All biopharmaceutical companies must produce scientific reports and summary documents for regulatory agencies. Good documentation should be not only scientifically sound, but also clear, effective and concise. This course provides the practical skills needed to write effective documents for the healthcare industry. You'll gain practice through hands-on exercises and group projects based on documentation used in pharmaceutical development.

Skills Needed

• To be successful in this class all students should have working knowledge of Google’s G Suite or Microsoft Office, proper email etiquette, and essential understanding of Canvas.

Learning Outcomes

At the conclusion of the course, you should be able to

• Demonstrate the basics of effective writing, with an emphasis on the English skills required to write clearly, concisely, and effectively.
• Streamline the process to go from raw ideas to finished documents.
• Develop an understanding of various medical communication and regulatory documents and how they fit into a regulatory submission.
• Identify and discuss writing scientific review articles, clinical study protocols, clinical study reports, investigator brochures, scientific posters, and press/news releases.

Topics Include

• The essentials of good writing required for any profession, including the proper use of grammar and punctuation
• Copyright, permission, and ethics
• Working with journal editors and regulatory reviewers
• Writing letters to the editor, scientific review articles, clinical study protocols, clinical study reports, and press releases
• Preparing scientific posters
• Drafting documents that are user-friendly and comply with regulations
• Creating clear and concise content

Notes

Professional Credit: CA BRN/LVN Credit--Provider #CEP13114.