Regulatory writing is an integral part of the product development and approval processes and plays a crucial role in speeding product submission and supporting compliance.
This course will provide an overview of the more complex documents prepared by regulatory and medical writers, including:
- The clinical sections of the New Drug Application (NDA) and Biologics License Application (BLA)
- Key sections of the Premarket Approval (PMA) and 510(k) Premarket Notification application
- The Periodic Safety Report Update (PSUR)
You will be introduced to the components of each of these document types and learn techniques for improving document quality in order to advance your career as a regulatory writer.
Learning Objectives
Upon completion of this course, participants will be able to:
- Describe the contents of the clinical sections of a NDA and BLA, including a brief overview of the Common Technical Document (CTD)
- Describe key sections of the PMA and 510(k) Premarket Notification applications
- Describe the basic principles and contents of the PSUR
- Formulate a plan for preparation of these documents and understand where to seek further guidance
- Identify factors that may affect quality of regulatory documents and strategies to improve their quality
Target Audience
Professionals with one to three years experience in regulatory writing and those who need a basic introduction to the regulatory documents discussed will benefit from this course.