What you'll learn
- How to create a registration dossier
- How to provide a qualified assessment of clinical documents
- How to develop an understanding of language fundamentals and style-guide conventions
- How to increase your salary
Requirements
- No. You will learn everything from this course
Description
Regulatory Affairs & Medical Writing course provides a possibility to learn strategies, tricks, action plans to become confident in collaboration within a clinical and regulatory environment to create accurate, clearly worded documents.
After this course, you will communicate simply and effectively.
You will find detailed information about essential moments in regulatory affairs and current examples that will be helpful in dossier developing. Lecture about grammatical structure, professional literature, parts of the dossier Module 2 and template for clinical study report - are inside this course!
Who this course is for:
- Regulatory Affairs Managers
- Regulatory Affairs Specialists
- Medical Writers
- Students
Course content
- Preview02:02
- 08:32CTD-peculiarities
- 1 questionOutline principles of Good Clinical Practice
Instructor
![Dasha Ladanovska](data:image/svg+xml,%3Csvg xmlns="http://www.w3.org/2000/svg" viewBox="0 0 64 64"%3E%3C/svg%3E){kind=avatar}
- 3.8 Instructor Rating
- 59 Reviews
- 152 Students
- 1 Course
Master of Science. Head of Analytical Projects Department. Several years of efficient development regulatory documents and professional assessment in regulatory affairs. As Regulatory Affairs Specialist (GLOBAL) - registration of original biological products, generics, veterinary products in 27 countries around the world (Europe, LATAM, ASEAN, MENA, Africa, CIS...). Member of regulatory committee CoVIg-19 Plasma Alliance, who accelerate the development of a potential treatment to fight COVID-19. Regulatory Affairs Professional Society Member.