- Duration: 6 weeks
- Commitment: 8-10 hours per week
- Price: US $1,995
- Class mode: Instructor-led
- Certificate of Achievement: Evidence your learning with a Certificate of Achievement from Medical Writing University on successful completion.
- Start: 15 September 2024
- Finish: 21 October 2024
- Enroll by: 06 September 2024
- Upcoming Information Session: TBD
Course Overview
Participants will explore the narrative authoring process, where clinical safety data fit into the development strategy, and how to efficiently author subject narratives. This course concentrates on the competencies and practices in the field of clinical and regulatory medical writing related to authoring narratives for inclusion in a clinical study report. This course is also excellent for individuals who will be leading narrative authoring teams. Various therapeutic areas will be covered.
Although much of the course will center on authoring narratives participants will also go beyond narrative authoring to explore safety data and standard safety reporting in the United States and rest-of-world.
Relevant medical writing course projects will be drawn from a range of applications to give context to conceptual information and participants will be encouraged to apply their learning to their own work through discussions and medical writing project work.
What Will I Learn?
- To recognize the role of the medical writer in authoring narratives for inclusion in clinical study reports
- To assess medical writing strategies as a narrative author or narrative authoring team lead
- To initiate, author, and finalize narrative(s)
- To understand the importance of patient safety and International Council for Harmonisation (ICH)/Good Clinical Practice (GCP) in the protocol authoring process
Who Is This Course For?
This course is suitable for:
- Professionals who are new to the field of medical writing
- Individuals who are transitioning into the field of medical writing from a closely related field (i.e., regulatory affairs, scientist, pharmacist, or clinician)
- Medical writers who want to broaden their skill set to enhance their career opportunities
- Individuals who hold an advanced degree (PhD, PharmD, RNs, or MD). *PhD postdocs are encouraged to apply