Clinical study protocols serve as the foundation for a single study, but also for an entire clinical program. Protocols need to be strategic, but they also need to be clear, user-friendly, and set to construct a study that will meet a company’s overall objectives for their drug. This webinar will focus on how to create a solid protocol in line with ICH E6 guidelines. Participants will gain an understanding of how to interpret the guidelines through real-life practical experiences from a seasoned medical writer. Topics of discussion will include the current standards and guidelines outlined by ICH E6, project planning, writing and review processes, strategic meetings, and project management.
At the conclusion of this webinar, attendees will be able to
- Describe the necessary project planning, processes, and management needed to develop an ICH-compliant clinical study protocol.
Learning Level: Basic, Intermediate
Content Area: Editing, Regulatory, Writing for Professional Audiences
About the speaker: For over 12 years, Lynne Munno has been working in the pharmaceutical industry as a medical writer in a variety of therapeutic areas, working on clinical documents for regulatory agencies and investigators, among other audiences. Lynne is currently Director, Medical Writing Submissions (Oncology), at Pfizer. Prior to this, Lynne has held medical writing positions both in the pharmaceutical industry (Pharmacyclics [an AbbVie company], Sanofi, AVEO Oncology, and Alkermes) and in clinical research organizations (Quanticate and ORA, Inc.). Lynne is a graduate of the University of Connecticut (B.A. in English and Sociology), University of Massachusetts Dartmouth (M.A. in Professional and Technical Writing), and the University of Sciences in Philadelphia (M.S. in Biomedical Writing).