Intermediate Medical Writing: Pharmaceuticals and Biologics
Regulatory and medical writing is an integral part of the product development and approval process and plays a crucial role in assuring that submissions for new products are well organized, accurate and reviewer-friendly.
This course will provide an overview of some of the more complex documents prepared by regulatory and medical writers, with a focus on the Common Technical Document (CTD). Key considerations associated with writing submissions in CTD format, including region-specific considerations for clinical sections in US New Drug Applications (NDA), US Biologics License Applications (BLA) and EU Marketing Authorisation Applications (MAA) will be discussed. You will be introduced to the components of each of these application types and learn techniques for improving document quality in order to advance your career as a medical writer.
At a Glance
- Target Audience: Professionals with one to three years’ experience in medical writing and those who need a basic introduction to the regulatory documents discussed.
- Learning Level: Basic
- Total Length of Course: 3 Hours
- RAC Points: 3
- Pharmaceutical Certificate Elective
- Enrollment Period: 12 months
Learning Objectives
Upon completion of this course, participants should be able to:
- Explain the modules contained within the CTD, including regional variations and considerations for document submission
- Describe and understand the contents of the clinical sections of an NDA, BLA and MAA
- Formulate a plan for preparing these documents and understand where to seek further guidance Identify factors that may affect the quality of regulatory documents and strategies to improve their quality
Lesson Titles
- Lesson 1: Common Technical Document (CTD)
- Lesson 2: New Drugs Application (NDA)
- Lesson 3: Biological License Application (BLA)
- Lesson 4: Marketing Authorisation Application (MAA)
This course is also included in:
