Board Certified Medical Affairs Specialist (BCMAS) Program

Who developed BCMAS: The BCMAS program was developed by subject matter experts and thought leaders from the life sciences industry, healthcare, and academia.

Features include:

• Online, self-paced program designed for busy professionals.
• Contains a glossary, knowledge check points, downloadable resources, applicable case studies and more..
• Earn CME/CE Credits
• Have a question? Instant chat function for live support with content related & technical questions.
• Progress check indicators to track your performance
• Contains a question bank of over 100 questions to prepare help you pass the board exam

Key Learning Outcomes:

• Align the basic direction and goals of a medical affairs organization by better understanding the cross functional areas that relate to medical affairs such as regulatory affairs, clinical development, marketing, compliance and drug development.
• Understand health economics outcomes research as it relates to medical affairs.
• Learn about clinical trial design, evidence based medicine, and become an expert at interpreting medical literature.
• Broaden your knowledge in diagnostics and medical devices as well as better understanding publication planning and regulations.

To learn more about each module click on the module below.

1. The Pharmaceutical Industry Overview CME / CE

   Explores the pharmaceutical industry’s (pharma) structure and function, the divisions within a pharmaceutical company, and the external factors governing the industry. Explains all of the functions within the industry and economic implications.

   Learning Objectives: 

   • Identify the global needs driving the growth of the pharma industry
   • Compare and contrast the different functions (medical affairs, legal, regulatory, clinical operations, clinical development, and commercial) within the pharmaceutical industry
   • Define the drug development process and path to approval
   • Recognize the role that the supply chain process plays in ensuring that pharmaceutical products are delivered to patients in both a timely manner and with high quality assurance
   • Describe the primary function of health economics outcomes research
2. Medical Device Industry

   This module provides an overview of the medical device industry, product influencers, trends, and regulatory controls. It also outlines the dynamics shaping the future of the industry.

   Learning Objectives:

   • Define and understand what a medical device is and is not
   • List medical device market segmentation categories
   • Describe the positive and negative factors influencing the medical device market trends (growth drivers)
   • Identify major constraints on medical devices in the US market (US Medical Device Industry Constraints)
   • Describe what the Device User Fee Amendment Act is
   • Identify the major regulatory activities (Brief medical device regulatory high points)
   • Recognize device classifications for the United States (FDA: Device classification brief)
   • Describe what the excise tax is and the conditions under which it applies
   • Compare and contrast progression from the identification of a novel and necessary medical device to its development, manufacturing, and ultimately to sales and post-market surveillance. (Medical device pathway from idea to purchase and user experience)

    

3. Diagnostics Industry CME / CE

   This module provides an overview of the diagnostics industry: Its importance, structure, and function, and how it differs from more traditional pharma as well as the external factors governing the industry.

   Learning Objectives:

   • Describe the various segments of the diagnostics industry and how it differs from pharmaceutical and medical device industries (diagnostic segments)
   • Compare and contrast the different types of diagnostic tests (diagnostic segments)
   • Discuss the most common in vitro diagnostic tests (diagnostic segments)
   • Compare and contrast the advantages and disadvantages of point of care diagnostics
   • Recognize the regulations of in vitro diagnostics
   • List the FDA requirements for IVD products
4. Rules Governing Interactions with Healthcare Professionals

   This module explains in detail how the interaction between pharma companies and HCPs are crucial elements for the benefits of not only the companies but also the patient populations and the healthcare system in general. It also provides a comprehensive overview related to the applicable laws and industry standards regarding the nature of interaction between how medical affairs personnel (as well as pharma in general) should be interacting with healthcare providers (HCPs).

   Learning Objectives:

   • Describe the purposes of interactions of pharma companies with HCPs (purposes of interactions, benefits of interaction)
   • Evaluate different rules governing interactions with HCPs
   • Recognize the impact of Medical Affairs on the overall relationships of companies with HCPs
   • Compare and contrast proactive vs reactive discussions (use case study here)
   • Define PHRMA (Pharmaceutical Research and Manufacturers of America) code regulations related to meals for physicians
   • Compare and contrast speaker programs vs CME events
   • Identify the Prescription Drug Marketing Act is and its applicability
   • Describe the Sunshine Act and its applicability
   • Recall the rules for accessing prescriber data
5. Health Economics Outcomes Research CME / CE

   This module provides the HEOR principles that medical affairs professionals should be familiar with, including the steps involved for assessing Pharmacoeconomics and health outcomes studies.

   Learning Objectives:

   • Define models of pharmacoeconomic analysis
   • Compare and contrast cost benefit and cost effectiveness analyses
   • Describe direct and indirect costs and the concept of discounting
   • Compare and contrast assessment of costs
   • Critically appraise health outcomes assessment studies and the cost effectiveness of drugs
   • Describe the steps involved in the analysis of pharmacoeconomic studies
6. Evidence Based Medicine

   As clinical practice has advanced tremendously over the last few decades, the explosion in scientific information is inevitable, which leads to the need for a selection of best medical knowledge that is clinically applicable. The “traditional” practice that focuses more on clinical expertise and conventional methodology is being gradually replaced by the integration of both clinical expertise and best up-to-date external clinical evidence. This contemporary approach has been widely acknowledged and defines what is called Evidence-Based Medicine (EBM).

   Learning Objectives:

   • Define the importance and the applicability of EBM in modern practice of medicine
   • Identify key steps to practice EBM and evaluate the significance of each step in the process
   • Describe the PICO method
   • Distinguish different study designs that are used in EBM
   • Compare and contrast different study designs (Table 6.1)
   • Rank the level of evidence-based information and categorize literature resources
   • Compare and contrast available resources to use for practicing EBM, including online databases, printed and computerized resources, and practice guidelines
   • Identify different types of EBM databases
7. Clinical Trial Designs

   This module provides an in-depth understanding of how clinical trials are designed with a number of parameters in order to generate clinically meaningful results. Prior to market approval, drugs (or medical devices or diagnostic tools) require specific phases of experimentation with proven efficacy and safety. These phases involve extensively well-designed protocols or clinical trials.

   Learning Objectives:

   • Describe the importance of clinical trials in the drug development process and identify different types of study designs
   • Analyze different parameters used in clinical trials
   • Compare and contrast different clinical trial designs
   • Give examples of key statistical concepts
   • Recognize various types and sources of bias and confounding variables in study design as well as the methods of controlling them
   • Compare and contrast the difference between superiority, inferiority, and equivalence
   • Define the terms randomization, blinding and masking
   • Describe the difference specificity vs sensitivity
   • Summarize relative risk present in a clinical trial
   • Identify examples of confounding in clinical trials
8. Presentation & Communication Skills

   This module will help you develop strong presentation skills specifically for the life sciences as well as establish the foundations of effective communication skills. More specifically, our focus will be on how to effectively present scientific data to a wide variety of audiences as well as cover fundamental presentation skills. Learning about effective communication skills will help you know how to best navigate the pharmaceutical or life sciences industry so that you optimize how to work cross functionally across groups within pharma.

   Learning Objectives:

   • Describe how to construct a clear, focused presentation
   • Identify the essentials of a successful presentation
   • Demonstrate improvisation & active listening skills during presentation or discussion
   • Compare and contrast effective strategies for handling interruptions & distractions
   • Evaluate the best ways to communicate information in an impactful way with cross-functional colleagues
   • Understand the importance of emotional intelligence
9. Regulatory Affairs

   The goal of this module is to provide you with an overview of the Regulatory Affairs function within a pharmaceutical company, both domestically and internationally. The module will discuss the different filings and consideration for medical devices, as well as pharmaceuticals in the United States and in the international community.

   Learning Objectives:

   • Describe regulatory affairs for medical devices
   • Compare and contrast clearance versus approval
   • Define a 510(k)
   • Identify an IDE and the different types
   • Evaluate the medical device classifications and regulatory affairs for the US, Canada, and the EU
   • Describe the role of OPDP
10. Compliance CME / CE

    This module provides you with the compliance rules, regulations, and functions within a pharmaceutical company for both drug and drug products, and medical devices. The module first discusses the different compliance issues specific to drugs and drug products. Then it presents compliance issues specific to medical devices. The information presented here is important to consider when engaging in clinical development or clinical trials within medical affairs.

    Learning Objectives:

    • Define Compliance and First Tier quality system related requirements
    • Compliance quality system for Drugs and Biologics
    • Compliance quality system for Medical Devices
    • Describe Compliance and Second Tier related requirements
    • 21 Code of Federal Regulations (CFR) Part 50 – Protection of Human Subjects Domestic
    • 21 CFR Part 56 – Institutional Review Board International
    • 21 CFR Part 58 – Good Laboratory Practice for Non-Clinical Laboratory Studies
    • Organize a plan for the Compliance and Third Tier related requirements
    • CFR Part 7 – Enforcement Policy
11. Abstract & Medical Writing

    This module focuses on two important aspects of writing that are beneficial for a medical affairs career in the pharmaceutical industry: the steps for effective abstract writing and critical values of medical writing.

    Learning Objectives:

    • Describe the purposes of abstract writing and the different types of abstracts
    • Apply the universal format to construct a concise abstract
    • Recognize the important role of medical writing and general knowledge/skills required for competent medical writing
    • Identify the main types of medical writing and requirements for each type
    • Explain the general steps in writing scientific documents
12. Publication Practices

    This module provides an overview of the publication planning process and the purpose of publications. We will also cover the most recent Good Publications Practice (GPP3) guidelines.

    Learning Objectives:

    • Describe the basic goals of publications and scientific communications within medical affairs
    • Explain the historical overview of publication practices and events
    • Define the basic elements of the GPP3 Guidelines
    • Explain why GPP Guidelines are relevant to medical writers and all stakeholders involved with industry sponsored presentations and publications
    • List the publications workflow and approval process
    • Compare and contrast industry and HCP relationships within scientific communications in pharma
    • Explain criteria for authorship
13. Drug Development Process

    This module provides an in-depth explanation of how a compound evolves from the initial discovery stage to the marketplace, detailing the requirements for each phase in the development cycle.

    Learning Objectives:

    • Recognize each stage in the drug development process
    • Compare & contrast what happens in different phases of drug development
    • Identify different types of applications required for drug approval
    • Compare and contrast an IND vs NDA
    • Describe how pharmaceutical companies manage a drug’s life cycle after the drug successfully launches the market
    • Identify the situations in which the FDA will fast track a medication. (e.g., rare/orphan diseases)
    • Define the components of a biological license application(BLA).
14. Overview of Medical Information

    This module provides an overview of the role of medical information (MI), and its greater contribution to the structure and function of the pharmaceutical and biopharmaceutical industries. It discusses the typical responsibilities of medical information, the competencies necessary to excel in the role of medical information, and the ongoing complexities of the role. Furthermore, you will learn the role that regulatory bodies have played in the day-to-day activities within medical information.

    Learning Objectives: 

    • Describe the role of medical information and its position within the greater pharmaceutical organization
    • Define the rules related to providing drug information to HCPs
    • Identify when medical information is typically involved (i.e. in phase III)
    • Describe the reporting structure of medical information within medical affairs and the organization at large
    • Compare and contrast the main roles, functions, and job responsibilities of medical information and how the function interacts with key company stakeholders
    • Identify and differentiate among primary, secondary, and tertiary sources of information
    • Describe steps necessary to answer a typical medical information question and how MI responds using standard response documents (SRDs)
    • Synthesize perspective on regulatory guidelines and the impact they have on medical information
15. Medical Science Liaisons & Field Based Medical Teams

    This module provides you with an overview of the role of the medical science liaison (MSL) and field-based medical teams. It discusses the typical responsibilities of the MSL, as well as the evolution of its specialization to developing and managing relationships between key experts while leveraging expectations by partner companies. In addition, it reviews territory management in relation to key opinion leader (KOL) strategy, review KOL interactions, distinguishes between local, regional and national KOLs. Examples of interaction metrics and how they deliver comprehensive analytics and reports to assess the job that the MSL plays in the field are also provided. Lastly, it discusses MSL responsibilities in the investigator sponsored research process and other core competencies that MSLs deliver within their position.

    Learning Objectives:

    • Describe the roles MSL plays within the greater pharmaceutical organization
    • Compare & contrast different types of KOLs within different regions
    • List the rules governing interactions with MSLs, sales teams and key company stakeholders
    • Describe the main functions and job duties of MSLs
    • Identify core competencies required to excel in an MSL position
    • Describe the regulatory guidelines impacting MSLs
    • Describe the role MSL plays in Investigator Sponsored Research
16. Grant & Investigator Initiate Study Funding and Process

    Pharmaceutical companies play an important role in furthering education and research within the medical community by providing funding to either individuals or institutions. As a medical affairs professional, depending on your role, you will be either directly or indirectly involved with the grants and IIS process. This module thus provides an overview of the grant and investigator initiated study (IIS) process.

    Learning Objectives:

    • Identify what an IIS is and its purpose
    • Recognize the key steps in the grant application process
    • Compare & contrast the different types of grants
    • Describe the level of involvement a pharmaceutical company has into an IIS proposal
    • Identify various funding opportunities and sources for IIS
    • Compare and contrast the case studies to demonstrate the “hands off approach pharma has to IIS studies”
17. Advisory Boards

    Advisory boards have always played a key role in the success of many organizations, foundations or corporate entities. For pharmaceutical companies, getting together the right group of HCPs helps inform them of whether or not their promotional or medical strategy will resonate with their audience or what the best design might be for an upcoming clinical trial. In this module, we will discuss in detail the roles advisory boards play in the pharmaceutical industry and other significant factors within advisory boards.

    Learning Objectives:

    • Describe the primary purpose for advisory boards in the pharmaceutical industry
    • Identify the elements of an advisory board
    • Recognize the challenges and key elements to the success of advisory boards
    • Identify the requirements and eligibility to be members of advisory boards
    • Assess the values of advisory boards in changing the landscape of Medical Affairs
    • Define the regulations governing advisory boards
    • Define the compliance aspects governing advisory boards
18. Phase IV/Post-Marketing Studies

    In this module, we will explain more about the various types and different purposes of postmarketing studies. We will discuss the purpose of phase IV (or postmarketing studies) as well as some of the underlying reasons why companies conduct these trials from a strategic perspective.

    Learning Objectives:

    • Describe the purpose of postmarketing research
    • Identify different types of postmarketing studies
    • Compare and contrast the different types of non-FDA mandated studies
    • Identify the role of medical affairs in phase IV trials
19. Risk Evaluation and Mitigation Strategies (REMS)

    Risk evaluation and mitigation, or REMS, is an essential process for evaluating drug benefit versus risk. Furthermore, REMS employs safety strategies to ensure that patient safety is prioritized and drug effects and usages are properly communicated to HCPs. This module thus provides an overview of the Risk Evaluation and Mitigation Strategies (REMS). The module provides a general overview of REMS with a focus on REMS within the pharmaceutical industry.

    Learning Objectives:

    • Define REMS
    • Compare and contrast the types of situations REMS tries to mitigate
    • Identify the intent of REMS providing examples
    • Describe Risk Evaluation and Mitigation strategies
    • List out the Risk Evaluation and Mitigation process
    • Identify what the FDA takes into consideration when determining the need for REMS
    • Describe the elements of a REMS program
20. Medication Safety & Pharmacovigilance

    Medication safety and pharmacovigilance are essential post-market processes that evaluate drug effects in a broad-spectrum population. This module will help you understand the process by which safety signals are evaluated and to learn about the current steps involved to monitor and assure medication safety and Pharmacovigilance.

    Learning Objectives:

    • Describe the major terms used in drug safety evaluation
    • List methods for categorizing adverse drug events
    • Compare and contrast the ways that drug safety problems are identified pre- and post-market approval