Regulatory Open Forum

Hi everyone,

Some colleagues and I intend to take the RAC drugs exam in Oct - Dec. If anyone who has taken it recently would like to post any tips that come to mind, we would appreciate it. We've taken the practice exam and we're reading Fundamentals of Pharmaceutical and Biologics Regulations, 4th edition. It's very helpful and also a lot of information to take in.

Each of us has a slightly different background, including eCTD publishing, project management, quality, devices, etc. 

Was there anything in your pre-test studies that you focused on and found to be particularly helpful when you took the test? Or anything you wished you'd focused on in your studies, after you took the test. Any of the other test prep resources that you found particularly helpful?

Thanks in advance,
Heidi

------------------------------
Heidi Unger
Senior Regulatory Publication Analyst
Indianapolis IN
United States
------------------------------

Hi Heidi

I took the exam recently and cleared it in my first go. What helped me most are the practice exams. After completing the Fundamentals of Pharmaceutical and Biologics Regulations 4th edition books once, I started going through the practice tests and revised the topics in detail around all the choices of each and every question. This helped me in revising the books, but the revision was centred around the topics in practice questions. This worked for me, but I understand everyone has their own study methodology.
Please note that none of the questions in RAC exam are an exact repeat of the earlier asked questions.  The questions, even if these are repeat, are twisted and reframed/ rephrased. So it is very important to understand the questions and all the choices well.
Another thing which I found extremely helpful is the 'comparative matrix of legislations' given at the end of US, EU and International Fundamentals books. It has a kind of brief summary of all the chapters and there were many direct recall questions from this summary. Besides these tips, your regulatory experience would be most helpful in cracking the exam.

Please feel free to reach out, should you have any other questions.

I wish you all Good Luck with your preparation.




------------------------------
Sharry Arora, M.Ph, RAC
Ireland
------------------------------

Original Message:
Sent: 02-Aug-2022 11:06
From: Heidi Unger
Subject: Asking for Tips for RAC Drugs Exam, from Recent Test-takers?

Hi everyone,

Some colleagues and I intend to take the RAC drugs exam in Oct - Dec. If anyone who has taken it recently would like to post any tips that come to mind, we would appreciate it. We've taken the practice exam and we're reading Fundamentals of Pharmaceutical and Biologics Regulations, 4th edition. It's very helpful and also a lot of information to take in.

Each of us has a slightly different background, including eCTD publishing, project management, quality, devices, etc.

Was there anything in your pre-test studies that you focused on and found to be particularly helpful when you took the test? Or anything you wished you'd focused on in your studies, after you took the test. Any of the other test prep resources that you found particularly helpful?

Thanks in advance,
Heidi

------------------------------
Heidi Unger
Senior Regulatory Publication Analyst
Indianapolis IN
United States
------------------------------

Hi Sharry,

Thanks so much for taking the time to provide this feedback. That sounds like a smart approach. I'll pass this information along to my colleagues, and also revisit the practice exams that I haven't looked at in a while.

Congratulations on successfully gaining certification!

Best,
Heidi

------------------------------
Heidi Unger
Senior Regulatory Publication Analyst
Indianapolis IN
United States
------------------------------

Original Message:
Sent: 04-Aug-2022 17:44
From: SHARRY ARORA
Subject: Asking for Tips for RAC Drugs Exam, from Recent Test-takers?

Hi Heidi

I took the exam recently and cleared it in my first go. What helped me most are the practice exams. After completing the Fundamentals of Pharmaceutical and Biologics Regulations 4th edition books once, I started going through the practice tests and revised the topics in detail around all the choices of each and every question. This helped me in revising the books, but the revision was centred around the topics in practice questions. This worked for me, but I understand everyone has their own study methodology.
Please note that none of the questions in RAC exam are an exact repeat of the earlier asked questions.  The questions, even if these are repeat, are twisted and reframed/ rephrased. So it is very important to understand the questions and all the choices well.
Another thing which I found extremely helpful is the 'comparative matrix of legislations' given at the end of US, EU and International Fundamentals books. It has a kind of brief summary of all the chapters and there were many direct recall questions from this summary. Besides these tips, your regulatory experience would be most helpful in cracking the exam.

Please feel free to reach out, should you have any other questions.

I wish you all Good Luck with your preparation.




------------------------------
Sharry Arora, M.Ph, RAC
Ireland

Original Message:
Sent: 02-Aug-2022 11:06
From: Heidi Unger
Subject: Asking for Tips for RAC Drugs Exam, from Recent Test-takers?

Hi everyone,

Some colleagues and I intend to take the RAC drugs exam in Oct - Dec. If anyone who has taken it recently would like to post any tips that come to mind, we would appreciate it. We've taken the practice exam and we're reading Fundamentals of Pharmaceutical and Biologics Regulations, 4th edition. It's very helpful and also a lot of information to take in.

Each of us has a slightly different background, including eCTD publishing, project management, quality, devices, etc.

Was there anything in your pre-test studies that you focused on and found to be particularly helpful when you took the test? Or anything you wished you'd focused on in your studies, after you took the test. Any of the other test prep resources that you found particularly helpful?

Thanks in advance,
Heidi

------------------------------
Heidi Unger
Senior Regulatory Publication Analyst
Indianapolis IN
United States
------------------------------

This message was posted by a user wishing to remain anonymous

Hi Sharry,

Thanks for the advice. I am unable to locate the 'comparative matrix of legislations' that you mention. Would you please share the page numbers?
Original Message:
Sent: 04-Aug-2022 17:44
From: SHARRY ARORA
Subject: Asking for Tips for RAC Drugs Exam, from Recent Test-takers?

Hi Heidi

I took the exam recently and cleared it in my first go. What helped me most are the practice exams. After completing the Fundamentals of Pharmaceutical and Biologics Regulations 4th edition books once, I started going through the practice tests and revised the topics in detail around all the choices of each and every question. This helped me in revising the books, but the revision was centred around the topics in practice questions. This worked for me, but I understand everyone has their own study methodology.
Please note that none of the questions in RAC exam are an exact repeat of the earlier asked questions.  The questions, even if these are repeat, are twisted and reframed/ rephrased. So it is very important to understand the questions and all the choices well.
Another thing which I found extremely helpful is the 'comparative matrix of legislations' given at the end of US, EU and International Fundamentals books. It has a kind of brief summary of all the chapters and there were many direct recall questions from this summary. Besides these tips, your regulatory experience would be most helpful in cracking the exam.

Please feel free to reach out, should you have any other questions.

I wish you all Good Luck with your preparation.




------------------------------
Sharry Arora, M.Ph, RAC
Ireland

Original Message:
Sent: 02-Aug-2022 11:06
From: Heidi Unger
Subject: Asking for Tips for RAC Drugs Exam, from Recent Test-takers?

Hi everyone,

Some colleagues and I intend to take the RAC drugs exam in Oct - Dec. If anyone who has taken it recently would like to post any tips that come to mind, we would appreciate it. We've taken the practice exam and we're reading Fundamentals of Pharmaceutical and Biologics Regulations, 4th edition. It's very helpful and also a lot of information to take in.

Each of us has a slightly different background, including eCTD publishing, project management, quality, devices, etc.

Was there anything in your pre-test studies that you focused on and found to be particularly helpful when you took the test? Or anything you wished you'd focused on in your studies, after you took the test. Any of the other test prep resources that you found particularly helpful?

Thanks in advance,
Heidi

------------------------------
Heidi Unger
Senior Regulatory Publication Analyst
Indianapolis IN
United States
------------------------------

The "comparative matrix of legislations" is in the old textbooks when they used to have separate books for US Reg Affairs and EU Reg Affais etc...The new textbooks don't have those.

On a separate note, for anyone who has taken the RAC exam, is Combination Products relevant to the exam?
Thanks in advance.

------------------------------
Kay Onike, MSRA
------------------------------

Original Message:
Sent: 05-Aug-2022 11:28
From: Anonymous Member
Subject: Asking for Tips for RAC Drugs Exam, from Recent Test-takers?

This message was posted by a user wishing to remain anonymous

Hi Sharry,

Thanks for the advice. I am unable to locate the 'comparative matrix of legislations' that you mention. Would you please share the page numbers?
Original Message:
Sent: 04-Aug-2022 17:44
From: SHARRY ARORA
Subject: Asking for Tips for RAC Drugs Exam, from Recent Test-takers?

Hi Heidi

I took the exam recently and cleared it in my first go. What helped me most are the practice exams. After completing the Fundamentals of Pharmaceutical and Biologics Regulations 4th edition books once, I started going through the practice tests and revised the topics in detail around all the choices of each and every question. This helped me in revising the books, but the revision was centred around the topics in practice questions. This worked for me, but I understand everyone has their own study methodology.
Please note that none of the questions in RAC exam are an exact repeat of the earlier asked questions.  The questions, even if these are repeat, are twisted and reframed/ rephrased. So it is very important to understand the questions and all the choices well.
Another thing which I found extremely helpful is the 'comparative matrix of legislations' given at the end of US, EU and International Fundamentals books. It has a kind of brief summary of all the chapters and there were many direct recall questions from this summary. Besides these tips, your regulatory experience would be most helpful in cracking the exam.

Please feel free to reach out, should you have any other questions.

I wish you all Good Luck with your preparation.




------------------------------
Sharry Arora, M.Ph, RAC
Ireland

Original Message:
Sent: 02-Aug-2022 11:06
From: Heidi Unger
Subject: Asking for Tips for RAC Drugs Exam, from Recent Test-takers?

Hi everyone,

Some colleagues and I intend to take the RAC drugs exam in Oct - Dec. If anyone who has taken it recently would like to post any tips that come to mind, we would appreciate it. We've taken the practice exam and we're reading Fundamentals of Pharmaceutical and Biologics Regulations, 4th edition. It's very helpful and also a lot of information to take in.

Each of us has a slightly different background, including eCTD publishing, project management, quality, devices, etc.

Was there anything in your pre-test studies that you focused on and found to be particularly helpful when you took the test? Or anything you wished you'd focused on in your studies, after you took the test. Any of the other test prep resources that you found particularly helpful?

Thanks in advance,
Heidi

------------------------------
Heidi Unger
Senior Regulatory Publication Analyst
Indianapolis IN
United States
------------------------------

Hi Sharry,

Thank you for guidance. Can you share "comparative matrix of legislations:"  as in latest edition i am unable to find in hard copy.i have 4th edition book.


my email id is: sapnaakhani@yahoo.com

Regards,
sapna

------------------------------
sapna rathi
Regulatory specialist
AHME
India
------------------------------

Original Message:
Sent: 04-Aug-2022 17:44
From: SHARRY ARORA
Subject: Asking for Tips for RAC Drugs Exam, from Recent Test-takers?

Hi Heidi

I took the exam recently and cleared it in my first go. What helped me most are the practice exams. After completing the Fundamentals of Pharmaceutical and Biologics Regulations 4th edition books once, I started going through the practice tests and revised the topics in detail around all the choices of each and every question. This helped me in revising the books, but the revision was centred around the topics in practice questions. This worked for me, but I understand everyone has their own study methodology.
Please note that none of the questions in RAC exam are an exact repeat of the earlier asked questions.  The questions, even if these are repeat, are twisted and reframed/ rephrased. So it is very important to understand the questions and all the choices well.
Another thing which I found extremely helpful is the 'comparative matrix of legislations' given at the end of US, EU and International Fundamentals books. It has a kind of brief summary of all the chapters and there were many direct recall questions from this summary. Besides these tips, your regulatory experience would be most helpful in cracking the exam.

Please feel free to reach out, should you have any other questions.

I wish you all Good Luck with your preparation.




------------------------------
Sharry Arora, M.Ph, RAC
Ireland

Original Message:
Sent: 02-Aug-2022 11:06
From: Heidi Unger
Subject: Asking for Tips for RAC Drugs Exam, from Recent Test-takers?

Hi everyone,

Some colleagues and I intend to take the RAC drugs exam in Oct - Dec. If anyone who has taken it recently would like to post any tips that come to mind, we would appreciate it. We've taken the practice exam and we're reading Fundamentals of Pharmaceutical and Biologics Regulations, 4th edition. It's very helpful and also a lot of information to take in.

Each of us has a slightly different background, including eCTD publishing, project management, quality, devices, etc.

Was there anything in your pre-test studies that you focused on and found to be particularly helpful when you took the test? Or anything you wished you'd focused on in your studies, after you took the test. Any of the other test prep resources that you found particularly helpful?

Thanks in advance,
Heidi

------------------------------
Heidi Unger
Senior Regulatory Publication Analyst
Indianapolis IN
United States
------------------------------