RAPS Latest

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

RAPS' New European Council Set to Shape and Support the Regulatory Profession

RAPS is stepping up its presence in Europe and supporting its European expansion with the launch of its first ever RAPS European Council (REC).

Categories: Articles, Under RAPS, HTML, RAPS Tags: RAPS European Council, Europe
When Pfizer Needed Customized Training, The Enterprise Member Company Turned to RAPS

Pfizer partnered with RAPS to develop a customized on-site, two-day training session for several groups with different, but related, regulatory roles within the company.

Categories: Articles, Under RAPS, HTML, RAPS Tags: training, on-site training, Enterprise, Pfizer
Global Reimbursement Strategy, Advertising, Labeling and Marketing, and a Preview of Health Related Foods

The following is a summary of feature articles posted over the past weeks with links and a preview of what's to come in October.

Categories: Nutritional and dietary supplements, Labeling, Reimbursement, Features, US, Canada, Europe, FDA, MHRA, NICE, Health Canada, Advertising and Promotion Tags: Regulatory Focus, Feature Articles, Editorial
Video: FDA Commissioner Scott Gottlieb's Keynote Speech at the 2017 Regulatory Convergence

Watch FDA Commissioner Scott Gottlieb's keynote address to attendees of RAPS’ 2017 Regulatory Convergence, focusing on making the clinical end of drug development more efficient and effective.

Categories: Tags: FDA, Commissioner, Scott Gottlieb, Regulatory Convergence, drug development, clinical trials, adaptive clinical trials, seamless clinical trials
RAPS Switzerland Chapter Becomes Official Nonprofit Association Under Swiss Law

RAPS announced today that its RAPS Switzerland Chapter has completed the official registration process as a not-for-profit association under Swiss law. Chapter leaders are planning more local events, training opportunities and social gatherings as a result.

Categories: Articles, Under RAPS, HTML, Switzerland Chapter, RAPS Tags: chapters, RAPS Switzerland Chapter
Health Technology Assessment, Reimbursement, Scientific Research, Risk Management, Generic Drug Legislation and a Preview of September

The following is a summary of feature articles posted over the past weeks with links and a preview of what's to come in September.

Categories: Biologics and biotechnology, Generic drugs, Medical Devices, Reimbursement, Regulatory strategy, Features, FDA, Health Canada Tags: Regulatory Focus, Feature Articles, Editorial
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, conference, networking
National Harbor Dine-Around Restaurants Offer Great Food, Convenient Locations

Dine-arounds provide a chance to spend some quality time with fellow attendees, and this year the National Harbor offers convenient dining options just steps away from the Gaylord National Resort.

Categories: Articles, Under RAPS, HTML, RAPS Tags: Regulatory Convergence, dining, dine-arounds
Diermeier to Give Convergence Opening Remarks; Gottlieb Keynote Moved to Monday

University of Chicago Provost Daniel Diermeier will be the featured speaker at the opening plenary session of the 2017 RAPS Regulatory Convergence conference on 10 September.

Categories: Articles, Under RAPS, HTML, RAPS Tags: Regulatory Convergence, Diermeier
UPDATE: FDA Commissioner Scott Gottlieb to Deliver Keynote at RAPS Regulatory Convergence

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: Articles, Under RAPS, HTML, RAPS Tags: FDA, commissioner, Gottlieb, Regulatory Convergence, keynote
Six Highly Accomplished Regulatory Pros to Join the Ranks of RAPS Fellows

RAPS has revealed the names of the six outstanding senior regulatory professionals who will join the elite group of RAPS Fellows in 2017.

Categories: Articles, Under RAPS, HTML, Fellows Tags: Fellows, RAPS Fellows
RAPS Honors Regulatory Leaders With Two New Awards

RAPS will honor two groups of exemplary regulatory leaders next month at its annual Regulatory Convergence conference. Four outstanding individuals will be the inaugural recipients of the Founder’s Award, the profession’s highest honor. Three honorees will be the first-ever recipients of the Community Leadership Award.

Categories: Under RAPS, HTML, Awards Tags: awards, Founder's Award, Community Leadership Award
RAPS Publishes 10th Edition of Fundamentals of US Regulatory Affairs, Plus Sector-Specific Books on Medical Devices, Biopharmaceuticals

RAPS has published the updated, 10th edition of Fundamentals of US Regulatory Affairs, the most extensive reference available on regulatory affairs for pharmaceuticals, medical devices, biologics and other healthcare products intended for the US market.

Categories: Articles, Under RAPS, HTML, RAPS Tags: regulatory affairs, text, book, Fundamentals of Regulatory Affairs
192 Earned Regulatory Affairs Certification (RAC) in Spring 2017

RAPS congratulates the 192 regulatory professionals who earned Regulatory Affairs Certification (RAC) during the recent spring 2017 exam period.

Categories: Articles, Under RAPS, HTML, RAC Tags: RAC, Regulatory Affairs Certification
FDA Commissioner Scott Gottlieb’s Keynote Among Highly Anticipated Sessions at RAPS Regulatory Convergence

RAPS will host its annual Regulatory Convergence conference at the Gaylord National Resort and Convention Center at National Harbor on the DC waterfront 9–12 September. This year’s event features more than 75 educational sessions and over 200 speakers, including an opening keynote from FDA Commissioner Scott Gottlieb.

Categories: Articles, Under RAPS, HTML, FDA, EMA, MHRA, PMDA, Anvisa, WHO, RAPS Tags:
Regulatory Career Paths and Progression, Resources and Training, FDA Inspections, Cleaning Validation and a Preview of August

Feature articles over the past several weeks highlighted regulatory affairs as a profession, including careers in regulatory advertising and promotion, possible pathways and career progression and resources and training for regulatory professionals. Other articles covered various types of inspections conducted by FDA and processes for cleaning validation in the pharmaceutical industry.

Categories: Career Development, Features Tags: Features, Regulatory Focus
10 Ways to Get the Most From RAPS' Regulatory Convergence

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: Articles, Under RAPS, HTML, RAPS Tags: The Regulatory Convergence, Regulatory Convergence, conference, annual conference, 2016 RAPS, #2016RAPS, San Jose
A View From the Top: An Interview with CRI President Jennifer Kerr, RAC

This article is based on an interview with Cook Research Incorporated (CRI) president Jennifer Kerr and covers a wide range of topics from her education, to how she became interested in regulatory, to her experiences in clinical affairs and her responsibilities at CRI.

Categories: Career Development, Features, Communication Tags: Interview, RAC
Careers in Regulatory Advertising and Promotion

This article provides an overview of Regulatory Advertising and Promotion (RAP) as a career in the pharmaceutical industry and discusses topics such as potential avenues for starting a career in RAP, qualities required to be successful, and some general career advice, including information on post-PharmD RAP fellowships and the benefits to be gained from serving them.

Categories: Career Development, Features, Advertising and Promotion Tags:
7 Things to Love About the Regulatory Convergence

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: RAPS Events, Career Development, Articles, Under RAPS, HTML, RAPS Tags: The Regulatory Convergence, Regulatory Convergence, conference, annual conference, #2016RAPS, San Jose
Pediatric Legislation, Quality Certificates, Global Regulatory Oversight, Biosimilars and a Preview of July

Feature articles over the past several weeks have highlighted global pediatric activities, certificates for small molecule drug products, the New Drug Application (NDA) process in Egypt and the global debate over naming biological products and biosimilars.

Categories: Biologics and biotechnology, Drugs, Medical Devices, Clinical, Regulatory intelligence, Submission and registration, Features, US, Canada, Europe, Asia, Africa, Oceania, FDA, EMA, Health Canada, MHLW, TGA, WHO Tags: Regulatory Focus, Feature Articles
6 Things You Need to Do to Prepare for the New EU Medical Devices Regulation

When the EU’s new Medical Devices Regulation (MDR) entered into force last month, it set in motion a three-year countdown to the new rules’ full application in 2020. For companies marketing devices in the EU that wish to continue to do so, there is a lot to do in that relatively short time, so it is critical to begin as soon as possible. Early preparation is key. Following are six things you should be doing to get ready.

Categories: Medical Devices, Europe, EC Tags: Europe MDR, medical device regulation, new device regulations in Europe
Syphilis: a Mysterious and Serious Ancient Disease

This article alerts regulatory professionals to the continued presence of what may be a "forgotten" disease–syphilis. Although syphilis is unique and may be considered a "relic" of the past, it does not belong in the dust bin of history. To the contrary, regulatory professionals may wish to know more about its controversial medical history, epidemiology and clinical manifestations as syphilis remains a serious public health threat in many parts of the world. These issues in addition to the possible serious consequences of untreated syphilis provide a clear rationale for developing a vaccine.

Categories: Drugs, Features Tags:
Global Harmonization Initiatives, FDA's User Fee Programs, Pediatric Legislation, Conditional Approvals, Quality Certificates and a Preview of June

The following is a summary of feature articles posted over the past weeks with links and a preview of what's to come in June.

Categories: Biologics and biotechnology, Drugs, Medical Devices, Submission and registration, Features, FDA, EMA, Health Canada, PMDA, ICH Tags: Regulatory Focus, Feature Articles
RAPS Announces Board President-Elect and New Directors Slate

The RAPS nominating committee announced the slate of officers and directors to join the board for the 2018–2020 term.

Categories: Articles, Under RAPS, HTML, Board of Directors Tags: RAPS board of directors
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