Pharma Drug Regulatory Affairs course – DRA 2022

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

Eligibility Requirements

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.

Announcement–

In this Advanced RA course the Detailed Practical and Theriotical aspects of Regulatory affairs can be learn in this course.

Like :-

• 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.