Core CurriculumDay & Time:
March 9, 8:00AM - 4:45PMRoom Number:
Regency Hall 1 & 2Description:
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 would gain the most from attending.
- Core Curriculum Schedule:
8:00-8:30 AM Session 1A – 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.
8:30 – 9:30 AM Session 1B – Regulatory Environment and Medical Communications Practices: This session introduces the current regulatory environment that influences the activities of a US-based Medical Communications professional. An overview of the pharmaceutical industry and DDMAC regulations will be reviewed, along with the rationale for many of the activities common in Medical Communications departments which will include a case study presentation.
9:30 – 9:45 AM Break
9:45 – 10:30 AM Session 2A – Helpful Tricks of the Trade 1: Advanced Literature Searching and Evaluation: Literature searching is a vital skill for Medical Communications professionals. This session will review “tricks of the trade” for searchers of medical literature. Attendees will walk away with a new trick that can be applied immediately in their daily work.
10:30 – 11:30 AM Session 2B – Helpful Tricks of the Trade 2: Regulatory Resources in the Public Domain: There are multiple regulatory resources available for Medical Communications professionals, many of them for free. This session will review resources available in the public domain and how they can help you successfully deliver results. An interactive case presentation will be discussed by the faculty and attendees.
11:30 AM – 12:30 PM Lunch
12:30 to 4:15 PM Session 3 4 (2:15 – 2:30 PM Break): These two sessions will delve deeper into the challenging aspects of six different areas of our industry practices. This includes activities such as identifying 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, the importance of fair balance and documenting responses. Topics will also include formulary dossier communications, global activities, promotional review, activities at scientific congresses, and medical writing considerations.
4:15 – 4:45 PM QA with Core Curriculum Faculty
Core Curriculum Learning Objectives:
At the conclusion of this activity, participants should be able to:
- Identify activities that Medical Communication professionals participate in that provide global value to both internal and external customers, as part of working in interdisciplinary teams
- Describe how the regulatory environment influences Medical Communications practices
- Identify regulatory resources available and how to apply them to your day-to-day work
- Identify critical steps that a Medical Communications professional should take when receiving an unsolicited inquiry, including evaluating the available data and sources of information
- Determine the important elements of planning for a scientific presence at a medical congress, including the provision of medical information and the optimal use of technology at this type of venue
- Recognize the importance of the payer environment by evaluating AMCP/EBM dossier requirements
- Describe the distinct scientific value that Medical Communications provides on promotional review committees and how to balance the provision of marketing support while avoiding common pitfalls in that role
- Describe the important elements of writing a concise and clear standard response letter
- Provide an overview of literature searching techniques and resources