Pharma Drug Regulatory Affairs course - DRA 2023
What you'll learn
- Basic concepts Pharma Regulatory Affairs
- Advanced Regulatory Affairs
- How Regulatory Authorities Regulates Drug product
- Career in Regulatory Affairs
- Job opportunities
- eCTD & CTD Structure
- eCTD Modules
- Dossier Preparation & Submission
- Drug master file
- Submission of Drug Master File
- General Demonstration of eCTD Software
- General demonstration of eValidator
- Registration Process
- ICH Guidelines
- USFDA regulations: INDA
- INDA concept
- New drug development
- FDA meetings
- IND Review process
- Market Approvals
- Requires basics Pharmacy Knowledge
- Having Medical and Pharmaceutical Background
- M. Pharmacy
- B. Pharmacy
- Online Education
- Curiosity for Learning
- Students from lifesciences background
- Ph.D Students and professionals
- Students who want to make career in Regulatory affairs
- Pharma industry professionals
Are you looking for Regulatory affairs Jobs in 2022 and want to make a career in Pharmaceutical Regulatory affairs?
If you are looking for Pharma Regulatory affairs course to start career as Regulatory Professional without paying huge amount or money then you are on right platform.
This updated course is for starting career and growing in existing profession as in Regulatory affairs with certificate of completion.
Complete the course as per your free time as life time access is available.
The Pharmaceutical industry discovers, develops, produces, and markets drugs or pharmaceutical drugs for use as medications to be administered to patients, with the aim to cure them, vaccinate them, or alleviate the symptoms. Pharmaceutical companies may deal in generic or brand medications and medical devices
Regulatory Affairs plays a crucial role in the pharmaceutical industry and is involved in all stages of drug development and also after drug approval and marketing. ...
Pharmaceutical companies use all the data accumulated during discovery and development stages in order to register the drug and thus market the drug.
So, this online course helps Pharmacy Students and Professionals to build their knowledge and skills towards career in Regulatory Affairs.
Regulatory course prepares students to be skilled in the field of global regulatory affairs, and enables existing regulatory affairs professionals to refine and update their knowledge of global regulatory affairs statutes and practices.
Prepare to play a pivotal role in managing the regulatory activities necessary to bring drugs and medical products to market.
Contents of this course :-
A. Basics of Regulatory affairs
1. Basic Regulatory Introduction
2. Career and opportunities in RA
3. Objectives in RA Profession
4. Websites and Usage
5. Intoduction to ICH Guidelines
6. Basic general information about DMF (Drug Master File)
7. DMF preparation and submission
B. CTD & eCTD
8. Module 1
9. Module 2
10. Module 3
11. Module 4
12. Module 5
13. eCTD software demo and eValidation
C. Types of Application
14. IND (Investigational New Drug Application)
15. NDA (New Drug Application)
16. ANDA (Abbreviated New Drug Application)
D. Registration and Submission
17. Introduction to ESG Gateway
18. Overview of Registration Process
19. FDA ESG web interface and electronic submission
Education and experience:
A minimum of a baccalaureate or equivalent first university degree and at least three years of regulatory or regulatory-related experience; or
A master’s degree of regulatory or regulatory-related experience; or
A doctorate degree (e.g., medical, dental degree, PharmD, PhD, ScD, JD) and at least one year regulatory or regulatory-related experience
No Prerequisite required only need Curiosity over new learnings
Regulatory Certification Benefits for Professionals
Anyone who works in the life science arena should consider the RAC program as an educational supplement to one’s current work environment. As identified in the RAC Certification, earning a RAC is useful in a variety of professional settings, within regulatory agencies, government and inter-governmental bodies, industry, consultancies, professional organizations, healthcare facilities, research institutions and educational institutions around the world.
Confidence is a true benefit from adding the RAC to your signature line, as a regulatory professional.
Course is designed to cover all aspects of healthcare product regulations, compliance and standards, giving a global perspective on regulatory affairs. There are practice exams available online to help prepare.
Certification by a Regulatory Professional platform not only gives you confidence in forming your regulatory advisements but also inspires confidence in those working with you or for whom you work. There is recognition that, by pursuing a regulatory certification, you have studied the regulations in your particular regulatory product area and are well versed in these regulations as well as in other product categories.
The ability to pass an exam written by your peers in your specific area of regulatory responsibility affirms that regulatory professionals have a clear understanding of the core components within their specialty area.
In this Advanced RA course the Detailed Practical and Theriotical aspects of Regulatory affairs can be learn in this course.
Basics of Regulatory affairs
ICH, DMF, ASMF, CTD, eCTD, CTD structure, 1-5 Modules of CTD.
Basic Demonstration of eCTD software & eValidator (Lorenz Docubridge) 21CFR complied.
Drug Product Development, Documents Required for filling.
Preperation & Submission of CTD, eCTD, DMF, Filling of Applications (IND, NDA, ANDA, BLA).
Other miscellaneous Aspects in RA.
Stringent GMPs are being followed for blood and its derivative as well as controlled manufacturing for Traditional Herbal Medicines, Cosmetics, Food and Dietary products which was otherwise differently a century before. Each regulatory system had faced certain circumstances which led to current well-defined controlled regulatory framework.
This course contains Commonly Asked Questions and Answers for interview that will help you while preparing for DRA interviews.
Last but not the least, this course also contains a bonus software demo entitled "General Demonstration and eValidation " which will help you to shape your career in which the points that must be taken into consideration while Preparing and submission of Dossier are covered.
In this course, more than 26 informative videos are included and are designed in an easily digestible format and going to take you through step by step approach to understand Drug Regulatory Affairs and relevant activities. This course will help you to develop the ability to conduct regulatory intelligence and develop a regulatory strategic plan.
I believe "Quality improvement is a continuous and lifetime process". Upon completion of this course, you will be a whole different professional with improved DRA skills and knowledge which will help you to garner more respect from your team members, managers, clients, or anyone with whom you are communicating/interacting.
Who this course is for:
- Pharmaceutical industry employees
- Pharmacy Students & Pharma Professionals
- Chemistry students
- Science Graduates
- Diploma in pharmacy
- Pharma professionals
- Students from lifesciences background
- Regulatory affairs professionals
I Am Mahesh Pratapwar.
I am Pharma Professional, having skill of Pharmaceutical Product development and Complying with Regulatory Specifications for Pharmaceutical products according to guidelines of US/Europe/CDSCO.
I have completed M.Pharm (P.Ceutics).
Work experience more than 6 years in Pharma Industry.
Regulatory Affairs plays a crucial role in the pharmaceutical industry and is involved in all stages of drug development and also after drug approval and marketing. ... Pharmaceutical companies use all the data accumulated during discovery and development stages in order to register the drug and thus market the drug.
Skills: Formulation & Development, Stability studies, QbD, OSD, Oral Liquids, Topical/Derma, DRA, CTD & eCTD, Plant exposure, Bioequivalence, DoE, etc...
Published more than 3 Research and review articles in high impact journals.
Top 9 pharma courses has been published on Udemy
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