By David Jensen, PhD RAC

The Regulatory Affairs Professional Society (RAPS) has announced changes to their Regulatory Affairs Certification (RAC) requirements (read the Regulatory Focus article). Essentially, the RAC has new eligibility requirements, a new fee structure, and some minor changes to the re-certification deadlines and process.

The biggest change comes in the eligibility requirements. Starting with the Fall 2014 exam period, RAPS will require a person seeking the RAC credential to have BOTH a college degree (Bachelors or above) AND (currently this is “or”) some number of years of professional regulatory or related healthcare product experience. There is no definition given for “related healthcare product experience” nor which experience is valid and which is not. The minimum number of years of required experience depends on the level of education (Bachelors = 3 yrs; Masters = 2 yrs; Doctorate = 1 yr).

The new fee structure for the exam simplifies the registration process. No longer will there be early and late registration dates plus member/non-member rates. Now, RAPS members will pay $425 and non-members will pay $525 to take the exam. Additionally, there are new registration deadlines: March 1st for the spring exam cycle and September 1st for the fall cycle.

Finally, some minor recertification changes. Recertification will occur every three years as currently required, but the deadline for recertification will change to reflect when a person received the RAC. If you took the spring exam your deadline will be June 15th; if you took the fall exam the deadline is December 15th. It is unclear from the announcement whether this will be instituted retroactively or just going forward. And if you forget to recertify by the deadline? Your RAC designation will be revoked 15 days after your recertification date. Certification may be restored within the next year as long as you supply the required 36 recertification credits and pay a late fee. If you fail to recertify within the one year “grace” period, you must then retake the exam in order to regain certification.

How might this affect the members of NCRAF? Given the eligibility change from an “or” to an “and” in the requirements, I might expect the demographics of our US and EU RAC workshop participants to change – more experienced people, less novices. But maybe not, one can attend the workshops to learn regulatory and product development without having to take the exam. Still, the new eligibility requirements might make it harder for new people to break into regulatory. I’m fairly certain that my attainment of the RAC credential before I had regulatory experience enabled my career transition from a bench scientist to regulatory professional.