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Filtering on: "organizations raps"

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7 Things to Love About the Regulatory Convergence By Zachary Brousseau - Published 06 July 2017

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: HTML, Articles, Under RAPS, RAPS Events, RAPS, Career Development

Tags: The Regulatory Convergence, Regulatory Convergence, conference, annual conference, #2016RAPS, San Jose

FDA Commissioner Scott Gottlieb to Deliver Keynote at RAPS Regulatory Convergence By Zachary Brousseau - Published 03 July 2017

FDA Commissioner Scott Gottlieb will address the global regulatory community on 10 September, delivering the opening keynote remarks at the 2017 Regulatory Convergence conference at National Harbor on the DC Waterfront.

Categories: HTML, Articles, Under RAPS, RAPS

Tags: FDA, commissioner, Gottlieb, Regulatory Convergence, keynote

RAPS Announces Board President-Elect and New Directors Slate By RAPS Staff - Published 05 June 2017

The RAPS nominating committee announced the slate of officers and directors to join the board for the 2018–2020 term.

Categories: HTML, Articles, Under RAPS, Board of Directors

Tags: RAPS board of directors

RAPS and Industry Experts Join Forces for Dedicated MDR Workshop By RAPS Staff - Published 18 May 2017

RAPS is bringing together a panel of Europe’s top industry experts to deliver a dedicated workshop on the new EU regulations for medical devices and in vitro diagnostic devices.

Categories: HTML, Articles, Under RAPS, Europe, RAPS

Tags: EU, Medical Device Regulations, IVD Regulations

RAPS Increases Investment in Europe By RAPS Staff - Published 20 April 2017

RAPS is stepping up its presence in Europe and expanding its European team in response to growing membership demand from those involved with the regulation of healthcare and related products.

Categories: HTML, Articles, Under RAPS, RAPS

Tags: Europe, Brussels, Munich

RAPS Executive Development Program Gives Regulatory Pros Needed Business Foundation By Zachary Brousseau - Published 07 April 2017

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: HTML, Articles, Under RAPS, RAPS Events, RAPS, Education, Career Development

Tags: Executive Development Program, executive, executive development, Kellogg, Northwestern, strategy, business, regulatory, training, education

UPDATE: RAPS Seeks Authors for EU Fundamentals Book; Deadline Extended By RAPS Staff - Published 30 March 2017

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

Categories: HTML, Articles, Under RAPS, RAPS

Tags: EU regulatory affairs, EU, European Union, Europe

RAPS Seeks Applications for 2017 Fellows By Zachary Brousseau - Published 28 March 2017

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: HTML, Articles, Under RAPS, Fellows

Tags: RAPS Fellows

RAPS Virtual Career Fair, 30 March, Connects Regulatory Job Seekers, Employers By RAPS Staff - Published 28 March 2017

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: HTML, Articles, Under RAPS, RAPS

Tags: Virtual Career Fair, jobs, careers

Why Regulatory Professionals Need Business Training By William C. Putnam, PhD, RAC - Published 02 March 2017

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: HTML, Articles, Under RAPS, RAPS Events, RAPS, Career Development

Tags: executive development, Kellogg, Northwestern, strategy, business, regulatory, training, education

Remembering RAPS Founder Richard Greco By Zachary Brousseau - Published 23 February 2017

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

Categories: HTML, Articles, Under RAPS, RAPS

Tags: Richard Greco

RAPS Seeks Board Nominations By Zachary Brousseau - Published 16 February 2017

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: HTML, Articles, Under RAPS, Board of Directors

Tags: board of directors, nominations, RAPS leadership

May Deadline for FDA's eCTD Transition Approaches By Zachary Brousseau - Published 13 February 2017

Beginning 5 May, pharmaceutical, biologic and generic manufacturers will have to submit to FDA all New Drug Applications, Biologics License Application and Abbreviated New Drug Applications using the electronic Common Technical Document (eCTD).

Categories: HTML, Articles, Under RAPS, RAPS, Compliance, Generic drugs, Prescription drugs, Submission and registration

Tags: eCTD, electronic Common Technical Document, Submissions

272 Pass Regulatory Affairs Certification Exams in Autumn 2016 By Zachary Brousseau - Published 10 February 2017

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: HTML, Articles, Under RAPS, RAC

Tags: Regulatory Affairs Certification, RAC

Is Regulatory Affairs Certification Right for You? By Zachary Brousseau - Published 06 February 2017

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: HTML, Articles, RAC, Under RAPS, RAC, Career Development

Tags: RAC, Regulatory Affairs Certification

RAPS Celebrates National Puzzle Day With Regulatory Crossword By Zachary Brousseau - Published 29 January 2017

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: HTML, Articles, Under RAPS, RAPS

Tags: Regulatory Word Challenge, crossword, puzzle

UPDATE: Showcase Your Expertise at Regulatory Convergence; Proposal Deadline Extended By Zachary Brousseau - Published 13 January 2017

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: HTML, Articles, Under RAPS, RAPS

Tags: Regulatory Convergence

RAPS' New Board of Directors Begins 2017 Term By Zachary Brousseau - Published 11 January 2017

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: HTML, Articles, Under RAPS, Board of Directors

Tags: board of directors

UPDATE: Authors for Four US Regulatory Fundamentals Chapters Needed By RAPS Staff - Published 05 January 2017

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

Categories: HTML, Articles, Under RAPS, US, RAPS

Tags: books, publications, Fundamentals of Regulatory Affairs

RAPS Holiday Schedule Announced By Zachary Brousseau - Published 15 December 2016

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

Categories: HTML, Articles, Under RAPS, RAPS

Tags: 2016 holiday schedule

RAPS' Regulatory Exchange Wins 'Most Successful Community' Award By Zachary Brousseau - Published 08 December 2016

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: HTML, Articles, Under RAPS, RAPS

Tags: Regulatory Exchange, RegEx, online community

Six Expert Regulatory Professionals Honored as RAPS Fellows By Zachary Brousseau - Published 29 September 2016

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: HTML, Articles, Under RAPS, Fellows

Tags: Fellows, Regulatory Convergence

Convergence Exhibit Hall Offers Fun, Prizes, Personal Connections By Zachary Brousseau - Published 14 September 2016

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: HTML, Articles, Under RAPS, RAPS

Tags: Convergence, exhibitors, exhibit hall

RAPS and the Regulatory Profession: The Future of Regulatory By Mary Meagher - Published 07 September 2016

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: HTML, Articles, Under RAPS, RAPS

Tags: regulatory profession, future, RAPS 40th anniversary

RAPS' New Book Offers 36 Articles on Eclectic Science Topics for Curious Readers By Zachary Brousseau - Published 06 September 2016

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: HTML, Articles, Under RAPS, RAPS

Tags: Max Sherman, science