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Medical Communications eLearning Program

Learn about key medical communication or information principles in this eight module eLearning program.


Overview

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:

  • Describe different types of crisis situations
  • Describe how a crisis can impact the pharmaceutical organization
  • Discuss the basic US regulatory requirements related to product recalls
  • Explain the areas of planning that should be included in a crisis management plan to manage a crisis
  • Recognize telecommunications terminology and related concepts that are important during a major crisis
  • Explain 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
  • Explain the process for receiving and responding to medical information requests
  • Differentiate between 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
  • Apply guidelines that are specific to providing verbal responses
  • Explain 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
  • Explain additional functions of a database system


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

  • Identify and apply regulatory guidelines that govern industry-generated responses for medical information when writing standard medical letters
  • Demonstrate mastery of medical writing excellence when writing a standard medical letters regarding inclusion of data, scientific rigor, grammar, brevity, and clarity
  • Identify the components of a complete standard medical letter
  • Describe 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:

  • Define and describe the purpose of prescription drug and biologics product labeling
  • Describe labeling requirements at the global and local levels
  • Define and identify the components of the Company Core Data Sheet (CCDS)
  • Identify the components and explain the structure and use of the Prescribing Information and the Medication Guide in the US
  • Identify the components and explain the structure and use of the Prescribing Information and Patient Labeling in the European Union
  • Identify the regulatory agency that governs product labeling, the format for labeling, and where to find the regulations/guidance for labeling for non-EU European countries, Canada, Japan, South Africa, Australia, Saudi Arabia, Brazil, China, India, and South Korea
  • Describe the departments involved in labeling development and maintenance


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

  • Assess and clarify 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
  • Select appropriate references, indexes, and abstracts for a search
  • Refine the results of a search to finalize the inquiry
  • Record and report 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
  • Recognize and apply 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
  • Explain 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
  • Explain 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
  • Describe 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
  • Describe causal and non-causal relationships, and criteria for causality
  • Outline how data is described in a study
  • Explain 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:

  • Explain the authority and jurisdiction under which the FDA regulates the dissemination of information, including advertising and promotional labeling, about prescription drugs
  • Explain the regulatory requirements for prescription drug advertisements and promotional labeling
  • Explain the issues concerning the dissemination of information about a prescription drug product prior to its approval
  • Explain 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
  • Explain on-label and off-label issues concerning approved prescription drugs and the issues concerning the dissemination of off-label information
  • Explain corporate integrity agreements
  • Explain the issues concerning direct-to-consumer advertising of prescription drugs
  • Describe 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:

  • Identify potential bias in the presentation of statistical data
  • Discuss the statistical concepts of population, sample, bias, distribution, and variability
  • Discuss types of data, summary measures, and estimation
  • Discuss hypotheses testing, type I and type II errors, statistical power, sample size, confidence intervals, and P-values
  • Interpret the results of research papers and abstracts
  • Distinguish among study designs, and identify techniques used to avoid bias
  • Use basic statistical terminology

 

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