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Medical Affairs eLearning Program

  • 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, the role of the Medical Science Liaison, considerations for safety reporting, stakeholder engagement, development and planning of publications, compliance, and necessary actions for medical information professionals. The program contains job aids, gamification, relevant examples, and/or scenarios designed to simulate tasks performed in the role of Medical Affairs. 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: Overview of Medical Affairs

    This module is designed to enhance knowledge of the Medical Affairs profession. It explains the role of Medical Affairs in an evolving industry, describes the functions served by medical affairs, and details various medical affairs professions.

    Featured Topics

    • Medical Affairs and the drug development process
    • What is the role of Medical Affairs?
    • Other medical affairs activities
    • Best practices for engaging stakeholders

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  • Module 2: Safety Reporting Considerations for Medical Affairs

    This module covers the role of Medical Affairs in safety reporting. It discusses some safety basics, including history and background, governing organizations, and safety targets. It covers important medical affairs safety activities such as monitoring and communicating safety. Finally, the module discusses other safety-related topics such as medical ethics and risk management.

    Featured Topics

    • Safety and medical affairs overview
    • Post-market activities
    • Guidances and reporting
    • Safety reporting: Best practices and case-study

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  • Module 3: Medical Science Liaison

    This module provides a detailed description of the Medical Science Liaison (MSL) role. It begins with an overview of the role, then provides information on key areas of responsibility including identifying and interacting with thought leaders, managing a territory, gathering competitive intelligence, supporting the product lifecycle, utilizing appropriate systems, understanding evaluation metrics, and finally, describing a career path.

    Featured Topics

    • About the MSL role
    • Identifying and interacting with thought leaders
    • Competitive intelligence
    • Territory management
    • MSL activities and the product lifecycle
    • MSL systems
    • MSL evaluation

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  • Module 4: Publication Planning and Development

    This module covers the management of clinical and scientific publications. It begins with a review of the publication planning process, and walks through steps and considerations for developing publications. It also covers the role of a Medical Writer in developing clinical and scientific publications. Finally, it describes the guidances that govern the creation of publications.

    This module was written with clinical trial publications in mind, as they are most relevant for the Medical Affairs audience. However, some content is also applicable to scientific and preclinical publishing.

    Featured Topics

    • Publication planning
    • Process for preparing and developing a publication
    • Role of Medical Writers
    • Publication guidances

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  • Module 5: Stakeholder Engagement Planning

    This module presents a process for establishing and maintaining relationships with stakeholders – individuals in the field who influence the practice of medicine. It explains how the stakeholder engagement process can be executed and describes the thinking behind it. The module includes knowledge checks and a detailed example that models the application of the process in a realistic scenario. It is applicable for Medical Affairs professionals who are involved in stakeholder engagement, as well as others who wish to learn more.

    Featured Topics

    • Basic principles of stakeholder engagement planning
    • Identifying and selecting stakeholders
    • Creating stakeholder engagement plan
    • Guidance on key types of stakeholder engagements
    • Monitoring and managing the execution of the stakeholder engagement plan using Key Performance Indicators (KPIs) and milestones

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  • Module 6: 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 7: 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 8: 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 9: 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 10: Crisis Management

    This module provides medical affairs professionals with an overview of crisis management. It 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 11: 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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  • Related Products

    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.

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