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Medical Communications eLearning Program

Learn about key medical communication or information principles in this eight module 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.  These eight modules will take approximately 21 hours to complete.

Featured topics

    • Receiving and a responding to request for medical information
    • Writing and editing an abstract
    • Literature search strategies and databases
    • Literature evaluation
    • Scientific exchange
    • Statistical concepts
    • Study designs
    • Crisis impacts and recalls
    • Global labeling

Who should attend?

  • This program is designed for professionals involved in:

    • Medical affairs
    • Medical communications
    • Medical information
    • Medical writing
    • Field-based medical affairs support (i.e., medical science liaison)
    • Medical call center environment
    • Regulatory affairs
    • Clinical research
    • Professional education, training, and development
    • Document management/eSubmissions

      Learning objectives

      • Module 1: Crisis Management: Upon completion of this module, learners should be able to:

        • Identify different types of crisis situations
        • Recognize how a crisis can impact the pharmaceutical organization
        • Examine the basic regulatory requirements related to product recalls
        • Outline the areas of planning that should be included in a crisis management plan to manage a crisis
        • Define telecommunications terminology and related concepts that are important during a major crisis
        • Analyze the actions that should be taken to manage a crisis

        Module 2: Medical Inquiries and Database Management: Upon completion of this module, learners should be able to:

        • List characteristics of a response to a medical information request
        • Recognize the process for receiving and responding to medical information requests
        • Categorize responses that are appropriate for healthcare professionals and non-healthcare professionals
        • Differentiate between standard responses and custom responses to medical information requests
        • Identify sources of information available when preparing responses
        • Utilize guidelines that are specific to providing verbal responses
        • Define the role of a database system in the Medical Communications department
        • List features and functions necessary for an effective medical communications database system
        • Identify data requirements and considerations for documenting a medical information request
        • Outline additional functions of a database system

        Module 3: Medical Response Excellence: Upon completion of this module, learners should be able to:

        • Recognize the regulatory guidelines that govern industry-generated responses for medical information when writing standard medical letters
        • Determine medical writing excellence in standard medical letters by verifying the use of data, scientific rigor, correct grammar, brevity, and/or clarity
        • Identify the components of a complete standard medical letter
        • Differentiate various levels of quality review that may be necessary for standard medical letters

        Module 4: Product Labeling: Upon completion of this module, learners should be able to:

        • Evaluate the purpose of prescription drug and biologic product labeling
        • Compare labeling requirements at the global and local levels
        • Identify the components of the Company Core Data Sheet (CCDS)
        • Recognize the components, structure, and use the Prescribing Information and the Medication Guide in the US
        • Outline the components, structure, and use of the Prescribing Information (Summary of Product Characteristics) and Patient Labeling (Package Leaflet) in the European Union
        • Identify the regulatory agencies and requirements that govern product labeling for non-US and EU European countries
        • List the departments involved in labeling development and maintenance

        Module 5: Literature Searching: Upon completion of this module, learners should be able to:

        • Analyze a request for medical information
        • Identify the requester to provide an appropriate answer
        • Identify the search terms for the query
        • Differentiate the purposes and strengths among various literature references
        • Determine appropriate references, indexes, and abstracts for a search
        • Record the results of a search
        • Identify sources of full-text copies of published information, both proprietary (available for a fee) and non-proprietary (available without cost in the public domain) where possible
        • Utilize relevant copyright considerations when providing results

        Module 6: Literature Evaluation: Upon completion of this module, learners should be able to:

        • Determine whether participants in a study are appropriately selected, and are representative of the patients who receive the interventions being investigated
        • Identify the purpose, key features, and possible bias of a published study abstract and introduction sections
        • Analyze the efficacy, safety, and effectiveness outcomes of a study
        • Recognize how tables and graphs can be used effectively, but may also misrepresent data
        • Evaluate the internal validity of a study
        • Identify when data is missing and the significance of the Intention to Treat analysis
        • Determine the importance of critically evaluating scientific literature, as well as the possible sources of bias within a published clinical study
        • Evaluate whether study results are objectively interpreted
        • Define causal and non-causal relationships, and criteria for causality
        • Categorize how data is described in a study
        • Recognize the role that population size, cause, strength, randomization, and generalizability play in determining the importance of a study

        Module 7: US Regulatory and Compliance Considerations: Upon completion of this module, learners should be able to:

        • Identify the authority and jurisdiction under which the FDA regulates the dissemination of information, including advertising and promotional labeling, about prescription drugs
        • Recognize the regulatory requirements for prescription drug advertisements and promotional labeling
        • Define the issues concerning the dissemination of information about a prescription drug product prior to its approval
        • Determine the issues around special types of advertising and promotional events, including the Sunshine Act (better known as open payments), and how they relate to HCP customers
        • Identify on-label and off-label issues concerning approved prescription drugs and the issues concerning the dissemination of off-label information
        • Recognize corporate integrity agreements
        • Define the issues concerning direct-to-consumer advertising of prescription drugs
        • Determine the interests of FDA and other federal and state law enforcement agencies in monitoring the dissemination of information about prescriptions drugs

        Module 8: Statistics for Medical Affairs: Upon completion of this module, learners should be able to:

        • Recognize basic statisticl terminology
        • Identify potential bias in the presentation of statistical data
        • Compare the statistical concepts of population, sample, bias, distribution, and variability
        • Categorize types of data, summary measures, and estimation
        • Outline hypotheses testing, type I and type II errors, statistical power, sample size, confidence intervals, and P-values
        • Distinguish among study designs, and identify techniques used to avoid bias

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