Interactive e-lectures (audio-visual), assignments can be accessed online across anywhere, anytime. Attend classes at your convenient time.
Course participant are provided with books which explains all concepts and provide practical cases for easy understanding.
Access to 1000’s of real life case studies and live simulations from pharmaceutical Strategic management cases.
Flexible online final examination (Computer Based Test by secure mode), can be taken from any devices, from anywhere.
Every course participant will receive personalized webpage with cutting edge course tracker – analytics for progress of courses.
The Internationally Accredited course – Accredited by International Association of Distance Learning (IADL), UK.
Course content is designed and updated as per the latest real life cases.
Course certificates will be provided at the end of the course.
Lipoxen (UK), Orchid Pharmaceuticals, Sanofi-Aventis, Astra-Zeneca, Hospira, Ranbaxy, Julphar, J&J-Ethicon, Pfizer, DRL, MSD, Medo Pharma, Nestle, Ind-Swift, Panacea, Bal Pharma, Aristo, Shaigan Pharmaceuticals, Reliance Lifesciences, Quality Pharma Pvt Ltd, Cipla, Ipca, Sherya Lifesciences, Promed, Torrent Pharmaceuticals, Zydus Candila, Himalaya Herbal Healthcare, Bangalore Pharmaceutical and Research laboratories, Teru Technomed, Indocoar Pharma, Fortis Hospitals, VRPL Healthcare, Medreich, Hospira, Indospectrum, Winatac Limited, Faveo Pharmaceuticals, Enzem, Leo, Accenture, Mylan, and many more companies across the pharma industry.
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Module 1: Global Business Environment Top Global companies – Innovator and Generic, Top brands, Top Segments – Growth and Attractiveness. Global Pharma Industry: Detailed Overview. Business AnalysisTop 100 brands micro analysis – Segment attractiveness US Pharmaceutical Market and Regulatory environment
Module 2: Drug Discovery and Development Pharmaceutical & Bio-Pharmaceuticals R&D Process & Introduction to drug discovery, Investigational New Drug Application (INDA), New Drug Application (NDA), Basic concept and understanding of the Generic Drug, Abbreviated New Drug Application (ANDA), Generic Drug User Fees Act (GDUFA), Prescription Drug User Fees Act (PDUFA), Handling of orange book, Priority Accelerated Review, Practical Training on INDA and ANDA filing, Promotion Advertisement Regulations (Practical), Biological Licensing Application (BLA), USFDA Warning Letter, Handling of warning letter Generic Drug Marketing Strategies Advance study on Para IV Filing, Evergreening – Patent Life Extension Strategies, Detailed understanding about 505(j) ANDA, 505(b)(2) NDA, 505(b)(1) NDA.
Module 3: Overview of Clinical Trial & Clinical Trial Terminologies
Introduction to Clinical Research : Definition, Terminologies and definition in Clinical Research, Difference between Clinical Research and Clinical Practice, Fundamental of Clinical Research, Types of Clinical Research, Phases of clinical research, Expanded access trial, Clinical Trial Protocol Writing, Ethics in Clinical Research, Observational Study and different types, Informed Consent, Experimental Stud, Randomized Controlled Trials, Randomized, controlled and Placebo controlled study, Active comparator study, Clinical Research Process, Importance of Reviews in Clinical Research
Module 4: GMP in Pharmaceutical Industry
G1 Premises & Plant Layout Designing, G2 Sanitation and Hygiene, G3 Equipment Modules, G4 Production Modules, G5 Documentation, G6 Quality Control, G7 Product Complaint, G8 Storage Module
Module 5 : Quality Management in Pharmaceutical Company – Handling of Internal Audit, QA detailed Study Pharmaceutical SOPs Management from regulatory perspective SOP Automation in Pharmaceutical Industry Formulation, Quality and Regulatory Manual for handling CAPA Introduction to CAPA, Root cause analysis and handling of deviations, Regulatory plant audit handling and liaising with the regulatory department. Access to sample Plant SOP database.
Module 6 Certification Pharmaceutical Companies / Plants – Certification in Pharmaceutical Companies. Analysis of Certification of leading global pharmaceutical companies (Interactive Case study) ISO and ISO Audits.
Module 7 Intellectual Property Right IPR – Introduction, Patent, Patent – Practical on search and filing, Trademark – Practical on TM Search & Registration Process, how to search and register brands in USPTO, Trademark – Practical on TM Search, Trademark Search assignment, 100 of cases demonstrating innovation management in pharmaceutical industry, Practical case studies on IP Management, Technology Transfer in Pharmaceutical Industry. How to register trademark globally.
Module 8: International Trade – Basics to advance learning International marketing: Basis of international trade, theories of international trade, Adam Smith, Ricardo. Difference between domestic and international marketing, EPRG framework. Scanning of international environment: Social, political, legal, economic, cultural environment for overseas markets; Factors affecting international trade: Methods of entry, WTO/GATT, regional agreements commodity agreements. Product: Identifying new products, international product planning, product design strategy, product elimination, adoption and diffusion of new products, branding strategies. Pricing strategies: Methods of pricing, pricing an international product, transfer pricing, exchange rates and its impact on pricing factors affecting international prices, dumping and anti-dumping regulations. Distribution strategies: Direct and indirect channels, factors affecting international channels, international channel management. Promotion strategy in overseas markets: Perspectives of international advertising, standardization v/s localization, global media decisions, global advertising regulations, industry self-regulation. Export documentation and procedures. Foreign trade policy: EXIM Policy.
Module 9: Export Documentation – Registration of the pharmaceutical products Introduction to Common Technical Document (CTD), Asean Common Technical Document (ACTD), Advance Practical Training on Dossier Preparation focusing on drug registration in export countries, Assignment and real life dossier preparation – step by step guideline, Overall understanding of dossier compilation process, Modules on Stability Study, Test on Stability Test, Module on Interchangeability, Stability Testing of API, Stability Testing of Finished Pharmaceutical Products, Review Test on Stability Testing, Advance Practical Training on Export Documentation E-CTD – Practical Training on ECTD Regulatory Strategies in different phases of Clinical Trial Packaging Development from Regulatory Perspective Packaging Development, Prescribing Information and Patient Information Leaflet development.
Module 10 DMF & SMF Drug Master File, Site Master File, Practical Training on preparing DMF and SMF
Module 11: Advance understanding on Biosimilar Drugs and Guidelines Introduction to Biosimilar, Biosimilar Approval process, Global Biosimilar Marketing Strategies.
Module 12: Project Management skills for Strategic Management Professionals – Introduction to Pharma Project Management – PERT, CPM, Critical Path, Project Diagram and its components, Basics of Project Management, Importance of Project Manager in Pharma Industry , Milestone and Cycle Time Development in Project, Project Termination and Project initiation in Pharmaceutical Industry, Project Control and importance of Asset Tracking as an adjunct to Project Tracking, Levels of the Project Management, Combining Portfolios From Mergers & Acquisitions in Bio/pharmaceutical R&D.
Module 13: Portfolio Management Advance understanding of the portfolio Management , Importance of market research in pharmaceutical industry, Co-promotion & Co-marketing strategy in pharma industry, Concept of Reverse co-promotion in pharma industry, In-Licensing Vs. Outlicensing, Importance of Publications in Pharmaceutical Industry, New Indication Approval Process and Promotion, OTC Switch.
Module 14: Register and Market Pharmaceuticals in ASEAN Countries
Country Analysis – Pharmaceutical Business and Regulatory Business Environment Analysis ASEAN Drug Regulatory Affairs, Asean Geography, Drug Registration in Brunei, Drug Registration in Malaysia, Drug Registration in Cambodia, Drug Registration in Mayanmar, Drug Registration in Philippines, Drug Registration in Singapore, Drug Registration in Vietnam, Drug Registration in Laos, Drug Registration in Indonesia, Drug Registration in Yemen, Drug Registration in Saudi Arabia, Drug Registration in Beherain, Drug Registration in Kuwait, Drug Registration in Qatar, Drug Registration in UAE.
Module 16: Register and Market Pharmaceutical and Bio-Pharmaceuticals in India – Pharmaceutical Business Environment, Drug Regulation in India – CDSCO, National Pharmaceutical Pricing Authority, Drug Price Regulation in India, Drug Registration in India – Practical, understanding drug registration process in CDSCO, Drug Price Control Order 2013.
Module 17: Pharmaceutical Business Anslysis in European Country – Country Profiling, Regulations – Centralized Procedure, Decentralized Procedure, Mutual Recognition Procedure, Dossier Preparation for European submission. EMEA, MHRA-UK – Pharmaceutical Registrations
Module 18: Drug Registration and Marketing in GCC countries – Country Profiling
Drug Registration in Saudi Arabia, Drug Registration in Beherain, Drug Registration in Kuwait, Drug Registration in Qatar, Drug Registration in UAE.
Module 19: African Drug Market – Strategic Analysis, Country Profiling from Pharmaceutical Business Perspective – african Country specific analysis
Module 20: Finance for strategic management professionals
Module 21: Strategy, Strategic Management Process Levels of Strategies- Corporate, Business and Operational level, Types of Strategies- Functional Strategies, H. R Strategy, Marketing strategy, Financial Strategy, Operational Strategy
Module 22: Corporate Restructuring
Introduction to Corporate Restructuring, Need for corporate restructuring and forms of corporate restructuring
Module 23: Strategic Deals
Merger, acquisition. Outsourcing
Module 24: Concept of Outsourcing in pharma business
Concept of Outsourcing in pharma business, Strategic Reasons of growing Outsourcing in pharmaceutical Business
Module 25 : Pharmaceutical Brand Management Module – Branding and its potential within the pharmaceutical industry: History, meaning, need, importance, branding in pharmaceutical industry, building brand values and brand strategy, timing, patient power, strategic brand management process. The role of advertising in branding pharmaceuticals. PMT – Job Responsibility, Hierarchy of marketing team, Career prospect in PMT, Product Management Process, Preparing a brand plan, Product Strategy, Tools of pharmaceutical promotion – Visual Aid, Leave Behind Literature (LBL), Technical Folder designing. Marketing campaign preparation – how to design marketing campaign, writing a marketing campaign, Implementation of campaign (on field & off field activity of PMT), Monitoring of campaign success. Detailing – Detailing for brand positioning, detailing talk preparation and Ideal detailing talk. Handling and usage of visual Aid.
Module 25: Corporate Positioning and Repositioning exercise
Module 26 – Basics of Operation Management Module 18 Top Pharma companies – Portfoilo and business focus analysis Case Study on Strategic Analysis / deals on global pharmaceutical industry
Module 27 Online Promotion Strategies
Introduction to SEO, Online B2B promotion, developing, executing digital marketing promotion techniques, Mobile Apps management in pharmaceutical busi