RAPS Latest

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

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
FDA Expresses Desire to Work With Industry on CGMPs for Combo Products

FDA officials and industry representatives discussed the agency’s draft guidance on current Good Manufacturing Practice (CGMP) for combination products during a workshop on the topic presented by RAPS and the Combination Products Coalition.

Categories: RAPS Events, Combination products, Manufacturing, Articles, Under RAPS, HTML, Video, US, FDA, RAPS Tags: Food and Drug Administration, FDA, Weiner, combination products, combo products, CGMP, workshop, webcast, Combination Products Coalition
Mastering the eCTD Format Critical for Regulatory Submissions 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 EMA requirement and will soon be required by FDA, 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
Tell RAPS How to Get Organized

In an effort to improve its website navigation, RAPS is asking site visitors, members and stakeholders to complete a brief, interactive card sorting exercise.

Categories: Articles, HTML, RAPS Tags: card sorting, card sort, RAPS.org, RAPS website, user experience, website navigation, website organization
Next RAPS Virtual Career Fair Coming Up 23 April

The next RAPS  Virtual Career Fair will take place 23 April 2015, bringing together hiring managers and recruiters from leading healthcare organizations with regulatory job seekers online in real time.

Categories: RAPS Events, Career Development, Articles, HTML, Video, RAPS Tags: virtual career fair, regulatory career fair, career fair, regulatory jobs, regulatory job, jobs, job, regulatory career, regulatory careers, careers, career
RAPS Seeks Board Nominations

RAPS is seeking regulatory leaders to serve on its board of directors  for the 2016–2018 term. Nominations and supporting materials are due by 1 May 2015.

Categories: Articles, Under RAPS, HTML, Board of Directors Tags: board, board of directors, nomination
RAPS Wants to Know How to Better Help You; Survey Deadline: 27 March

RAPS has launched a new survey as part of its effort to  improve the RAPS.org website and make it the best source of information and  resources for regulatory professionals around the world.

Categories: Articles, HTML, RAPS Tags: RAPS, RAPS.org, website, survey
Call for Authors: We're Seeking Your Expertise

Regulatory Focus is looking for authors to write on themes selected by our Board of Editors for their usefulness to healthcare regulatory professionals.

Categories: Articles, HTML, RAPS Tags: Regulatory Focus, publication, authors, writers
Introducing a New Way to Keep Track of What We're Doing at Regulatory Focus

Since its launch in January 2012, Regulatory Focus has published thousands of pieces of content, including news updates, in-depth explanations of regulatory issues, information trackers, and editions of Regulatory Reconnaissance. With so much content on our website, it could be difficult to quickly find the information you were looking for. Until now.

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As the EU Gears up for Major Device Changes, What do Regulatory Pros Need to Know?

In Europe, medical devices currently are regulated much the same way they have been since the 1990s. Now, almost 20 years and several major scandals later, EU officials are preparing a massive overhaul of the region's medical device regulatory directives in the hopes of modernizing the system—if only they could agree on what those changes should look like.

Categories: In vitro diagnostics, Medical Devices, Submission and registration, Under RAPS, Europe, EC Tags:
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