RAPS Latest

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

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:
RAPS Announces 2014 Board Nominations

The RAPS Nominating Committee has announced the slate of candidates to serve as officers and directors of the RAPS board of directors for the 2015–17 term. 

Categories: Under RAPS, RAPS Tags:
Finding Your Pathway Into Regulatory

Categories: Under RAPS Tags: Regulatory Affairs Career, Getting into Regulatory Affairs, Starting in Regulatory Affairs, How to get into Regulatory Affairs, regulatory
Adaptive Clinical Trials Likely to Increase; RAPS Program to Cover Regulatory Requirements

Adaptive design clinical trials can give sponsor companies the flexibility to make changes to a trial in progress without compromising the validity of its findings, but also present unique challenges. Regulatory Focus spoke to experts participating in an upcoming RAPS virtual program on adaptive trials and their regulatory requirements about their benefits, potential pitfalls and FDA expectations.

Categories: Tags:
RAPS Congratulates 338 Regulatory Professionals Who Earned RAC in Autumn 2012

RAPS has announced the names of the 338 regulatory professionals who earned their Regulatory Affairs Certification(RAC) during the autumn 2012 RAC exam period.

Categories: RAC Tags: RAC EU, RAC CAN
Business Skills Crucial to Regulatory Professionals’ Success

Categories: RAPS Tags:
RAPS Announces Spring 2012 Class of RACs

The Regulatory Affairs Professionals Society has announced the names of the 203 individuals who earned their Regulatory Affairs Certification during the spring 2012 RAC exam period.

Categories: Under RAPS, RAPS, RAC Tags: Regulatory Regulatory Affairs Certification Exam, spring 2012, RACB, RAC GS, RAC EU, RAC CAN, RAC US
The All-Digital Regulatory Focus

You spoke and we listened. Starting in 2012, you will be getting more from Regulatory Focus. Our new all-digital publication (www.regulatoryfocus.org) will be unveiled on 3 January 2012, offering more content, more access and more interactivity from the articles you have come to enjoy. Plus, we will be adding additional news and links to information you need on a daily basis.

Categories: Under RAPS Tags: Focus, Regulatory Focus
Mobile-Friendly Upgrades Coming to Regulatory Focus

Regulatory Focus will soon adopt responsive design, which will make RF content easy to read and navigate on any device.

Categories: Under RAPS Tags: Regulatory Focus
RAPS and China's SFDA to Collaborate on Regulatory Education and Training

RAPS and China's State Food and Drug Administration Institute of Executive Development (SFDAIED) have signed a memorandum of understanding, creating a cooperative framework to further international education and training for regulatory professionals in China and the US.

Categories: Education, Medical Devices, Under RAPS, China, RAPS Tags: SFDAIED, SFDA, training
A Conversation With From Alzheimer's to Zebrafish Author Max Sherman

Pharmacist and seasoned regulatory professional Max Sherman has written on science and medical topics for years, and began writing for RAPS' magazine Regulatory Affairs Focus, as it was called at the time, more than a decade ago. Over the years, his writing has covered a range of diverse and occasionally unusual subjects related to the practice of medicine, medical research, regulatory issues, biology, chemistry and other related disciplines. He has taught university-level classes on quality and regulatory affairs, and his writing is often educational, whether it's a history lesson about quack medical devices, a biology lesson about bats or a peek into processes of the US Food and Drug Administration (FDA), it's almost impossible not to learn something new reading one of Sherman's articles. At the same time, he writes in an accessible and entertaining style. RAPS has now published a collection of Sherman's articles from Regulatory Focus and other publications, entitled From Alzheimer's to Zebrafish: Eclectic Science and Regulatory Stories. I recently had a chance to talk with him about the book and his writing. Following is an edited transcript of our conversation.

Categories: Under RAPS Tags: Interesting, Sherman, Science, Animal, Bug, Insect, medicines, interview, book, disease, regulatory
RAPS Scope of Practice Study: Tracking the Regulatory Profession

RAPS recently fielded the 2012 iteration of its ongoing research initiative on the regulatory profession, the RAPS Global Scope of Practice & Compensation Survey. This research has been conducted by RAPS for more than 20 years, and it continues to be the largest, most comprehensive study of the healthcare product regulatory profession. RAPS Executive Director Sherry Keramidas, PhD, FASAE, CAE, recently spoke with Regulatory Focus about the study and its implications.

Categories: Under RAPS Tags: Sherry Keramidas, Scope of Practice, regulatory profession, study
RSS Comes to Regulatory Focus: One More Way You Can Follow Focus

You spoke, and we listened. We're proud to unveil a brand new way to connect with Regulatory Focus: through RSS feeds. Regulatory Focus now has several RSS feeds you can subscribe to, depending on your needs.

Categories: Under RAPS Tags: RSS, Focus, Regulatory Focus, social media
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: Education Tags: Executive Development Program, Executive, Kellogg, advancement
Regulatory Experts Urge Caution With Communications Activities

During a panel discussion at 2012 RAPS: The Regulatory Convergence, regulatory professionals discussed the various ways drugmakers' missteps, small and large, could result in FDA enforcement actions against questionable promotional activities.

Categories: Labeling, Under RAPS, FDA Tags: patient education, clinical recruitment, 2012 RAPS, advertising, promotion, social media, annual conference, The Regulatory Convergence, regulatory
Call for Authors: Regulatory Focus Wants You

Writing for Regulatory Focus is a rewarding experience that can place your work in front of a substantial segment of the regulatory profession.

Categories: Tags:
As 510(k) Process Evolves, Questions Remain

The 510(k) premarket notification process provides a clearance pathway for new, low-risk medical devices to be sold in the US by proving to the US Food and Drug Administration (FDA) that a proposed product is substantially equivalent to another, existing, legally marketed device. But the process has come under fire from critics in Congress and others who have called it a "loophole" that allows devices onto the market without putting them through a rigorous approval process.

Categories: Under RAPS, FDA, CDRH Tags: 2012 RAPS, Loophole, User Fees, MDUFA, 510(k), medical device
Autumn 2011 RAC Class

Categories: Under RAPS, RAPS, RAC Tags: RACB, Autumn 2011, Regulatory Affairs Certification Exam, RAC GS, RAC EU, RAC CAN, RAC US, regulatory
Book Excerpt: Risk Management in the Future: Looking Into the Crystal Ball

Pharmacovigilance has been defined by the World Health Organization as, "The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem." Pharmacovigilance (or risk management) should help to inform both healthcare professionals and patients, allowing them to make educated decisions when choosing a treatment.

Categories: Under RAPS Tags: pharmaceutical, drug, risk management, pharmacovigilance
Embracing Change in EU Medical Device Regulation: The Notified Body Perspective

Change is underway in the EU and the medical device industry needs to be ready sooner than anticipated.

Categories: Under RAPS, RAPS Tags: RAPS San Fransisco, RAPS Chapter Even, AIMDD, MDD, EU, medical device
RAPS Advances to Fit Your Needs

Since 1976, RAPS has supported the regulatory profession by providing education and training, certification, professional standards, research, knowledge-sharing, publications, networking and career development opportunities, and other valuable resources. RAPS is committed to helping its members continually develop the knowledge and skills they need to excel. From the introduction of the Regulatory Affairs Certification (RAC), the only certification specifically for regulatory professionals in the healthcare product sector, to RAPS Online University, the gold standard in self-paced continuing education, RAPS has continued to grow and evolve in step with the continuous changes in the global regulatory environment.

Categories: Education, Under RAPS, RAPS Tags: teams, skills, organization, knowledge, assessment
« 1 2 3 »