How do I stay current on Regulatory Affairs?

[eileenr]

Dear all
I am a quality professional who is trying to learn as much as I can about regulatory affairs. Can someone please advise me on how to stay on top of new developments, eg. the requirement for a QP now for medical devices. If there is a forum I need to join, or a website that I need to keep on top of. I am based in Ireland so if there are conferences I need to be attending. All suggestions will be greatly appreciated.
Kind regards
E.

 

[Ajit Basrur]

Re: How do I stay current on Regulatory Affairs ?

RAPS would be a good start to understand the regulations across US, Europe and Global - www.raps.org

You can also refer an existing thread - http://elsmar.com/Forums/showpost.php?p=535327&postcount=2

Some of the other sites that would help you stay current are the

Irish Medicines Board - http://www.imb.ie/default.aspx

European MEDDEV - http://ec.europa.eu/health/medical-devices/index_en.htm

 

[Paul Simpson]

Hi, Eileen. It will help if you can give us an idea of where you are working and what countries' legislation you are interested in. We may be able to give you some more specific sites / support advice.

 

[Ronen E]

Dear all
I am a quality professional who is trying to learn as much as I can about regulatory affairs. Can someone please advise me on how to stay on top of new developments, eg. the requirement for a QP now for medical devices. If there is a forum I need to join, or a website that I need to keep on top of. I am based in Ireland so if there are conferences I need to be attending. All suggestions will be greatly appreciated.
Kind regards
E.

Keep track of all the medical devices related forums at Elsmar, and you'll be fine!

All important updates and developments in the field find their way here. I've benefited some, over the years - thanks everyone.

Cheers,
Ronen.

 

[John Broomfield]

Dear all
I am a quality professional who is trying to learn as much as I can about regulatory affairs. Can someone please advise me on how to stay on top of new developments, eg. the requirement for a QP now for medical devices. If there is a forum I need to join, or a website that I need to keep on top of. I am based in Ireland so if there are conferences I need to be attending. All suggestions will be greatly appreciated.
Kind regards
E.

Eileen,

Start by determining the relevant regulating bodies. You may be able to assign other subject matter experts who work for your company to monitor a regulator or two for changes in legal requirements (laws and regulations).

Many, if not all, regulators these days publish their laws and regs via their websites and they provide a service that would alert you and the other SMEs of upcoming intentions to change a legal requirement.

Of course, you'll be sharing a process to deploy relevant legal requirements to your management system so users can be assured of compliance and you and the other subject matter experts can periodically evaluate compliance.

And you'll be visiting the Cove to ask questions and share your advice.

John

 

[eileenr]

Dear all
Thank you so much for the feedback I appreciate it so much. I work for a start up medical device company in Ireland. My background is essentially in Science and Quality Management Systems, but I am involved with obtaining CE certification for a medical device and I want to learn as much as I can. I have found the European Academy for compliance very good and I will look at these other links also.
Again thank you for all the information.
regards
E

 

[Paul Simpson]

Here are a couple of good resources:
http://ec.europa.eu/health/medical-devices/regulatory-framework/index_en.htm

http://ec.europa.eu/enterprise/poli...onised-standards/medical-devices/index_en.htm

Good luck.

 

[eileenr]

Good Morning Paul
Thank you so much for your help it is much appreciated. I will trawl through these websites in my spare time, what fun ahead of me!!!!! heh heh heh
E

 

[Julie O]

I am a quality professional who is trying to learn as much as I can about regulatory affairs. Can someone please advise me on how to stay on top of new developments.

Well, I am a regulatory affairs professional, and I can assure you that there is absolutely no hope of staying on top of new developments.

Stay focused, or you will quickly be drowning in new developments. I recommend that you first get a broad understanding of the regulations that apply to you now, and then hang out in forums with other people who do what you do and who are also trying to stay on top of new developments that affect what you do. (You don't actually need to be on top of new developments; you just need to not be noticeably farther behind on new developments than everyone else.)

Focus on new developments that have a direct impact on what you are doing now, or that you are planning to do soon. Developments that aren't likely impact you for a year or two, you can get on top of those later. They will probably have changed by then, anyway. In particular, avoid the endless stream of commentary, analysis, dire predictions, and blow-by-blow reports on pending new developments, like the tidal wave of information about the new MDD that has been flooding the internet for the past several years. Once something finally gets implemented, then all of that will be water under the bridge, and now you can get on top of whatever it finally turned out to be. Until then, the only thing you need to stay on top of is whether or not it has been implemented yet.