With new exams introduced this year, the Regulatory Affairs Certification (RAC) program has seen major changes since the beginning of 2019, as announced at the Regulatory Affairs Professional Society (RAPS) Regulatory Annual Convergence meeting in October 2018.

There are two new Regulatory Affairs Certifications with the associated exams for RAC (Drugs) and RAC (Devices). These two new RACs specifically focus on the pharmaceutical and the medical device regulations in the healthcare environment.

The RAC program is a voluntary certification program established in 1991 that recognizes individuals who have the overall knowledge and skills to shepherd products through the worldwide regulatory pathway. The RAC is specifically designed for regulatory professionals in the healthcare product sector. Maintaining the RAC certification is the responsibility of the holder and can be achieved through continuing education and professional development.

As with any organized group where the members’ contributions are key to ensuring the future success of the organization, this modification is significant, and reflects the complexity of modern regulatory requirements

New Exams Focus on Drugs and Devices

The RAC (Devices) exam will test the individual’s knowledge of the full product and lifecycle requirements for medical devices and IVDs under U.S. and European regulations and guidances, as well as globally applicable regulatory practices. The RAC (Drugs) exam will cover the equivalent scope for pharmaceutical, medicinal and related products, APIs, biologics and biotechnology products.

RAPS executive Director Paul Brookes provided the clearest reasons for the separate credentials devoted to the pharmaceutical and device regulations, effective mid-January: “The regional RAC exams, such as for the U.S. or EU, require extensive regulatory knowledge for products that are quite different and are regulated differently. And while many regulatory professionals work across different product types, many are specialists working prominently in a primary product sector. We listened to increasing calls for sector-specific RACs from our regulatory community. Over the past year, the RAC Board explored the demand for, and feasibility of, these exams and confirmed there was a need that RAPS could and should meet.”

Eligibility Requirements

There are now six examinations: United States (U.S.), European Union (EU), Canada (CAN), Global, Drugs, and Devices. All RAC exams continue to be offered twice a year, in the spring and autumn. The eligibility requirements are as follows:

1. Education and experience:

• A minimum of a baccalaureate or equivalent first university degree and at least three years of regulatory or regulatory-related experience; or
• A master’s degree and at least two years of regulatory or regulatory-related experience; or
• A doctorate degree (e.g., medical, dental degree, PharmD, PhD, ScD, JD) and at least one year regulatory or regulatory-related experience

1. Submission of complete application materials
2. Agreement to abide by the RAPS Code of Ethics

The regulatory-related experience referred to in the requirements may include quality assurance, quality control, clinical research, healthcare product project management or other related areas. Membership in RAPS is not a requirement to apply for or take an RAC examination or to maintain the RAC credential.

Regulatory Certification Benefits for Professionals

Anyone who works in the life science arena should consider the RAC program as an educational supplement to one’s current work environment. As identified in the RAPS RAC Certification Policy and Procedures, earning a RAC is useful in a variety of professional settings, within regulatory agencies, government and inter-governmental bodies, industry, consultancies, professional organizations, healthcare facilities, research institutions and educational institutions around the world.

While I have held a RAC credential since November 2005, over the years I have met professionals who shied away from taking the exam because it focused on either device- or drug information they were not familiar with in their current position. Now, with the new categories, there is more reason to take the exams for RAC (Drugs), and RAC (Devices). Confidence was a true benefit from adding the RAC to my signature line, as a regulatory professional.

Earning the RAC enables individuals to advise and provide regulatory strategies to peers and management. Regulatory management support within a company develops on a different level when a collaborator takes on the task of preparing and passing the RAC exams.

The scope of each exam is extensive, designed to cover all aspects of healthcare product regulations, compliance and standards, giving a global perspective on regulatory affairs. There are practice exams available online to help prepare.

Preparing the exam is like being back at night school—working a full day, then off to class. Although in this case the full day at work is a solid base that makes the study materials easier to absorb.

Certification by a regulatory professional organization not only gives you confidence in forming your regulatory advisements but also inspires confidence in those working with you or for whom you work. There is recognition that, by pursuing a regulatory certification, you have studied the regulations in your particular regulatory product area and are well versed in these regulations as well as in other product categories.

The ability to pass an exam written by your peers in your specific area of regulatory responsibility affirms that regulatory professionals have a clear understanding of the core components within their specialty area.

The Upshot

In summary, the new format accommodates the practical deployment of regulatory responsibilities in the industry, which is often regionally oriented with an emphasis on drugs and / or medical devices. While the RAC certification process and exams are voluntary, organizations that employ RAC certification professionals can be confident that these individuals have a firm grasp on the core components of each regulatory specialization.

Finally, RAC certified professionals can be confident that their foundational expertise is both current and correct; this often lays the groundwork to take on a more challenging role within an organization.

References

• RAPS—Regulatory Affairs Professional Society: https://www.raps.org/
• RAC Credential Exam Preparation: https://www.raps.org/rac-credential/prepare-for-the-exam
• RAPS Code of Ethics: https://www.raps.org/who-we-are/advancing-the-profession/code-of-ethics
• RAPS Introduces Pharmaceutical- and Medical Device-Focused Regulatory Affairs Certifications (RACs): https://www.raps.org/news-and-articles/news-articles/2018/10/raps-introduces-pharmaceutical-and-medical-device

Lynn C. Hansen, RAC, is Director of Regulatory Affairs with Pharmatech Associates. Lynn has worked in the development and regulatory management of product programs within the pharmaceutical and bioscience industries for 30 years. Her experience spans the drug development lifecycle from product development and research, through to commercial launch and post-market monitoring for solid dose, parenteral, and combination products. She has held leadership positions in both large Pharma and virtual start-up organizations overseeing the regulatory submission and maintenance programs for multiple products. Lynn’s expertise includes CMC, clinical and non-clinical modules and extends to both U.S. and global regulatory filings that utilize the eCTD format. She is an active member of the Regulatory Affairs Professional Society (RAPS) certification program and currently sits on the RACB (Regulatory Affairs Certification Board).