Search Results for The Regulatory Convergence

Showing 1 – 25  of 30

UPDATE: FDA Commissioner Scott Gottlieb to Deliver Keynote at RAPS Regulatory Convergence By Zachary Brousseau - Published 23 August 2017

FDA Commissioner Scott Gottlieb will address the global regulatory community on 11 September, delivering keynote remarks at the 2017 Regulatory Convergence conference at National Harbor on the DC Waterfront.

Categories: HTML, Articles, Under RAPS, RAPS

Tags: FDA, commissioner, Gottlieb, Regulatory Convergence, keynote

10 Ways to Get the Most From RAPS' Regulatory Convergence By Zachary Brousseau - Published 01 August 2017

Attending RAPS' Regulatory Convergence conference is an investment in your job, your career and your regulatory knowledge. To get the most out of it, you will want to think a little bit about how best to spend your precious time.

Categories: HTML, Articles, Under RAPS, RAPS

Tags: The Regulatory Convergence, Regulatory Convergence, conference, annual conference, 2016 RAPS, #2016RAPS, San Jose

7 Things to Love About the Regulatory Convergence By Zachary Brousseau - Published 06 July 2017

Here are seven things to love about the Regulatory Convergence, the largest annual conference anywhere in the world for regulatory professionals working in the healthcare product space and RAPS’ signature event.

Categories: HTML, Articles, Under RAPS, RAPS Events, RAPS, Career Development

Tags: The Regulatory Convergence, Regulatory Convergence, conference, annual conference, #2016RAPS, San Jose

10 Hot-Button Issues FDA’s New Commissioner Will Face By Zachary Brennan - Published 11 May 2017

Like his predecessors, Scott Gottlieb, the newly sworn-in commissioner of the US Food and Drug Administration (FDA), will have a full plate to tackle as he takes the reins of the short-staffed agency.

Categories: News, Europe, US, FDA, Biologics and biotechnology, Drugs, Government affairs, Manufacturing, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: Scott Gottlieb, FDA commissioner, LDTs, Cures, opioids, off-label marketing, regulatory convergence

Six Expert Regulatory Professionals Honored as RAPS Fellows By Zachary Brousseau - Published 29 September 2016

Last week at RAPS’ Regulatory Convergence in San Jose, CA, RAPS honored six regulatory experts who recently joined the elite ranks of RAPS Fellows. The RAPS Fellows program recognizes senior regulatory professionals for their continued contributions and leadership toward the advancement of the profession and the professional.

Categories: HTML, Articles, Under RAPS, Fellows

Tags: Fellows, Regulatory Convergence

Regulatory Convergence Preview: Regulation and Innovation By Zachary Brousseau - Published 01 September 2016

RAPS will bring the largest annual gathering of the global healthcare regulatory profession to San Jose, CA, 17–20 September. The 2016 Regulatory Convergence will take place at the San Jose McEnery Convention Center. This year marks RAPS’ 40th anniversary, and the Convergence will celebrate RAPS’ four decades, as well as examine the future of the profession, healthcare product innovation and regulation. The focus on innovation is particularly apt this year as the event convenes in the heart of technology hub, Silicon Valley.

Categories: HTML, Articles, Under RAPS, RAPS

Tags: Regulatory Convergence, 2016 Regulatory Convergence, San Jose

10 Disruptive Technologies and the Regulatory Implications By Zachary Brousseau - Published 17 August 2016

The healthcare products sector has seen the introduction and development of a number of disruptive technologies in recent years. The future of healthcare lies in groundbreaking tech like 3D printing and personalized medicine. But these new innovations also bring regulatory challenges. This article examines 10 disruptive technologies regulatory professionals should be tracking.

Categories: HTML, Articles, Under RAPS, RAPS, Advertising and Promotion, Biologics and biotechnology, Clinical, Communication, Compliance, Ethics, Labeling, Manufacturing, Medical Devices, Packaging

Tags: disruptive technology, regulation, Regulatory Convergence, #2016RAPS

RAPS Members on the Value of Regulatory Convergence By Zachary Brousseau - Published 14 July 2016

We recently asked a number of RAPS members at various stages of their regulatory careers about the value of attending the Regulatory Convergence. Hear what they had to say.

Categories: HTML, Video, Articles, Under RAPS, RAPS, Career Development

Tags: The Regulatory Convergence, Regulatory Convergence, conference, annual conference, 2016 RAPS, #2016RAPS, San Jose

Bay Area Regulatory Pros Looking Forward to Convergence's Return to San Jose By Zachary Brousseau - Published 29 June 2016

Hear from San Francisco Bay Area regulatory professionals what makes the area such a special place, and why San Jose in particular is a great place to host RAPS' 2016 Regulatory Convergence.

Categories: HTML, Video, Articles, Under RAPS, San Francisco Bay Area Chapter, RAPS

Tags: The Regulatory Convergence, Regulatory Convergence, conference, annual conference, 2016 RAPS, #2016RAPS, San Jose

Former FDA and NIH Heads Call for Regulatory Harmonization By Zachary Brennan - Published 11 May 2016

Former US Food and Drug Administration (FDA) commissioner Margaret Hamburg and former National Institutes of Health (NIH) director Elias Zerhouni are calling for more global regulatory drug and device harmonization in an editorial posted Wednesday in Science Translational Medicine.

Categories: News, Africa, Asia, Canada, Europe, US, CDSCO, EMA, FDA, GHTF, Health Canada, ICH, IMDRF, MHRA, WHO, Active pharmaceutical ingredients, Drugs, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: regulatory harmonization, regulatory convergence, Margaret Hamburg, Sanofi

Handling Regulatory Challenges: Responding With Grace Under Pressure By Nancy Singer - Published 26 January 2016

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: HTML, Articles, Under RAPS, Business and Leadership, Communication, Crisis management

Tags: Regulatory Convergence, 2015 Regulatory Convergence, webcast

Regulatory Convergence Exhibit Hall Preview By Zachary Brousseau - Published 22 October 2015

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: HTML, Articles, Under RAPS, RAPS Events, RAPS

Tags: Regulatory Convergence, 2015 Regulatory Convergence, Baltimore, exhibit hall, exhibitors

10 Outstanding Regulatory Professionals to be Honored as RAPS Fellows By Zachary Brousseau - Published 21 October 2015

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: HTML, Articles, Under RAPS, RAPS Events, Fellows

Tags: Fellows, RAPS Fellows, 2015 RAPS Fellows, Regulatory Convergence, 2015 Regulatory Convergence,

IMDRF Sets New Long-Term Priorities on Pre-Market Review, Post-Market Surveillance of Devices By Zachary Brennan - Published 16 October 2015

The International Medical Device Regulators Forum (IMDRF) says its focus over the next four years will be to hone in on the convergence of regulations across jurisdictions, and in supporting innovation and timely access to safe and effective medical devices, according to a strategic plan unveiled earlier this month.

Categories: News, Asia, Canada, Europe, US, IMDRF, Clinical, Compliance, Medical Devices, Postmarket surveillance, Regulatory intelligence, Regulatory strategy, Research and development

Tags: IMDRF, medical device regulations, regulatory convergence, IVD

Convergence Attendees Can Use New RAPS Mobile App for Info, Fun and Prizes By Zachary Brousseau - Published 14 October 2015

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: HTML, Articles, Under RAPS, RAPS Events, RAPS

Tags: Regulatory Convergence, 2015 Regulatory Convergence, conference, mobile app

Acting FDA Commissioner Stephen Ostroff, Author Daniel Pink to Headline RAPS' Regulatory Convergence Conference in Baltimore By Zachary Brousseau - Published 07 October 2015

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: HTML, Articles, Under RAPS, RAPS Events, Anvisa, EMA, FDA, Health Canada, MHLW, MHRA, PMDA, WHO, DC/Baltimore Area Chapter, RAPS

Tags: Regulatory Convergence, 2015 Regulatory Convergence, conference, Baltimore, Ostroff, Pink

Locals Look Forward to Showcasing Baltimore to Convergence Attendees By Zachary Brousseau - Published 17 September 2015

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: HTML, Video, Articles, Under RAPS, RAPS Events, FDA, DC/Baltimore Area Chapter, RAPS

Tags: Regulatory Convergence, 2015 Regulatory Convergence, conference, Baltimore

Q & A With Regulatory Convergence Keynoter, Behavior Expert Daniel Pink By Zachary Brousseau - Published 15 September 2015

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: HTML, Articles, Under RAPS, RAPS Events, RAPS, Business and Leadership, Communication

Tags: Daniel Pink, Dan Pink, Regulatory Convergence, 2015 Regulatory Convergence, 2015 RAPS, conference

Looking Forward to Seeing You in Baltimore By Sherry Keramidas, PhD, FASAE, CAE, Executive Director, RAPS - Published 09 September 2015

RAPS Executive Director Sherry Keramidas talks about why Baltimore was chosen to host RAPS' 2015 Regulatory Convergence, and where you can find answers to questions you may have in the wake of the challenges the city faced earlier this year.

Categories: HTML, Video, Articles, Under RAPS, RAPS Events, RAPS

Tags: Regulatory Convergence, 2015 Regulatory Convergence, conference, Baltimore

Get RAC Questions Answered at the Regulatory Convergence By Zachary Brousseau - Published 20 August 2015

If you are planning to attend RAPS’ upcoming Regulatory Convergence in Baltimore, 24–28 October, and you are thinking about pursuing Regulatory Affairs Certification (RAC) or have questions about the RAC, you should plan to attend one of the conference’s two scheduled RAC mini-sessions.

Categories: HTML, Articles, Under RAPS, RAPS Events, RAC, Career Development

Tags: RAC, Regulatory Affairs Certification, Regulatory Convergence, RAC min-sessions

Meet Regulatory Convergence Keynote Speaker Daniel Pink By Zachary Brousseau - Published 13 August 2015

This year’s Regulatory Convergence opening keynote from author and TV host Daniel Pink promises to be a memorable one. Pink is known for using “diabolical psychology for the greater good,” as he likes to say. He delves into concepts of human behavior and social science while making them understandable and entertaining to millions of people.

Categories: HTML, Articles, Under RAPS, RAPS Events, RAPS, Business and Leadership, Communication

Tags: Daniel Pink, Dan Pink, Regulatory Convergence, 2015 Regulatory Convergence, 2015 RAPS, conference

Acting FDA Commissioner Stephen Ostroff to Speak at RAPS' Regulatory Convergence By Zachary Brousseau - Published 18 June 2015

Acting Commissioner of the US Food and Drug Administration (FDA) Stephen Ostroff, MD, will speak to attendees of the 2015 RAPS Regulatory Convergence. RAPS’ signature annual event for the regulatory profession will take place 24–28 October in Baltimore.

Categories: HTML, Articles, Under RAPS, RAPS Events, US, FDA, RAPS

Tags: 2015 RAPS, Regulatory Convergence, Stephen Ostroff, Ostroff, FDA commissioner, acting FDA commissioner, FDA, US Food and Drug Administration, keynote, plenary, Baltimore, conference

What Will it Take to Build Global Regulatory Capacity? By Zachary Brousseau - Published 22 October 2014

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: Video, Under RAPS, RAPS Events

Tags: 2014 RAPS, The Regulatory Convergence, regulatory capacity

FDA’s Woodcock Talks About Advancing Innovation at 2014 RAPS By Zachary Brousseau - Published 16 October 2014

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

Categories: Under RAPS, RAPS Events, FDA, Clinical

Tags: 2014 RAPS, The Regulatory Convergence, FDA, Woodcock

2014 RAPS Keynote Examines Future of Healthcare in Complex World By Zachary Brousseau - Published 30 September 2014

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