RAPS Latest

The latest from RAPS, including important updates on events, products and initiatives, as well as other useful articles from RAPS.

RAPS and the Regulatory Profession: Two-Way Communication Between Industry and Regulators

When the regulatory profession convenes for the 2016 Regulatory Convergence in San Jose next month, it will be an occasion for members from both government and industry to build on their working relationships, to discuss with one another new guidelines and compliance issues and, generally, to bridge their understanding about regulatory matters unique to those who work in different facets of the profession.

Categories: Articles, Under RAPS, HTML, About the Profession, Communication Tags: RAPS 40th Anniversary, regulatory profession, communication
10 Disruptive Technologies and the Regulatory Implications

The healthcare products sector has seen the introduction and development of a number of disruptive technologies in recent years. The future of healthcare lies in groundbreaking tech like 3D printing and personalized medicine. But these new innovations also bring regulatory challenges. This article examines 10 disruptive technologies regulatory professionals should be tracking.

Categories: Biologics and biotechnology, Medical Devices, Clinical, Compliance, Ethics, Labeling, Manufacturing, Packaging, Articles, Under RAPS, HTML, RAPS, Advertising and Promotion, Communication Tags: disruptive technology, regulation, Regulatory Convergence, #2016RAPS
RAPS' Scope of Practice Survey Shows Regulatory Pros Play Increasingly Strategic Role; Compensation Up

RAPS today released the results of its biennial survey of healthcare product regulatory professionals around the world. The survey asked respondents about their daily work, education and professional backgrounds, and compensation. RAPS has compiled and published key survey results and analysis in its 2016 Scope of Practice & Compensation Report for the Regulatory Profession.

Categories: Career Development, Articles, Under RAPS, HTML, About the Profession Tags: Scope of Practice, compensation, salary, survey, 2016 Scope of Practice & Compensation Report
Head of Cuban Regulatory Agency to Make First Appearance at Regulatory Convergence

This year, for the first time ever at RAPS’ Regulatory Convergence, attendees will have the opportunity to hear directly from Cuba’s top regulatory authority. Rafael Perez Cristia, head of the National Regulatory Agency, Cuba, will participate in two sessions, both taking place Tuesday, 20 September. Perez Cristia will discuss the country’s regulatory environment and biotech industry.

Categories: Articles, Under RAPS, HTML, Latin America and Caribbean, RAPS Tags: Regulatory Convergence, Cuba, #2016RAPS
RAPS Appoints Paul Brooks as Next Executive Director

RAPS today announced that Paul Brooks has been appointed executive director. Brooks will officially join RAPS on 12 September 2016. He succeeds Sherry Keramidas, who retired last January after 20 years at RAPS.

Categories: Articles, Under RAPS, HTML, Board of Directors Tags: RAPS executive director, Paul Brooks
10 Can't Miss Regulatory Convergence Sessions: 6-10

We highlight some standout sessions that might help you with your Convergence plans, but bear in mind this list is by no means complete. Of the more than 100 individual sessions, featuring more than 250 speakers, there are many that will be highly informative and well worth attending. With that caveat, we present in no particular order the second five of the 10 sessions we identified that are likely to be popular this year. The first five were presented in part one of this two-part series.

Categories: In vitro diagnostics, Medical Devices, Clinical, Postmarket surveillance, Articles, Under RAPS, HTML, RAPS, Advertising and Promotion Tags: Regulatory Convergence, #2016RAPS, sessions
Prepare for the Digital Revolution, Says Convergence Keynote Speaker Ray Wang

Regulatory Focus asked 2016 Convergence keynote speaker, R “Ray” Wang, who is principal analyst, founder, and chairman of Silicon Valley-based Constellation Research, about the healthcare product industry, changing business models, disruptive technologies and what it all means for regulatory professionals.

Categories: Articles, Under RAPS, HTML, RAPS Tags: Regulatory Convergence, conference, San Jose, 2016, keynote, speaker, Ray Wang
10 Can't Miss Regulatory Convergence Sessions: 1-5

We highlight some standout sessions that might help you with your Convergence plans, but bear in mind this list is by no means complete. Of the more than 100 individual sessions, featuring more than 250 speakers, there are many that will be highly informative and well worth attending. With that caveat, we present in no particular order five of the 10 sessions we identified that are likely to be popular this year. Sessions six through 10 will follow in part two.

Categories: Articles, Under RAPS, HTML, RAPS Tags: Regulatory Convergence, #2016RAPS, sessions
Convergence Keynote Speaker Lori Hartwell Passionate About Patients

Regulatory Convergence closing keynote speaker, Lori Hartwell is a four-time kidney transplant recipient, a patient advocate, founder of the Renal Support Network and author of the book, Chronically Happy—Joyful Living in Spite of Chronic Illness. You can’t help but to be inspired not just by her story, but by her optimistic way of looking at the world.

Categories: Articles, Under RAPS, HTML, RAPS Tags: Regulatory Convergence, keynote, Lori Hartwell, #2016RAPS, patient advocacy
RAPS' First Chapter Celebrates 25 Years

The RAPS Bay Area Chapter is RAPS’ first, and will celebrate its 25th anniversary as RAPS celebrates its 40th during the 2016 Regulatory Convergence in San Jose, CA. We look back at the chapter’s origins, and at its current state as one of RAPS’ largest, most active chapters.

Categories: Career Development, Articles, Under RAPS, HTML, US, San Francisco Bay Area Chapter, About the Profession Tags: RAPS 40th Anniversary, regulatory profession, San Francisco, Bay Area, Chapter
RAPS and the Regulatory Profession: The Global Professional Network

Because regulatory issues are relatively unique—and a shared body of knowledge is important to regulatory professionals’ work—RAPS helps provide the continued education, skills and connections to address the challenges regulatory professionals face every day. RAPS provides the platforms for regulatory professionals to interact with one another, whether they work for regulatory agencies, in industry, academia or elsewhere. This shared professional network helps everyone better understand the issues that are evolving and how to engage in creating solutions.

Categories: Articles, Under RAPS, HTML, About the Profession Tags: RAPS 40th Anniversary, regulatory profession
RAPS and the Regulatory Profession: Elevating Standards Through Education and Certification

Forty years ago, RAPS was born as members of a burgeoning profession desired to keep abreast of regulatory developments in the medical device industry. As the scope of work of regulatory professionals has expanded, so too has RAPS’ mission to drive regulatory excellence for the profession, paving the way with training and certification.

Categories: Articles, Under RAPS, HTML, About the Profession Tags: RAPS 40th Anniversary, regulatory profession
RAPS and the Regulatory Profession: How Far We Have Come

As RAPS  celebrates 40 years of driving regulatory excellence, it has seen its membership  transformed from a  collection of individuals from varied fields, tasked  with the administrative aspects of a growing body of regulatory requirements,  to a group of regulatory professionals who are asked to work throughout the  product lifecycle—who link science, technology and innovation with clinical  needs, and maintain a watchful eye on regulations, policy and good business  practice.

Categories: Articles, Under RAPS, HTML, About the Profession Tags: RAPS 40th Anniversary, regulatory profession
RAPS Members on the Value of Regulatory Convergence

We recently asked a number of RAPS members at various stages of their regulatory careers about the value of attending the Regulatory Convergence. Hear what they had to say.

Categories: Career Development, Articles, Under RAPS, HTML, Video, RAPS Tags: The Regulatory Convergence, Regulatory Convergence, conference, annual conference, 2016 RAPS, #2016RAPS, San Jose
8 Networking Tips for Regulatory Convergence Attendees

RAPS’ Regulatory Convergence offers attendees more than educational sessions and workshops. A big part of the value of the Convergence—or of any conference—lies in its networking opportunities. To make the best impression you can, and hopefully build long-lasting, mutually beneficial relationships, there are a few networking basics you should keep in mind.

Categories: RAPS Events, Business Skills, Articles, Under RAPS, HTML, RAPS Tags: Regulatory Convergence, 2015 Regulatory Convergence, conference, networking
219 Earned Regulatory Affairs Certification (RAC) Credential in Spring 2016

More than 200 regulatory professionals attained Regulatory Affairs Certification (RAC) during the spring 2016 exam cycle. Earned by passing one of four exams, the RAC is the only professional credential for regulatory professionals in the healthcare product sector.

Categories: Career Development, Articles, Under RAPS, HTML, RAC Tags: Regulatory Affairs Certification, RAC
Bay Area Regulatory Pros Looking Forward to Convergence's Return to San Jose

Hear from San Francisco Bay Area regulatory professionals what makes the area such a special place, and why San Jose in particular is a great place to host RAPS' 2016 Regulatory Convergence.

Categories: Articles, Under RAPS, HTML, Video, San Francisco Bay Area Chapter, RAPS Tags: The Regulatory Convergence, Regulatory Convergence, conference, annual conference, 2016 RAPS, #2016RAPS, San Jose
2015 Regulatory Convergence Highlights: Stephen Ostroff's Keynote

Each year, the Regulatory Convergence features dozens of speakers and panelists representing global regulatory agencies, including FDA and many others. Among the highlights of the 2015 Convergence in Baltimore was the opportunity to hear a keynote address from then-Acting FDA Commissioner Stephen Ostroff.

Categories: Articles, Under RAPS, HTML, Video, RAPS Tags: Regulatory Convergence, 2015, FDA, Ostroff, FDA Commissioner
Regulatory Job Seekers, Employers to Connect via RAPS Virtual Career Fair, 23 June

RAPS will host its next Virtual Career Fair on Thursday, 23 June, from 12:00 to 4:00 pm EDT. RAPS’ Virtual Career Fairs are held regularly throughout the year. They are a convenient way for regulatory job seekers and employers looking to hire regulatory talent to connect online in real time.

Categories: Talent Recruiting, Career Search, Articles, Under RAPS, HTML, RAPS Tags: virtual career fair, regulatory career fair, career fair, regulatory jobs, regulatory job, jobs, job, regulatory career, regulatory careers, careers, career
10 Ways to Get the Most From RAPS' Regulatory Convergence

Attending RAPS' Regulatory Convergence conference is an investment in your job, your career and your regulatory knowledge. To get the most out of it, you will want to think a little bit about how best to spend your precious time.

Categories: Articles, Under RAPS, HTML, RAPS Tags: The Regulatory Convergence, Regulatory Convergence, conference, annual conference, 2016 RAPS, #2016RAPS, San Jose
Knowledge Center Provides RAPS Members With Free Content

RAPS has launched a new online Member Knowledge Center, where RAPS members can access a library of free content, including e-books, recorded webcasts and session recordings from RAPS’ Regulatory Convergence.

Categories: Articles, Under RAPS, HTML, Membership Tags: Knowledge Center, member resources, member benefits
8 Pieces of Advice for New Regulatory Professionals

A veteran regulatory pro offers 8 pieces of advice for new regulatory professionals or those changing product lines or industries.

Categories: Career Development, Articles, Under RAPS, HTML Tags: advice, new regulatory professionals, new professional, entry-level
7 Things to Love About the Regulatory Convergence

Here are seven things to love about the Regulatory Convergence, the largest annual conference anywhere in the world for regulatory professionals working in the healthcare product space and RAPS’ signature event.

Categories: RAPS Events, Career Development, Articles, Under RAPS, HTML, RAPS Tags: The Regulatory Convergence, Regulatory Convergence, conference, annual conference, #2016RAPS, San Jose
RAPS Executive Development Program Gives Regulatory Pros Needed Business Foundation

Increasingly, regulatory professionals are involved in making organizational business decisions, yet few have formal business training. RAPS' Executive Development Program was designed to help them hone their business, management and leadership skills.

Categories: RAPS Events, Education, Career Development, Articles, Under RAPS, HTML, RAPS Tags: Executive Development Program, executive, executive development, Kellogg, Northwestern, strategy, business, regulatory, training, education
Why Regulatory Professionals Need Business Training

Because regulatory decisions have a direct impact on business outcomes, regulatory professionals need to have a comprehensive understanding of business, such as the business acumen provided by extensive on-the-job training, professional development programs or formal business training.

Categories: RAPS Events, Career Development, Articles, Under RAPS, HTML, RAPS Tags: executive development, Kellogg, Northwestern, strategy, business, regulatory, training, education
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