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Overview

Healthcare professionals and patients look to medical communication and medical information professionals to provide essential, accurate, and unbiased drug information, therefore making medical communications an integral part of the healthcare industry. Because we work in the second most regulated industry, the pharmacy professionals who provide these services need to have a comprehensive understanding of not only the medical content, but also the regulatory and compliance environment which directly affects their daily activities.

This primer will address many of the common responsibilities of medical communications staff and dig deeper into challenging aspects of each role. This activity is specifically designed to meet the needs of individuals new to biopharmaceutical industry-based medical communications. Many times, their understanding is limited to only their own companies’ SOPs and “way of doing things.” In this activity, attendees will learn and discuss important skill sets that provide value to both internal and external customers and compare these across companies. These include activities such as identifying the critical steps that a medical communications professional should take when receiving an inquiry, evaluating the sources of information/data, and the importance of fair balance and documenting responses. Topics will also include important elements of writing a standard response letter (formulary dossier communications), promotional review committee best practices, and activities at scientific congresses. Role playing and mock examples will be used to re-enforce principles that emphasize the importance of our role to the industry and to the customers we serve.

Attendees will be presented with real-life scenarios that represent challenges that are common to our roles; groups will be asked to discuss and share their responses to the situations. Attendees will gain a better understanding of best practices within their job function and a broader awareness of the regulatory environment. Attendees will also learn how to work better as part of interdisciplinary teams, practice evidence-based medicine evaluation, and effectively use technology.

Learning objectives

At the conclusion of the primer, 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

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Other Preconference Short Course

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Short Course 2: Pubs Planning

Short Course 3: Effective Delivery of NDA and MAA Submission Packages

Short Course 4: Advertising and Promotional Content Review: A Medical Information Perspective