Search Results for conference

Showing 1 – 25  of 25

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

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

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

Brexit Creating a Period of Uncertainty for EU, UK Drug and Device Regulators By Zachary Brennan - Published 28 June 2016

The fallout from the UK referendum is continuing to create strife among the ranks of the European Medicines Agency (EMA), though a top EMA official told the DIA annual conference on Tuesday in Philadelphia that business at the agency will carry on as usual as negotiations continue.

Categories: News, Europe, EMA, FDA, MHRA, Drugs, Government affairs, Medical Devices, Research and development

Tags: Brexit, UK drug legislation, UK drug regulations, DIA conference 2016

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

ICH Genomic Sampling Guidance: FDA Begins Consultation By Michael Mezher - Published 02 June 2016

The US Food and Drug Administration (FDA) on Thursday launched a two-month public consultation for input on a recently drafted International Conference for Harmonization (ICH) guideline on genomic sampling.

Categories: News, US, EC, FDA, Health Canada, ICH, MHLW, PMDA, Biologics and biotechnology, Clinical, Drugs

Tags: ICH, International Conference for Harmonization, E18, Genomic Sampling

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

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

10 Great Things to Do and See in Baltimore By Zachary Brousseau - Published 30 September 2015

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

Tags: Regulatory Convergence, conference, Baltimore

Baltimore's Inner Harbor Offers Plenty to do for Convergence Attendees By Zachary Brousseau - Published 29 September 2015

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

Tags: Regulatory Convergence, conference, Baltimore, inner harbor

Baltimore's Thriving Dining Scene Offers Choices for all Tastes By Zachary Brousseau - Published 23 September 2015

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

Tags: Regulatory Convergence, conference, Baltimore, dining, restaurants

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

A Global Regulatory Gathering in FDA's Backyard By Zachary Brousseau - Published 03 September 2015

RAPS’ 2015 Regulatory Convergence will bring together regulatory professionals, experts and agency representatives from all over the world, including FDA’s acting commissioner and other FDA officials, as well as representatives from at least 22 global agencies and organizations.

Categories: HTML, Articles, Under RAPS, RAPS Events, Anvisa, CFDA, EMA, FDA, Health Canada, MFDS, MHLW, MHRA, PMDA, WHO, RAPS

Tags: Regulatory Convergence, conference, annual conference, regulatory agencies

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

ICH Takes Step Toward New eCTD Version By Michael Mezher - Published 24 February 2015

The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) announced it has completed a step in the development of the next major version of the electronic Common Technical Document (eCTD).

Categories: News, Japan, Europe, US, EMA, FDA, ICH, PMDA, Submission and registration

Tags: ICH, International Conference on Harmonization, eCTD, electronic submissions

FDA Adopts International Photosafety Testing Standard By Alexander Gaffney, RAC - Published 27 January 2015

New guidance published by the US Food and Drug Administration (FDA) would bring the US into alignment with an international standard meant to ensure new drug products don't cause photosensitivity in patients.

Categories: News, US, FDA, ICH, Active pharmaceutical ingredients, Clinical, Drugs

Tags: Photosafety, S10, ICH, International Conference on Harmonization, Guidance, Final Guidance, Phototoxicity, Photosensitivity, Photoallergy

Experts Examine Regulation of Health-Related Mobile Apps, Software and Social Media By Zachary Brousseau, RAPS senior manager, communications - Published 29 October 2012

When it comes to the regulation of mobile apps, software and social media in the healthcare space, intent is key but absolute clarity is elusive, according to the expert presenters who spoke to attendees during a session at 2012 RAPS: The Regulatory Convergence in Seattle.

Categories: Under RAPS, FDA, MHRA

Tags: Center for Medicine in the Public Interest, 2012 RAPS, Mobile Apps, Software, Mobile Health, regulators, social media, annual conference, The Regulatory Convergence, regulatory

Regulatory Experts Urge Caution With Communications Activities By Zachary Brousseau, RAPS senior manager, communications - Published 29 October 2012

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: Under RAPS, FDA, Labeling

Tags: patient education, clinical recruitment, 2012 RAPS, advertising, promotion, social media, annual conference, The Regulatory Convergence, regulatory

Regulatory Professionals, Top Regulators From Around the World to Converge in Seattle for 2012 RAPS By Zachary Brousseau, senior manager, communications - Published 28 September 2012

Categories: Under RAPS

Tags: 2012 RAPS, regulators, annual conference, The Regulatory Convergence, regulatory