RAPS Latest

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

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
RAPS to Host First Virtual Career Fair of 2016 This Week

RAPS will host its first Virtual Career Fair of 2016 on Thursday, 11 February, from 12:00 to 4:30 pm EST.

Categories: Talent Recruiting, Career Search, Articles, Under RAPS, HTML Tags: virtual career fair, regulatory career fair, career fair, regulatory jobs, regulatory job, jobs, job, regulatory career, regulatory careers, careers, career
253 Regulatory Professionals Earned RAC Credential in Autumn 2015

RAPS has announced the names of the 253 regulatory professionals who earned Regulatory Affairs Certification (RAC) in autumn 2015. The RAC is the only professional credential specifically for the healthcare product regulatory field. 

Categories: Career Development, Articles, Under RAPS, HTML, RAC Tags: Regulatory Affairs Certification, RAC, autumn 2015
4 Reasons to Invest in Regulatory Intelligence

Justifying the need for regulatory intelligence investments is uniquely challenging—so where do you even begin to convince your organization that RI has value? Here’s what your organization may not know.

Categories: Regulatory intelligence, Articles, Under RAPS, HTML Tags: regulatory intelligence, ROI, Graematter, RIQ, Regulatory Intelligence Quotient
RAPS Southeast Regional Career Day Educates Participants on Regulatory Careers

The 2015 RAPS Southeast Regional Career Day, held at Georgia Tech, brought together those interested in regulatory careers, veterans of the field and regulatory employers for panel discussion on regulatory careers and networking.

Categories: Career Development, Career Search, Articles, Under RAPS, HTML, Atlanta Chapter Tags: RAPS Southeast Regional Career Day, Southeast Career Day, career day, careers, jobs, regulatory careers, regulatory jobs, Atlanta, RAPS Atlanta Chapter
Sherry Keramidas: An Interview With RAPS’ Outgoing Executive Director

Regulatory Focus sat down Thursday with Sherry Keramidas, PhD, FASAE, CAE, who for the past 20 years has run the Regulatory Affairs Professionals Society (RAPS) as executive director but will be signing off at the end of January.

Categories: Under RAPS Tags: RAPS
Handling Regulatory Challenges: Responding With Grace Under Pressure

During a recent interactive webcast based on a popular session at the RAPS 2015 Regulatory Convergence in Baltimore last October, participants voted on the best solutions to some challenging regulatory scenarios while a panel of seasoned regulatory experts share their insights.

Categories: Crisis management, Articles, Under RAPS, HTML, Business and Leadership, Communication Tags: Regulatory Convergence, 2015 Regulatory Convergence, webcast
Book Review: The FDA Clinical Submission Survival Manual

A regulatory professional's primary role is communication with FDA, other regulatory agencies and internal stakeholders in the written and oral form. The quality of a regulatory professional's communication skills can make or break a company. "The FDA Clinical Submission Survival Manual" contains useful tips and processes to improve FDA communication. It contains specifics on how to plan, develop and test strategy and key messages for a marketing application, with a focus on clinical data.

Categories: Drugs, Clinical, Regulatory strategy, Under RAPS, US, FDA, Communication Tags: The FDA Clinical Submission Survival Manual
Book Excerpt: Fundamentals of EU Regulatory Affairs, Seventh Edition, Chapter 8: European Union Falsified Medicines Directive: Requirements and Implications for Multi-Stakeholder Healthcare Delivery

European Union Falsified Medicines Directive: Requirements and Implications for Multi-Stakeholder Healthcare Delivery is chapter 8, excerpted from Fundamentals of EU Regulatory Affairs, Seventh Edition.

Categories: Drugs, Books, Articles, Under RAPS, HTML, Europe, EMA, RAPS Tags: falsified medicines, Fundamentals of EU Regulatory Affairs, EU Fundamentals, sample chapter, regulatory information, regulatory resources
RAPS Announces Holiday Schedule

RAPS will close its headquarters office this year from Christmas Day until 4 January 2016. However, during the office closure, online orders may still be placed and will be shipped.

Categories: Articles, Under RAPS, HTML Tags: RAPS news
RAPS Announces Retirement of Executive Director

RAPS announced today the retirement of its  Executive Director Sherry Keramidas whose leadership during a 20-year tenure  helped advance the healthcare regulatory profession.

Categories: Articles, Under RAPS, HTML, Board of Directors Tags: RAPS, executive director, Keramidas
RAPS Virtual Career Fair to Take Place 10 December

RAPS will host its final Virtual Career Fair of 2015 on 10 December from 12:00 to 4:30 pm EST. The online event provides a convenient venue for regulatory job seekers and recruiters to connect confidentially and in real time without having to leave the comfort of their homes or offices.

Categories: RAPS Events, Talent Recruiting, Career Search, Articles, Under RAPS, HTML, RAPS Tags: virtual career fair, regulatory career fair, career fair, regulatory jobs, regulatory job, jobs, job, regulatory career, regulatory careers, careers, career
Walking the Digital Tight-Rope

On behalf of the Regulatory Focus Board of Editors, we would like to introduce you to a collection of articles on the regulatory oversight of advertising, labeling and social media.

Categories: Drugs, Under RAPS, US, China, FDA, Advertising and Promotion, Communication Tags: Social media guidance, Office of Prescription Drug Promotion, OPDP, Regulatory Focus
Regulatory Convergence Exhibit Hall Preview

In addition to everything else at RAPS’ Regulatory Convergence, there will be an exhibit hall featuring more than 100 exhibitors from around the world. The exhibit hall will open to attendees immediately following the opening plenary and it tends to be a major center of activity throughout the Convergence.

Categories: RAPS Events, Articles, Under RAPS, HTML, RAPS Tags: Regulatory Convergence, 2015 Regulatory Convergence, Baltimore, exhibit hall, exhibitors
10 Outstanding Regulatory Professionals to be Honored as RAPS Fellows

RAPS announced its 2015 class of RAPS Fellows. The Fellows will be honored Monday, 26 October, during the opening plenary of RAPS’ Regulatory Convergence conference in Baltimore. The RAPS Fellows program recognizes senior regulatory professionals for their continued contributions and leadership toward the advancement of the profession and the professional.

Categories: RAPS Events, Articles, Under RAPS, HTML, Fellows Tags: Fellows, RAPS Fellows, 2015 RAPS Fellows, Regulatory Convergence, 2015 Regulatory Convergence,
5 Myths About Regulatory Intelligence

Even as regulatory intelligence emerges as a key tool for regulatory professionals, it’s still surrounded by myth and misinformation. In this article we’ll explore five common myths about RI and why you owe it to yourself to consciously incorporate it into your daily work to develop the most effective regulatory strategies and avoid costly, time-consuming missteps.

Categories: Regulatory intelligence, Articles, Under RAPS, HTML Tags: regulatory intelligence, myths, Graematter, RIQ, Regulatory Intelligence Quotient
Convergence Attendees Can Use New RAPS Mobile App for Info, Fun and Prizes

Regulatory Convergence attendees will be able to use the new RAPS Events mobile app to find information about conference sessions, speakers, events and activities; share their own photos and comments; see updates from fellow attendees and earn prizes by completing certain activities.

Categories: RAPS Events, Articles, Under RAPS, HTML, RAPS Tags: Regulatory Convergence, 2015 Regulatory Convergence, conference, mobile app
RAPS-National University of Singapore Certificate Program Celebrates First Graduating Class

The Medical Device Regulatory Affairs Graduate Certificate Program, a joint academic program from RAPS and the School of Biomedical Engineering at the National University of Singapore, graduated its first cohort of 31 students.

Categories: RAPS Events, Articles, Under RAPS, HTML, Asean, RAPS Tags: Medical Device Regulatory Affairs, graduate certificate, Singapore, National University of Singapore, regulatory workforce
8 Networking Tips for Regulatory Convergence Attendees

RAPS’ Regulatory Convergence offers attendees more than educational sessions and workshops. A big part of the value of the Convergence—or of any conference—lies in its networking opportunities. To make the best impression you can, and hopefully build long-lasting, mutually beneficial relationships, there are a few networking basics you should keep in mind.

Categories: RAPS Events, Business Skills, Articles, Under RAPS, HTML, RAPS Tags: Regulatory Convergence, 2015 Regulatory Convergence, conference, networking
Acting FDA Commissioner Stephen Ostroff, Author Daniel Pink to Headline RAPS' Regulatory Convergence Conference in Baltimore

RAPS’ annual Regulatory Convergence is now less than three weeks away. The event, taking place this year 24–28 October in Baltimore, is the largest annual gathering of the global healthcare regulatory community, including healthcare product regulators, scientists, innovators, and regulatory professionals from life sciences companies of all sizes. This year’s conference will feature keynote remarks from Acting Commissioner of the US Food and Drug Administration (FDA) Stephen Ostroff; and best-selling author and TV host Daniel Pink.

Categories: RAPS Events, Articles, Under RAPS, HTML, FDA, EMA, MHRA, Health Canada, MHLW, PMDA, Anvisa, WHO, DC/Baltimore Area Chapter, RAPS Tags: Regulatory Convergence, 2015 Regulatory Convergence, conference, Baltimore, Ostroff, Pink
10 Great Things to Do and See in Baltimore

If you are coming to Baltimore for RAPS’ 2015 Regulatory Convergence, don’t miss the chance to experience some of what the city has to offer. As a starting point, here is a list of 10 great things to do and see around town.

Categories: RAPS Events, Articles, Under RAPS, HTML, RAPS Tags: Regulatory Convergence, conference, Baltimore
Baltimore's Inner Harbor Offers Plenty to do for Convergence Attendees

Faneca Porter, an ambassador with Baltimore’s Waterfront Partnership, has a warm welcome for Regulatory Convergence attendees as she points out some the many attractions that draw visitors and locals alike to Charm City’s vibrant inner harbor.

Categories: RAPS Events, Articles, Under RAPS, HTML, Video, RAPS Tags: Regulatory Convergence, conference, Baltimore, inner harbor
Baltimore's Thriving Dining Scene Offers Choices for all Tastes

Baltimore is quickly becoming one of the East Coast’s premier dining destinations. RAPS recently caught up with the executive chefs from four popular Baltimore restaurants to talk about the city’s dining scene and what Convergence attendees can expect.

Categories: RAPS Events, Articles, Under RAPS, HTML, Video, RAPS Tags: Regulatory Convergence, conference, Baltimore, dining, restaurants
Locals Look Forward to Showcasing Baltimore to Convergence Attendees

With RAPS’ Regulatory Convergence coming to Baltimore, 24–28 October, the signature annual event for the regulatory profession will not only be held within close proximity to FDA's Maryland headquarters, it also will return to the home turf of one of RAPS’ most active chapters. Several local members of the RAPS DC/Baltimore Chapter gathered at Baltimore’s inner harbor recently to record a short welcome video singing the praises of the town known as Charm City and encouraging Convergence attendees to take advantage of Baltimore while they’re in town.

Categories: RAPS Events, Articles, Under RAPS, HTML, Video, FDA, DC/Baltimore Area Chapter, RAPS Tags: Regulatory Convergence, 2015 Regulatory Convergence, conference, Baltimore
Q & A With Regulatory Convergence Keynoter, Behavior Expert Daniel Pink

Best-selling author, TV host, behavior expert and Regulatory Convergence keynote speaker Daniel Pink has spent years looking at why people do the things they do, and how sometimes subtle changes can make big differences in their behaviors. As host of The National Geographic Channel’s Crowd Control, he has conducted fascinating experiments that show just how some of these changes play out in real-world situations, and how social science can be used to tackle real problems. Regulatory Focus had a chance to ask him about his work, some of the things he’s learned over the years and how it all may relate to the world regulatory professionals operate in every day.

Categories: RAPS Events, Articles, Under RAPS, HTML, RAPS, Business and Leadership, Communication Tags: Daniel Pink, Dan Pink, Regulatory Convergence, 2015 Regulatory Convergence, 2015 RAPS, conference
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