Search Results for Regulatory Convergence

Showing 1 – 25  of 45

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

UPDATE: Showcase Your Expertise at Regulatory Convergence; Proposal Deadline Extended By Zachary Brousseau - Published 13 January 2017

Participating as a speaker or session leader offers an opportunity for regulatory experts to share their knowledge and insight with the global regulatory community and to enhance the own professional reputations and personal brand

Categories: HTML, Articles, Under RAPS, RAPS

Tags: Regulatory Convergence

RAPS Regulatory Convergence - 2016 Hot Topic Review By Sara Bobbit - Published 09 November 2016

This article provides a round-up of hot topics presented at this year's RAPS Regulatory Convergence and includes a high level recap of several sessions covering innovation and technology, Zika, real world evidence, patient access to innovative medicines and recent developments in off-label promotion.

Categories: News, Japan, Europe, US, FDA, MHLW, PMDA, Advertising and Promotion, Biologics and biotechnology, Clinical, Communication, Drugs, Labeling, Medical Devices, Research and development, Submission and registration

Tags: Regulatory Convergence, 2016 RAPS

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

Popular RAPS App Back Again for 2016 Regulatory Convergence By Zachary Brousseau - Published 31 August 2016

The RAPS Events app offers users a convenient tool for finding information about sessions, speakers, events and activities; creating personalized agendas; accessing speaker presentation materials; reviewing sessions and speakers; participating in polls and surveys; and sharing comments and photos; as well as a fun way to earn points and prizes.

Categories: HTML, Articles, Under RAPS, RAPS

Tags: Regulatory Convergence, RAPS Events, mobile, app

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

Head of Cuban Regulatory Agency to Make First Appearance at Regulatory Convergence By Zachary Brousseau - Published 15 August 2016

This year, for the first time ever at RAPS’ Regulatory Convergence, attendees will have the opportunity to hear directly from Cuba’s top regulatory authority. Rafael Perez Cristia, head of the National Regulatory Agency, Cuba, will participate in two sessions, both taking place Tuesday, 20 September. Perez Cristia will discuss the country’s regulatory environment and biotech industry.

Categories: HTML, Articles, Under RAPS, Latin America and Caribbean, RAPS

Tags: Regulatory Convergence, Cuba, #2016RAPS

10 Can't Miss Regulatory Convergence Sessions: 6-10 By Zachary Brousseau - Published 09 August 2016

We highlight some standout sessions that might help you with your Convergence plans, but bear in mind this list is by no means complete. Of the more than 100 individual sessions, featuring more than 250 speakers, there are many that will be highly informative and well worth attending. With that caveat, we present in no particular order the second five of the 10 sessions we identified that are likely to be popular this year. The first five were presented in part one of this two-part series.

Categories: HTML, Articles, Under RAPS, RAPS, Advertising and Promotion, Clinical, In vitro diagnostics, Medical Devices, Postmarket surveillance

Tags: Regulatory Convergence, #2016RAPS, sessions

Prepare for the Digital Revolution, Says Convergence Keynote Speaker Ray Wang By Zachary Brousseau - Published 04 August 2016

Regulatory Focus asked 2016 Convergence keynote speaker, R “Ray” Wang, who is principal analyst, founder, and chairman of Silicon Valley-based Constellation Research, about the healthcare product industry, changing business models, disruptive technologies and what it all means for regulatory professionals.

Categories: HTML, Articles, Under RAPS, RAPS

Tags: Regulatory Convergence, conference, San Jose, 2016, keynote, speaker, Ray Wang

10 Can't Miss Regulatory Convergence Sessions: 1-5 By Zachary Brousseau - Published 03 August 2016

We highlight some standout sessions that might help you with your Convergence plans, but bear in mind this list is by no means complete. Of the more than 100 individual sessions, featuring more than 250 speakers, there are many that will be highly informative and well worth attending. With that caveat, we present in no particular order five of the 10 sessions we identified that are likely to be popular this year. Sessions six through 10 will follow in part two.

Categories: HTML, Articles, Under RAPS, RAPS

Tags: Regulatory Convergence, #2016RAPS, sessions

Convergence Keynote Speaker Lori Hartwell Passionate About Patients By Zachary Brousseau - Published 28 July 2016

Regulatory Convergence closing keynote speaker, Lori Hartwell is a four-time kidney transplant recipient, a patient advocate, founder of the Renal Support Network and author of the book, Chronically Happy—Joyful Living in Spite of Chronic Illness. You can’t help but to be inspired not just by her story, but by her optimistic way of looking at the world.

Categories: HTML, Articles, Under RAPS, RAPS

Tags: Regulatory Convergence, keynote, Lori Hartwell, #2016RAPS, patient advocacy

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

8 Networking Tips for Regulatory Convergence Attendees By Zachary Brousseau - Published 01 July 2016

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: HTML, Articles, Under RAPS, RAPS Events, RAPS, Business Skills

Tags: Regulatory Convergence, 2015 Regulatory Convergence, conference, networking

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

2015 Regulatory Convergence Highlights: Stephen Ostroff's Keynote By Zachary Brousseau - Published 23 June 2016

Each year, the Regulatory Convergence features dozens of speakers and panelists representing global regulatory agencies, including FDA and many others. Among the highlights of the 2015 Convergence in Baltimore was the opportunity to hear a keynote address from then-Acting FDA Commissioner Stephen Ostroff.

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

Tags: Regulatory Convergence, 2015, FDA, Ostroff, FDA Commissioner

10 Ways to Get the Most From RAPS' Regulatory Convergence By Zachary Brousseau - Published 14 June 2016

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 02 June 2016

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

EU Proposes More Structured Convergence With FDA on Pharma Regulations By Zachary Brennan - Published 26 May 2016

The European Union has offered a new proposal that would further harmonize the pharmaceutical regulations between the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA), which could speed new drug approvals and manufacturing inspections in both regions.

Categories: News, Europe, US, EC, EMA, FDA, Active pharmaceutical ingredients, Biologics and biotechnology, Clinical, Drugs, Government affairs, Manufacturing

Tags: regulatory convergence, regulatory harmonization, FDA and EMA collaborations

Disruptive Technologies Expert Ray Wang to Keynote Regulatory Convergence in San Jose, CA By Zachary Brousseau - Published 16 May 2016

R "Ray" Wang, principal analyst, founder, and chairman of Silicon Valley-based Constellation Research will deliver the opening keynote Sunday evening, 18 September, at RAPS' 2016 Regulatory Convergence conference in San Jose, CA.

Categories: HTML, Articles, Under RAPS, RAPS

Tags: Regulatory Convergence, conference, San Jose, 2016, keynote, speaker, Ray Wang

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