Medical Communications eLearning Program
DIA’s Medical Communications eLearning Program includes eight modules, covering key medical communication or information principles. Each module contains relevant examples or scenarios designed to simulate medical information related tasks, so learners can apply the concepts to their day-to-day job responsibilities. The core topics covered include literature searching and evaluation, handling medical inquiries, writing medical responses, compliance, understanding study designs and statistics, product labeling, and crisis management. The online program is self-paced and can be accessed anytime, anywhere. Users will have one year to complete the modules and continuing education credits are offered.
Immediately apply practical and imperative information to your daily medical affairs work! This module is contains current resources and the latest search strategies from industry experts. It is designed to help you search for medical literature in order to satisfy requests for information from consumers, external health care professionals, and internal colleagues.
- Identifying, Assessing, and Clarifying Inquiries
- Developing a Search Strategy
- Selecting Literature Databases
- Refining Results and Finalizing an Inquiry
- Sources of Published References and Copyright Considerations
Learn how to effectively evaluate scientific literature so you can identify and provide relevant and reliable information to health care professionals regarding the use of a particular drug.
- Study Design and Controls
- Measuring Study Results
- Describing the data, Interpreting, and Presenting the Results
- Establishing Causality
- Determining Importance and Generalizability of Results
Get an overview of the utility and application of database management systems in the Medical Communications or Information Department. This resource will assist the medical communications professional in fielding questions, retrieving information, and delivering responses verbally.
- Using a Database for Information Management
- Receiving and a Responding to Request for Medical Information
- Types of Responses
Get familiarized with the preparation of written responses to specific drug information questions.
- Regulatory Guidelines
- Writing Tips and Recommendations (including writing and editing an abstract)
- Anatomy of a Complete Written Response
Learn how to evaluate statistical data presented in medical literature. This module will help you apply statistical concepts when evaluating literature, identify strengths and weaknesses in study design, and detect potential bias in the presentation of statistics.
- Statistical Concepts
- Basic Statistics
- Hypothesis Testing
- Study Designs
Understand and comply with regulations and guidance around the dissemination of information about drug products. This modules focuses on the United States FDA and its regulations.
- FDA Regulatory Standards for Advertising and Promotional Labeling
- Requirements for Advertising and Promotional Labeling
- Special Types of Advertising and Promotional Events
- Promotion versus Scientific Exchange
- The On-Label and Off-Label Controversy
- Direct-To-Consumer Promotion
Get an overview of crisis management! This moduled provides a brief background on product recalls and associated regulations. An emphasis is placed upon the actions needed to prepare for and successfully manage a crisis.
- Types of Crisis Situations
- Crisis Impacts and Recalls
- Contingency Planning
- Actions in Managing a Crisis
This module explains the need for, and definition of, labeling for prescription drugs and biologic products. It discusses how labeling is developed and maintained throughout the product’s marketed life, the components and structure of prescription drug and biological product labeling, and pertinent regulatory and legal requirements with which they must comply.
- Global Labeling: The Company Core Data Sheet
- Labeling in the US: Prescribing Information and the Medication Guide
- Labeling in the European Union: The Summary of Product Characteristics
- Labeling in Non-US and Non-EU Countries
- Maintenance of Product Labeling
Medical Affairs eLearning Program
DIA’s Medical Affairs eLearning Program includes eleven modules covering key elements for success in medical affairs. Learners will: gain knowledge in elements of medical affairs including an overview of medical affairs; explore the role of the Medical Science Liaison; recognize important considerations for safety reporting; examine the skill of stakeholder engagement; strategize for the successful development and planning of publications; discern the necessary actions for medical responses; learn how to handle a crisis; apply methods for communicating statistics; better understand the utilization of databases for medical inquires; and consider US regulations and what is required to maintain compliance. The program contains job aids, gamification, relevant examples, and/or scenarios designed to simulate tasks performed in the role of Medical Affairs.