Search Results for Zachary Brousseau

Showing 1 – 25  of 145

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

Video: FDA Commissioner Scott Gottlieb's Keynote Speech at the 2017 Regulatory Convergence By Zachary Brousseau - Published 28 September 2017

Watch FDA Commissioner Scott Gottlieb's keynote address to attendees of RAPS’ 2017 Regulatory Convergence, focusing on making the clinical end of drug development more efficient and effective.

Tags: FDA, Commissioner, Scott Gottlieb, Regulatory Convergence, drug development, clinical trials, adaptive clinical trials, seamless clinical trials

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

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

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

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.

Categories: HTML, Articles, Under RAPS, Fellows

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.

Categories: HTML, Articles, Under RAPS, RAPS

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

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.

Categories: HTML, Articles, Under RAPS, RAC

Tags: RAC, Regulatory Affairs Certification

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

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 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

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

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

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.

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Tags: board of directors

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.

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Tags: 2016 holiday schedule