RAPS Latest

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

From the Editor: A Fond Farewell

All things—even the best things—must eventually come to an end. After five wonderful years working at RAPS, including the last four writing for Regulatory Focus, this week will be my last writing for the publication.

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US RAC Prep Webcast Series to Kick Off 15 July

On 15 July, RAPS will host the first of its six-part webcast series designed to help candidates for the US RAC exam fill knowledge gaps and more efficiently prepare for the exam.

Categories: eCourses, Career Development, Articles, Under RAPS, HTML, US, RAC, RAC Tags: Regulatory Affairs Certification, RAC, Regulatory Affairs Certification exam, RAC exam, RAC (US), US RAC, RAC exam prep, RAC exam preparation, exam prep, exam preparation, webcast, RAC webcast series
RAPS, National University of Singapore Gear up for 2nd Year of Certificate Program

Last year, RAPS and the National University of Singapore launched a joint graduate certificate program in Medical Devices Regulatory Affairs for Singapore-based regulatory professionals. The program currently is enrolling its next group of students, who will begin classes in September. Applications will be accepted until the 16 July deadline.

Categories: Career Development, Articles, Under RAPS, HTML, Asean, RAPS Tags: Medical Device Regulatory Affairs, graduate certificate, Singapore, National University of Singapore, regulatory workforce
RAPS Announces New Board Slate

The RAPS Nominating Committee has announced its slate of one new officer and three directors nominated to serve on the RAPS board of directors for terms beginning January 2016.

Categories: Articles, Under RAPS, HTML, Board of Directors Tags: RAPS board of directors, RAPS board, board of directors, nominations, board nominations
Acting FDA Commissioner Stephen Ostroff to Speak at RAPS' Regulatory Convergence

Acting Commissioner of the US Food and Drug Administration (FDA) Stephen Ostroff, MD, will speak to attendees of the 2015 RAPS Regulatory Convergence. RAPS’ signature annual event for the regulatory profession will take place 24–28 October in Baltimore.

Categories: RAPS Events, Articles, Under RAPS, HTML, US, FDA, RAPS Tags: 2015 RAPS, Regulatory Convergence, Stephen Ostroff, Ostroff, FDA commissioner, acting FDA commissioner, FDA, US Food and Drug Administration, keynote, plenary, Baltimore, conference
RAPS to Host Career Fair in Minneapolis

Twin Cities-area regulatory professionals and other interested job seekers will have a chance to network and meet in person with hiring managers and recruiters from leading medical device and biotech organizations at the RAPS Career Fair, Minneapolis on 25 June 2015.

Categories: RAPS Events, Career Search, Articles, Under RAPS, HTML, US, RAPS Tags: RAPS Career Fair, Minneapolis, career fair, careers, jobs, regulatory careers, regulatory jobs
RAPS Switzerland Chapter to Host 2015 EU Medtech Reimbursement Roundtable

The elements of market access in Europe will be examined in depth at the 2015 EU Medtech Reimbursement Roundtable, taking place 25 June in Zurich, and hosted by the RAPS Switzerland Chapter.

Categories: RAPS Events, Medical Devices, Reimbursement, Articles, Under RAPS, HTML, Europe, Switzerland Chapter, RAPS Tags: MedTech Roundtable, medtech, medical device, device, market access, reimbursement, pricing, coverage policy, Europe, EU
Experts to Offer Ad, Promo and Labeling Advice at RAPS Virtual Event

As the Internet and social media have become increasingly powerful forces in our everyday lives and important sources of information on personal healthcare decisions, regulators, marketers and healthcare companies all have had to contend with a slew of new challenges. RAPS’ virtual event Advertising, Promotion and Labeling: the US Regulated Environment will bring together experts to offer their advice.

Categories: RAPS Events, Compliance, Labeling, Articles, Under RAPS, HTML, US, FDA, FTC, RAPS, Advertising and Promotion Tags: advertising, promotion, labeling, social media, social media regulation, FDA, FTC
RAPS Mid-Atlantic Career Day Draws Nearly 100 to Learn, Network

Nearly 100 regulatory professionals, career changers, students and others gathered at the Montgomery County (MD) campus of Johns Hopkins University to learn, network and perhaps take the next steps in their regulatory careers. 

Categories: RAPS Events, Career Development, Career Search, Articles, Under RAPS, HTML, US, FDA, DC/Baltimore Area Chapter, New York/New Jersey Area Chapter Tags: RAPS Mid-Atlantic Career Day, Mid-Atlantic Career Day, career day, careers, jobs, regulatory careers, regulatory jobs, Johns Hopkins, RAPS DC/Baltimore Chapter, RAPS New York/New Jersey Chapter
RAPS Virtual Career Fair Planned for 18 June

RAPS’ next Virtual Career Fair is planned for Thursday, 18 June 2015, from 12 to 4:30 pm EDT. The event allows regulatory job seekers the opportunity to chat live in an interactive virtual environment with hiring managers and recruiters from top healthcare organizations looking to fill regulatory openings.

Categories: RAPS Events, Career Search, Articles, Under RAPS, HTML, Video, RAPS Tags: virtual career fair, regulatory career fair, career fair, regulatory jobs, regulatory job, jobs, job, regulatory career, regulatory careers, careers, career
Regulatory Focus on Holiday

We're taking some time off next week. Find out when you can get your fix of Focus again here.

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How to be a Regulatory Leader

Increasingly, regulatory professionals need to be effective leaders. Not only are they leading regulatory departments and cross-functional work groups, they also are being called upon to play key roles on corporate and organizational leadership teams. But how can you develop your own skills as a leader? Several senior regulatory leaders addressed this during a recent RAPS webcast.

Categories: RAPS Events, On Demand, Career Development, Articles, Under RAPS, HTML, RAPS Tags: leadership, regulatory leadership, communications skills, RAPS webcast, ECG
Regulatory Pros and Hopefuls Gather in Chicago for Midwest Career Day

The first-ever RAPS Midwest Regional Career Day was held last month outside Chicago, attracting 75 attendees who came to network, meet with recruiters and hear presentations on regulatory careers from a range of speakers.

Categories: RAPS Events, Articles, Under RAPS, HTML, US, Chicago Chapter, RAPS Tags: RAPS Midwest Career Day, Midwest Career Day, career day, careers, jobs, regulatory careers, regulatory jobs, Chicago, RAPS Chicago Chapter
An Individual’s Experience at the RAPS Executive Development Program

Regulatory leaders need to deliver strategic value to their organizations—the RAPS Executive Development Program is a key component in building the necessary skill set to succeed.

Categories: Career Development, Features, Under RAPS, RAPS Tags: RAPS Kellogg, Executive Development
New Regulatory Approaches Key to Future of Personalized Medicine

While full realization of the potential of personalized medicine may yet be years off, it already is beginning to pose new challenges for both regulators and those involved with developing and marketing personalized medicine and companion diagnostic products.

Categories: RAPS Events, In vitro diagnostics, Articles, Under RAPS, HTML, Europe, RAPS Tags: personalized medicine, precision medicine, personalised medicine, EU, EMA, FDA
Be Curious and Be Professional, Says Medtronic China Regulatory Director Yin

Annie Yin, regulatory affairs director for Medtronic in China, and a faculty member for RAPS' Medical Device Regulatory Affairs Certificate Program in partnership with the National University of Singapore, shares her thoughts and analysis of the regulatory profession in China today.

Categories: Articles, Under RAPS, HTML, China, About the Profession Tags: China, regulatory profession, Annie Yin
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
Should You Pursue a Master's Degree or a Regulatory Affairs Certificate?

If you are looking to advance your regulatory career, earn more money or improve your knowledge, both master’s degrees and professional certificates are worthy of consideration. What factors should regulatory professionals consider in deciding whether to pursue a degree in regulatory affairs or a professional certificate?

Categories: Career Development, Articles, Under RAPS, HTML, RAPS Tags: master's degree, master's in regulatory affairs, certificate, certificate in regulatory affairs, regulatory education, continuing education, RAPS Online University, Regulatory Affairs Certificate Program
RAPS Seeks Applications for 2015 Fellows

RAPS is calling for applications for the 2015 class of RAPS Fellows. The RAPS Fellows program was launched in 2008 to recognize senior regulatory professionals for their continued significant contributions and leadership in the advancement of the regulatory profession. Applications are due 13 July.

Categories: RAPS Events, Articles, Under RAPS, HTML, Fellows Tags: RAPS Fellows, Fellows, RAPS Fellows Program
Regulatory Profession a Promising Field in China, Says RAPS China Advisory Committee Member Lin

Linda Lin, vice president of international business for Shanghai MicroPort Medical (Group) Co. Ltd., and a member of RAPS’ China Advisory Council, offers her opinions on the regulatory profession and shares lessons from her experience for young Chinese men and women who may wish to pursue a regulatory career.

Categories: Articles, Under RAPS, HTML, China, About the Profession Tags: China, RAPS China, China Advisory Council, Linda Lin
Accessibility, Usability and Flexibility Critical for Regulatory Content Management

Implementing a regulatory content management system that is accessible, usable and flexible can improve organizational efficiency across geographic and departmental lines, and enable greater standardization and dissemination of best practices.

Categories: On Demand, Project management, Articles, Under RAPS, HTML, RAPS Tags: regulatory content, content management, regulatory content management, Veeva Systems, Dararutana
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
Inadequate Medical Device Validation a Common Problem; RAPS Publishes 'How-to' Resource

RAPS' Medical Device Validation Handbook, edited by Max Sherman, provides a unique compilation of expert thought and analysis of the validation and verification processes for medical devices. The book examines multiple aspects of validation, including process, design, software, equipment and cleaning validation.

Categories: Medical Devices, Compliance, Quality, Books, Articles, Under RAPS, HTML, RAPS Tags: medical device, medical devices, medical device validation, validation, medical device process validation, verification, Sherman, book publication
Book Excerpt: The Medical Device Validation Handbook, Chapter 1: Introduction and History

RAPS' Medical Device Validation Handbook, edited by Max Sherman, provides a unique compilation of expert thought and analysis of the validation and verification processes for medical devices. The book examines multiple aspects of validation, including process, design, software, equipment and cleaning validation.

Categories: Medical Devices, Compliance, Quality, Books, Articles, Under RAPS, HTML, RAPS Tags: medical device, medical devices, medical device validation, validation, medical device process validation, verification, Sherman, book, publication
Regulatory Professionals Need Better Understanding of Medical Device Validation

Author Max Sherman says regulatory professionals need a better understanding of medical device validation, and he hopes The Medical Device Validation Handbook fills a void for those who have been waiting for a comprehensive resource on the topic.

Categories: Medical Devices, Compliance, Quality, Books, Articles, Under RAPS, HTML, RAPS Tags: medical device, medical devices, medical device validation, validation, medical device process validation, verification, Sherman, book publication
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