustryÂ
Lecture 174Promotion in Pharmaceutical Industry : Communication Model, Effective promotional communication, Push Vs. Pull Strategy and Buying Decision Process
Lecture 175Practical understanding on Prescription Accelerating Materials used in pharmaceutical promotion
Lecture 176Method of Promotional Budgeting
Lecture 177Brand Recall | Brand Recognition |Top of mind - How to calculate brand recall value?
Section 12Advertisement and Brand Promotion in Pharmaceutical Industry
Lecture 178Advertising - Introduction | Objective | Types of Advertising
Lecture 179ATL, BTL & TTL Advertising
Lecture 180Advertising Agency - Understanding on various types of advertising agency
Lecture 181Selection of Advertising Agency
Lecture 182What is creative Briefing? How to Prepare !
Lecture 183Creative Briefing - Practical Simulation
Lecture 184Request for Proposal | Concepts in advertising
Lecture 185Advertising Message Strategy Development and Evaluation
Lecture 186Creative Approach and Styles
Lecture 187Steps of Development of Creatives
Lecture 188Advertisement Copy Development
Lecture 189How to prepare Ad Campaign Step By Step
Section 13Practical Training : Brand Logo and Trademarking
Lecture 190Brand Name, Logo and Trademark filing- Practical Hands on Simulation
Lecture 191Advance Understanding of Pharmaceutical Brand Logo Development
Lecture 192Component of Brand Logo
Lecture 193Brand Name and TM Registration Process
Lecture 194Trademark Searching Process | Hands on Practical Training
Lecture 195How to design an excellent brand logo : Tricks of the trade
Lecture 196Logo colour theme | Colour system | Colour coding | Significance of colour
Lecture 197Few Case Studies related to brand names and logos
Lecture 198Simulation:Â Can one innovator company keep 2 or more brand name?
Lecture 199Colour Branding
Lecture 200Global Trademarking : Brand Protection GloballyÂ
Lecture 201Logo Rebranding - Reasons | Practical Examples | How to handle logo rebranding | Forced RebrandingÂ
Lecture 202Brand Logo Development: Real Life Simulation
Lecture 203Tagline - Development, Finalization and Protection
Lecture 204Brand Tagline - Punchline
Lecture 205Pharma Brand Name Generator
Section 14Practical Training in Brand plan and Marketing Plan
Lecture 206Fundamental of Pharma Marketing PlanÂ
Lecture 207Basic Understanding how to launch a pharmaceutical product into the marketÂ
Lecture 208Practical Training on Marketing Plan Preparation with real life example
Lecture 209Marketing Campaign Development : Importance of Target Audience Segmentation for effective targetingÂ
Lecture 210Sample Marketing PlanÂ
Lecture 211Decide about brand USP -What to promoteÂ
Lecture 212How to prepare promotogram. Download sample Promotogram
Lecture 213Importance and Handling of Cycle Meeting and its importance
Lecture 214Sample Marketing Plan :Â FebuxostatÂ
Lecture 215Sample Marketing Plan : Orlistat
Lecture 216Sample Marketing Plan
Lecture 217CSR Initiatives : Case Based Learning
Lecture 218Increase the brand reach with advance segmentation
Lecture 219Concept of uniform branding for better brand acceptability
Lecture 220Concept of Brand Differentiation
Section 15Visual Aid and Input Designing
Lecture 221Introduction to visual aid designing | V3M Concept | Components of the visual aid page | Component of Visual Aid designing
Lecture 222Practical Training in visual aid designing | Step By Step Visual Aid Preparation | Creative Designing | Guideline on Proofing | USPs to differentiate the visual aid
Lecture 223Visual Aid Printing | Establishing Visual Aid Printing Specs for effective management of the vendors
Lecture 224Visual Aid Analysis with practical example
Lecture 225Guideline on Visual Aid Development
Lecture 226Marketing Plan followed by Visual Aid Development
Lecture 227Visual Aid, Literature reference Sample
Lecture 228Interactive Visual Aid | E-detailing | Remote Detailing | Analysis of Animated Video based e-detailing visual aidsÂ
Lecture 229Visual aid detailing story writing
Section 16Packaging and Marketing Input creation
Lecture 230Artwork Development Process in PMT Department
Lecture 231Product List and Reminder card development
Lecture 232Catch Cover Development
Lecture 233Packaging DevelopmentÂ
Lecture 234Prescribing Information and Patient Information Leaflet development
Lecture 235Pharma Packaging Case Studies
Lecture 236DHCP letter or Dear Doctor Letter
Lecture 237Product Packshot Designing : Practical Knowledge
Lecture 238Creativity to develop brand essence
Lecture 239Advance Training on Pharmaceutical Packaging -Â Creative Packaging for Brand DifferentiationÂ
Lecture 240Unique identifier & anti-tampering device on outer packaging
Section 17Market Sizing, Forecasting, Analytics - Hands on Training
Lecture 241Moving Average | Moving Annual Total | YTD | How to calculateÂ
Lecture 242Compound Annual Growth Rate | CAGR Calculation
Lecture 243RCPA
Lecture 244Sales Forecasting in Life Science Industry
Lecture 245New Product Forecast Algorithm
Lecture 246Patient Based Forecasting Model | Applying more filters and variables
Lecture 247Prescription Based Forecasting Model | Differences between Patient Based and Prescription Based Forecasting Model | Which model to use and when?
Lecture 248Prevalence Vs. Incidence Model
Lecture 249EPI Based Forecasting | Sales Based Forecasting | When and where to apply which forecasting model
Lecture 250Sales Forecasting Tools | New Product Forecasting | In Market Forecasting
Lecture 251Market Size Assignment 1 [Oncology Brand] - Applying sales forecasting tools to carry out next 6 years sales forecast | Excel Based Model
Lecture 252Market Size Assignment 2 [Asthma Brand] - Applying sales forecasting tools to carry out multiple years sales forecast | Excel Based Model
Lecture 253Patient Based Model Vs. Patient Flow Model | Critical Differences in Model | Concept of Black Box in Patient Flow Model | Application of both model
Lecture 254Concomitancy and polypharmacy | How it alter the basic forecasting algorithm | Practical Working | Comorbidity
Lecture 255Forecasting Techniques | Simple Conjoint-type Models | Zipf's Law | Simple Elasticity Model | The Bass Model |Simple Extrapolation
Lecture 256Bottom-up or Top-down Forecasting | LRx | Significance of LRx data analysis
Lecture 257Simulation on Bottom-up forecasting
Lecture 258Assessment on Bottom-up forecasting
Lecture 259Oncology Brand Forecasting
Lecture 260Revenue Forecasting Case Study - Novel AntihypertensiveÂ
Lecture 261Patent Cliff | How to calculate the patent cliff
Lecture 262Portfolio Based Forecasting | Forecasting Model Development in ExcelÂ
Lecture 263QALY | How to calculate QALY | Importance and SignificanceÂ
Lecture 264ICER | How to calculate ICER | Importance and SignificanceÂ
Section 18Basic Finance for Pharma managers
Section 19Strategy Discussion
Lecture 266Concept of uniform branding for better brand acceptability
Lecture 267Brand Line Extension : Importance and Strategic PlanningÂ
Lecture 268Disease Awareness Campaign - Brand Building Activities on Specific Health Day
Lecture 269Medical Animation for Brand BuildingÂ
Section 20Conference Management
Lecture 270Promotion of Pharmaceutical Brands in Medical Conferences
Lecture 271Conference Banner
Lecture 272Roll Up Standee
Section 21Celebrity Endorsement in Pharma Brand Promotion
Lecture 273Celebrity Endorsement in Pharmaceutical Brand Promotion
Lecture 274Celebrity Endorsement Vs. BootleggingÂ
Section 22Pharma Digital Marketing
Lecture 275Introduction to Digital MarketingÂ
Lecture 276Inbound and outbound marketing in pharma | Types of inbound and outbound marketingÂ
Lecture 277Digital 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 278Digital 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 279Digital marketing strategy development | Planning process | E-Marketing Plan | Planning for MNC Vs. Start Up | Strategic Outcome measurement
Lecture 280Relationship marketing using digital platform | CRM | Concept of permission marketing | User Satisfaction and loyalty management | Feedback mechanism
Lecture 281Campaign 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 282Search Engine Optimization | Search Engine Marketing | Social Media Marketing
Lecture 283Web Analytics - Tool and ImplementationÂ
Lecture 284Web Host - Check the hosting detailsÂ
Lecture 285Page Speed- importance and practical understanding | Check the web speedÂ
Lecture 286Keyword | Keyword Planning for SEO and SEM | Keyword Planner
Lecture 287Mobile Responsive | Tracking the SiteÂ
Lecture 288Google Ad - Practical Training on Campaign Development and Execution
Lecture 289HCP sites and Patient Site
Lecture 290Digital Marketing Strategies for innovator brand | Pre launch - comuing soon, DSE Marketing | Launch activities - Day of approval (DOA) site | FDA Compliance | FDA 2253 Filing
Lecture 291Brand Portal Development
Lecture 292Relationship Marketing : KOL Management and Patient Advocacy GroupÂ
Lecture 293Public Relation - PR firm | PR Campaign | Press Release | Technical understanding of press release writing | Digital Press Release
Lecture 294Developing Ad - Pharmaceutical Prescription, OTC Vs FMCG Brands
Lecture 295Difference between FMCG and OTC Brand Ad
Lecture 296Digital Marketing Techniques
Lecture 297Video Marketing
Lecture 298Video Marketing Techniques For Small Business Owners
Lecture 299Promoting Brand through Article Advertising and Marketing