
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.
- 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