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Filtering on: "content types under raps"

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RAPS Seeks Authors for EU Fundamentals Book By RAPS Staff - Published 09 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

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

Book Review: Eclectic Science and Regulatory Compliance: Stories for the Curious By Edward Tabor, MD, Member, RAPS Board of Directors - Published 14 October 2016

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

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

Regulatory Convergence Preview: Regulation and Innovation By Zachary Brousseau - Published 01 September 2016

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: HTML, Articles, Under RAPS, RAPS

Tags: Regulatory Convergence, 2016 Regulatory Convergence, San Jose

Popular RAPS App Back Again for 2016 Regulatory Convergence By Zachary Brousseau - Published 31 August 2016

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: HTML, Articles, Under RAPS, RAPS

Tags: Regulatory Convergence, RAPS Events, mobile, app

Dine Around San Jose at Regulatory Convergence By Zachary Brousseau - Published 30 August 2016

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.”

Categories: HTML, Articles, Under RAPS, RAPS

RAPS and the Regulatory Profession: Two-Way Communication Between Industry and Regulators By Mary Meahger - Published 22 August 2016

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: HTML, Articles, Under RAPS, About the Profession, Communication

Tags: RAPS 40th Anniversary, regulatory profession, communication

RAPS' Scope of Practice Survey Shows Regulatory Pros Play Increasingly Strategic Role; Compensation Up By Zachary Brousseau - Published 17 August 2016

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: HTML, Articles, Under RAPS, About the Profession, Career Development

Tags: Scope of Practice, compensation, salary, survey, 2016 Scope of Practice & Compensation Report

10 Disruptive Technologies and the Regulatory Implications By Zachary Brousseau - Published 17 August 2016

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: HTML, Articles, Under RAPS, RAPS, Advertising and Promotion, Biologics and biotechnology, Clinical, Communication, Compliance, Ethics, Labeling, Manufacturing, Medical Devices, Packaging

Tags: disruptive technology, regulation, Regulatory Convergence, #2016RAPS

Head of Cuban Regulatory Agency to Make First Appearance at Regulatory Convergence By Zachary Brousseau - Published 15 August 2016

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: HTML, Articles, Under RAPS, Latin America and Caribbean, RAPS

Tags: Regulatory Convergence, Cuba, #2016RAPS