Pharma course (NDA, ANDA, CTD, DMF, USFDA, Regulatory strategy, GMP, Clinical Research, Orange Book, Pharmaceuticals)
What you’ll learn
Basic understanding and terminologies related to Dug Regulatory Affairs (DRA).
Why Regulatory Affairs (RA) professional is required in Pharma Industry and essential qualities of RA professionals.
Understand the role of a Regulatory Affairs Professional in Pharmaceutical industry, Types of companies hiring RA professionals, and DRA objectives.
Navigation through historical background of US Drug Law and Regulations, and The USFDA regulations for Research and Development (R&D) of Pharmaceuticals.
Major Agencies for drug regulations In USA and other Countries (Along with downloadable website hyperlinked PDFs).
Drug approval process in USA, New drug development-Preclinical Steps, IND, NDA, ANDA, Hatch-Waxman Act, etc.
Orange book, Therapeutic Equivalence Evaluations Codes.
Drug Master File- Related Terms, benefits, Annual update, Database status, Requirements, Process, Types, etc.)
Common Technical Document (CTD), Modules, ACTD Vs ICH-CTD.
Electronic Common Technical Document (eCTD), eCTD technical components, eCTD submissions, Paper CTD Vs eCTD , Various eCTD softwares.
Good Manufacturing Practices (GMP) and Current Good Manufacturing Practices (cGMP).
Biologics License Application (BLA) and Purple Book.
Discover how to navigate important websites including ICH Guidelines to find more relevant information.
Professional reputation building and career success enhancement through proper understanding of Drug Regulatory Affairs and related concepts.
Strong desire in understanding how the drug development process works and curiosity in understanding Dug Regulatory Affairs activities.
Basic level of English, Good quality Internet connection, Desktop/Laptop/Smartphone required (Since dealing with Online Mode).
Basic knowledge of Pharmaceutical/Medical field is helpful but is not necessary.
If you find the Drug Regulatory Affairs field challenging, well, in that case, this is the best course for you.
The pharmaceutical industry is one of the extremely regulated industries, with several government regulations to protect public health. Therefore, the important target of the pharmaceutical industry is to develop a Drug product passing the regulatory requirements. On the other hand, regulation of drug development, manufacturing, marketing, and sales involves paradoxical objectives. It must ensure that safe and effective pharmaceutical formulations reach the public quickly while concurrently protecting against ineffective/unsafe/harmful therapies. Drug Regulatory authorities ensure the safety, efficacy, and quality of all pharmaceuticals that are in circulation in their country. The major challenge for the regulatory expert is to make sure that the pharmaceuticals are developed as per regulatory requirements of that country which involves the assessment of critical factors during the Drug product development. The United States Food and Drug Administration (USFDA) is one of the most regulated agencies wherein the Drug submission process is very strenuous and complicated. Understanding the crucial points in the Drug registration procedure will have a considerable impact on the accomplishment of its submission strategy. This course focuses on the following points that could make a Drug registration procedure smooth without any significant delays/failures,
• Basic Understanding and Terminologies related to DRA,
• Need and essential qualities of Regulatory Affairs Professional,
• DRA objectives,
• The USFDA regulatory requirements and Drug Approval Procedure,
• History of US Drug Law and Regulations,
• Investigational New Drug Application (INDA),
• New Drug Application (NDA),
• Abbreviated New Drug Application (ANDA),
• Supplemental New Drug Application (SNDA),
• Orange Book,
• Drug Master File (DMF),
• Common Technical Document (CTD),
• Electronic Common Technical Document (eCTD),
• Regulatory Strategy,
• Good Manufacturing Practices (GMP) and Current Good Manufacturing Practices (cGMP),
• Clinical Research,
• Biologics License Application (BLA) and Purple Book,
• Important Literature Search Websites for DRA Professional,
• Many more…
There will be several downloadable documents so that you can follow along with them whenever you need them.
This course contains Commonly Asked Questions that will help you while preparing for DRA interviews.
Last but not the least, this course also contains a bonus course entitled “Meeting etiquettes” which will help you to shape your career in which the points that must be taken into consideration while attending/conducting meetings are covered.
In this course, more than 30 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:
- This course is for employees of Pharmaceutical Industry, Pharma entrepreneurs, and Pharma Consultants dealing with Pharmaceuticals and related activities.
- Graduates, Postgraduates, PhD. Students (Pharmacy, PharmD, Science, Medical).
- Anyone who is eligible and wants to make a career in Drug Regulatory Affairs.