Regulatory Affairs Courses
The Regulatory Affairs department is a significant part of the managerial structure of pharmaceutical companies. Internally it coordinate at the inter segment of drug development, industrialized, advertising and clinical research. Externally it is the key boundary between the company and the regulatory authorities. Regulatory Affairs Courses is involved in the expansion of new medicinal products from early on, by incorporating regulatory principles and by preparing and submitting the significant regulatory dossiers to health authorities. Regulatory Affairs is actively implicated in every stage of enlargement of a new medicine and in the post-marketing activities with certified medicinal products. Regulatory Affairs contributes effectively to the overall success of drug development, both at early pre-marketing stages and at all period post-marketing. The pharmaceutical industry deals with a growing number of interesting drug candidates, all of which require the association of the Regulatory Affairs’ department. Regulatory Affairs professionals can play a key role in directing drug development strategy in an increasingly global environment.
The major objective of this course is to provide an interdisciplinary acquaintance of pharmacy and law as appropriate in the field of pharmaceutical regulation at National and International levels. The regulatory affairs course provided by RM Code prepares the students to pursue career in pharmaceutical industry, drug licensing and direct authorities, and export-import agencies dealing with the pharmaceuticals.
Course Objectives:
The RM Code, Regulatory Affairs Program is developed to prepare professionals for regulatory affairs position in the pharmaceutical, bio-pharmaceutical and medical device industries i.e. to assist them with the educational groundwork that will support them progress in the regulatory affairs profession. The program will provide the students with the fundamentals mandatory in both regulatory affairs and quality operations. This course is designed to give industry level instruction in field of legal and regulatory issues. The program focuses on regulatory affairs concept which the Pharmaceutical companies must comply to sell their drugs both internally and in the international market. Pharmaceutical regulatory affairs courses in Healthcare Industry are associated to IPR (Intellectual Property Rights), Patents, copyrights and Trademarks with quality standards.
Online Live Sessions
There will be allocated hours of trainer with live online session with real time experience.
Real-time Case Studies
Live project based on any of the particular use cases on the above selected Domain.
Assignments
Each class will be followed by set of assignments which can be finished before the next class.
24 x 7 Expert Supports
We have 24×7 support team available to help you with any practical queries you may have during the course and after completion of the course within a year along with placement assistance.
Certification
Towards the end of the course, you will be functioning on a project. RM Code certifies you as an expert in Regulatory Affair domain based on the project.
Training Details
Eligibility
- A minimum requirement of an undergraduate degree is significant for a profession in Drug Regulatory Affairs and should have premeditated subjects in the Science stream like Biotechnology, Bio Chemistry and Life Sciences.
- Pharmacy is also an added subject that led to a profession in Drug Regulatory Affairs.
- Having a Postgraduate degree or Research experience is an additional advantage.
Topics Covered
- Pharmaceutical Regulatory Affairs
- National & International Drug Approvals & Bioethics
- Basics of Medical & Scientific Writing
- Emerging concept in Regulatory Affairs
