Introduction
Course Deliverable
Eligibility
Course Comparison
Related Courses
1 Month Drug Regulatory Affairs course is conceptualized with vision to train 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.
- 6 different Printed Book / printable booklet provided to all course registrant
- Access the e-lectures, case studies, self assessment modules and practical sessions through personalized webpage. Refer Learning Schedules by scrolling down the page.
- Flexible online final examination (Computer Based Test by secure mode)
- Access to real life case studies
Minimum qualification required is Graduation in any discipline or 2 years of work experience in pharmaceutical company.
Course |
Department / Functional Area |
Pharma Global Business – Executive Program |
Regulatory Affairs |
Biopharma Regulatory Affairs |
Biologic Regulatory Affairs |
DRA + Pharmacovigilance Dual Specialization |
RA and Pharmacovigilance |
DRA + Production Management Dual Specialization |
RA, Production / F&D |
DRA + PMT Dual Specialization |
RA, PMT, Strategic Management and International Marketing Professionals |
European Drug Regulatory Affairs |
RA – EU, handling regulated market. |
GCC Drug Regulatory Affairs |
RA / BD professionals handling GCC market. |
African Drug Regulatory Affairs |
RA / BD professionals handling African continent. |
ASEAN Drug Regulatory Affairs |
RA / BD professional handling ASEAN market |
Latam Regulatory Affairs Course |
RA / BD professional handling LATAM market |
Middle East Drug Regulatory Affairs |
RA / BD professional handling Middle East + GCC market |
MENA Drug Regulatory Affairs |
RA / BD professional handling MENA market Middle East + North Africa + GCC market |
Drug Dossier Preparation |
RA / QA / QC / Production Management professionals |
DMF and SMF preparation |
RA / QA / QC / Production Management professionals |
ANDA Filing and Strategic Management |
RA / QA / QC / Production Management professionals |
Japan Drug Regulatory Affairs |
RA / BD professional handling Japan market |
China Drug Regulatory Affairs |
RA / BD professional handling China market |
Drug Registration and Regulation UAE |
RA / BD professional handling UAE market |
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 4Basic concept and understanding of the Generic Drug
Lecture 5Abbreviated New Drug Application (ANDA)
Lecture 6Review on Drug Discovery and Development
Lecture 7Biological Licensing Application (BLA) | 351(a) application | Form 356h | Differentiation with NDA | Timeline | Handling FDA queries
Lecture 8Abbreviated Biosimilar Application - 351(k): Advance Strategic Planning Process : Originator Vs. Biosimilar Development and Regulatory Approval Process | Reference Biologic | Purple Book | Data Requirements
Lecture 9Handling of orange book
Lecture 10Purple Book: Significance | Searching | Assignments
Lecture 11Complete Response Letter | Key understanding | Management and Action Plan
Lecture 12USFDA expedited programs
Lecture 13Authorized Generics: Key Understanding
Lecture 14Exploratory IND Vs. Traditional IND
Lecture 15Patents Vs. exclusivity
Lecture 16505(j) ANDA, 505(b)(2) NDA, 505(b)(1) NDA
Lecture 17Patent & Exclusivity - Strategic Understanding | Patent Restoration| Orphan Drug Exclusivity (ODE) | NCE & NCI Exclusivity | GAIN Exclusivity | Pediatric Exclusivity | 180 days exclusivity
Lecture 18Orphan Drug Designation
Lecture 19Advance Learning on 505B2 Pathway
Lecture 20Chemistry, Manufacturing & Controls
Section 2Clinical Trial
Lecture 21Clinical Trial Detailed Study (Topic - 1-11)
Lecture 22Clinical Trial Protocol Writing
Lecture 23Ethics in Clinical Research
Lecture 24Informed Consent
Lecture 25FDA Forms and How to fill the resources
Lecture 26Strategic Discussion: PreIND, EOP1, EOP2 - What to expect !
Section 3Regulatory Strategies
Lecture 27Regulatory Strategies in different phases of Clinical Trial
Lecture 28Advance study on Para IV Filing
Lecture 29Para IV Notices
Lecture 30Evergreening - Patent Life Extension Strategies
Lecture 31In-Licensing Vs. Outlicensing
Lecture 32LOE Strategies for Innovator Brands with case study
Lecture 33Paediatric Exclusivity and Paediatric Study Plan Development
Lecture 34Drug Repurposing
Lecture 35Practical Queries on different USFDA application and Filing
Section 4DMF & SMF
Lecture 36Key Consideration for Drug Master File Preparation and Submission
Lecture 37Site Master File
Lecture 38Practical Training on preparing DMF and SMF
Section 5Drug Registration Dossier
Lecture 39Submission Dossier
Lecture 40Chemistry, Manufacturing & Controls - Fundamental Understanding
Lecture 41Advance Practical Training on Dossier Preparation focusing on drug registration in export countries
Lecture 42Advance Practical Training on Dossier Preparation
Lecture 43Modules on Stability Study : Stability Study - Fundamental Understanding | Interchangebility | Reports | API & FPP Stability Study
Lecture 44Importance of effective dossier management
Lecture 45Deficiencies observed in CTD Dossiers
Lecture 46Certificate of Analysis
Lecture 47Introduction to Electronic Common Technical Document (ECTD)
Lecture 48Importance of effective dossier management
Lecture 49Prior Approval Submission (PAS)
Lecture 50etailed Understanding on 505(b)(2) VS. Suitability Petition : Case Based Learning
Lecture 51NCE Vs. 505b2 application - Case Based Learning
Lecture 52Classic case study of the 505b2 filing : Case Based Learning
Section 6Final Examination
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