Overview

This activity is specifically designed to meet the needs of individuals new to biopharmaceutical industry-based medical communications. Attendees will 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 would gain the most from attending.

Core Curriculum Agenda

8:30 - 11:30AM CORE CURRICULUM – SESSION 1

8:30 – 9:00AM 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 – 10:15AM An Introduction to the US Regulatory Environment and Medical Communications Practices
This session describes how the US 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.

10:15 – 10:30AM Break

10:30 – 11:00AM Best Practices for Handling Medical Inquiries
This session identifies 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.

11:00 – 11:30AM Unsolicited Request Case Scenario Roundtable Discussions

11:30AM – 12:30PM LUNCH

12:30 - 4:15PM CORE CURRICULUM – SESSION 2 AND 3
These two sessions will delve deeper into the challenging aspects of six different areas of our industry practices. This includes activities such as literature searching and medical writing. Topics will also include scientific congress support, collaborations with medical science liaisons, AMCP formulary dossier communications, and promotional review.

12:30 – 2:15PM Session 2
30 Literature Searching Tips in 30 Minutes
Tips for Effective Medical Writing
Medical Congress Planning and Medical Information Booth Support

2:15 – 2:30PM Break

2:30 – 4:15PM Session 3
Medical Communications and Medical Science Liaisons: Opportunities for Collaboration
AMCP Dossier and the Managed Care Perspective
Promotional Review Committee Overview

4:15-4:45 PM Q&A with Core Curriculum Faculty

Learning objectives

At the conclusion of this session, 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

Have an account?

Core Curriculum

Overview

Learning objectives

Be informed and stay engaged.