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Medical Communications 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 21.75 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 contingency 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: Database Management and Medical Inquiries: Upon completion of this module, learners should be able to:

  • Describe the role, features, and design of a database management system for the Medical Communications/Information Department
  • Explain the process involved in responding to medical information requests and documenting the request in the database management system
  • Describe the various types of responses to requests for medical information
  • Explain additional functions of a database system
  • Identify and evaluate the sources of information available when preparing a response
  • State guidelines for developing a response, including when a verbal response versus a written response should be given, and the advantages of a written follow-up
  • Differentiate between fair balance and scientific balance
  • Describe situations the medical communications professional should be prepared for when delivering a response
  • Prepare for issues that may arise due to the type of caller or the type of inquiry
  • Describe methods for documenting, storing, and reviewing responses


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 a standard response
  • Demonstrate mastery of medical writing excellence when writing a standard response regarding inclusion of data, scientific rigor, grammar, brevity, and clarity
  • Identify the components of a complete written response
  • Describe various levels of quality review that may be necessary for standard letters


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

  • Define prescription drug/medicinal product labeling and describe the purpose of it
  • 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 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 maintenance of product labeling


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

  • Assess and clarify a request for medical information
  • Adequately 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:

  • Explain the purpose, key features and possible bias in a study abstract and introduction
  • Evaluate whether subjects in a study were appropriately selected, and are representative of the subjects who will receive the drug
  • Evaluate the internal validity of a clinical drug trial
  • Identify efficacy, safety, and effectiveness outcomes of a study
  • Identify missing data and evaluate Intention to Treat (ITT) analysis
  • Explain how data is described in a study
  • Explain how tables and graphs can be used effectively, but can also sometimes misrepresent data
  • Evaluate whether study results are objectively interpreted
  • Explain causal and non-causal relationships, and criteria for causality
  • 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 FDA’s authority and jurisdiction under which it 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 Physician Financial Transparency Reports (also known as the Physician Payments Sunshine Act), and how they relate to physician 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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