TypeOnline Course
Price$700 / Rs. 32500
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Course Objective: B.Pharm/D.Pharm/ B.Sc/ Any graduates or those who are in 3rd / final year of those courses, who want to make career in pharmaceutical marketing can pursue the course.

Features of the Course:

1. Comprehensive study material covering all important aspects of Pharmaceutical Marketing and Regulatory Affairs

2. Understanding/ Decision Making/ Strategy Creation in the field of Pharma Marketing, international marketing and regulatory affairs.

3. Pharma Marketing & Regulatory Affairs Case Study (Online Databank) File for effective skill enhancement for strategic decision making

4. Support : Resume Development, Placement Assistance.

5. Specialized modules on International Marketing of Pharmaceutical Products and Strategic Management

Course Duration: 1 Year

Course is accredited by International Association of Distance Learning

Nature of the Course: Distance & e-Learning

Fees: Rs. 38,500/- Indian Rupees (For payment within India)

          700 USD (For payment outside India)

Unique Features

  • Comprehensive study material covering all important aspects of Pharmaceutical marketing
  • Orientation to job related practical aspects of Pharmaceutical marketing and regulatory affairs
  • Access to industry data bank of marketing and regulatory case studies
  • Specialized modules covering all Pharmaceutical international marketing

 

Learning Mode:

  • Interactive e-lectures (virtual classroom)
  • Online interactive sessions with the expert Industry faculty
  • e-Library and e-pharma dictionary
  • Access to 1000’s of real life case studies
  • Online assignments & self Assessment Test
  • Printed Course Material
  • 24/7 Online Support With the Live Chat Facility
  • Special On demand Modules
  • Secure access to e-module with passwords.
  • Flexible online final examination (Computer Based Test by secure mode)
  • 100% Placement assistance is provided once the course is completed
  • The Internationally Accredited course – Approved by International Association of Distance Learning (IADL), UK
  • Personalized web page
  • Our courses can be accessed anytime from anywhere

Marketing Syllabus: 

1. Basics of Marketing: What is marketing? Why business needs marketing orientation? 4 P’s of Marketing. Marketing Environment & competitor analysis – SWOT & PEST. Factors affecting Marketing. Market orientated strategic planning. Competition & Competitors. Targeting, Segmentation & Positioning. Developing competitive differentiation.

2. Product- Introduction, Basic concepts of product, Product Differentiartion, Differentiation tools, Product Classification, Product Mix & Product Lines, Brand Decisions Product Development Process. Product Life Cycle & Product Life Cycle Management

3. Price- Definition, History of Price Control in Indian Pharmaceutical Market, Price in Marketing Mix? Basis for pricing, Pricing strategies, Pricing management.

4. Distribution – Basics of distribution in Indian Pharmaceutical market, Pharmaceutical Distribution Channels, single channel v/s multiple channel strategies , AIOCD, NOC & LOC, Physical distribution, Role & Responsibilities of chemist.

5. Marketing Research – Introduction: Nature, scope and importance of marketing research, role of marketing research in decision marking; Factors influencing marketing research decisions, marketing information systems, the marketing research process., Problem identification, Research design: Exploratory, descriptive and conclusive. Methods of data collection – observation, experimentation, survey, desk research method, Sampling Plan: Sampling method, sample size, designing of questionnaire, Field investigation., Data processing: Editing, coding, classification and tabulation, Data analysis: Hypothesis testing., Application: Product research, advertising research, market and sales analysis research.

6. Promotion – Integrated Marketing Mix – Introduction, objective, Communication Mix, Basics of Marketing communication, Marketing Communication Process, Factors affecting communication mix, Media Mix, Developing a communication campaign, Budegeting for marketing communication Issues in pharma product promotion, approaches for pharma product promotion, DTC, e-detailing, physician related promotional programmes for increasing acceptance and sales of pharma products.

7. Pharmaceutical Brand Management– 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.

8. Strategy – Brand Strategy, Types of strategy with case study, Strategy for new product launch – Forecasting, Technical, Budgeting, market plan. Co-promotion. Case Study

9. International Marketing – 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.

10. Drug Development & Lifecycle Management Strategies:

New Drug Development Strategies

Lifecycle Management Strategies

Generic Drug Development and Management Strategies

Blockbuster Drug Management Strategies

Clinical Trial for Lifecycle Management

Licensing for Growth – In Licensing Vs. Out Licensing

11. Pharmaceutical Business Model

Product Development > Manufacturing > Marketing

Product Development > Manufacturing > Licensing

Manufacturing > Marketing

3rd Party Manufacturing > Marketing

Marketing

 

Regulatory Affairs

Phase 1 Drug Regulation Fundamentals
R&D Process & Introduction to drug discovery
Investigational New Drug Application (INDA)
New Drug Application (NDA) >> Start
Basic concept and understanding of the Generic Drug
DRA working in DRA department
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)

Phase 2 Certification Pharmaceutical Companies / Plants
Certification in Pharmaceutical Companies

Phase 3 ISO and ISO Audits

Phase 4 GMP in Pharmaceutical Industry
Introduction to Good Manufacturing Practices
Short Test on GMP
G1 Lecture Premises & Plant Layout Designing
G2 Lecture Sanitation and Hygiene
G3 Lecture Equipment Modules
G4 Lecture Production Modules
G5 Lecture Documentation
G6 Lecture Quality Control
G7 Lecture Product Complaint
G8 Lecture Storage Module

Phase 5 Intellectual Property Right
IPR – Introduction
Patent \
Patent – Practical on search and filing
Trademark – Practical on TM Search & registration Process
Trademark – Practical on TM Search
Trademark Search assignment

Phase 6 Dossier Reparation
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

Phase 7 Registration of the Drug Products in the overseas market
Practical Training on Export Documentation

Phase 8: Drug Regulatory Review (48 Chapters with case studies)

Phase 9 E-CTD

Phase 10 Regulatory Strategies in different phases of Clinical Trial

Phase 11 Packaging Development from Regulatory Perspective
Packaging Development
Prescribing Information and Patient Information Leaflet development
Phase 12 DMF & SMF
Drug Master File
Site Master File
Practical Training on preparing DMF and SMF

Phase 13 Generic Drug Marketing Strategies
Advance study on Para IV Filing
Evergreening – Patent Life Extension Strategies

Phase 14 ASEAN DRA
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

Phase 15 Advance understanding on Biosimilar Drugs and Guidelines
Introduction to Biosimilar
Biosimilar Approval process

Phase 16:
Biological Licensing Application (BLA)
Vaccine development and approval Process

Phase 17 API Regulatory Affairs

Phase 18
USFDA Warning Letter
Handling of warning letter

Phase 19
Technology Transfer in Pharmaceutical Industry

Phase 20
Handling of Internal Audit
QA detailed Study

Phase 21 SOP Management for better effectiveness of plant
Pharmaceutical SOPs Management from regulatory perspective
SOP Automation in Pharmaceutical Industry

Phase 21 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

Phase 22
Global Pharma Industry
Indian Pharma Industry

Phase 23
48 different topics of the Regulatory Affairs, Case Studies and Self Assessment Tests
Phase 24 CDSCO – Drug Regulation in India

Phase 24 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

Phase 25 Drug Registration in GCC countries

Drug Registration in Saudi Arabia
Drug Registration in Beherain
Drug Registration in Kuwait
Drug Registration in Qatar
Drug Registration in UAE

Phase 26 Project Management skills for regulatory 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

Phase 27 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
Juxtapid Case Study
New Indication Approval Process and Promotion
OTC Switch

Phase 28 Drug Registration in European Country
Centralized Procedure
Decentralized Procedure
Mutual Recognition Procedure
Dossier Preparation for European submission