Showing posts with label RAPS PHL. Show all posts
Showing posts with label RAPS PHL. Show all posts

Why professional associations matter

The following remarks were delivered to the Temple University QA/RA program during their 2015 career night. I'm providing here the prepared remarks, which differ slightly from what was actually presented.

I’m Dale Cooke, the president of PhillyCooke Consulting, which is an FDA regulatory consulting firm that helps pharmaceutical companies and technology platforms make information about FDA-regulated products available via new and emerging technologies.

I also serve as the co-chair of the local Regulatory Affairs Professionals Society (RAPS) chapter, and it’s in that capacity that I’ve been asked to speak to you.

Specifically, I’ve been asked to speak about the importance of professional society involvement in your ongoing career development.

So, here it is: It’s really important to be involved in professional societies.

Seriously.

What’s in it for you?

Well, first, you get to meet other people outside of your specific company. The value of having those contacts is very high. I like to say that when you hire someone you’re also hiring their Rolodex.

For those of you who have never heard of a Rolodex, it’s a mid-20th century technology, kind of like an offline LinkedIn.

And the reason you want to hire someone’s Rolodex is that no matter how talented you are, there’s always something you don’t know. There’s nothing wrong with that. It’s just a fact of life, and when you’re facing that area where your own knowledge is lacking, it’s important to be able to reach out to other people who can help. Not to mention that at some point, you hope your company will be expanding, and when you do so, the first place you turn is your (and your team’s) Rolodex to look for more talent.

So, professional societies are an important means of extending your brain to tap into the larger community of professionals who also work in your field.

Second, professional societies keep their membership up to date on the latest developments. If you’ve been paying attention to the news, you’re certainly aware that Congress has been completely gridlocked and absolutely nothing is going on in Washington…except for FDA.

In the past few years, there have been several landmark pieces of legislation passed to address issues such as the supply chain, compounding pharmacies, and generic drug development, just to point out a few items that are near and dear to my heart.

Two days ago, new draft legislation that would drastically overhaul the FDA was released. I don’t know whether it’s going to pass, but if it does, I’ll be turning to RAPS, the Drug Information Association, and Food & Drug Law Institute (I’m an active member of all three) to find out how it affects me, my job, and my clients.

For example, next week, the local RAPS chapter is hosting an event with Jay Crowley, the godfather of UDI, about how the Unique Device Identification system is being implemented. This is a massive challenge for medical device manufacturers (i.e., some of the people you might be working for).

So, perhaps there’s some value for you in learning about it. Maybe?

By the way, if you want more information about the event, stop by our table to pick up a flier.

Finally, actively participating in professional societies enables you to demonstrate to your current and future employers your commitment to your career. It looks good on your resume.

If on a Thursday night, you choose to go the Maggiano’s in King of Prussia to hear Jay Crowley speak about UDI, instead of playing Quizzo at a local watering hole, then you’re showing how highly you value staying at the top of your game in your chosen career.

And serving actively in your local chapters is a further demonstration of that commitment. I always say that if you have two hours a month to volunteer with RAPS, then I’ll find a way to have you help the chapter in those two hours. If you have 10 hours, we’ll give you an award.

In addition, actively participating is fun. If I weren’t involved with RAPS, I’d never have met Linda Bowen [Editor's Note: Linda was in the audience], and Linda’s a hoot.

So, my advice to you is to get involved with at least one (and preferably several) professional societies. They’ll help you expand your network, stay on top of the latest developments, and demonstrate your commitment to current and potential employers, all while having some fun.

Using Periscope for Regulatory Updates

Twitter released a new app a few weeks ago called Periscope. Periscope enables users to broadcast live from their mobile devices. Depending on how the broadcast is shared, you can either make the broadcast available to everyone or only a select few people.

I've been playing around with Periscope to get a feel for how people are using it and also to see what if any interesting regulatory issues it raises.

It's possible to create a distinct identity on Periscope from your Twitter identity; however, I'm using Periscope as @PhillyCooke.

One way I've seen Periscope be adopted by the larger non-pharma community is to provide additional "behind the scenes" footage from television performers, specifically people who host interview programs. I've also seen it used successfully for Q&A sessions because viewers can type responses, feedback, and questions into the app, and those comments are then seen by everyone viewing the broadcast including the presenter.

Next week, I'll be broadcasting the Philadelphia RAPS chapter meeting. We're having Jay Crowley speak about UDI.

Jay spent more than 25 years at FDA and is widely regarded as the godfather of the Unique Device Identification system, so we're extremely excited to have him speak. Another chapter chair asked whether we could turn the event into a webinar or otherwise make Jay's talk available to a wider audience, and that's when I decided to leverage Periscope.

So, start following @PhillyCooke on Periscope, and tune in next Thursday, May 7, at 6:30 to listen in to Jay's talk.

PHL RAPS Meeting September 9

Update: Registration is now live: http://www.raps.org/EventDetail.aspx?id=19972#horizontalTab3

Our next local RAPS meeting will be held Tuesday, September 9, again at the Primavera Pizza Kitchen in Ardmore. The event will lead up to the RAPS national conference in Austin, TX, Sept. 27 – Oct. 1. Here’s the online registration for the national conference: http://connect.raps.org/2014raps/home/?ssopc=1

Linda Bowen of sanofi will be joining us to present conference overview, and Alec Gaffney, who reports for RAPS Regulatory Focus, will be providing an exclusive preview of the panel discussion he’s participating in at RAPS national about using technology for regulatory intelligence.

Some of you might know Alec for his recently published lists of 460 to Follow and RSS Feeds for Regulatory Pros. I'm proud to say that I'm included on both lists and am really looking forward to hearing from Alec himself on how he manages to stay on top of so much information.