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.

The Medical Affairs eLearning Program is divided into eleven modules:

• Module 1: Overview of Medical Affairs
• Module 2: Safety Reporting Considerations for Medical Affairs
• Module 3: Medical Science Liaison and Field Medical Affairs
• Module 4: Publication Planning and Development
• Module 5: Stakeholder Engagement Planning
• Module 6: Medical Inquiries and Database Management
• Module 7: Medical Response Excellence
• Module 8: Statistics for Medical Affairs
• Module 9: US Regulatory and Compliance Considerations
• Module 10: Product Labeling
• Module 11: Managing Unexpected Events, Incidents, and Crises

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 responding to medical information requests
• Requirements for advertising and promotional labeling
• Types of unexpected events
• The company core data sheet
• Labeling in the US and European Union
• Statistical concepts
• Study designs

• This program is designed for professionals involved in:

  • 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

At the conclusion of this program, participants should be able to:

Module 1: Overview of Medical Affairs

• Define Medical Affairs' role in an evolving pharmaceutical industry
• Identify the functions fulfilled by Medical Affairs
• List the roles that exist within Medical Affairs departments and provide a general description of those roles

Module 2: Safety Reporting Considerations for Medical Affairs

• Identify Medical Affairs' responsibilities as a safety stakeholder under ICH E6(R3)
• Describe Medical Affairs’ Role in Post-Marketing Pharmacovigilance Activities
• Recognize potential safety information from both clinical and post-marketing sources
• Determine appropriate actions for documenting and escalating safety information in accordance with regulatory expectations

Module 3: Medical Science Liaison

• Recognize the primary purpose of the MSL position, including functions it serves, primary responsibilities, and activities
• Outline key factors in successful interactions with Thought Leaders in both virtual and in-person settings
• Define competitive intelligence and how MSLs incorporate it into their work
• Recognize medical insights and the role they play in the work of an MSL
• Identify considerations for successful territory management, including individual credentialing for medical center access
• Determine how the MSL role supports activities across the product lifecycle
• Recognize the systems, tools, and documentation processes commonly used by field medical teams

Module 4: Publication Planning and Development

• List the components of a publication plan
• Outline process steps and considerations for developing a publication
• Recognize the role of a medical writer in the publication process and the differentiation from ghostwriters
• Identify the role of various guidances that govern medical publications

Module 5: Stakeholder Engagement Planning

• Recognize 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
• Recall 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
• Identify key types of stakeholder engagements including investigator-initiated studies, promotional speaker programs, medical advisory boards, and medical society engagements

Module 6: Medical Inquiries and Database Management

• List the steps involved in the process of responding to medical information requests
• Distinguish the different types of responses to medical information requests
• Recognize the role of a database system in a Medical Communications department
• List the features, functions, and data fields necessary for an effective medical communications database system
• Identify key additional functions of a database system

Module 7: Medical Response Excellence

• Recognize regulatory guidelines that govern how to respond to unsolicited requests for medical information
• Utilize best practices for medical affairs writing
• Identify the components of a complete medical response document
• Determine the various types of quality assurance reviews that may be necessary for standard medical response documents

Module 8: Statistics for Medical Affairs

• Recognize basic statistical terminology
• Determine potential bias in the presentation of statistical data
• Compare the statistical concepts of population, sample, bias, distribution, and variability
• Identify different types of data, summary measures, and estimation
• Outline hypotheses testing, type I and type II errors, statistical power, sample size, confidence intervals, and p-values
• Distinguish between study designs and identify techniques used to avoid bias

Module 9: US Regulatory and Compliance Considerations

• Identify the authority and jurisdiction under which the FDA regulates the dissemination of information, including advertising and promotional labeling, about prescription drugs
• Recognize the regulatory requirements for prescription drug advertisements and promotional labeling
• Define the issues concerning the dissemination of information about a prescription drug product prior to its approval
• Determine issues around special types of advertising and promotional events and how they relate to healthcare professionals
• Identify on-label and off-label issues concerning approved prescription drugs and the issues concerning the dissemination of off-label information
• Recognize what information is classified as ""scientific exchange"" versus ""promotional""
• Define the issues concerning direct-to-consumer advertising of prescription drugs
• Determine the interests of FDA and other federal and state law enforcement agencies in monitoring the dissemination of information about prescription drugs

Module 10: Product Labeling

• Evaluate the purpose of prescription drug and biologic product labeling
• Compare labeling requirements at the global and local levels
• Identify the components of the Company Core Data Sheet (CCDS)
• Recognize the components, structure, and use of the Prescribing Information and the Medication Guide in the US
• Outline the components, structure, and use of the Prescribing Information (Summary of Product Characteristics) and Patient Labeling (Package Leaflet) in the European Union
• Identify the regulatory agencies and requirements that govern product labeling for non-US and EU European countries
• List the departments involved in labeling development and maintenance

Module 11: Managing Unexpected Events, Incidents, and Crises

• Identify types of unexpected events, incidents, and crises
• Recognize how unexpected events, incidents, and crises can impact the pharmaceutical organization
• Examine the basic regulatory requirements related to product recalls
• Define terminology and concepts related to staffing and technology when managing unexpected events, incidents, and crises
• Outline the areas of planning that should be included in managing unexpected events, incidents, and crises
• Analyze the actions that should be taken to manage unexpected events, incidents, and crises