• 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

• 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

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 post-market safety reporting
• Identify global guidances that relate to post-market 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

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

• List characteristics of a response to a medical information request
• Recognize the process for receiving and responding to medical information requests
• Categorize responses that are appropriate for healthcare professionals and non-healthcare professionals
• Differentiate between standard responses and custom responses to medical information requests
• Identify sources of information available when preparing responses
• Utilize guidelines that are specific to providing verbal responses
• Define the role of a database system in the Medical Communications department
• List features and functions necessary for an effective medical communications database system
• Identify data requirements and considerations for documenting a medical information request

Medical Response Excellence: Upon completion of this module, learners should be able to:

• Recognize regulatory guidelines that govern industry-generated responses for medical information when writing standard medical letters
• Determine medical writing excellence in standard medical letters by verifying the use of data, scientific rigor, correct grammar, brevity, and/or clarity
• Identify the components of a complete standard medical letter
• Differentiate various levels of quality review that may be necessary for standard medical letters

US Regulatory and Compliance Considerations: Upon completion of this module, learners should be able to:

• 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, including the Sunshine Act (better known as Open Payments), and how they relate to HCP customers
• Identify on-label and off-label issues concerning approved prescription drugs and the issues concerning the dissemination of off-label information
• Recognize corporate integrity agreements
• 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 prescriptions drugs

Crisis Management: Upon completion of this module, learners should be able to:

• Identify different types of crisis situations
• Recognize how a crisis can impact the pharmaceutical organization
• Examine the basic US regulatory requirements related to product recalls
• Outline the areas of planning that should be included in a crisis management plan to manage a crisis
• Define telecommunications terminology and related concepts that are important during a major crisis
• Analyze the actions that should be taken to manage a crisis

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

• 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 

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

• Recognize basic statistical terminology
• Identify potential bias in the presentation of statistical data
• Compare the statistical concepts of population, sample, bias, distribution, and variability
• Categorize 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 among study designs, and identify techniques used to avoid bias