TypeOnline Course
Student Enrolled15
(10 ratings)
Price$650 / Rs. 32500
Buy NowBook Now

Admission Process

Admission Process

Upon receiving your filled up application form, our admin team will generate PROVISIONAL ADMISSION ID and send you the PROVISIONAL ADMISSION LETTER along with instruction to course fees payment options.

Course Application Form

Introduction

Feature

Accreditation

Eligibility

Fees

Admission Process

Course Objectives:

Pharmaceutical Regulatory Affairs courses are conceptualized with vision to create effective Regulatory Affairs Manager for Pharma Industry. This course gives practical knowledge of the functionalities of Regulatory Manager with practical exposure.

Career in Drug Regulatory Affairs

A career in Regulatory Affairs is both a challenging and highly rewarding career. It opens up lot of opportunities as it covers a variety of disciplines. Individuals who are directly involved in regulatory submission, compliance, clinical trials, quality assurance, drug safety, pharmacovigilance and others are considered regulatory professionals.

The Pharma industry is growing at a rapid pace and there is a rising concern over the safety and efficacy of pharmaceutical and medical device products. To maintain safety and efficacy in pharma & medical device products, regulatory agencies like US FDA,UK MHRA, EDQM, DCGI etc all over the world are imposing no of regulation. This has resulted in creation of distinct department with highly qualified professionals who will help companies meet these requirements with ease.

 Our Registerants are in Lipoxen (UK), Orchid, 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.

1. Printed Book / printable booklet provided to all course participants. There will be total 18 books will be provided. Refer syllabus copy to view the details. 

2. Access the e-lectures, case studies, self assessment modules and practical sessions through personalized webpage. 

3. Flexible online final examination (Computer Based Test by secure mode)

4. Access to 1000s of real life case studies

  • The Internationally Accredited course – Accredited by International Association of Distance Learning (IADL), UK
  •  Knowledge Process Enhancer is registered under Trademark Registry of India, under class 42.

B.Pharma/D.Pharma/ 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.

27500.00 (From payment from India) / 550 USD for payment outside India

FAQ RELATED TO THE COURSE

Frequently asked questions

Read FAQs

ADMISSION PROCESS

Course Flow – 

Section 1Fundamental of Drug Discovery, Development (US Regulation)
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 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 (Detailed Understanding)
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
Lecture 15Patents Vs. exclusivity
Lecture 16Case Study New Drug Development & R&D Incentive Plans
Lecture 17Submission Requirements for Orphan Drug Designation
Lecture 18Advance Learning on 505B2 Pathway
Section 2Clinical Trial / Research - Fundamental
Lecture 19Clinical Trial Detailed Study (Topic - 1-11)
Lecture 20Clinical Trial Protocol Writing
Lecture 21Ethics in Clinical Research
Lecture 22Informed Consent
Lecture 23FDA forms and How to fill FDA forms
Lecture 24Strategic Discussion: PreIND, EOP1, EOP2 - What to expect !
Section 3IPR Related Topics (Optional)
Lecture 25USPTO - Introduction
Lecture 26Patent - Fundamental Concepts
Lecture 27Patent Application Process - USPTO
Lecture 28Trademark Search and Registration in US
Lecture 29Steps Know How & Key Points - Patent Application
Lecture 30IPR - Patent Grant and Handling Process in India (Optional)
Lecture 31Patent Search in Indian Patent Office (Optional)
Lecture 32Trademark - Practical on TM Search & Registration Process in India (Optional)
Lecture 33Trademark Search assignment (optional)
Lecture 34Fundamental Understanding of Patent, Trademark Licensing and related terminology
Section 4Regulatory Strategies
Lecture 35Regulatory Strategies in different phases of Clinical Trial
Lecture 36Advance study on Para IV Filing
Lecture 37Para IV Notice
Lecture 38Evergreening - Patent Life Extension Strategies
Lecture 39Pay For Delay Strategy
Lecture 40REMS Strategic Planning
Lecture 41Compulsory Licensing
Lecture 42Technology Licensing
Lecture 43In-Licensing Vs. Outlicensing
Lecture 44LOE Strategies for Innovator Brands with case study
Lecture 45Paediatric Exclusivity and Paediatric Study Plan Development
Lecture 46Drug Re-purposing
Section 5GMP
Lecture 47Definition of GMP
Lecture 48Certification Pharmaceutical Companies / Plants
Lecture 49Introduction to Good Manufacturing Practices
Lecture 50Premises & Plant Layout Designing
Lecture 51Sanitation and Hygiene
Lecture 52Equipment
Lecture 53Production Modules
Lecture 54GMP Documentation
Lecture 55Quality Control
Lecture 56Handling of Product Complaint
Lecture 57GMP Storage
Lecture 58ISO and ISO Audits
Lecture 59Pharmaceutical SOPs
Lecture 60SOP Automation
Section 6DMF & SMF
Lecture 61DMF & SMF
Lecture 62Site Master File
Lecture 63Practical Training on preparing DMF and SMF
Section 7Biosimilar
Lecture 64Introduction to Biosimilar
Lecture 65Biosimilar Approval process
Lecture 66Biological Licensing Application (BLA)
Lecture 67Vaccine development and approval Process
Section 8USFDA warning Letter & CAPA
Lecture 68CAPA - Introduction
Lecture 69USFDA Warning Letter
Lecture 70Handling of warning letter
Lecture 71Case Study: Warning Letter
Section 9Drug Registration in European Country (Optional)
Lecture 72Overview of EU Regulation
Lecture 73Orientation to European Countries and National Regulatory Bodies
Lecture 74Overview of EU Regulation
Lecture 75EMEA Procedures
Lecture 76Summary of Product Characteristics (SmPC)
Lecture 77Compassionate Use
Lecture 78MHRA - UK Regulation
Lecture 79EU Orphan Medicinal Products Regulation
Lecture 80The 'sunset clause' for marketing authorisations of pharmaceuticals
Section 10GCC Regulatory Affairs (Optional)
Lecture 81Regions in Pharma Business : Common Terminologies
Lecture 82GCC Pharma Market
Lecture 83GCC Export
Lecture 84GCC Registration Procedure
Lecture 85Drug Registration in Saudi Arabia
Lecture 86Documentation Required for the GCC countries
Lecture 87Drug Registration in Beherain, UAE, Kuwait, Qatar, Oman
Lecture 88Medical Device Regulation in GCC countries
Section 11Drug Registration Dossier
Lecture 89Introduction to Common Technical Document (CTD)
Lecture 90Asean Common Technical Document (ACTD)
Lecture 91ECTD
Lecture 92Advance Practical Training on Dossier Preparation focusing on drug registration in export countries
Lecture 93Modules on Stability Study
Lecture 94Stability Study Test
Lecture 95Module on Interchangeability
Lecture 96Stability Testing of API
Lecture 97Stability Testing of Finished Pharmaceutical Products
Lecture 98Review on Stability Testing
Lecture 99Black Box Warning
Lecture 100Importance of effective dossier management
Lecture 101Deficiencies observed in CTD Dossiers
Lecture 102Certificate of Analysis
Section 12Portfolio Management and Related Topics
Lecture 103Advance understanding of the portfolio Management
Lecture 104Importance of market research in pharmaceutical industry
Lecture 105Co-promotion & Co-marketing strategy in pharma industry
Lecture 106Concept of Reverse co-promotion in pharma industry
Lecture 107Publication Management from Regulatory perspective
Lecture 108Juxtapid Case Study
Lecture 109New Indication Approval Process and Promotion
Lecture 110OTC Switch
Lecture 111Practical Case Study in Rx to OTC Switch
Section 13API Regulatory Affairs
Section 14Case Study Access
Lecture 11348 different topics of the Regulatory Affairs, Case Studies and Self Assessment Tests
Lecture 114Access to Case study directory
Section 15Drug Registration in ASEAN countries (Optional)
Lecture 115ASEAN Drug Regulatory Affairs
Lecture 116Asean Geography
Lecture 117Drug Registration in Brunei
Lecture 118Drug Registration in Malaysia
Lecture 119Drug Registration in Cambodia
Lecture 120Drug Registration in Mayanmar
Lecture 121Drug Registration in Philippines
Lecture 122Drug Registration in Singapore
Section 16CDSCO : Drug Registration in India (Optional)
Lecture 123Drug Regulation in India - CDSCO
Lecture 124National Pharmaceutical Pricing Authority
Lecture 125Drug Price Regulation in India
Lecture 126Drug Registration in India - Practical understanding drug registration process in CDSCO
Lecture 127Drug Price Control Order 2013
Lecture 128Case Study of New Drug Approval in India
, , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , ,