The Regulatory Affairs Certification Board (RACB) has approved a number of changes to the policies governing Regulatory Affairs Certification (RAC) that will go into effect in 2014. The changes affect both those taking an RAC exam for certification and those who have already been certified and wish to maintain their RAC credential in good standing.
New Eligibility Requirements
The most significant change is to the eligibility requirements for candidates seeking the credential. Beginning with the autumn 2014 exam cycle, candidates for the RAC must have at least a bachelor's, baccalaureate or university-awarded first degree. Those who have only a bachelor's or equivalent with no postgraduate degree must also have at least three years of professional regulatory or related healthcare product experience. Candidates with a master's degree must have at least two years of such professional experience, and for those with a doctorate, the experience requirement is at least one year.
This is a significant change from the previous requirement that candidates have a bachelor's degree or three years' experience, but not necessarily both. "Regulatory professionals today have more technical responsibilities that require advanced skills and experience beyond what an academic degree provides. The RAC exams have always been experience-based and they are intended to certify a level of professional competence, so it is reasonable to require some professional experience in regulatory or closely related areas," said Louise Ebbert, director of the RAC program.
New Fee Structure and Deadlines
Exam application fees and deadlines also will change for the autumn 2014 cycle. Instead of having an early deadline and a final deadline with four different application fees, each RAC exam period will now have one deadline and two fees-$425 (US) for RAPS members and $525 for nonmembers. The new deadlines will be 1 March for the spring exam cycle and 1 September for autumn.
"We believe eliminating the early and late deadlines and moving to a single date for each cycle is clearer for applicants and will streamline the application process," said Ebbert. "The RACB, as well as the certifying agencies, require that member and nonmember fees are reasonable and fair for candidates around the world, and the new pricing meets these standards."
A final policy change concerns RAC recertification. RAC holders will need to recertify every three years from the spring or autumn they first earned the RAC-by either 15 June or 15 December. If a person with the RAC fails to recertify, the RAC designation will be revoked 15 days after his or her recertification date. However, certification may be restored within one year of the recertification date as long as the individual supplies the required 36 recertification credits and pays a late fee of $150 for RAPS members or $250 for nonmembers. After one year of delinquency, a lapsed RAC holder must retake the exam in order to regain certification.
"This policy change clarifies the recertification process and sets a clear cutoff for submitting evidence of continued professional development," said Ebbert. "The one-year delinquency period is consistent with other professional credentials and clearly reflects the importance of continued learning for the regulatory professional."
Summary of Updates for Candidates
(through spring 2014 Exams)
Effective for Autumn 2014 Exams
|Education and Experience Requirements|
- Bachelor's or university-awarded equivalent; or
- Minimum of three years of healthcare product regulatory experience
- Bachelor's or university-awarded equivalent and at least three years of regulatory or related healthcare product experience; or
- Master's degree and at least two years of regulatory or related healthcare product experience; or
- Doctorate degree and at least one year of regulatory or healthcare product related experience
|Exam Application Deadline||
Spring: 15 February; 8 March (late)
||Autumn: 1 September (no late registration)
|Exam Registration Fees||
RAPS member: $325|
RAPS member (late): $425
Nonmember (late): $635
RAPS member: $425|
(No late registration)
Summary of Updates for Recertification
Effective 1 January 2014
- Three-year recertification cycle begins 1 January of the year after exam was passed
- Recertification materials must be submitted by 15 December
- Three-year recertification cycle begins 15 June for those who pass the spring exam; 15 December for those who pass the autumn exam
- Recertification materials must be submitted by 15 June for those who pass the spring exam; 15 December for those who pass the autumn exam
- Recertification materials submitted after 15 December but before 31 December of the recertification year are not considered late
- Recertification materials submitted after 31 December of the recertification year are considered late and will be subject to a late fee
- Recertification materials submitted after the recertification deadline
(15 June or 15 December) are considered late and subject to a late fee
|Failure to Meet Recertification Requirements||
You will lose your RAC credential 1 January and will not be listed as an RAC until you meet the following conditions for reinstatement:
- Recertification credits must be submitted for the current three-year time period. A late fee for each year of delinquency will be assessed in addition to the standard applicable recertification fee.
- You may retake and pass the examination, following the standard application procedures and fees.
- When five or more years have passed from the recertification deadline, you will be required to retake the examination, following all procedures and requirements.
You will lose your RAC credential 15 days after the recertification due date (15 June or 15 December) and will not be listed as an RAC until you meet the following conditions for reinstatement:
- The RAC designation can be reinstated only if recertification credits and fees are submitted within one year of the your recertification deadline
- Recertification credits must be submitted for the delinquent three-year time. You must submit the recertification payment plus the delinquency fee.
- The recertification due date will not be adjusted based on the late submission. You will maintain your original recertification due date.
- After the one-year delinquency period, you will be required to retake the RAC examination to reinstate your RAC status.
- Failure to recertify within one year of the recertification due date will inactivate all RAC credentials you hold. However, retaking one of the previously held RAC credential exams will reinstate all previously held RAC credentials.
RAPS member: $100|
Nonmember: $310 (includes one-year RAPS membership)
* Late fees apply if more than one year has lapsed. See Candidate Guide (PDF) for details.
RAPS member: $150|
* Late fees may apply if more than one year has lapsed. See Candidate Guide (PDF) for details.