• Receiving and a responding to request for medical information
• Writing and editing an abstract
• Literature search strategies and databases
• Literature evaluation
• Scientific exchange
• Statistical concepts
• Study designs
• Crisis impacts and recalls
• Global labeling

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

Module 1: 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 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

Module 2: 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
• Outline additional functions of a database system

Module 3: Medical Response Excellence: Upon completion of this module, learners should be able to:

• Recognize the 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

Module 4: 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 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 5: Literature Searching: Upon completion of this module, learners should be able to:

• Analyze a request for medical information
• Identify the requester to provide an appropriate answer
• Identify the search terms for the query
• Differentiate the purposes and strengths among various literature references
• Determine appropriate references, indexes, and abstracts for a search
• Record the results of a search
• Identify sources of full-text copies of published information, both proprietary (available for a fee) and non-proprietary (available without cost in the public domain) where possible
• Utilize relevant copyright considerations when providing results

Module 6: Literature Evaluation: Upon completion of this module, learners should be able to:

• Determine whether participants in a study are appropriately selected, and are representative of the patients who receive the interventions being investigated
• Identify the purpose, key features, and possible bias of a published study abstract and introduction sections
• 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
• Identify when data is missing and the significance of the Intention to Treat analysis
• Determine the importance of critically evaluating scientific literature, as well as the possible sources of bias within a published clinical study
• Evaluate whether study results are objectively interpreted
• Define causal and non-causal relationships, and criteria for causality
• Categorize how data is described in a study
• Recognize the role that population size, cause, strength, randomization, and generalizability play in determining the importance of a study

Module 7: 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 the 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

Module 8: Statistics for Medical Affairs: Upon completion of this module, learners should be able to:

• Recognize basic statisticl 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