Regulatory Affairs Certification - RAPS Basics overview

2. Regulatory Affairs Professionals Society (RAPS) is the largest global organization of
and for those involved with the regulation of healthcare and related products, including
medical devices, pharmaceuticals, biologics and nutritional products.
Headquarters location:
Rockville, Maryland, (outside Washington, DC)
United States of America
Founded: 1976
REGULATORY
What is regulatory affairs?
Regulatory affairs are composed of a group of people who act as a liaison between the Health Agencies, industry, and consumers to help make sure that
marketed products are safe and effective when used as advertised.
The Regulatory function role often begins in the research and development phases, moving into clinical trials and extending through premarket
approvals, manufacturing, labeling and advertising, and post-market surveillance as its vital in making safe and effective healthcare products.
RAPS offers
• Education and Training,
• Professional standards,
• Publications,
• Research,
• Knowledge Sharing,
• Networking,
• Career development opportunities,
• Regulatory Affairs Certification (RAC)
Sharan Murugan

3. REGULATORY AFFAIRS CERTIFICATION (RAC), THE ONLY POST-ACADEMIC PROFESSIONAL CREDENTIAL TO RECOGNIZE
REGULATORY EXCELLENCE..
REGULATORY AFFAIRS CERTIFICATION (RAC)
What is the RAC?
Regulatory Affairs Certification (RAC), is the leading post-academic professional credential for regulatory professionals
in the healthcare product sector.
Regulatory Affairs Certification tests expertise in two sectors (Any one can chosen for Exam)
• Pharmaceuticals - RAC DRUGS Exam
• Medical Devices - RAC DEVICES Exam
Candidates who pass an RAC exam will be equally recognized by the RAC program and will be eligible to put ‘RAC’ after their name
RAC Benefits for You
1. Illustrates your regulatory proficiency
2. Highlights your professional and personal
accomplishments in regulatory affairs
3. Encourages continuous career development through
credential maintenance
4. Promotes career longevity and advancement through
continued skill development
5. Secures greater earning potential (RAC holders earn an
average of 18% more than those without the credential)
RAC Benefits for Your Employer
1. Validates your employee’s professional competence in the
regulatory field
2. Promotes ongoing professional development through
credential maintenance
3. Encourage development of a more productive and highly
trained workforce

4. TYPES OF RAC EXAM?
So what happened to REGIONAL RAC Exams?
❖ The regional exams were last offered in the
autumn of 2019 and not available any more.
❖ RAC holders who took regional versions of the
RAC can continue to maintain their RAC
status for as long as they wish, as long as they
continue to recertify.
• The only way to gain RAC status is to take and pass one of the RAC exams.
• Questions on the examinations are updated every year to reflect current regulations, guidelines and practice.
• Recent RAC program research showed that regulatory professionals tend to focus on a primary product area. To meet that need, The RAC
program launched two sector-focused exams:
The RAC Drugs and the RAC Devices.
Beginning in 2020, only the DRUGS and the DEVICES exam will be offered to candidates.

5. 1. 2 different RAC exams: RAC Drugs and RAC Devices (both MDD and MDR).
2. Each examination is based on a survey of the scope of practice and specific roles and responsibilities of regulatory professionals in the
workplace with at least three years of regulatory experience.
3. Exam content for RAC exams is based on regulations and guidelines in effect on December 31 of the year prior. So, exams taken in
2020 will be based on regulations ‘on the books’ on December 31, 2019.
4. Each examination consists of 100 multiple choice questions to be answered in a two-hour period. All scores are reported on a scale
of 0 to 99 with 75 being the passing score.
5. The RAC exams are computer-based and administered only at testing centers selected and confirmed by the testing vendor.
6. There are three question formats which may be used in the RAC exams:
• Recall questions asked for specific information, typically about regulations and guidance related to regulatory process.
• Application questions require relating specific knowledge to a situation that may be encountered in the scope of practice
• Analysis questions requires the candidate to read an assemble information in order to identify and evaluate various solution
7. Regulatory Affairs Certification Board (RACB) oversees the development of the RAC examinations.
8. Each examination is developed by an examination committee comprised of practicing regulatory experts knowledgeable about the
relevant regulations for the region
RAC EXAMINATION OVERVIEW

6. RAC ELIGIBILITY REQUIREMENTS
• Baccalaureate or equivalent first university degree and a minimum of three years of regulatory or regulatory-related work experience.
• Master’s degree and a minimum of two years of regulatory or regulatory-related work experience.
• Doctorate degree and a minimum of one year of regulatory or regulatory-related work experience.
• In addition, submission of complete application materials and agreement to abide by the RAPS Code of Ethics are required.
RAC APPLICATION PROCESS
1. Include your name on the application as it appears
on your government-issued photo identification
(ID).
2. Provide a valid e-mail address that will be
maintained throughout your RAC application
period.
3. Complete the RAC examination application fully. As
part of the application process, you must attest to
the following:
4. Incomplete applications will delay processing and
may cause your application to be rejected if not
completed by the application deadline.
HOW THE RAC IS DEVELOPED

7. KNOWLEDGE REQUIRED
RAC DRUGS
1. Knowledge of the full product development and lifecycle for
pharmaceutical and medicinal and related products, APIs,
biologics and biotechnology products.
2. Knowledge of US FDA requirements (30%); European
regulations and guidance from the European Commission, EMA,
and competent authorities (30%); and globally applicable
regulatory practices* (40%). (*ICH, IGDRP (Generics) and WHO
guidelines and standards).
3. Critical thinking and analytical skills.
RAC MEDICAL DEVICES
1. Knowledge of the full product development and lifecycle
requirements for medical devices, and IVDs.
2. Knowledge of US FDA requirements (30%); European
regulations and guidance from the European Commission
and competent authorities (30%); and globally applicable
regulatory practices* (40%). (*IMDRF, WHO and ISO
guidelines and standards).
3. Critical thinking and analytical skills.
Certification vs. Certificates
Regulatory Affairs Certification (RAC) is a professional certification, The only way to gain RAC status is to take and pass one of the RAC exams and
must not be confused with 6 to 12 month Certificate Programs `such as Drug, Devices & dual Certificate Programs.

8. EXAM SECTIONS AND CONTENT
RAC Devices Content Outlines (GUIDE)
1. Domain I: Strategic Planning – Exam Weighting approximately 29%
2. Domain II: Pre-marketing – Exam Weighting approximately 25%
3. Domain III: Post-marketing – Exam Weighting approximately 38%
4. Domain IV: Interfacing – Exam Weighting approximately 8%
2020 Exam Schedule
RAC Drug Content Outlines (GUIDE)
1. Domain I: Strategic Planning – Exam Weighting approximately 24%
2. Domain II: Pre-marketing – Exam Weighting approximately 37%
3. Domain III: Post-marketing – Exam Weighting approximately 28%
4. Domain IV: Interfacing – Exam Weighting approximately 11%
The exams are offered in three testing windows throughout the year
Testing Window Registration Deadline Register Online RAC Drugs Examination Fees RAC Devices Examination Fees
SUMMER*
13 July – 21 August 2020
8 June 2020 Closed N/A
N/A
AUTUMN
2 November – 11 December 2020
8 October 2020 Apply Today
Autumn-Drugs:
Member: $485.00 (Rs:35,636)
Nonmember: $605.00 (Rs: 44,453)
Autumn-Devices:
Member: $485.00 (Rs:35,636)
Nonmember: $605.00 (Rs: 44,453)
SPRING
22 March – 30 April 2021
25 February 2021 Apply Today
Autumn-Drugs:
Member: $485.00 (Rs:35,636)
Nonmember: $605.00 (Rs: 44,453)
Autumn-Devices:
Member: $485.00 (Rs:35,636)
Nonmember: $605.00 (Rs: 44,453)

9. RAC APPLICATION FEES
RAC Application Fees Member Nonmember
Exam Registration $485
(Rs: 35,636)
$605
(Rs: 44,453)
Change in Test Site Location and/or Date (after
scheduling)
$50 (payable to testing
vendor)
(Rs: 3673)
Processing fee for withdrawn, cancelled or
incomplete applications
$100 (Rs: 7,347)
Rescheduling fee prior to application deadline No Charge
Rescheduling fee after application deadline $250 (Rs: 18,369)
Change in examination (e.g., Device to Drugs) $50 (Rs: 3,673)
RAC testing centers available worldwide and either of the two RAC exams
may be taken on-site at any location
RAC TESTING CENTERS
Submitting Payment
The correct payment must accompany your application.
You will receive an email notification thanking you for your order, which signifies that your application has been received.
Once you have successfully applied for an exam, you will schedule your examination online directly with RAPS’ contracted testing vendor, Scantron.
You will receive a “Notice to Schedule” email from Scantron approximately 15 days prior to the start of the testing window with instructions about how
to schedule your examination.

10. RAC PREP TOOLS
RAPS' RAC Prep Tools categories:
Toolboxes
RAC Prep Toolboxes bring together a full range of valuable resources to help you identify your strengths and gap areas, gives you a sense for the
kinds of questions you will be tested on and clarifies how the exam is structured.
Bundles
RAC Prep bundles combine several of RAPS individual RAC prep tools together at a discounted rate
Individual Products
Individual RAC Devices/Drugs Prep Tools offered by RAPS include multiple single products that candidate can choose.
• Recertification credits must be obtained during the three-
year certification period.
• The RAC designation is revoked 15 days after the
certificate's recertification due date.
• The individual will not be listed as a RAC and will not be
able to use the RAC designation.
• The RAC credential can be reinstated if recertification
credits and fees are submitted within one year of the
certification expiration date.
Member Non-member
Recertification $180
(Rs: 13,225)
$290
(Rs: 21,308)
Late Fees
(added to recertification fee
above)
$150 (Rs: 11,021)
(within one-year grace
period)
$250 (Rs: 18,360)
(within one-year
grace period)
RAC Emeritus Status
Application (60+ years of age)
$150
(Rs: 11,021)
$250
(Rs: 18,360)
RECERTIFICATION RECERTIFICATION FEES