This course is designed exclusively with objective to impart Induction Training for the BD, Regulatory and Production professionals
Maximum Access Duration: 3 Month
Core Learning Areas
- GMP and related topics of Production Management
- Business Development, Licensing,
- EU Regulatory Affairs,
- Generic Drug Understanding.
- Dossier Preparation
- Templates – GMP Audit, Plant SOPs, Sample Technical Dossiers.
Methodology: Login with your user id and password and access the course step by step.
===========================================================================
Corporate Training: Specialized designed for the employees of Wellbrit LTD.
Usage Restricted to Wellbrit LTD Employees Only !
==========================================================================
Section 1Understanding of Innovator and Generic Drugs
Lecture 1Drug Regulation Fundamentals
Lecture 2Investigational New Drug Application (INDA)
Lecture 3New Drug Application (NDA)
Lecture 4Basic concept and understanding of the Generic Drug
Lecture 5Abbreviated New Drug Application (ANDA) Filing
Lecture 6Review on Drug Discovery and Development
Lecture 7505(j) ANDA, 505(b)(2) NDA, 505(b)(1) NDA
Lecture 8Authorized Generics: Key Understanding
Lecture 9Exploratory IND Vs. Traditional IND
Lecture 10Orphan Drug Designation
Lecture 11Advance Learning on 505B2 Pathway
Lecture 12Chemistry, Manufacturing & Controls
Lecture 13Patent & Exclusivity - Strategic Understanding | Patent Restoration| Orphan Drug Exclusivity (ODE) | NCE & NCI Exclusivity | GAIN Exclusivity | Pediatric Exclusivity | 180 days exclusivity
Lecture 14Clinical Trials Terminologies
Section 2Liccensing and Technology Transfer Fundamental Session
Lecture 15Licensing & Technology Transfer
Lecture 16In-Licensing Vs. Outlicensing
Lecture 17LOE Strategies for Innovator Brands with case study
Lecture 18Licensing - Advance Learning
Section 3Good Manufacturing Practices and Management of GMP
Lecture 19GMP Introduction | Plant Certification Re
Lecture 20Premises & Plant Layout Designing
Lecture 21Sanitation and Hygiene
Lecture 22Equipment Modules
Lecture 23Production Modules
Lecture 24Documentation
Lecture 25Quality Control
Lecture 26G7 Lecture Product Complaint
Lecture 27G8 Lecture Storage Module
Lecture 28Data Integrity
Lecture 29Plant Inspection Handling
Lecture 30Product Recall | Product Withdrawal | Types of Recall | Handling and Management of Product Recall
Section 4Global Business : European Union - Regulatory & Strategic Planning
Lecture 31Introduction to EU Regulation
Lecture 32Orientation to European Countries and National Regulatory Bodies
Lecture 33Orientation to European Countries and National Regulatory Bodies
Lecture 34Overview of EU Regulation
Lecture 35EMA and EMA Authorisation Process
Lecture 36Summary of Product Characteristics
Lecture 37Compassionate Use
Lecture 38EU MA Strategic Planning: Full, Full-mixed, hybrid applications. Generic, Similar biologic application pathway, Well-established use application, Fixed combination application, Informed consent application
Lecture 39Validity 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 40Data Exclusivity and Market Protection - Supplementary Patent Protection, Exclusivity, 6/10 Rule, 8+2+1 Formulae
Lecture 41EU Orphan Medicinal Products Regulation
Lecture 42Conditional marketing authorisation | Marketing authorisation under exceptional circumstances
Lecture 43Paediatric use marketing authorisation (PUMA) & Paediatric Investigation Plan (PIP)
Lecture 44Summary of Product Characteristics
Lecture 45Compassionate Use
Lecture 46MHRA - UK Regulation
Lecture 47The 'sunset clause' for marketing authorisation of pharmaceuticals
Lecture 48EU variation - Types, Requirement & Planning - IA, IAIN, IB, II ; US FDA Variation AR, CBE-0, CBE-30, PAS - Strategic Discussion | Similarities & Differentiation
Lecture 49EU Prime Designation
Lecture 50Accelerated assessment by EMEA
Lecture 51EU Adaptive Pathway
Lecture 52European public assessment report (EPAR) - Importance, Component, Management, Updation
Lecture 53SPOR - Concept of Master Data Management
Section 5Drug Registration Dossier
Lecture 54MA Submission Dossier Management
Lecture 55CMC Dossier & Compliance Management
Lecture 56Introduction to Electronic Common Technical Document (ECTD)
Lecture 57Advance Practical Training on Dossier Preparation focusing on drug registration in export countries
Lecture 58Modules on Stability Study 1
Lecture 59Importance of effective dossier management
Lecture 60Certificate of Analysis
Lecture 61Detailed Understanding on ANDA Submission Dossier
Lecture 62Prior Approval Submission
Lecture 63Detailed Understanding on ANDA Fees
Lecture 64Discussion on 85 common deficiency in CTD submission dossier
Lecture 65Key Consideration for Drug Master File Preparation and Submission
Lecture 66Practical Understanding on Drug Master File Preparation and Submission
Lecture 67Associated Learning: Site Master File - Detailed Understanding
Lecture 68DMF Completeness Assessment
Lecture 69Drug Master File - Fees
Lecture 70Drug Master File - Global Perspective [Across Different Regions]
Section 6Plant Inspection and Audit Handling
Lecture 71Data Integrity issues in Pharmaceutical Industry
Lecture 72Plant Inspection Management
Lecture 73CAPA
Section 7Business Development Skill Training
Lecture 74Pharma Business Development Job Functionality | Strategic Planning Process | Knowledge Area of Business Development | Lead targeting | Licensing term sheets
Lecture 75Portfolio Management Process | Portfolio Characteristics | Portfolio Analysis | Balancing the Portfolio | BD and Strategic Planning Department
Lecture 76Identifying the corporate Need of business development | Objective – Strategy - Tactics | Portfolio constraints | SWOT | Numerical SWOT
Lecture 77Profiling and Searching | Objectives | Search Database | Creating Opportunity Anatomy for deal analysis | Mind Mapping | Searching Tools and Techniques - Web Search | Conference | Confidentaility - CDA | MTA
Lecture 78Numerical SWOT Practical training
Lecture 79Modelling 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 80Market Size Determination - Market Share | Relative Market Share | Total Vs. Actual Vs. Penetrated Market
Lecture 81Forecasting : Tools and Techniques
Lecture 82Market Sizing & Forecasting Case Study
Lecture 83Royalty Management - Royalty structuring | Royalty Calculation Method| Tiered Royalties | Terms | Royalty Reductions | Royalty Stacking - Concept and Calculation | Minimum Annual Royalties | Reach through royalties
Lecture 84Average Royalty Rates
Lecture 85Factor affecting the Royalty Rate in Pharmaceutical and Biopharmaceutical Deal
Lecture 86Distribution Licensing | Geography | Indication Splitting | Execlusive and Non-Exclusive Licensing | Sub Licenses
Lecture 87Acquisition in Pharma | Product Acquisition| Company Acquisitions| Steps in acquisition | Financing acquisition deals | Trademark Assignment Process
Lecture 88Join Ventures in Pharmaceutical and Biopharmaceutical Industry
Lecture 89SPECIAL PURPOSE VEHICLES (SPV)
Lecture 90Indication Splitting | Concept | Implementation feasibility analysis
Lecture 91Types of Deals from Discovery to Commerialication
Lecture 92Review: What are the fundamental areas of business development
Lecture 93Licensing Term Sheet | Content Structuring | Sample Term Sheet
Lecture 94Licensing Payment Scheduling: Different Types
Lecture 95Valuation Methods: DCF | rNPV | Sunk Cost Method | Comparables | Sum of Parts | Deterministic Vs. Probabilistic rNPV | Peak Sales - Max-Min Approach
Lecture 96Valuation Methods: EBITDA method of valuation | Enterprise Value and Enterprise Multiple Calculation
Lecture 97Negotiation Skill Training for Business Development and Strategic Management Professionals
Lecture 98Business Development Simulation and Decision Making | Early Stage VS. Late Stage Valuation Methodology | Stair Step Model
Lecture 99Licensing Agreement : Confidentiality Agreement | MTA | A deed of Assignment | Exclusive | Non-Exclusive License | Sole License | Components - Terms - Duration - Key Considerations
Lecture 100Step By Step Implementation of Licensing Deal by Business Development Team
Lecture 101Due Diligence Activities in Pharmaceutical Licensing
Lecture 102Pharma Business Development - Competency Test. Check your competency
Lecture 103Co-promotion & Co-marketing strategy in pharma industry
Lecture 104Concept of Reverse co-promotion in pharma industry
Lecture 105Importance of Publications in Pharmaceutical Industry
Lecture 106Juxtapid Case Study
Lecture 107New Indication Approval Process and Promotion
