RAPS Latest

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

UPDATE: Showcase Your Expertise at Regulatory Convergence; Proposal Deadline Extended

Participating as a speaker or session leader offers an opportunity for regulatory experts to share their knowledge and insight with the global regulatory community and to enhance the own professional reputations and personal brand

Categories: Articles, Under RAPS, HTML, RAPS Tags: Regulatory Convergence
RAPS' New Board of Directors Begins 2017 Term

The 2017 term for the board of directors of the Regulatory Affairs Professionals Society (RAPS) began officially on 1 January. For the new term, Todd Chermak of Abbott Established Pharmaceuticals takes over as chairman. In addition, Susumu Nozawa of BD assumes the role of president; Don Boyer, formerly of Health Canada and currently of BOYER@RegulatorySolns, steps in as president-elect; and Salma Michor of Michor Consulting e.U, continues to serve as treasurer. Two new directors also have joined the board: Gert Bos of Qserve Group and Michael Morton of Medtronic.

Categories: Articles, Under RAPS, HTML, Board of Directors Tags: board of directors
UPDATE: Authors for Four US Regulatory Fundamentals Chapters Needed

RAPS currently is seeking authors for chapters to be published in the 10th edition of Fundamentals of US Regulatory Affairs.

Categories: Articles, Under RAPS, HTML, US, RAPS Tags: books, publications, Fundamentals of Regulatory Affairs
Biosimilar Drug Development, Complex Medicinal Products, Medical Device Regulations, Research and Technology and a Preview of January

The following is a summary of feature articles posted throughout December with links and a preview of what's to come in January.

Categories: Biologics and biotechnology, Drugs, Medical Devices, Features Tags:
RAPS Holiday Schedule Announced

RAPS wishes all our members, readers, customers and the entire global regulatory community a healthy and happy holiday season and new year.

Categories: Articles, Under RAPS, HTML, RAPS Tags: 2016 holiday schedule
RAPS' Regulatory Exchange Wins 'Most Successful Community' Award

RAPS’ members-only online community, Regulatory Exchange or “RegEx” as it is often called, was recently named one of three “Most Successful Community” award winners of 2016 by Higher Logic. RegEx is built on the Higher Logic platform.

Categories: Articles, Under RAPS, HTML, RAPS Tags: Regulatory Exchange, RegEx, online community
Quality and Compliance, Regulatory Research, Policy Issues and a Preview of December

The following is a summary of feature articles posted throughout November with links and a preview of what's to come in December.

Categories: Compliance, Quality, Features Tags: Regulatory Focus, Feature Articles, Feature Summary
Book Review: Eclectic Science and Regulatory Compliance: Stories for the Curious

The following is an insightful review of a compilation of essays featuring new, somewhat obscure information about science, regulatory and healthcare products.

Categories: Under RAPS Tags:
Six Expert Regulatory Professionals Honored as RAPS Fellows

Last week at RAPS’ Regulatory Convergence in San Jose, CA, RAPS honored six regulatory experts who recently joined the elite ranks of RAPS Fellows. The RAPS Fellows program recognizes senior regulatory professionals for their continued contributions and leadership toward the advancement of the profession and the professional.

Categories: Articles, Under RAPS, HTML, Fellows Tags: Fellows, Regulatory Convergence
Convergence Exhibit Hall Offers Fun, Prizes, Personal Connections

In addition to being the location for the opening reception, the exhibit hall also provides a place for you to take a break in between education sessions, network with fellow attendees and connect with representatives from companies that may be helpful to you in your daily work or regulatory career.

Categories: Articles, Under RAPS, HTML, RAPS Tags: Convergence, exhibitors, exhibit hall
RAPS and the Regulatory Profession: The Future of Regulatory

Over the past 40 years, RAPS has sought to elevate the regulatory profession through education, certification and the sharing of knowledge. While RAPS members will celebrate this drive toward regulatory excellence in San Jose at the 2016 Regulatory Convergence, the regulatory environment continues to evolve.

Categories: Articles, Under RAPS, HTML, RAPS Tags: regulatory profession, future, RAPS 40th anniversary
RAPS' New Book Offers 36 Articles on Eclectic Science Topics for Curious Readers

RAPS has just published a new book that offers curious readers a collection of 36 brief, interesting articles on a range of science and regulatory topics, some published for the first time. The new book, Eclectic Science and Regulatory Compliance: Stories for the Curious, by Max Sherman, is a follow-up to his popular 2012 book From Alzheimer’s to Zebrafish: Eclectic Science and Regulatory Stories.

Categories: Articles, Under RAPS, HTML, RAPS Tags: Max Sherman, science
Regulatory Convergence Preview: Regulation and Innovation

RAPS will bring the largest annual gathering of the global healthcare regulatory profession to San Jose, CA, 17–20 September. The 2016 Regulatory Convergence will take place at the San Jose McEnery Convention Center. This year marks RAPS’ 40th anniversary, and the Convergence will celebrate RAPS’ four decades, as well as examine the future of the profession, healthcare product innovation and regulation. The focus on innovation is particularly apt this year as the event convenes in the heart of technology hub, Silicon Valley.

Categories: Articles, Under RAPS, HTML, RAPS Tags: Regulatory Convergence, 2016 Regulatory Convergence, San Jose
Popular RAPS App Back Again for 2016 Regulatory Convergence

The RAPS Events app offers users a convenient tool for finding information about sessions, speakers, events and activities; creating personalized agendas; accessing speaker presentation materials; reviewing sessions and speakers; participating in polls and surveys; and sharing comments and photos; as well as a fun way to earn points and prizes.

Categories: Articles, Under RAPS, HTML, RAPS Tags: Regulatory Convergence, RAPS Events, mobile, app
Dine Around San Jose at Regulatory Convergence

The 2016 Regulatory Convergence in San Jose is now just a few weeks away. If you have attended Convergence in the past you probably know that some of the most popular social opportunities each year are the “dine-arounds.”

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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
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