RAPS Latest

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

RAPS Virtual Career Fair, 30 March, Connects Regulatory Job Seekers, Employers

Regulatory professionals looking for new employment opportunities and employers seeking regulatory staff will have another opportunity to connect when RAPS hosts its next Virtual Career Fair Thursday, 30 March.

Categories: Articles, Under RAPS, HTML, RAPS Tags: Virtual Career Fair, jobs, careers
RAPS Seeks Applications for 2017 Fellows

RAPS is seeking applications for the 2017 class of RAPS Fellows. Since 2008, the RAPS Fellows program has recognized senior-level regulatory professionals for continued significant contributions to, and leadership in advancing, the global regulatory profession.

Categories: Articles, Under RAPS, HTML, Fellows Tags: RAPS Fellows
RAPS Seeks Authors for EU Fundamentals Book

RAPS currently is seeking chapter authors for the upcoming eighth edition of Fundamentals of EU Regulatory Affairs.

Categories: Articles, Under RAPS, HTML, RAPS Tags: EU regulatory affairs, EU, European Union, Europe
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
Remembering RAPS Founder Richard Greco

RAPS Founder Richard E. Greco died last week near his home  outside of Buffalo, NY. He was 87 years old.

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RAPS Seeks Board Nominations

RAPS has begun the nomination process for openings for the 2018–2020 term of its board of directors, and is now accepting nominations for president-elect and up to four director positions.

Categories: Articles, Under RAPS, HTML, Board of Directors Tags: board of directors, nominations, RAPS leadership
272 Pass Regulatory Affairs Certification Exams in Autumn 2016

Another 272 regulatory professionals passed one of four challenging exams last autumn to attain Regulatory Affairs Certification (RAC). The RAC is the only professional credential for regulatory professionals in the healthcare product sector. Currently, more than 4,000 individuals around the world are RAC-credentialed.

Categories: Articles, Under RAPS, HTML, RAC Tags: Regulatory Affairs Certification, RAC
Is Regulatory Affairs Certification Right for You?

The decision to pursue Regulatory Affairs Certification (RAC) is a personal one with many variables to consider—from the amount of regulatory experience you have and the potential value of having the credential to how much time you can devote to studying. So while there is no one-size-fits-all answer to the question ‘Is the RAC right for me?,’ there are some important factors to take into account.

Categories: Career Development, Articles, Under RAPS, HTML, RAC, RAC Tags: RAC, Regulatory Affairs Certification
Regulatory Intelligence, Leading Edge Technology, Compliance Strategy, Scientific Research and a Preview of February

The following is a summary of feature articles posted over the past weeks with links and a preview of what's to come in February.

Categories: Biologics and biotechnology, Drugs, Medical Devices, Compliance, Regulatory intelligence, Submission and registration, Features, US, Canada, Europe, China, FDA, EMA, Health Canada, CFDA Tags: Regulatory Focus, Feature Articles, Feature Summary
RAPS Celebrates National Puzzle Day With Regulatory Crossword

RAPS has created a crossword puzzle just for regulatory professionals. The answers to RAPS’ Regulatory Word Challenge include words from the areas of pharma, biotech and medical devices. If you see yourself as a "regulatory nerd," download the puzzle and see if you're up to the challenge.

Categories: Articles, Under RAPS, HTML, RAPS Tags: Regulatory Word Challenge, crossword, puzzle
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.

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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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