Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hi, I am interested in knowing if anybody has taken the regulatory medical writing course with RAPS. Do you have any suggestions about it?  I was planning to take this course, but I also found that there is a Regulatory Affairs Certificate Course. As I am more inclined to write, I would like to take the course, but the certificate course seems to be more intensive. Please suggest.

Dear anon
One way to think about the difference between regulatory writing and becoming a certified regulatory professional is exactly as you stated: the professional career path to a "regulatory certified" status is quite a bit "more intensive" than the one component of regulatory "writing". By all means, you can certainly get started by writing well and learning more about the regulations. If your intent is to be a writer this will suffice; however, if you intend to certify your regulatory expertise then writing skill alone will not be enough. I believe the certificate courses are designed to help you learn and apply the regulations to different situations and be able to craft appropriate documents which requires more knowledge and experience than solely "writing" knowledge. Hope this makes the two different choices more clear.

------------------------------
Joy Frestedt PHD, CPI, RAC, FRAPS, FACRP
President and CEO
Frestedt Incorporated (www.frestedt.com)
Saint Louis Park MN
United States
612-219-9982
jf@frestedt.com
------------------------------

Original Message:
Sent: 01-Feb-2023 14:56
From: Anonymous Member
Subject: Regulatory Medical Writing vs Regulatory Affairs Course

This message was posted by a user wishing to remain anonymous

Hi, I am interested in knowing if anybody has taken the regulatory medical writing course with RAPS. Do you have any suggestions about it?  I was planning to take this course, but I also found that there is a Regulatory Affairs Certificate Course. As I am more inclined to write, I would like to take the course, but the certificate course seems to be more intensive. Please suggest.

This was so helpful! I learned something from your response. Where do I find the Regulatory Medical writing course on RAPS? 

Thank you,
Michelle

------------------------------
Michelle Mbok
Redding CA
United States
------------------------------

Original Message:
Sent: 02-Feb-2023 08:25
From: Joy Frestedt
Subject: Regulatory Medical Writing vs Regulatory Affairs Course

Dear anon
One way to think about the difference between regulatory writing and becoming a certified regulatory professional is exactly as you stated: the professional career path to a "regulatory certified" status is quite a bit "more intensive" than the one component of regulatory "writing". By all means, you can certainly get started by writing well and learning more about the regulations. If your intent is to be a writer this will suffice; however, if you intend to certify your regulatory expertise then writing skill alone will not be enough. I believe the certificate courses are designed to help you learn and apply the regulations to different situations and be able to craft appropriate documents which requires more knowledge and experience than solely "writing" knowledge. Hope this makes the two different choices more clear.

------------------------------
Joy Frestedt PHD, CPI, RAC, FRAPS, FACRP
President and CEO
Frestedt Incorporated (www.frestedt.com)
Saint Louis Park MN
United States
612-219-9982
jf@frestedt.com

Original Message:
Sent: 01-Feb-2023 14:56
From: Anonymous Member
Subject: Regulatory Medical Writing vs Regulatory Affairs Course

This message was posted by a user wishing to remain anonymous

Hi, I am interested in knowing if anybody has taken the regulatory medical writing course with RAPS. Do you have any suggestions about it?  I was planning to take this course, but I also found that there is a Regulatory Affairs Certificate Course. As I am more inclined to write, I would like to take the course, but the certificate course seems to be more intensive. Please suggest.

I just went online and searched Regulatory Writing in the Search | RAPS and this resulted in 39 hits (some were courses, and some were books and other resources). Also note, other professional societies also offer great writing classes AMWA, ACRP, SOCRA, etc. and certain business also offer writing classes like Barnett International, etc.

------------------------------
Joy Frestedt PHD, CPI, RAC, FRAPS, FACRP
President and CEO
Frestedt Incorporated (www.frestedt.com)
Saint Louis Park MN
United States
612-219-9982
jf@frestedt.com
------------------------------

Original Message:
Sent: 02-Feb-2023 18:57
From: Michelle Mbok
Subject: Regulatory Medical Writing vs Regulatory Affairs Course

This was so helpful! I learned something from your response. Where do I find the Regulatory Medical writing course on RAPS?

Thank you,
Michelle

------------------------------
Michelle Mbok
Redding CA
United States

Original Message:
Sent: 02-Feb-2023 08:25
From: Joy Frestedt
Subject: Regulatory Medical Writing vs Regulatory Affairs Course

Dear anon
One way to think about the difference between regulatory writing and becoming a certified regulatory professional is exactly as you stated: the professional career path to a "regulatory certified" status is quite a bit "more intensive" than the one component of regulatory "writing". By all means, you can certainly get started by writing well and learning more about the regulations. If your intent is to be a writer this will suffice; however, if you intend to certify your regulatory expertise then writing skill alone will not be enough. I believe the certificate courses are designed to help you learn and apply the regulations to different situations and be able to craft appropriate documents which requires more knowledge and experience than solely "writing" knowledge. Hope this makes the two different choices more clear.

------------------------------
Joy Frestedt PHD, CPI, RAC, FRAPS, FACRP
President and CEO
Frestedt Incorporated (www.frestedt.com)
Saint Louis Park MN
United States
612-219-9982
jf@frestedt.com

Original Message:
Sent: 01-Feb-2023 14:56
From: Anonymous Member
Subject: Regulatory Medical Writing vs Regulatory Affairs Course

This message was posted by a user wishing to remain anonymous

Hi, I am interested in knowing if anybody has taken the regulatory medical writing course with RAPS. Do you have any suggestions about it?  I was planning to take this course, but I also found that there is a Regulatory Affairs Certificate Course. As I am more inclined to write, I would like to take the course, but the certificate course seems to be more intensive. Please suggest.

This message was posted by a user wishing to remain anonymous

I completed the Regulatory Affairs Certificate (Medical Devices) in 2019 and thought investment was worth it. You will have 12 months to complete the 9 courses. You have the 4 required courses and then select 5 electives of your choice. I'd think it is the first step on training/certification. But it really depends on what you want to focus on, and what knowledge you have currently to be able to make the most of the Writing course. Best of luck!
Original Message:
Sent: 01-Feb-2023 14:56
From: Anonymous Member
Subject: Regulatory Medical Writing vs Regulatory Affairs Course

This message was posted by a user wishing to remain anonymous

Hi, I am interested in knowing if anybody has taken the regulatory medical writing course with RAPS. Do you have any suggestions about it?  I was planning to take this course, but I also found that there is a Regulatory Affairs Certificate Course. As I am more inclined to write, I would like to take the course, but the certificate course seems to be more intensive. Please suggest.

This message was posted by a user wishing to remain anonymous

How many hours did it take for all the 9 courses?

Original Message:
Sent: 02-Feb-2023 12:02
From: Anonymous Member
Subject: Regulatory Medical Writing vs Regulatory Affairs Course

This message was posted by a user wishing to remain anonymous

I completed the Regulatory Affairs Certificate (Medical Devices) in 2019 and thought investment was worth it. You will have 12 months to complete the 9 courses. You have the 4 required courses and then select 5 electives of your choice. I'd think it is the first step on training/certification. But it really depends on what you want to focus on, and what knowledge you have currently to be able to make the most of the Writing course. Best of luck!
Original Message:
Sent: 01-Feb-2023 14:56
From: Anonymous Member
Subject: Regulatory Medical Writing vs Regulatory Affairs Course

This message was posted by a user wishing to remain anonymous

Hi, I am interested in knowing if anybody has taken the regulatory medical writing course with RAPS. Do you have any suggestions about it?  I was planning to take this course, but I also found that there is a Regulatory Affairs Certificate Course. As I am more inclined to write, I would like to take the course, but the certificate course seems to be more intensive. Please suggest.