Introduction to Regulatory Affairs for Pharmaceuticals
Introduction to Regulatory Affairs for Pharmaceuticals
Basic Level | Course | English | Pharma | 46 minutes
Corresponds to ½ day of teacher-directed learning
Description
This introductory course provides a basic understanding of the regulatory processes for drug development, approval, and post-marketing surveillance. You'll learn about key regulators and regulations in the EU and US, clinical trial approvals, drug registration, and compliance. Enhance your skills to ensure your pharmaceutical products meet global safety and efficacy standards.
This training has been developed by the experts at Key2Compliance® . The films are animated and designed to enhance understanding and perception of the presented concepts and are presented by AI generated speakers.
The training is divided into 2 modules: a general presentation and short exam. After the successful completion of both modules, you will receive your Certificate of Completion.
Content
- Key concepts and requirements in regulatory affairs for pharmaceuticals
- Important regulations and regulators in the EU and US covered by EudraLex, 21CFR 210 and 211 as well International Council on Harmonisation and international pharmacopoeia
- Regulatory interactions within the drug development process from preclinical to post market monitoring and reporting
- Overview on the Common Technical Document used for registration for marketing authorization or making changes post authorization
Course module
1. Introduction to Regulatory Affairs for Pharmaceutcals
This course covers regulatory processes for drug development and approval in the EU and US, ensuring pharmaceutical products meet global safety standards.
Trainer: Virtual character
Duration: 46 minutes (Total duration of the course: 46 minutes)
Course material
There is no additional course material for this course.
Notes
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Training organisation
Key2Compliance AB
Key2Compliance AB is an independent international organization providing its training and services to a variety of functions in the Life Science industry, from development to market in terms of Quality Systems and Regulatory compliance.
By helping organizations to comply with regulatory expectations, to enhance workforce knowledge and motivation and to promote a correct attitude towards quality, we believe we contribute to the supply of safe health care products - and in a wider perspective we save lives.
Trainer
Virtual character
This training is created by Key2Compliance AB and uses a digital avatar to convey the presented concepts, which enhances clarity and understanding of the content.
The course results in a diploma that shows that you have the skills required.
All prices shown exclude VAT.
Save time
Online education is faster than traditional education. We make the same courses and content accessible in just under a third of the time normally required.
The efficiency gain is due to the fact that there are no lunch breaks, no commute, no group discussions, and no breaks. However, the total time spent teaching always remains intact.
1 h - Equivalent to a half-day course
2 h - Equivalent to an all-day course
4 h - Equivalent to a 2-day course
6 h - Equivalent to a 3-day course
Please note that the duration specified does not include time for breaks or revision. Don't forget to set aside time for any workshops and time to take the tests of the course, which is required to earn a diploma.
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