Blogs

Meet Emily, Your New Community Manager

By RAPS Membership Team posted 13-Nov-2018
Emily Stamm is taking over as community manager for the RAPS RegEx platform . Since she’s been on board, she’s learned a lot about RAPS members and the regulatory affairs profession. Now, she’s sharing a little about how RAPS members are finding value in the RegEx platform, and how the regulatory profession as a whole can benefit from the conversations being held. What is RegEx ? Emily: I think of RegEx as a platform where regulatory professionals come to network, and to build and share their professional knowledge. RAPS members are collaborative and have created a strong sense of community. Members are able to reach out about issues they are facing and ...

Successful EU MDR/IVDR Workshop In Brussels

By RAPS Membership Team posted 08-Jun-2018
With the EU MDR/IVDR changes on the horizon, RAPS pulled together a workshop in Brussels in May 2018 to focus on preparing for these updates. The intent of the program was to support European regulatory affairs professionals, by bringing them together to discuss and share experience, expectations and concerns in preparing to meet the new EU regulations. Over 120 registrants signed up to be a part of the workshop, signaling the need for support and guidance through implementation process. Speakers like Gert Bos, Bassil Akra and Anja Wiersma helped provide participants with the skills to create their own transition and implementation plans. RAPS Executive Director ...

Vancouver Chapter’s MDSAP Program Soars Above Challenges

By RAPS Membership Team posted 13-Nov-2017
On 18 October 2017, a group of people experienced a RAPS chapter event of epic proportions. Attendees and chapter organizers alike struggled through extreme winds and rain, finding unlikely refuge and uplifted spirits in an event guiding them through the Medical Device Single Audit Program (MDSAP). RAPS Vancouver Chapter leaders, Jennifer Cabralda , Karen Long and Dinar Suleman , had begun the day excited about an event that was hard to pull off successfully. The three planned to work in concert to have dinner and information ready for attendees. Suleman was on site ensuring everything was set up, Cabralda would drive in and bring the drinks, Long would ...

RAPS Members Meet For the Holidays

By Austen Gage posted 06-Dec-2016
RAPS Members Meet for the Holidays As 2016 draws to a close, some RAPS Chapters are taking time to celebrate with fellow regulatory professionals. Enjoy these photos gathered from recent RAPS meet ups! Looking for a local event? Check out our events page to find something close to you! <Photos with captions> Interested in having your RAPS event photos featured in UnderRAPS? Contact Austen Gage at agage@raps.org .

Call for Proposals—2017 RAPS Regulatory Convergence in National Harbor, MD

By Austen Gage posted 06-Dec-2016
Description: RAPS is seeking expert insight on topics and ideas for our global annual conference—RAPS' Regulatory Convergence. We value your guidance on current and emerging issues in the healthcare product regulatory area. Convergence will take place 9-12 September 2017 at the Gaylord National Resort & Convention Center in National Harbor, MD. This is the largest professional meeting for those engaged with the regulation of healthcare products worldwide. The event attracts participants representing global regulatory bodies, industry, research, academic and clinical organizations involved with the full range of healthcare products across all facets of ...

FDA Guidance: Analytical Procedures and Methods Validation for Drugs and Biologics

By David Lim posted 24-Jul-2015
Today (July 24, 2015), FDA issued an important guidance entitled " Analytical Procedures and Methods Validation for Drugs and Biologics ." To learn more information on Process Validation on Drugs and Devices, you may visit at http://regulatorydoctor.us/process-validation-drugs-medical-devices/ s/ David ____________________________________________________________ Dr. David Lim, Ph.D., RAC, ASQ-CQA President and CEO | REGULATORY DOCTOR http://www.regulatorydoctor.US Phone (Toll-Free): 1-(800) 321-8567 E-mail: David@RegulatoryDoctor.US "Knowledge is power only when it is practiced and put into action." - Regulatory Doctor s/ David ____________________________________________________________ ...

Regulatory Has a Seat at the Table - Now What?

By Karin Hjorth posted 07-May-2015
We’ve been saying we need a seat at the table. And now we finally have one. So what next? As Regulatory partners we’ve been asking to be consulted earlier in the product development cycle and in other business decisions affecting Regulatory Affairs. Our message has been simple – include us in early strategies and we can help streamline the regulatory process to drive and enhance the quality and efficiency of global business. Our Regulatory strategies can develop in parallel (instead of sequentially) for many Regulatory pathways and turn obstacles into stagegates when allowed enough lead time. Over the past years the hard work of Regulatory professionals ...

Request for HUD Designation (HDE Application)

By Robert Wilkinson posted 07-May-2015
Does someone out there have proven templates for a HDE Designation application and a application for HUD. Thanks in advance for your help. Bob Wilkinson

The Black Hole

By Constance Hampton posted 23-Apr-2015
Have you ever heard of anyone saying that they sent their resume to a company but it seems to have disappeared into a black hole? How does that happen? Let’s ask some questions of the process. Did you send an unsolicited resume to random.unknown.hr.person (at) company.com? If it was not marked “spam”, it may still not have made it to the real, live person who takes care of HR. Does the company have a person whose sole job is HR or recruiting? If not, the office manager probably reviews the emails to HR @ company. com and deletes them if the company is not currently hiring – your resume attachment may not ever get opened. Did you send your resume ...

Reframing the Millenial Discussion

By Karin Hjorth posted 21-Apr-2015
There is a lot of information out there about who these Millenials are and why they work differently. I get it. They are driven, they want medals, and they want a work-life balance. Some even EXPECT it. Regardless of how right (or wrong) these analyses are, I feel the Millenial and GenX/Baby Boomer conversation has become stale and misdirected. I think we’ve confused the issues at hand with the characterization of the Millenial generation. There seems to be this “us vs. them” discussion that is often had around the water cooler or in vanilla HBR articles, where we identify the Millenial generation habits, drivers, and differences and compare them to GenX ...

Where are you in your job search?

By Constance Hampton posted 03-Apr-2015
New blog posted http://networkpolishkit.com/where-are-you-in-your-job-search/ Are you likely to look for a new job this year? Are you doing what "everybody" is or have you "gone pro"?

I Am Not The Fairy Job Mother

By Constance Hampton posted 17-Mar-2015
I Am Not The Fairy Job Mother I am not the job fairy, but, oh, how I wish I were! I get emails and resumes, requests for connections and phone calls every day from smart, unique, creative people with excellent skills. And I don’t have a job for them. Why? Because recruiters don’t “have jobs”. We have searches. Contingency recruiters are willing to work for free and shop around the best of the resumes that come to them in the hopes that there will be a big payoff eventually. Retained recruiters only work on the searches their contracted clients want them to work on. Both have to choose to use their time wisely because, in truth, only 5% of all ...

Finding and being found

By Constance Hampton posted 06-Mar-2015
Finding and being found March 1, 2014 by Connie Hampton · Leave a Comment Some people, when about to lose a job or just after finishing an assignment, think of themselves as “being available for reassignment” or “available”. This may work for rock stars, star athletes and other people, famous for their particular skills and expertise, but it really does not for the majority of workers. If it does work for you, stop reading. For the rest of us, job search really is about finding and being found. You have to do both. Waiting to be found is like being the average-looking high school good girl who is “available” but still doesn’t get asked ...

How to network with people you don't know

By Constance Hampton posted 09-Feb-2015
We know that personal networking fills 75% of all jobs. But what if you want a job in a company where you know no one? How can you network with people you don't know? Short video on job search And do join us for a complimentary webinar on Targeted networking

RAC Exam and Cosmetics

By Robert Falcone posted 12-Jan-2015
Has anyone ever asked RAPS the potential of having a Cosmetics / Personal Care section in the RAC exam? Also, is anyone working to take the RAC in the Fall? Particularly in NJ/NY Metro area? Thanks, Robert

Sell medical device as RUO in US?

By Izumi Ishii-Clifford posted 29-Dec-2014
Hi all, I need your input on this subject. We have a class I medical devices which can be sold in US, and the medical devices have registered number on the instrument. We have a tracking method to see where the instrument (serial number) goes and also if the instrument can be as a medical device or RUO. We haven't sell the medical device as an RUO in US. We sell only as a medical device (class I) in US. My question is that can we sell the medical device only by tracking the device as RUO without changing the label on the instrument (having the class I registered number on the instrument)? We do obtain an agreement letter with every customer whether they ...

1 Key Tip to Nailing your Regulatory Affairs Job Interview

By Andrew Ahn posted 18-Nov-2014
This post was originally published on www.regdy.com . This isn’t your average interview, this is a Regulatory Affairs interview. If you have a face interview lined up, the following probably already happened: 1. You survived the weeding process. The recruiters checked your work history on your resume, your Linkedin, and searched the FDA 510(k) database to see how many 510(k)s you were involved in. I know that many folks are frustrated with the 510(k) numbers game because anyone who worked in the industry knows that many hands touch the 510(k) but there’s only room for a primary/secondary author on the 510(k) summary. Regardless, congratulations, you ...

A Snapshot of 2014 OPDP Enforcement Letters

By Julie Tibbets posted 10-Nov-2014
As the end of the year quickly approaches, I thought I would share a quick snapshot of enforcement letters issued by FDA's Office of Prescription Drug Promotion (OPDP) so far this year. Here are some interesting numbers and statistics to consider: - 9 letters, year-to-date (1 warning letter; 8 untitled letters) - 1 warning letter (citing a Bad Ad program complaint and noting violations as "extremely concerning from a public health perspective" due to evidence of use promotion beyond FDA approval) - 8 untitled letters identified through routine monitoring and surveillance - Year-after-year downward trend in letters continues: compare this year with 2010 ...

Drug Compounding Outsourcing Facilities question

By Lisa Apolis posted 03-Nov-2014
Is anyone working with any compounding outsourcing facilities? The new Section 503B states that "the drug cannot be sold or transferred by an entity other than the outsourcing facility that compounded such drug." Does this mean to exclude virtual companies or 3rd parties to take/coordinate orders for the compounding facility?

How to find an entry level regulatory job?

By Nupur Gangopadhyay posted 28-Oct-2014
My response to Zachary's explanation on RAC course Hi Zachary, Thanks for your response but, unfortunately, your response does not answer my question. Have you got a chance to read my mail? Let me try again: ”Recently, I have completed an online course on Regulatory Affairs Certificate (Dual) and accordingly obtained a certificate. As most of the degree abbreviation method, I was using this certificate as RAC after my other degrees but most of the RAPS members pointed out that RAC is stand for certification. In this context, more elaborately, examples are: Bachelor of Science= B.S ., Master of Science= M.S., Membership of the Royal College of ...