Core Curriculum Registration: 7:30am-8:30am
This activity is specifically designed to meet the needs of individuals new to biopharmaceutical industry-based medical communications. Attendees will learn and discuss skill sets that provide value to both internal and external customers. Those who have been in their functional role for less than one year will gain the most from attending.
Core Curriculum Agenda
8:30 - 9:00 AM - Welcome and Introductions: Following opening remarks, the Core Curriculum faculty will introduce themselves to the attendees and provide descriptions of their career paths leading to their current roles in Medical Communications. The faculty will then describe their current responsibilities, allowing the audience to begin to see similarities and differences in the practice of Medical Communications across the industry.
9:00 – 10:00 AM Session 1 – Part 1 An Introduction to the U.S. Regulatory Environment and Medical Communications Practices: This presentation will describe how the U.S. regulatory environment impacts Medical Communications within the pharmaceutical industry. An introduction to key concepts in Medical Communications practice based on FDA statutes, regulations, policies and guidance will be provided. In addition, useful regulatory resources that are accessible in the public domain will be shared.
10:00 – 10:15 AM Break
10:15-10:45 AM Session 1 – Part 2 Best Practices for Handling Unsolicited Medical Inquiries: This presentation will identify the critical steps that a medical communications professional should take when receiving an inquiry, evaluating the sources of information/data available when preparing a response, and the importance of fair balance and documenting responses.
10:45-11:15 AM Session 1 – Part 3 Unsolicited Request Case Scenario Roundtable Discussions
11:15-11:45 AM Session 1 – Part 4 Literature Searching for Medical Communications Professionals: Literature searching is a vital skill for Medical Communications professionals. This talk will provide an overview of key biomedical literature resources used for responding to medical inquiries. Participants will walk away with practical tips that can be applied in their daily work.
11:45AM-12:45 PM Lunch
12:45-2:30 PM Session 2: This session will delve deeper into the challenging aspects of different areas of our industry practices. Topics will include medical writing, scientific congress support, and collaborations with medical science liaisons.
2:45-4:00 PM Session 3: This session will delve deeper into the challenging aspects of different areas of our industry practices. Topics will include AMCP formulary dossier communications, and promotional review.
4:00-4:30 PM Q&A with Core Curriculum Faculty
4:30 PM Core Curriculum Adjourns
At the conclusion of this tutorial, participants should be able to:
- Describe how the regulatory environment influences medical communications practice
- Identify critical steps that a medical communications professional should take when receiving an unsolicited inquiry, including evaluating the available data and sources of information
- Describe the important elements of writing a concise and clear standard response letter
- Recognize key biomedical literature resources used for answering medical information inquiries, including strategies and techniques for finding literature to answer medical information questions
- Discuss medical information roles and responsibilities at medical congresses
- Recognize the differences and similarities between the roles of medical communications and medical science liaisons, including ways to share information and resources and share best practices and ideas for collaboration to enhance productivity and value for both organizations
- Discuss ways that medical communications professionals can support the needs of managed care customers including understanding the background, content, and purpose of the AMCP Formulary Dossier
- Describe the distinct scientific value that medical communications provides on promotional review committees