This program is designed for professionals involved in:

• Medical affairs
• Medical communications
• Medical information
• Medical writing
• Field-based medical affairs support (i.e., Medical Science Liaison)
• Medical call center environment
• Regulatory affairs
• Clinical research
• Professional education, training, and development
• Document management/eSubmissions

At the conclusion of each corresponding module, participants should be able to:

Module 1: 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 2: 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 3: Literature Searching

• Analyze a request for medical information
• Develop a strategy to address a medical inquiry successfully
• Recognize the five main databases used for literature searching and their area of focus
• Determine if search results are valuable and relevant to the question
• Utilize relevant copyright considerations when providing results

Module 4: Literature Evaluation

• Determine whether participants in a study are appropriately selected, and are representative of the patients who receive the interventions being investigated
• Analyze the efficacy, safety, and effectiveness outcomes of a study
• Recognize how tables and graphs can be used effectively, but may also misrepresent data
• Evaluate the internal validity of a study
• Define causal and non-causal relationships, and the criteria for causality
Categorize how data are described in a study

Module 5: 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 6: 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 7: 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 8: 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