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Discover the path to becoming a Certified Nurse Medical Affairs Professional through our comprehensive program.
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Certified Nurse Medical Affairs Professional (CNMAP)

  • Released on 06/19/2023
  • Expiration date: 06/18/2026

Program Faculty

Janice Nissen, BSN, MBA, MS Population Health

Independent Consultant

Accreditation Council for Medical Affairs - Oradell, NJ

Kiana Dixson, PharmD, BCMAS

Associate Director, Educational Programs

Accreditation Council for Medical Affairs - Oradell, NJ

Activity Overview

The Certified Nurse Medical Affairs Program (CNMAP™) is a self-paced, online, certificate program that provides nurses and advanced degree nurses the opportunity to educate themselves in the areas of medical affairs and life sciences, and therefore, creating a new avenue to career development. The CNMAP™ program enhances understanding of the medical affairs landscape within the pharmaceutical industry, allowing nursing professionals to power and advance their career in this rapidly expanding field.

Program Format

Web-based on demand

Intended Audience
  • Nurse or advance practice nurse
  • Graduate of relevant degree from an accredited college, university, or institution
  • RN, BSN, MSN, DNP, etc

Learning Objectives

By the end of this module, you will be able to:

  • Identify the global needs driving the growth of the biopharmaceutical industry
  • Compare and contrast the different functions within the biopharmaceutical industry, such as Medical Affairs, legal, regulatory, clinical operations, clinical development, and commercial
  • Describe the stages involved in drug manufacturing, from research and development to commercial production.
  • Outline the key stages involved in drug development, from preclinical research to clinical trials.

By the end of this module, you will be able to:

  • Define and categorize medical device market segmentation categories and the constraints on them in the U.S. market
  • Identify major regulatory activities associated with medical device classification
  • Describe the various segments of the diagnostics industry and how it differs from the biopharmaceutical and medical device industries
  • Compare and contrast the different types of diagnostic tests

By the end of this module, you will be able to:

  • Recognize each stage in the drug development process.
  • Compare and contrast the different types of application required for drug approval, including IND, NDA, and BLA.
  • Describe how pharmaceutical companies manage a drug’s life cycle after the drug successfully launches the market

By the end of this module, you will be able to:

  • Describe the importance of clinical trials in the drug development process
  • Compare and contrast different clinical trial designs and the difference between superiority, inferiority, and equivalence
  • Analyze different parameters used in clinical trials
  • Recognize various types of sources of bias, and confounding variables in study designs as well as the methods of controlling them
  • Identify examples of confounders in clinical trials

By the end of this module, you will be able to:

  • Describe the regulatory requirements for prescription drug advertisements and promotional labeling
  • Discuss on-label and off-label issues regarding approved prescription drugs and the concerns surrounding the dissemination of off-label information
  • Identify the issues concerning direct-to-consumer advertising of prescription drugs
  • Recognize the role of the compliance team in pharmaceutical organizations in maintaining compliance with FDA laws and regulations
  • Interpret the three tiers of compliance in the context of the 21 Code of Federal Regulations

By the end of this module, you will be able to:

  • Describe regulatory affairs for the biopharmaceutical industry
  • Identify key international and U.S. regulatory agencies
  • Describe the different regulatory application types, including Investigational New Drug (IND), New Drug Application (NDA), and Abbreviated New Drug Application (ANDA).
  • Identify key components of the FDA approval and review processes

By the end of this module, you will be able to:

  • Define models of pharmacoeconomic analysis
  • Compare and contrast cost-benefit and cost-effectiveness analyses
  • Describe direct and indirect costs and the concept of discounting
  • Assess health outcomes assessment studies and the cost effectiveness of drugs
  • Describe the steps involved in the analysis of pharmacoeconomic studies

By the end of this module, you will be able to:

  • Describe the role of medical information and its functions, responsibilities, and reporting structure within the overall life sciences organization
  • Define the rules related to providing drug information to HCPs
  • 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

By the end of this module, you will be able to:

  • Define pharmacovigilance and its role in ensuring medication safety
  • Explain the importance of monitoring, detecting, assessing, and preventing adverse drug reactions (ADRs)
  • Evaluate the implications of safety signals for patient safety and regulatory decision-making
  • Describe the objectives and components of REMS programs
  • Understand the role of clinical trials, adverse event reporting, and post-marketing studies in evaluating drug safety

By the end of this module, you will be able to:

  • Define the importance and the applicability of EBM in the modern practice of medicine
  • Identify key steps to practice EBM and evaluate the significance of each step in the process
  • Distinguish different study designs that are used in EBM
  • Compare and contrast different study designs
  • Rank the level of evidence-based information and categorize literature resources

By the end of this module, you will be able to:

  • Identify the benefits and potential risks associated with interactions between pharmaceutical companies and HCPs.
  • Describe the relevant guidelines, regulations, and codes of conduct that govern interactions between pharmaceutical companies and HCPs
  • Compare and contrast proactive and reactive discussions
  • Familiarize oneself with the guidelines and considerations of involving HCPs in collaboration of advisory boards, drug advertising, and investigator-initiated studies (IIS)

By the end of this module, you will be able to:

  • Outline specific roles that nurses typically can assume in the life science industry.
  • Explain the specific skills required for roles within medical affairs, research and development, commercial, and corporate.
  • Envision a typical day in the life for roles within medical affairs, research and development, commercial, and corporate.

CE Accreditation and Credit Designation Statement

Nurses

The Institute for Medical and Nursing Education, Inc (IMNE) is accredited as a provider of continuing professional development by the American Nurses Credentialing Center’s (ANCC’s) Commission on Accreditation.

This educational program provides 15.0 contact hours of continuing education credit.

Disclosures

It is the policy of IMNE to ensure fair balance, independence, objectivity, and scientific rigor in all programming. All individuals involved in planning (eg, faculty, CME provider staff, and educational partner staff) are expected to disclose any relevant financial relationships with ineligible companies over the past 24 months. It is also required that faculty identify and reference off-label products or investigational uses of pharmaceutical agents and medical devices.

Mitigation of Relevant Financial Interests

IMNE utilizes a peer review process to mitigate potential and actual conflicts of interest disclosed by all persons in a position to influence the planning process or content development of this educational activity. All peer reviewers are without relevant financial relationships. A copy of the mitigation worksheet is available by request from steve.weinman@imne.com

The following disclosures have been made:

Faculty & Planning Committee

The following faculty members have nothing to disclose:

ACMA Faculty:

  • Kiana Dixson, PharmD, BCMAS
  • Janice Nissen, BSN, MBA, MS Population Health

ANCC Accredited Provider:

  • Steve Weinman, MSc, RN - Program DirectorIMNE

The following planning committee members have these disclosures:

CNMAP Committee Members:

  • Michell Davi, DNP, RN, CPNP, AAHIVE

    Disclosure: Dr. Davi has disclosed that she is an employee of Merck.

  • Julia Lanouette, BSN, MS Nursing Innovation

    Disclosure: Ms. Lanouette has disclosed that she is an employee of Moderna.

  • Jessica Saucier, BSN, RN, CCTN, CCRP

    Disclosure: Ms. Saucier has disclosed that she is an employee of IQVIA.

  • Margaret Weston, BSN

    Disclosure: Ms. Weston has disclosed that she is an employee of Johnson & Johnson.

Disclaimer

This activity is designed for healthcare professionals (HCPs) for educational purposes. Information and opinions offered by the faculty/presenters represent their own viewpoints. Conclusions drawn by the participants should be derived from careful consideration of all available scientific information.

While IMNE makes every effort to have accurate information presented, no warranty, expressed or implied, is offered. The participant should use his/her clinical judgment, knowledge, experience, and diagnostic decision making before applying any information, whether provided here or by others, for any professional use.

Method of Participation

To obtain CE credit, each participant should:

  • View the content presented

  • Answer all questions posed in the post-tests

  • Complete and submit the CME/CE demographic and evaluation form at the end of the program

  • Download and/or print the online CME/CE certificate

The expiration date for this activity is June 19, 2024. No credit will be granted after this date.

Minimum System Requirements

The following system requirements are recommended for the best presentation-viewing experience:

  • Microsoft Windows Vista, Windows 7, or Macintosh OS X 10.5 (Leopard)

  • Display resolution of 1024 × 768 pixels or greater

  • Windows-compatible sound card

  • Microsoft Internet Explorer 8 or above on PC, Safari version 5 on Mac

  • Windows Media Player 11

  • Flash Player 11.0

  • Broadband Internet connection (512 kbps and above)

Estimated time to complete this activity in its entirety:

15-20 hours

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Become a Certified Nurse Medical Affairs Professional

All ACMA accredited certifications and certificate programs have successfully passed rigorous standards established by the International Accreditors for Continuing Education and Training/American National Standards Institute (IACET/ANSI).