Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

​Dear,

This year RAC (US) based exam offered last time. Starting from next year, they will not be offering Region based exam, rather it would be Drug, Medical Device, Biologics based exams. Any advice, which exam should I take, US based this year or Drug based?

For RAC exam preparation, where to start? I am confused. What is step by step preparation process. Should I read "Fundamentals of Regulatory Affairs - US edition" book only for exam preparation? should I read all guidance documents from FDA website, but they are hundreds of them?

Please guide me. An suggestions. I have 3 years of experience in Regulatory affairs but on Operation side such as publishing, and CMC submission coordination only and do not have any experience on Regulatory Strategy and real time experience on handling NDA/post approval NDA filling etc.

Please suggest what are the nest material to read for this exam.

Thanks

Hello, I cleared RAC (US) in my first attempt and here is my experience / advice. I would suggest strongly to go through the book, engage with group discussions to understand the practical experiences / challenges from people with varying background. Regarding when to take, it is all depends on how much time you have this year to commit for this. You need to get into one of the study groups and actively join all the discussions chapter by chapter to gain a good understanding of the regulations. I had my masters degree in regulatory affairs which helped me to a very good extent to crack the RAC exam! If you have good understanding of regulations and basic regulatory knowledge to apply on the challenges, you will be able to get through this easily.

Good luck!

------------------------------
Loganathan Kumarasamy, MS RAC
Senior Consultant
Waukegan IL
United States
------------------------------

Original Message:
Sent: 19-Jun-2019 07:43
From: Anonymous Member
Subject: RAC exam - US or Drug? - Exam preparation advice

This message was posted by a user wishing to remain anonymous

​Dear,

This year RAC (US) based exam offered last time. Starting from next year, they will not be offering Region based exam, rather it would be Drug, Medical Device, Biologics based exams. Any advice, which exam should I take, US based this year or Drug based?

For RAC exam preparation, where to start? I am confused. What is step by step preparation process. Should I read "Fundamentals of Regulatory Affairs - US edition" book only for exam preparation? should I read all guidance documents from FDA website, but they are hundreds of them?

Please guide me. An suggestions. I have 3 years of experience in Regulatory affairs but on Operation side such as publishing, and CMC submission coordination only and do not have any experience on Regulatory Strategy and real time experience on handling NDA/post approval NDA filling etc.

Please suggest what are the nest material to read for this exam.

Thanks

This message was posted by a user wishing to remain anonymous

Anyone in Memphis TN area considering taking Drugs exam?
Original Message:
Sent: 19-Jun-2019 07:43
From: Anonymous Member
Subject: RAC exam - US or Drug? - Exam preparation advice

This message was posted by a user wishing to remain anonymous

​Dear,

This year RAC (US) based exam offered last time. Starting from next year, they will not be offering Region based exam, rather it would be Drug, Medical Device, Biologics based exams. Any advice, which exam should I take, US based this year or Drug based?

For RAC exam preparation, where to start? I am confused. What is step by step preparation process. Should I read "Fundamentals of Regulatory Affairs - US edition" book only for exam preparation? should I read all guidance documents from FDA website, but they are hundreds of them?

Please guide me. An suggestions. I have 3 years of experience in Regulatory affairs but on Operation side such as publishing, and CMC submission coordination only and do not have any experience on Regulatory Strategy and real time experience on handling NDA/post approval NDA filling etc.

Please suggest what are the nest material to read for this exam.

Thanks

Hi,

 

I cleared RAC (US) in my first attempt, here is what worked for me. I used the current "Fundamentals of Regulatory Affairs- US edition", read through the CFR and I purchased the practice exam as well. I found the practice exam extremely valuable. It provided a look at what the test questions would be like.

 

Best of luck to you!

------------------------------
Carolyn Schmitt RAC
Regulatory Analyst
Fishers IN
United States
------------------------------

Original Message:
Sent: 19-Jun-2019 07:43
From: Anonymous Member
Subject: RAC exam - US or Drug? - Exam preparation advice

This message was posted by a user wishing to remain anonymous

​Dear,

This year RAC (US) based exam offered last time. Starting from next year, they will not be offering Region based exam, rather it would be Drug, Medical Device, Biologics based exams. Any advice, which exam should I take, US based this year or Drug based?

For RAC exam preparation, where to start? I am confused. What is step by step preparation process. Should I read "Fundamentals of Regulatory Affairs - US edition" book only for exam preparation? should I read all guidance documents from FDA website, but they are hundreds of them?

Please guide me. An suggestions. I have 3 years of experience in Regulatory affairs but on Operation side such as publishing, and CMC submission coordination only and do not have any experience on Regulatory Strategy and real time experience on handling NDA/post approval NDA filling etc.

Please suggest what are the nest material to read for this exam.

Thanks