RAPS Latest

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

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.

Categories: Under RAPS Tags:
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:
243 Regulatory Professionals Earned RAC in Autumn 2014

RAPS announced the names of the 243 professionals who earned their Regulatory Affairs Certification (RAC) by passing one of the four RAC exams in autumn 2014.

Categories: Career Development, Articles, HTML, RAC Tags: Regulatory Affairs Certification, RAC, spring 2014
How to Schedule Your RAC Exam

Scheduling your Regulatory Affairs Certification exam is a simple but important step in your quest for the RAC credential. 

Categories: Career Development, Articles, HTML, RAC, RAC Tags: Regulatory Affairs Certification, RAC, RAC exam, exam scheduling
How to Prepare for the RAC Exam

To pass the challenging Regulatory Affairs Certification (RAC) exams, even a seasoned regulatory professional will need to develop a personalized study plan and take advantage of critical exam preparation resources.

Categories: Career Development, Articles, Under RAPS, HTML, RAC, RAC Tags: RAC, Regulatory Affairs Certification, RAC exam, exam preparation
Can Some Medical Devices Skip China's Clinical Trial Mandate?

To market class II or III medical devices in China, products must undergo a registration process that also may require clinical trials, but in certain situations devices may be exempted or be allowed to undergo modified trials.

Categories: Medical Devices, Clinical, Articles, China, RAPS Tags: China, medical device, regulations, webcast
RAC Eligibility Explained

If you are considering taking one of the four Regulatory Affairs Certification (RAC) exams, one of the first things you need to do is determine whether you meet the exam eligibility requirements.

Categories: Career Development, Articles, Under RAPS, HTML, Regulatory Affairs Certification Board, RAC Tags: RAC, Regulatory Affairs Certification
The Four RAC Credentials Explained

There are four Regulatory Affairs Certification (RAC) credentials available: the RAC (US), RAC (EU), RAC (CAN) and RAC (Global). Which one is right for you? 

Categories: Career Development, Articles, Under RAPS, HTML, RAC, RAC Tags: RAC, Regulatory Affairs Certification
Is Regulatory Affairs Certification Right for You?

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: Career Development, Articles, Under RAPS, HTML, RAC, RAC Tags: RAC, Regulatory Affairs Certification
Happy Holidays, and Thank You

Regulatory Focus is going on Holiday and will not publish between 20 December 2014 and 5 January 2014. We look forward to again providing you with regulatory news, analysis and intelligence in the new year. Before we go, we just have one thing to say...

Categories: Under RAPS Tags: Regulatory Focus
New RAPS Netherlands Chapter Announced

The RAPS Netherlands Chapter is the newest in RAPS' global chapter network.

Categories: Articles, Under RAPS, Europe, RAPS Tags: Netherlands, chapters, Europe
J&J’s Regulatory Executives Groomed as Business Leaders

J&J’s innovative AcceleRAte program grooms regulatory professionals to be the company’s future business leaders.

Categories: Career Development, Under RAPS Tags: Johnson & Johnson, J&J, business, leadership
RAPS’ e-News Holiday Schedule

RAPS e-newsletters will operate on a modified schedule for the holiday season.

Categories: Under RAPS, HTML, RAPS Tags:
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