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Medical Communications eLearning Program

Medical Communications eLearning Program (all eight modules!)

The 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.

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Module 1: Literature Searching

This module is designed to help medical affairs professionals search for medical literature in order to satisfy requests for information from consumers, external healthcare professionals, and internal colleagues. Containing current resources and the latest search strategies compiled by industry experts, the module can be immediately applied to your daily work in medical affairs.

Featured Topics:

  • How to start to assess an inquiry
  • Steps in Developing the Search Strategy
  • Literature Databases
  • Refining Results and Finalizing the Inquiry
  • Sources of Published References
  • General Copyright Considerations

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Module 2: Literature Evaluation

This module is designed to help medical affairs professionals effectively evaluate scientific literature so they can identify and provide relevant and reliable information to health care professionals regarding the safe and/or effective use of a particular therapeutic intervention, such as a drug.

Featured Topics:

  • Abstract and Introduction
  • Study Participants
  • Study Design and Controls Measuring Study Results
  • Data Management Problems
  • Describing the Data
  • Presenting the Results
  • Interpreting the Results
  • Establishing Causality
  • Determining Importance and Generalizability of Results

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Module 3: Medical Inquiries and Database Management

The goal of this module is to help medical communications professionals differentiate between product inquiries from health care professionals (HCPs) and non-HCPs, to respond appropriately to different types of information requests, and to use the company's database management system when fielding questions, retrieving information, and delivering responses.

Featured Topics:

  • Receiving and Responding to Requests for Information
  • HCP Requests and Non-HCP Requests
  • Using a Database for Information Management
  • Design of the System
  • Additional Functions of the Database

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Module 4: Medical Response Excellence

This module familiarizes medical affairs professionals with the preparation of standard medical letters in response to specific drug information questions.

Featured Topics:

  • Regulatory Guidelines
  • Writing Tips and Recommendations
  • Anatomy of a Standard Medical Letter
  • Quality Assurance - Editing/Review Process

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Module 5: Statistics for Medical Affairs

This module is designed to help medical affairs professionals and others in the pharmaceutical industry evaluate statistical data presented in medical literature. It will help users apply statistical concepts when evaluating literature, identify strengths and weaknesses in study design, and detect potential bias in the presentation of statistics.

Featured Topics:

  • Statistical Concepts
  • Basic Statistics
  • Hypothesis Testing
  • Study Designs

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Module 6: US Regulatory and Compliance Considerations

The goal of this module is to assist the medical affairs professional understand and comply with regulations and guidance around the dissemination of information about drug products. Note that this module focuses on the United States FDA and its regulations. Other countries or regions have their own governing agencies with regulations that may or may not reflect those discussed here.

Featured Topics:

  • FDA Jurisdiction Over Prescription Drug Advertising and Promotional Labeling
  • 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 and Solicited versus Unsolicited Requests
  • The On-Label and Off-Label Controversy
  • Direct-To-Consumer Promotion
  • Compliance and Other Law Enforcement Agencies

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Module 7: Crisis Management

This module provides medical affairs professionals with an overview of crisis management and 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.

Featured Topics:

  • Types of Crisis Situations
  • Crisis Impacts
  • Recalls
  • Crisis Management Planning
  • Telecommunications and Related Concepts
  • Actions in Managing a Crisis

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Module 8: Product Labeling

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.

Featured Topics:

  • 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 and Package Leaflet
  • Labeling in Non-US and Non-EU Countries
  • Maintenance of Product Labeling
  • Case Studies

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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.

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