I live in Pennsylvania, just outside Philadelphia, in Montgomery County. Currently, Montco is the worst hit county in Pennsylvania for the COVID-19 outbreak. Consequently, the governor ordered all non-essential businesses to close more than a week ago in Montco, and yesterday expanded that order statewide.
Because most of my work is from home, the outbreak has not yet affected my ability to provide client service; however, for the foreseeable future all live speaking engagements are cancelled.
I was scheduled to deliver the device workshop at DIA advertising conference last week and also had some workshops scheduled with FDAnews for May and June. DIA's conference was been delayed with a decision about how to proceed still to be determined. I'll post an update here when I know more.
The May FDAnews workshop has been cancelled, and the June workshop is on hold. When I know more, I'll post an update.
In addition, I am part of the leadership committee for the Philadelphia RAPS chapter. We held our last event on March 5 at Temple University, and the next day, RAPS HQ sent out a notice asking chapters to hold off on live meetings for March and April. Currently, the chapter leadership is discussing other options, such as webinars to continue getting information to our membership during the outbreak.
While we adjust to life during a pandemic, I'll provide updates as I can. Stay safe and wash your hands!
Showing posts with label RAPS. Show all posts
Showing posts with label RAPS. 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.
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.
Upcoming Speaking Engagements
The conference season starts up in February, and I have a few engagements (listed in the right hand column as always) coming up. If you follow this blog, then keep in mind that I sometimes have discounts available and will send you the info if you register for updates or send me an email using the form that is also in the right hand column.
First up on Tuesday, February 10 is a webinar I'm delivering with LSTI on the current state of social media guidance. This is an updated version of the webinar that I presented in the fall on the same topic. Since that initial presentation, the comment period has closed on the two social media guidances from last summer (though of course, it's always permitted to send comments even after the docket is closed).
The following week on February 18-19, I'll be leading an exciting panel on leveraging innovative technologies at DIA's Marketing Pharmaceuticals conference. Here's the official description of the conference:
The week of February 23 will see me back in DC for the final session of the ACDRS program. This is something I started doing last year and really enjoy because of the intimate classroom setting of working with a group of professionals who have spent more than a year following the development of prescription drugs and studying the regulatory requirements. It's an intense program, and I speak in the final session dedicated to commercialization and (no surprise) the need to understand and leverage new and emerging communication channels.
Before that travel gets started, I'll be attending the local Philadelphia RAPS chapter meeting next week on Thursday, January 29. Gary Buehler from Teva Pharmaceuticals will be speaking about the Citizens Petition process and ways companies use it to delay introduction of generic versions of products. Gary spent nearly 10 years at FDA's office of generic drugs before moving over to Teva four years ago. It should be a great topic, and I hope you'll join.
But whether you're also in the Philadelphia area, will be traveling to one of these events, or joining a webinar remotely, please stop by or drop a line and say hello.
First up on Tuesday, February 10 is a webinar I'm delivering with LSTI on the current state of social media guidance. This is an updated version of the webinar that I presented in the fall on the same topic. Since that initial presentation, the comment period has closed on the two social media guidances from last summer (though of course, it's always permitted to send comments even after the docket is closed).
The following week on February 18-19, I'll be leading an exciting panel on leveraging innovative technologies at DIA's Marketing Pharmaceuticals conference. Here's the official description of the conference:
The panel I'm leading will feature participation by AstraZeneca, J&J, Twitter, and YouTube. Here's the description from the conference webpage:The importance of understanding the complex regulations regarding the marketing of pharmaceuticals, veterinary products, biologics, and medical devices has never been higher. The DIA Marketing Pharmaceuticals 2015 conference will explore drug and device marketing in an evolving environment while serving as a vital forum for all stakeholders involved with the marketing, advertising, and promotion of a wide range of health care products.Featured Topics:
- Latest enforcement actions and policies issued by the FDA
- Leveraging innovative technologies compliantly
- How other companies are complying with government regulatory requirements
- Best review and approval practices with industry colleagues
- Novel promotional tactics trending in the pharmaceutical industry
- Emerging issues in the oversight of marketing materials
Consumers and health care professionals rely on the Internet and their mobile devices as essential tools for finding information about health care, medicine, and other treatment options. Makers of prescription products have been lagging behind in the uptake of these tools. This session provides the hands-on experience of some of the people who are leveraging YouTube and Twitter at the time and in the platform that people are using.You can see the full conference agenda and get registration information here.
The week of February 23 will see me back in DC for the final session of the ACDRS program. This is something I started doing last year and really enjoy because of the intimate classroom setting of working with a group of professionals who have spent more than a year following the development of prescription drugs and studying the regulatory requirements. It's an intense program, and I speak in the final session dedicated to commercialization and (no surprise) the need to understand and leverage new and emerging communication channels.
Before that travel gets started, I'll be attending the local Philadelphia RAPS chapter meeting next week on Thursday, January 29. Gary Buehler from Teva Pharmaceuticals will be speaking about the Citizens Petition process and ways companies use it to delay introduction of generic versions of products. Gary spent nearly 10 years at FDA's office of generic drugs before moving over to Teva four years ago. It should be a great topic, and I hope you'll join.
But whether you're also in the Philadelphia area, will be traveling to one of these events, or joining a webinar remotely, please stop by or drop a line and say hello.
Developing Compliant Search Engine Marketing
The week of Google text ads is here, at least for me and readers of this blog.
Last week, I spoke at a CBI social media summit about this topic, and on Monday, my article about the same topic was published by RAPS in its September issue of Regulatory Focus. By the way, this issue was guest edited by John Driscoll, and RAPS members can read more exclusive content at the RAPS website.
As always, I'm posting the article to my Scribd.com page and the presentation to my SlideShare page (links always available in the right rail).
But wait there's more!
All week, I'll be posting on some of the topics that didn't make the final cut for either the article or the presentation because it is definitely worth examining what I regard as the most important promotional tactic in the contemporary marketer's mix.
But wait there's more!
All week, I'll be posting on some of the topics that didn't make the final cut for either the article or the presentation because it is definitely worth examining what I regard as the most important promotional tactic in the contemporary marketer's mix.
By the way, my distribution list received an email about this yesterday. To make sure you don't miss any new developments, just complete the contact form (also in the right rail).
I also offer discounts to speaking engagements and training sessions exclusively to people on my distribution list, and I promise not to spam you. So, hey, sign up for the list.
Finally, keep in mind that I'm available for a training session to help your company understand how to make use of this incredibly important technique and to design policies and procedures to ensure all of your promotional communications are compliant. Just fill out the contact form in the right rail and request a free initial consultation.
Google Text Ads Revisited
I just submitted a draft of my article about Google text ads for the September issue of RAPS Regulatory Focus. I was surprised at how much has changed since my initial piece on this topic about two years ago.
If RAPS agrees, I'll make a copy available on my Scribd.com page (which is always accessible via the link in the right rail of the blog).
I'll also be drawing upon much of that material for a presentation I'm delivering on September 12 at the CBI Social Media Summit in Philadelphia. I hope you'll join us.
If RAPS agrees, I'll make a copy available on my Scribd.com page (which is always accessible via the link in the right rail of the blog).
I'll also be drawing upon much of that material for a presentation I'm delivering on September 12 at the CBI Social Media Summit in Philadelphia. I hope you'll join us.
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.
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.
Let's talk about paid search!
For many people, Google serves as the home page of the Internet, so it seems fitting that Google paid search ads and FDA's 2009 enforcement activity started the five-year path to the social media guidances FDA released this year.
I'm currently drafting an article about this topic for the September issue of RAPS Regulatory Focus, which is dedicated to the topic of advertising and promotional regulation, and I just accepted an invitation to speak about the same topic at a conference in Philadelphia on Friday, September 12.
CBI is holding the one-day event, and the agenda is packed with experts and friends, including both industry and consultants. It's certain to be a great event, and I hope you'll join us.
I'm currently drafting an article about this topic for the September issue of RAPS Regulatory Focus, which is dedicated to the topic of advertising and promotional regulation, and I just accepted an invitation to speak about the same topic at a conference in Philadelphia on Friday, September 12.
CBI is holding the one-day event, and the agenda is packed with experts and friends, including both industry and consultants. It's certain to be a great event, and I hope you'll join us.
June PHL RAPS Networking Event
The Philadelphia chapter of Regulatory Affairs Professionals Society (RAPS) is holding a networking meeting on Thursday, June 19 at the Primavera Pizza Kitchen in Ardmore, PA.
Here's the link to the RAPS Philadelphia group announcement.
I hope you'll join us.
Here's the link to the RAPS Philadelphia group announcement.
I hope you'll join us.
Generics Marketing Receives Another Letter
The Office of Prescription Drug Promotion posted a new letter to its website for the marketing of a generic product (disulfarim tablets) by Alvogen.
Alec Gaffney provides a nice overview of the letter in Regulatory Focus.
Traditionally, generics marketing has not received as much attention from OPDP or its predecessor DDMAC. That has probably been true in large part because there was not as much marketing of generics.
But the post-blockbuster era in pharma meant that lots of drugs with extremely high sales volumes lost their patent exclusivity and generics companies have leapt in to more competitive markets attempting to distinguish themselves and promote their offerings.
FDA has not apparently believed there was any need to provide generics-specific guidance on marketing, as none of the generics guidances provided by the Agency have focused on marketing.
With the recent enforcement actions for generics marketing (in addition to disulfarim, see here, here, and here), and the soon-to-be-approved biosimilars with different possible approvals (interchangeability and biosimilarity), it would be good to hear more from FDA about how it views some of the unique aspects of marketing follow-on products.
Alec Gaffney provides a nice overview of the letter in Regulatory Focus.
Traditionally, generics marketing has not received as much attention from OPDP or its predecessor DDMAC. That has probably been true in large part because there was not as much marketing of generics.
But the post-blockbuster era in pharma meant that lots of drugs with extremely high sales volumes lost their patent exclusivity and generics companies have leapt in to more competitive markets attempting to distinguish themselves and promote their offerings.
FDA has not apparently believed there was any need to provide generics-specific guidance on marketing, as none of the generics guidances provided by the Agency have focused on marketing.
With the recent enforcement actions for generics marketing (in addition to disulfarim, see here, here, and here), and the soon-to-be-approved biosimilars with different possible approvals (interchangeability and biosimilarity), it would be good to hear more from FDA about how it views some of the unique aspects of marketing follow-on products.
RAPS Philadelphia Chapter Meeting
The May 19 meeting of the Philadelphia chapter of Regulatory Affairs Professionals Society will feature Paul Brooks of BSI, speaking about the upcoming changes to the EU medical device regulations.
We have settled on the Primavera Pizza Kitchen as our host location.
I hope you'll join us.
Here's the registration page.
We have settled on the Primavera Pizza Kitchen as our host location.
I hope you'll join us.
Here's the registration page.
April Travels Bring May Posts
I spent much of last month on the road, including a presentation at the DTC National conference, a stint lecturing in the University of California, San Francisco, a few client presentations, and a virtual conference for Regulatory Affairs Professionals Society.
As a result, I haven't been posting much, but there are two new presentations available on my SlideShare site.
You can access them from the link in the right rail. I hope you enjoy them.
Let me know what you think.
As a result, I haven't been posting much, but there are two new presentations available on my SlideShare site.
You can access them from the link in the right rail. I hope you enjoy them.
Let me know what you think.
Staying Compliant in a Social World
I just posted my presentation from last night's meeting of the Philadelphia chapter of Regulatory Affairs Professionals Society (RAPS). Here's the link.
I'm curious what your impression is of the presentation. I make available most of my public presentation decks, but frequently, I just post the deck I presented without any alterations, and I design presentation decks very differently from decks that are intended to be sent for reading rather than presentation. So, let me know what you think
I'm curious what your impression is of the presentation. I make available most of my public presentation decks, but frequently, I just post the deck I presented without any alterations, and I design presentation decks very differently from decks that are intended to be sent for reading rather than presentation. So, let me know what you think
RAPS PHL Meeting Moved
Tonight's presentation to the Philadelphia RAPS chapter on the January social media guidance from the FDA has moved venues.
Previously, we were at the Homewood Suites in Malvern.
We moved across the street to Baxter's.
The address is 20 Liberty Boulevard, Malvern, PA 19355. It's in the Shops at Great Valley plaza.
There's no registration fee for the new venue, so no concerns about registering late. Join us at 5:30 in Malvern!
Previously, we were at the Homewood Suites in Malvern.
We moved across the street to Baxter's.
The address is 20 Liberty Boulevard, Malvern, PA 19355. It's in the Shops at Great Valley plaza.
There's no registration fee for the new venue, so no concerns about registering late. Join us at 5:30 in Malvern!
RAPS Philadelphia Chapter Presentation
I'll be speaking at the Philadelphia chapter of the Regulatory Affairs Professionals Society on April 1 at the Homewood Suites Hotel in Malvern.
I'll be covering the first FDA social media guidance, which you can read here.
The presentation will cover my view that is also presented here. In addition, there are updates from the Drug Information Association's Marketing Pharmaceuticals conference last month. BTW, here's one of my presentations from that event.
Here's the registration page on RAPS website for the April 1 event. I hope you'll join me!
I'll be covering the first FDA social media guidance, which you can read here.
The presentation will cover my view that is also presented here. In addition, there are updates from the Drug Information Association's Marketing Pharmaceuticals conference last month. BTW, here's one of my presentations from that event.
Here's the registration page on RAPS website for the April 1 event. I hope you'll join me!
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