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RAPS' New European Council Set to Shape and Support the Regulatory Profession By RAPS Staff - Published 19 October 2017

RAPS is stepping up its presence in Europe and supporting its European expansion with the launch of its first ever RAPS European Council (REC).

Categories: HTML, Articles, Under RAPS, RAPS

Tags: RAPS European Council, Europe

When Pfizer Needed Customized Training, The Enterprise Member Company Turned to RAPS By Zachary Brousseau - Published 05 October 2017

Pfizer partnered with RAPS to develop a customized on-site, two-day training session for several groups with different, but related, regulatory roles within the company.

Categories: HTML, Articles, Under RAPS, RAPS

Tags: training, on-site training, Enterprise, Pfizer

RAPS Switzerland Chapter Becomes Official Nonprofit Association Under Swiss Law By Zachary Brousseau - Published 12 September 2017

RAPS announced today that its RAPS Switzerland Chapter has completed the official registration process as a not-for-profit association under Swiss law. Chapter leaders are planning more local events, training opportunities and social gatherings as a result.

Categories: HTML, Articles, Under RAPS, Switzerland Chapter, RAPS

Tags: chapters, RAPS Switzerland Chapter

National Harbor Dine-Around Restaurants Offer Great Food, Convenient Locations By Zachary Brousseau - Published 24 August 2017

Dine-arounds provide a chance to spend some quality time with fellow attendees, and this year the National Harbor offers convenient dining options just steps away from the Gaylord National Resort.

Categories: HTML, Articles, Under RAPS, RAPS

Tags: Regulatory Convergence, dining, dine-arounds

8 Networking Tips for Regulatory Convergence Attendees By Zachary Brousseau - Published 24 August 2017

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: HTML, Articles, Under RAPS, RAPS Events, RAPS, Business Skills

Tags: Regulatory Convergence, conference, networking

Diermeier to Give Convergence Opening Remarks; Gottlieb Keynote Moved to Monday By Zachary Brousseau - Published 23 August 2017

University of Chicago Provost Daniel Diermeier will be the featured speaker at the opening plenary session of the 2017 RAPS Regulatory Convergence conference on 10 September.

Categories: HTML, Articles, Under RAPS, RAPS

Tags: Regulatory Convergence, Diermeier

UPDATE: FDA Commissioner Scott Gottlieb to Deliver Keynote at RAPS Regulatory Convergence By Zachary Brousseau - Published 23 August 2017

FDA Commissioner Scott Gottlieb will address the global regulatory community on 11 September, delivering 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

Six Highly Accomplished Regulatory Pros to Join the Ranks of RAPS Fellows By Zachary Brousseau - Published 22 August 2017

RAPS has revealed the names of the six outstanding senior regulatory professionals who will join the elite group of RAPS Fellows in 2017.

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Tags: Fellows, RAPS Fellows

RAPS Honors Regulatory Leaders With Two New Awards By Zachary Brousseau - Published 17 August 2017

RAPS will honor two groups of exemplary regulatory leaders next month at its annual Regulatory Convergence conference. Four outstanding individuals will be the inaugural recipients of the Founder’s Award, the profession’s highest honor. Three honorees will be the first-ever recipients of the Community Leadership Award.

Categories: HTML, Under RAPS, Awards

Tags: awards, Founder's Award, Community Leadership Award

RAPS Publishes 10th Edition of Fundamentals of US Regulatory Affairs, Plus Sector-Specific Books on Medical Devices, Biopharmaceuticals By Zachary Brousseau - Published 16 August 2017

RAPS has published the updated, 10th edition of Fundamentals of US Regulatory Affairs, the most extensive reference available on regulatory affairs for pharmaceuticals, medical devices, biologics and other healthcare products intended for the US market.

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Tags: regulatory affairs, text, book, Fundamentals of Regulatory Affairs

FDA Commissioner Scott Gottlieb’s Keynote Among Highly Anticipated Sessions at RAPS Regulatory Convergence By Zachary Brousseau - Published 10 August 2017

RAPS will host its annual Regulatory Convergence conference at the Gaylord National Resort and Convention Center at National Harbor on the DC waterfront 9–12 September. This year’s event features more than 75 educational sessions and over 200 speakers, including an opening keynote from FDA Commissioner Scott Gottlieb.

Categories: HTML, Articles, Under RAPS, Anvisa, EMA, FDA, MHRA, PMDA, WHO, RAPS

192 Earned Regulatory Affairs Certification (RAC) in Spring 2017 By Zachary Brousseau - Published 10 August 2017

RAPS congratulates the 192 regulatory professionals who earned Regulatory Affairs Certification (RAC) during the recent spring 2017 exam period.

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Tags: RAC, Regulatory Affairs Certification

10 Ways to Get the Most From RAPS' Regulatory Convergence By Zachary Brousseau - Published 01 August 2017

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: HTML, Articles, Under RAPS, RAPS

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

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

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.

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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.

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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 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.

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Tags: Virtual Career Fair, jobs, careers

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.

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Tags: RAPS Fellows

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.

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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