RAPS Latest

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

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:
What Will it Take to Build Global Regulatory Capacity?

View a 2014 RAPS panel discussion about the importance of building regulatory capacity around the world, and how regulatory and healthcare leaders can go about building that capacity.

Categories: RAPS Events, Under RAPS, Video Tags: 2014 RAPS, The Regulatory Convergence, regulatory capacity
FDA’s Woodcock Talks About Advancing Innovation at 2014 RAPS

CDER Director Janet Woodcock told 2014 RAPS attendees about how FDA is helping to get important new therapies to patients more quickly.

Categories: RAPS Events, Clinical, Under RAPS, FDA Tags: 2014 RAPS, The Regulatory Convergence, FDA, Woodcock
2014 RAPS Keynote Examines Future of Healthcare in Complex World

2014 RAPS keynote by David Bosshart, PhD, CEO of the Switzerland-based think tank the Gottlieb Duttweiler Institute, discusses the future of healthcare.

Categories: Under RAPS, About the Profession Tags: 2014 RAPS, The Regulatory Convergence
Join RAPS or Renew at The Regulatory Convergence and Get a RAPS Jersey

Attendees at 2014 RAPS can get a free RAPS soccer jersey when they join RAPS or renew their memberships.

Categories: RAPS Events, Under RAPS, US, RAPS Tags: 2014 RAPS, The Regulatory Convergence, Austin, membership, jersey
Introducing Some New Voices (and Changes) Here at Regulatory Focus

Focus is teaming up with several trusted content providers to offer you unparalleled access to breaking news, unique data-based insights and regulatory events.

Categories: Under RAPS, About Regulatory Focus Tags: Regulatory Focus
2014 RAPS Closing Plenary Will Touch on Benefit-Risk, Risk Mitigation in Global Healthcare

Attendees at the 2014 RAPS Convergence closing plenary session will hear from four respected thought leaders about the global regulatory healthcare market. One issue likely to come up during the session is how different healthcare models deal with benefit-risk and risk mitigation strategies.

Categories: Drugs, Ethics, Under RAPS, RAPS Tags:
2014 RAPS Opening Keynote to Address Global Healthcare Evolution, ‘Simplexity’

David Bosshart, PhD, CEO of the Gottlieb Duttweiler Institute, will speak 29 September at the opening plenary session of 2014 RAPS: The Regulatory Convergence. Regulatory Focus recently had a chance to speak to Bosshart about his talk, “The Future of Healthcare: Trends, Disruptions and Scenarios” in a globalized market.

Categories: RAPS Events, RAPS Tags:
10 Sessions We Can't Wait to Attend at 2014 RAPS

Among the sessions at 2014 RAPS: The Regulatory Convergence are some that stand out to me, your Regulatory Focus editor, as particularly exciting—sessions that cover important topics, emerging trends, new developments and the critical aspects of actually being a regulatory professional.

Categories: RAPS Events, Under RAPS, US, FDA, EMA, RAPS Tags:
10 Ways to Make the Most of Your 2014 RAPS Experience

Attending 2014 RAPS: The Regulatory Convergence is not just an opportunity to get out of the office for a few days and see the inside of a new and different convention center. It’s an investment in your job, your career and your regulatory knowledge. But to get the most out of it, you will want to think a little bit about how best to spend your precious time in Austin.

Categories: Under RAPS, US, FDA, EMA, EC, Health Canada, MHLW, PMDA, CFDA, RAPS Tags:
Earning the RAC Means Better Pay and More

RAPS’ 2014 Scope of Practice & Compensation Survey found that US-based regulatory professionals who have earned their Regulatory Affairs Certification (RAC), on average, earn 10.6% more than their peers without the credential. At some levels, the salary differential is even more significant, with base salaries for regulatory associates holding the RAC at 17% more than their non-certified colleagues.

Categories: Career Development, Under RAPS, RAC Tags:
2014 RAPS Takes the Regulatory Convergence to Austin

Next month, Austin will play host to regulatory professionals from around the world attending 2014 RAPS: The Regulatory Convergence, RAPS’ signature annual event and the world’s largest annual gathering for the healthcare product regulatory profession. The conference will draw approximately 2,000 participants to the Austin Convention Center, 27 September–1 October, to learn about and discuss important developments in medicine and healthcare technology, and the myriad regulations that help ensure their safety and effectiveness for patients and consumers across the globe.

Categories: RAPS Events, Under RAPS, US, RAPS Tags:
What Can Employers Do to Attract and Retain Top Regulatory Talent?

A recent report on workplace trends has sparked renewed concern within pharmaceutical companies about employee turnover and retention.

Categories: Talent Recruiting, Career Development, Career Search, Under RAPS, About the Profession Tags:
Regulatory Salaries Up; Position, Experience and Credentials Drive Compensation

The results of the 2014 Scope of Practice & Compensation Report for the Regulatory Profession, consistent with past surveys, show regulatory careers continue to offer good pay, growth opportunities and challenging and diverse work.

Categories: Career Development, Under RAPS, About the Profession Tags:
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