Pharma Drug Regulatory Affairs course – DRA 2022
What you’ll learn
Basic concepts Pharma Regulatory Affairs
Advanced Regulatory Affairs
How Regulatory Authorities Regulates Drug product
Career in Regulatory Affairs
eCTD & CTD Structure
Dossier Preparation & Submission
Drug master file
Submission of Drug Master File
General Demonstration of eCTD Software
General demonstration of eValidator
USFDA regulations: INDA
New drug development
IND Review process
This course includes:
7.5 hours of video
15 articles + resources
Certificate of completion
Requires basics Pharmacy Knowledge
Having Medical and Pharmaceutical Background
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