RAPS Latest

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

RAPS and the Regulatory Profession: Elevating Standards Through Education and Certification

Forty years ago, RAPS was born as members of a burgeoning profession desired to keep abreast of regulatory developments in the medical device industry. As the scope of work of regulatory professionals has expanded, so too has RAPS’ mission to drive regulatory excellence for the profession, paving the way with training and certification.

Categories: Articles, Under RAPS, HTML, About the Profession Tags: RAPS 40th Anniversary, regulatory profession
RAPS and the Regulatory Profession: How Far We Have Come

As RAPS  celebrates 40 years of driving regulatory excellence, it has seen its membership  transformed from a  collection of individuals from varied fields, tasked  with the administrative aspects of a growing body of regulatory requirements,  to a group of regulatory professionals who are asked to work throughout the  product lifecycle—who link science, technology and innovation with clinical  needs, and maintain a watchful eye on regulations, policy and good business  practice.

Categories: Articles, Under RAPS, HTML, About the Profession Tags: RAPS 40th Anniversary, regulatory profession
RAPS Members on the Value of Regulatory Convergence

We recently asked a number of RAPS members at various stages of their regulatory careers about the value of attending the Regulatory Convergence. Hear what they had to say.

Categories: Career Development, Articles, Under RAPS, HTML, Video, RAPS Tags: The Regulatory Convergence, Regulatory Convergence, conference, annual conference, 2016 RAPS, #2016RAPS, San Jose
8 Networking Tips for Regulatory Convergence Attendees

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: RAPS Events, Business Skills, Articles, Under RAPS, HTML, RAPS Tags: Regulatory Convergence, 2015 Regulatory Convergence, conference, networking
219 Earned Regulatory Affairs Certification (RAC) Credential in Spring 2016

More than 200 regulatory professionals attained Regulatory Affairs Certification (RAC) during the spring 2016 exam cycle. Earned by passing one of four exams, the RAC is the only professional credential for regulatory professionals in the healthcare product sector.

Categories: Career Development, Articles, Under RAPS, HTML, RAC Tags: Regulatory Affairs Certification, RAC
Bay Area Regulatory Pros Looking Forward to Convergence's Return to San Jose

Hear from San Francisco Bay Area regulatory professionals what makes the area such a special place, and why San Jose in particular is a great place to host RAPS' 2016 Regulatory Convergence.

Categories: Articles, Under RAPS, HTML, Video, San Francisco Bay Area Chapter, RAPS Tags: The Regulatory Convergence, Regulatory Convergence, conference, annual conference, 2016 RAPS, #2016RAPS, San Jose
2015 Regulatory Convergence Highlights: Stephen Ostroff's Keynote

Each year, the Regulatory Convergence features dozens of speakers and panelists representing global regulatory agencies, including FDA and many others. Among the highlights of the 2015 Convergence in Baltimore was the opportunity to hear a keynote address from then-Acting FDA Commissioner Stephen Ostroff.

Categories: Articles, Under RAPS, HTML, Video, RAPS Tags: Regulatory Convergence, 2015, FDA, Ostroff, FDA Commissioner
Regulatory Job Seekers, Employers to Connect via RAPS Virtual Career Fair, 23 June

RAPS will host its next Virtual Career Fair on Thursday, 23 June, from 12:00 to 4:00 pm EDT. RAPS’ Virtual Career Fairs are held regularly throughout the year. They are a convenient way for regulatory job seekers and employers looking to hire regulatory talent to connect online in real time.

Categories: Talent Recruiting, Career Search, Articles, Under RAPS, HTML, RAPS Tags: virtual career fair, regulatory career fair, career fair, regulatory jobs, regulatory job, jobs, job, regulatory career, regulatory careers, careers, career
10 Ways to Get the Most From RAPS' Regulatory Convergence

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: Articles, Under RAPS, HTML, RAPS Tags: The Regulatory Convergence, Regulatory Convergence, conference, annual conference, 2016 RAPS, #2016RAPS, San Jose
Knowledge Center Provides RAPS Members With Free Content

RAPS has launched a new online Member Knowledge Center, where RAPS members can access a library of free content, including e-books, recorded webcasts and session recordings from RAPS’ Regulatory Convergence.

Categories: Articles, Under RAPS, HTML, Membership Tags: Knowledge Center, member resources, member benefits
8 Pieces of Advice for New Regulatory Professionals

A veteran regulatory pro offers 8 pieces of advice for new regulatory professionals or those changing product lines or industries.

Categories: Career Development, Articles, Under RAPS, HTML Tags: advice, new regulatory professionals, new professional, entry-level
7 Things to Love About the Regulatory Convergence

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: RAPS Events, Career Development, Articles, Under RAPS, HTML, RAPS Tags: The Regulatory Convergence, Regulatory Convergence, conference, annual conference, #2016RAPS, San Jose
RAPS Executive Development Program Gives Regulatory Pros Needed Business Foundation

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: RAPS Events, Education, Career Development, Articles, Under RAPS, HTML, RAPS Tags: Executive Development Program, executive, executive development, Kellogg, Northwestern, strategy, business, regulatory, training, education
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
RAPS DC-Baltimore Chapter to Host Career Day This Weekend

The RAPS DC/Baltimore Chapter will once again host its Mid-Atlantic Career Day this Saturday, 21 May, on the Johns Hopkins University Montgomery County campus in Rockville, MD.

Categories: Career Development, Career Search, Articles, Under RAPS, HTML, FDA, DC/Baltimore Area Chapter, RAPS Tags: RAPS Mid-Atlantic Career Day, Mid-Atlantic Career Day, career day, careers, jobs, regulatory careers, regulatory jobs, Johns Hopkins, RAPS DC/Baltimore Chapter
Disruptive Technologies Expert Ray Wang to Keynote Regulatory Convergence in San Jose, CA

R "Ray" Wang, principal analyst, founder, and chairman of Silicon Valley-based Constellation Research will deliver the opening keynote Sunday evening, 18 September, at RAPS' 2016 Regulatory Convergence conference in San Jose, CA.

Categories: Articles, Under RAPS, HTML, RAPS Tags: Regulatory Convergence, conference, San Jose, 2016, keynote, speaker, Ray Wang
Updated: RAPS Seeks Authors for International Fundamentals of Regulatory Affairs Book

RAPS will be publishing the third edition of Fundamentals of International Regulatory Affairs later this year. We are looking for authors for chapters on general information, pharmaceuticals, biologics and other product types .

Categories: Articles, Under RAPS, HTML, RAPS Tags: Fundamentals of International Regulatory Affairs, book, authors
RAPS Chicago Chapter to Host 2nd Annual Midwest Career Day

Saturday, 7 May, the RAPS Chicago Chapter will host its second annual Midwest Regulatory Career Day. The event will go from 10 am to 3:30 pm at the Hilton Garden Inn in Mettawa, IL.

Categories: Career Development, Career Search, Articles, Under RAPS, HTML, Chicago Chapter, About the Profession Tags: RAPS Chicago Chapter, Chicago, chapters, careers, Midwest Regulatory Career Day, Midwest Career Day
Updated: RAPS Calls for Board Nominations; Deadline Extended to 1 June

RAPS has opened the nomination process for four open positions on its board of directors for the 2017–19 term. Nominations and supporting materials must be submitted to RAPS by 1 June 2016.

Categories: Articles, Under RAPS, HTML, Board of Directors Tags: RAPS board of directors, RAPS board, board, board of directors, nomination, board nominations
RAPS Releases Position Specification for New Executive Director

RAPS has taken the next step in its search for a new executive director, releasing the position specification, which details the qualifications, responsibilities and competencies required of potential candidates.

Categories: Articles, Under RAPS, HTML, Board of Directors Tags: RAPS, executive director
Power Up: Best Practices for Regulatory Intelligence

Regulatory intelligence allows you to use information to be proactive rather than reactive. RI has grown from a “nice to have” option that was owned and operated exclusively by large companies into a key instrument essential to every regulatory affairs practitioner’s success.

Categories: Regulatory intelligence, Articles, Under RAPS, HTML Tags: regulatory intelligence, Graematter, RIQ, Regulatory Intelligence Quotient
RAPS' New Regulatory Competency Framework Helps Organizations, Individuals Plan Professional Development, Training, Career Advancement

RAPS has released its new Regulatory Competency Framework, a tool to help design training and map professional and career development plans for regulatory professionals. The one-of-a-kind Framework is beneficial for individual professionals as well as regulatory employers and academics developing curriculum and education.

Categories: Career Development, Articles, Under RAPS, HTML, About the Profession Tags: Regulatory Competency Framework, competencies, professional development, regulatory careers
GSK's Sue James Praises RAPS' Regulatory Competency Framework

RAPS recently released its new Regulatory Competency Framework, a tool to help professionals and organizations develop regulatory training, and plan career and professional development. A few organizations have already begun using the Framework. Regulatory Focus spoke to former RAPS Chair Sue James, who is vice president of global regulatory affairs at GlaxoSmithKline (GSK) Consumer Healthcare about the Framework and its use thus far within GSK.

Categories: Career Development, Articles, Under RAPS, HTML, About the Profession Tags: Regulatory Competency Framework, competencies, professional development, regulatory careers
RAPS Seeks Applications for 2016 Fellows

RAPS is now seeking applications for the 2016 class of RAPS  Fellows. Applications will be due approximately 26 May. 

Categories: Articles, Under RAPS, HTML, Fellows Tags: RAPS Fellows, Fellows, RAPS Fellows Program
Mastering the eCTD Format Critical for Regulatory Pros

The electronic Common Technical Document (eCTD) provides a common global standard for companies to electronically submit the quality, safety and efficacy information required by regulatory agencies. It is an FDA and EMA requirement, so anyone working on drug regulatory submissions needs to understand the format well.

Categories: RAPS Events, Prescription drugs, Generic drugs, Compliance, Submission and registration, Articles, Under RAPS, HTML, RAPS Tags: eCTD, electronic Common Technical Document, Submissions, event, MDUFA, workshop, PDUFA, regulatory
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