Medical Affairs and Medical Science Liaison (MSL) Board Certification: A Comprehensive Review

Growing need for medical affairs certification

The medical affairs function in the pharmaceutical industry, and specifically the medical science liaison (MSL) role, has grown significantly over the last 10 years.  Industry estimates put the worldwide number of field- and HQ-based medical affairs professionals at 50,000 in 2000. Today, a review of LinkedIn combined with government statistics shows that number north of 500,000.

Since Upjohn established the first MSL program in 1967, the field has changed drastically.  In particular, most companies today focus on hiring individuals who have a terminal degree (MD, PharmD, or PhD); however, most professionals graduate from pharmacy school, medical school, or a PhD program without training to work in medical affairs departments. To complement the rising bar for scientific knowledge, companies and individuals are seeking more professional training in cross-functional medical affairs job responsibilities.

This need for standardized training has driven the growing popularity of specialized board certifications specifically designed for medical affairs professionals. The rise of online learning tools and more sophisticated learning management systems (LMS) has made these types of programs convenient and more readily available to medical affairs professionals globally. Training programs come in a variety of structures. Some are company-managed, some are provided by outside experts paid for by the company and some are driven by individual initiative to continue professional development.

In this article, we will provide a comprehensive review of the board certification programs that are currently available to MSLs and other medical affairs professionals.

What constitutes a board certification designation?

It is important to understand what constitutes a ‘board certification’ designation.  Board certification requires three main components:

1. Assessment 

2. Accreditation 

3. An independent and recognized board of experts for oversight

Assessment

Assessment, through objective and standardized testing of professional knowledge, is the first criteria for board certification. Such testing can take different forms in different professions. For medical affairs professionals, successful certification depends on showing a thorough mastery of key areas such as operating processes, scientific knowledge, ethical rules and regulations, the life sciences business, clinical development and communication skills. Proficiency is demonstrated by passing carefully proctored exams.

Other related fields can provide useful examples and models to consider. In medicine, to become a board-certified specialist, one must undergo extensive specialty training and successfully pass a board examination. Organizations such as the American Board of Physician Specialties will administer this exam and have stringent eligibility criteria as well as a process for recertification. Typically, board certification programs in medical specialties offer preparatory courses to increase the chances of success during the board exam.

In pharmacy, some U.S. professionals choose to pursue the Board-Certified Pharmacotherapy Specialist (BCPS) credential. The BCPS designation allows the pharmacy professional to demonstrate pursuit of further training and successful completion of an exam administered by the accredited body, the Board of Pharmacy Specialties. The designation conveys the individual’s ongoing commitment to a high level of knowledge and capability and the certifying body’s acknowledgement of the individual’s achievement.

Accreditation

Accreditation by an external body is essential for certification programs, as it establishes educational standards. Continuing medical education (CME) paints a clear picture of the value of accredited training and certification beyond the initial credentialing of graduate, pharmacy or medical school.

In medicine, board certified physicians are expected to maintain their education by completing continuing medical education credits, which are accredited by the Accreditation Council for Continuing Medical Education (ACCME).  In pharmacy, the Accreditation Council for Pharmacy Education (ACPE) is the governing board for U.S. licensed pharmacists. Accreditation ensures that the CME/CE credits adhere to a set of rigorous standards. Independent accreditation also provides oversight on the organization conferring the certification, thereby ensuring that the organization is following best practices with regard to procedures, policies and content.

Another example is the recent introduction in June 2019 of the UK General Medical Council GMC-regulated credentials for doctors. These new programs are focused on discrete areas of practice falling outside recognized medical specialties and where consistent and recognized clinical standards across the United Kingdom are necessary to support better and safer patient care. The GMC-regulated credentials will provide approved approaches to develop doctors in an assured and educationally supervised environment.

Independent board of recognized experts for oversight

The third component of board certification programs is assurance that there is a team of experts who oversee the development and maintenance of the certification.  These individuals should have extensive experience in the specialized field of interest (medical affairs and its subfunctions in this case). Experts should represent a heterogeneous mix of individuals from diverse professional backgrounds to ensure all areas of study are addressed in the examination appropriately. 

* ACMA: Accreditation Council for Medical Affairs

* IFAPP: International Federation of Associations of Pharmaceutical Physicians and Pharmaceutical Medicine

* MSL: Medical Science Liaison

* BCMAS: Board Certified Medical Affairs Specialist

* CMD: Certified in Medicines Development

* MSL-BC: Medical Science Liaison-Board Certification

Review of accreditations

Based on the current review of the primary board certifications available to medical affairs and MSL professionals, the Board Certified Medical Affairs Specialist (BCMAS) is currently the only program to be fully accredited by globally recognized bodies. This accreditation makes clear how and by whom an organization’s procedures, policies, and content are overseen. The BCMAS program is offered by the Accreditation Council for Medical Affairs (ACMA).

The ACMA is accredited by the International Association for Continuing Education and Training/American National Standards Institute (IACET/ANSI) and is also an organizational member of the Institute for Credentialing Excellence (ICE). In partnership with Scientia CME, the BCMAS program is accredited by the Accreditation Council for Continuing Medical Education (ACCME) and the Accreditation Council for Pharmacy Education (ACPE).

Cost-benefit comparison

As seen in Figure 1, MSL Society’s program costs $450-$550, the BCMAS program costs $1,999, and the IFAPP program costs $8,600-$9,600. To better understand the overall value of each program it is important to examine what each program provides.

MSL Society Program: MSL Society’s program is an exam rather than a full professional development system. MSL Society’s program does not include training content and does not offer preparatory exam materials. While it may be the least expensive option, the lack of training content and exam preparation materials is a drawback. Additionally, there is no outcomes measurement for the MSL Society Program.

ACMA BCMAS Program: The BCMAS program includes a 20-module preparatory training course that is designed so that participants can ensure they are prepared for the BCMAS board exam. The curriculum includes case studies, knowledge checks for each of the 20 modules and an industry glossary. Preparatory areas include technical competencies, life sciences comprehension, business skills, process management, and regulatory affairs and compliance. The program includes downloadable resources to study offline for those preparing to become board certified in medical affairs via BCMAS. The ACMA BCMAS Program measures outcomes (skills competency, motivation, and stakeholder value as perceived by key opinion leaders, for example) to assess effectiveness.

IFAPP Program: The International Federation of Associations of Pharmaceutical Physicians and Pharmaceutical Medicine program also includes training content and a certification exam. IFAPP training contains six modules, including health economics, drug discovery, clinical trial management, regulatory affairs and medical affairs as a strategic business partner. Some content requires attendance at set classroom times, which can be cumbersome for working professionals. The IFAPP Academy program does not measure outcomes.

Conclusion and summary

Several pharmaceutical industry leaders at a recent Medical Affairs Leadership Forum held in London emphasized the importance of working to calibrate and standardize core competencies across their medical affairs teams. A comprehensive specialty board certification training program for the entire team offers an effective approach to achieve this goal. Certification does not only demonstrate mastery of specific skills; it also signals to managers and key opinion leader stakeholders that the individual is committed to reaching for a higher bar of professional knowledge and personal conduct.

As we have seen with the recent upheaval caused by COVID-19, the flexibility to adapt to expanding responsibilities is critical. For both short-term demands and long-term professional development, certification is a key asset for medical affairs professionals. In the short term, certification ensures that team members have the cross-functional knowledge to take on different responsibilities and excel. In the long term, board certification ensures that colleagues, managers, and key opinion leaders understand and trust the skills and knowledge that a credentialed medical affairs professional offers. 

References

Moss, Robert et al, Therapeutic Innovation and Regulatory Science, DOI: 10.1177/2168479014549859

https://anab.ansi.org/. Accessed April 2020.

https://www.gmc-uk.org/education/standards-guidance-and-curricula/projects/credentialing/what-is-a-gmc-regulated-credential. Accessed May 2020.

https://www.themsls.org/msl-board-certification/. Accessed April 2020.

https://www.medicalaffairsspecialist.org/board-certified-medical-affairs-specialist-program/. Accessed April 2020.

https://ifappacademy.org/program-information/. Accessed April 2020.

https://www.roberthalf.com/blog/management-tips/4-reasons-a-professional-certification-benefits-the-entire-company. Accessed April 2020.

https://www.policymed.com/2014/06/compliance-challenges-within-medical-affairs.html. Accessed April 2020.

Authors

Eric Bouilloux, Associate Vice President, Scientific Affairs - Operations at Accord Healthcare, Tina Kanmaz, Assistant Dean for Experiential Pharmacy Education at St. Johns University, Jill Massey, Global Head, Safety and Pharmacovigilance at Immunomedics.