InstructorKnowledge Process Enhancer
TypeOnline Course
Student Enrolled2
Price$390 / Rs. 19500
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Introduction

Course Deliverable

Accreditation

Eligibility

Course Comparison

Course Deliverables

Course Objective – 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. This is ideally suits to those who wants Drug Regulatory Affairs Certification within a span of 1 month.

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 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, 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. 6 different Printed Book / printable booklet provided to all course registrant

2. Access the e-lectures, case studies, self assessment modules and practical sessions through personalized webpage. Refer Learning Schedules by scrolling down the page.

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

4. Access to 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.

Minimum qualification required is Graduation in any discipline or 2 years of work experience in pharmaceutical company.

View comparison of 1 Week / 1 month / 1 Year program.

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Course Content / Learning Schedules

Section 1Drug Regulation Fundamentals
Lecture 1R&D Process & Introduction to drug discovery
Lecture 2Investigational New Drug Application (INDA)
Lecture 3New Drug Application (NDA)
Lecture 4Abbreviated New Drug Application (ANDA)
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 Program
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 Vs. Traditional IND
Lecture 15Patents Vs. exclusivity 
Lecture 16Learning from New Drug Approvals
Lecture 17Orphan Drug & Orphan Drug Act
Lecture 18Advance Learning on 505B2 Pathway
Lecture 19Patent & Exclusivity - Strategic Understanding | Patent Restoration| Orphan Drug Exclusivity (ODE) | NCE & NCI Exclusivity | GAIN Exclusivity | Pediatric Exclusivity | 180 days exclusivity
Section 2Clinical Trial
Lecture 20Clinical Trial Detailed Study (Topic - 1-11)
Lecture 21Clinical Trial Protocol Writing
Lecture 22Ethics in Clinical Research
Lecture 23Informed Consent
Lecture 24FDA Forms and How to fill the resources
Section 3Regulatory Strategies
Lecture 25Regulatory Strategies in different phases of Clinical Trial
Lecture 26Advance study on Para IV Filing
Lecture 27Evergreening - Patent Life Extension Strategies
Lecture 28Drug Repurposing
Lecture 29In-Licensing Vs. Outlicensing
Lecture 30LOE Strategies for Innovator Brands with case study
Lecture 31Paediatric Exclusivity and Paediatric Study Plan Development
Section 4DMF & SMF
Lecture 32DMF & SMF introduction
Lecture 33Site Master File
Lecture 34Practical Training on preparing DMF and SMF
Section 5Drug Registration Dossier
Lecture 35CTD
Lecture 36Chemistry, Manufacturing & Controls - Fundamental Understanding
Lecture 37Advance Practical Training on Dossier Preparation focusing on drug registration in export countries
Lecture 38Advance Practical Training on Dossier Preparation
Lecture 39Modules on Stability Study : Stability Study - Fundamental Understanding | Interchangebility | Reports | API & FPP Stability Study
Lecture 40Importance of effective dossier management
Lecture 41Deficiencies observed in CTD Dossiers
Lecture 42Certificate of Analysis
Lecture 43Introduction to Electronic Common Technical Document (ECTD)
Lecture 44Importance of effective dossier management
Section 6Final Examination
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