Pre-submission messaging and prototyping apply principles of strategic communication to the work of development teams as they document their learnings and accumulate study reports/documentation that eventually populate their submission preparation. By learning the discipline of message-driven and issue-oriented documentation, teams benefit from clear and consistent messages and identified issues, allowing them to be fully explored and explained.
By doing this throughout the development process and early in the submission process, teams can create supportive data that is effectively placed. Participants will learn to build persuasive arguments that help smooth project management and regulatory strategy during development, submission and beyond.
Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity.
Advanced: Content is designed for individuals who are well-versed in most, if not all, concepts associated with the topic(s). Activities place a high concentration on analysis and application of concepts or demonstration of competencies through exercises such as case studies, scenario building, and group projects. A high level of participation is expected from each attendee.
Upon the webcast's conclusion, you will be able to:
- Track messages through the development cycle of a product
- Identify potential issues early
- Build persuasive arguments and create message-driven, issue-orientated documents
Who Should Attend
- Regulatory professionals that are, have, or may be preparing submission documents
- Regulatory professionals who want to improve their writing or filing expertise
Aaron Bernstein, PhD, consultant/principal medical writer, Aaron Bernstein Consulting, LLC
Frank Carillo, CEO, ECG, Inc.