RAPS RAC EU EXAM

Sana Banu

Registered
Hi all! I'm new to the cove. I've been working in regulatory for about 3 years - in almost exclusively pharmaceuticals. I was looking at the possibility of taking the exam in the coming year but from what I'm gathering, I may need more prep time.

For anyone who has taken the exam or is preparing, I would really appreciate it if you could direct me to or add on any study groups.

Also, for the exam, please guide me on the best study materials to refer for the test.

Thank you
Sana Banu
 

EmiliaBedelia

Quite Involved in Discussions
RAPS only offers the RAC-Drugs and RAC-Devices exams now so you should take the RAC-Drugs exam.

Caveat with everything below: my certification is in RAC - Devices, not in Drugs.

I took the test basically at 3 years experience and studied for maybe 4 months? I don't recall when I started prepping but it wasn't a super long time, and I only spent a few hours every week. I did well on my first pass and didn't have to retake it.

I used the RAPS study materials and they were sufficient for me. I didn't use a study group, but I did share materials with other people in my department who were taking the exam the same year. The practice tests were the most helpful. Take one before you start studying just to get a feel for the questions and how the test is set up, and then take them as you go to check your knowledge. Also, I am fairly certain that I saw some repeat questions (or at least, extremely similar ones) on the test itself... so, this one may or may not happen for you but you could get some freebies :)

I bought the physical books as I found them nicer to read than staring at a screen, and I also wanted to use them as a reference and pass them along to others who were going to take the test after me. My test was the very first Devices exam so RAPS didn't have much specific material - they literally just took the "Devices" sections out of the other exam books and sold them as 4 separate books. I made my own flash cards based on the books so I would suggest doing that as opposed to buying a set, if you're looking to save money.

Personally, I felt like at least 50% of what I needed to know was covered by my job experience. The studying just gave me more context on the laws/regulations/"whys" of what I already knew. For example, I basically knew about device classification and could generally explain why devices are classified in certain ways, but studying for the test forced me to memorize the classification rules. A lot of the material I "learned for the test" and will likely never need again (I've never needed to actually cite the Kefauver-Harris amendment by name for any reason other than random trivia whenever thalidomide comes up) but I honestly didn't find it hard to cram. It is like any other school test - if you're good at multiple choice and learning for a test, you will do fine on the RAC.

If I were you I would take a practice test and see how you fare. That's the best way to gauge how much study time you will actually need. Review the candidate guide/test content guide and see how much you think you know. Your own job experience will be the most helpful study material for you so try to use that as much as you can - ask your manager for more opportunities in areas you're not as familiar with so you can learn it on the job before you take the test!

Good luck!
 
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