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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, 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. 

The eleven modules take an average of 24 hours to complete.

Featured topics

  • The role of Medical Affairs
  • Safety reporting
  • Identifying and interacting with thought leaders
  • MSL activities, systems, and evaluation
  • Publication planning and guidances
  • Creating a stakeholder engagement plan
  • Receiving and a responding to medical information requests
  • Requirements for advertising and promotional labeling
  • Types of crisis situations
  • The Company Core Data Sheet
  • Labeling in the US and European Union
  • Statistical concepts
  • Study designs

Who should attend?

This program is designed for professionals involved in the following areas or roles:

  • Medical Director/Manager
  • Medical Science Liaison
  • Medical affairs
  • Medical communications
  • Medical information
  • Publication planning/development
  • Medical writing
  • Medical call center environment
  • Regulatory affairs
  • Professional education, training, and development
  • Marketing
  • Professional relations
  • Advocacy development
  • Advertising and promotion legal counsel

Learning objectives

Overview of Medical Affairs: Upon completion of this module, learners should be able to:

  • Explain Medical Affairs’ role in an evolving industry
  • Describe the functions fulfilled by Medical Affairs departments
  • List roles that exist within Medical Affairs departments and provide a general description of those roles, which may vary based on the organization

Safety Reporting Considerations for Medical Affairs: Upon completion of this module, learners should be able to:

  • Discuss the relationship between safety reporting and Medical Affairs, including history, governing organizations, safety targets and role overview
  • List and describe Medical Affairs activities for postmarket safety reporting
  • Identify global guidances that relate to postmarket safety reporting and discriminate between solicited versus unsolicited reports
  • Outline best practices for Medical Affairs with respect to safety reporting and identify lessons from a safety reporting case study

Medical Science Liaison: Upon completion of this module, learners should be able to:

  • State the primary purpose of the MSL position; explain the history and importance of the MSL role, including functions it serves and primary responsibilities and activities
  • Explain the importance and process of tiering thought leaders and outline key factors in successful thought leader interactions
  • Explain considerations for successful territory management, including credentialing, and describe preparation activities that lead to a successful interaction
  • Explain how MSLs support the product lifecycle, identify their focus during each stage of the product lifecycle, and list key activities the MSL completes during that stage
  • Explain how a CRM can be a valuable tool for an MSL and describe factors for successful customization
  • Describe regulatory guidances that govern the work of an MSL, including the Sunshine Act and state regulations and state the fact that the MSL is responsible for being aware of the laws, regulations, and guidelines that govern their work
  • Explain the metrics that are used to evaluate an MSL’s success in the role, as well as the career path options that are available to MSLs

Publication Planning and Development: Upon completion of this module, learners should be able to:

  • List and describe the components of a publication plan
  • Outline process steps and considerations for developing a publication for a clinical trial
  • Describe the role of a medical writer in the publication process and differentiate medical writers from ghost writers
  • Identify and explain the role of various guidances that govern medical publications

Stakeholder Engagement Planning: Upon completion of this module, learners should be able to:

  • Explain the basics of stakeholder planning, including definition, participants, relevance, principles for effective execution, and the “what” of stakeholder engagement planning: scientific platform
  • Define the “who” of stakeholder engagement planning: explain and complete a process by which the right stakeholders are identified and ranked
  • Explain and apply the “how” of stakeholder engagement planning: an approach for creating segments of stakeholders, identifying plans for those segments, and maintaining a successful plan on an ongoing basis
  • Describe key types of stakeholder engagements including investigator-initiated studies, promotional speaker programs, medical advisory boards, and medical society engagements

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

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

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

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

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

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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