I appreciate your desire to obtain RAC certification as quickly as possible. This is an important and useful distinction in the field. I am bring up the following as a general topic of discussion, and so it is not meant to be directed at you personally.
The current minimum qualifications required to sit for the RAC exam no longer demand (if they ever did) any actual experience is regulatory affairs, which I believe is a flaw in the system. As long as you have at least a bachelor's degree (or 3 years of related experience), you may apply to take the exam. Smart people can pass these tests with adequate study. However, the examination itself is still geared so that a passing score should represent a minimally competent candidate with 3-5 years of regulatory experience. I have worked with people (including some with new PhDs similar to what you are working on) who studied diligently and passed their RAC exam right out of school. Then they entered the workforce fresh, eager and naïve. Even equipped with their RAC, their lack of experience was a significant handicap in the application of their regulatory knowledge, which was often flawed due to inadequate perspective. Regulatory affairs is not just the rote application of technical regulations. People were asking them for regulatory advice, since they were self-presented as a qualified and certified professional. This led to some issues with inconsistency and misdirected effort.
Even very smart people with an RAC still need some experience to be a productive and useful resource in regulatory affairs, and I hope you gain your experience in a good environment. This takes time. (Your course selections are reasonable, but you always take your chances with knowledge gaps as the exam profile changes all the time). Good luck.
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Jan Peterson, MS, CCRA, RAC, MICR
Director, Regulatory Affairs
The EMMES Corp
Rockville MD
United States
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Original Message:
Sent: 07-14-2013 22:41
From: Lingqian Li
Subject: RAPS online program course selection
Hi,
I am new to RA field and currently a PhD student in biomedical sciences graduating this year.
I am taking the dual program of RAPS online university. could anyone give me some advice on course selection? I hope to get a general idea for preparation of RAC.
Here are the courses I chose:
core course: Ethics,Global Regulatory Strategy for Medical Devices, Global Regulatory Strategy for Pharmaceuticals, Medical Devices: Definition and Lifecycle, Pharmaceuticals: Definition and Lifecycle, Role of the Regulatory Professional
selective: Chemistry, Manufacturing and Controls
Medical Devices: Risk Management
Medical Devices: US Regulations
Pharmaceuticals: Compliance and Audits
Pharmaceuticals: Compliance and Audits for Cause Inspection
Pharmaceuticals: US Regulations
Quality System Regulation
Regulation of US and EU Biologics
Understanding and Managing the US Clinical Trial Process
I have no experience in RA, but I am starting to prepare for RAC or just be familiar with it right now.
Thank you.
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Lingqian Li
Georgia Regents University
augusta, GA 30912
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