RAPS Latest

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

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
Medicine's Unsung Heroes

This article introduces readers to Boyd Woodruff, a legend in the field of microbiology, and discusses his groundbreaking achievements in antibiotic development and Merck's research laboratories.

Categories: Drugs, Research and development, Features, US Tags:
RAPS and Industry Experts Join Forces for Dedicated MDR Workshop

RAPS is bringing together a panel of Europe’s top industry experts to deliver a dedicated workshop on the new EU regulations for medical devices and in vitro diagnostic devices.

Categories: Articles, Under RAPS, HTML, Europe, RAPS Tags: EU, Medical Device Regulations, IVD Regulations
Biosimilars, 21st Century Cures Act, Clinical Trial Regulations, PDUFA, Global Regulatory Strategy and a Preview of May

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

Categories: Biologics and biotechnology, Combination products, Drugs, Medical Devices, Submission and registration, US, Europe, Asia, FDA, EMA, ISO Tags: Features, Regulatory Focus
RAPS Increases Investment in Europe

RAPS is stepping up its presence in Europe and expanding its European team in response to growing membership demand from those involved with the regulation of healthcare and related products.

Categories: Articles, Under RAPS, HTML, RAPS Tags: Europe, Brussels, Munich
RAPS Executive Development Program Gives Regulatory Pros Needed Business Foundation

Increasingly, regulatory professionals are involved in making organizational business decisions, yet few have formal business training. RAPS' Executive Development Program was designed to help them hone their business, management and leadership skills.

Categories: RAPS Events, Education, Career Development, Articles, Under RAPS, HTML, RAPS Tags: Executive Development Program, executive, executive development, Kellogg, Northwestern, strategy, business, regulatory, training, education
Regulatory Business and Strategy, Medical Device Regulations, Adverse Event Reporting Requirements and a Preview of April

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

Categories: Human cell and tissue, Medical Devices, Business Skills, Features, US, Europe, Asia, Oceania, FDA, EC Tags: Features, Regulatory Focus
UPDATE: RAPS Seeks Authors for EU Fundamentals Book; Deadline Extended

RAPS currently is seeking chapter authors for the upcoming eighth edition of Fundamentals of EU Regulatory Affairs.

Categories: Articles, Under RAPS, HTML, RAPS Tags: EU regulatory affairs, EU, European Union, Europe
RAPS Virtual Career Fair, 30 March, Connects Regulatory Job Seekers, Employers

Regulatory professionals looking for new employment opportunities and employers seeking regulatory staff will have another opportunity to connect when RAPS hosts its next Virtual Career Fair Thursday, 30 March.

Categories: Articles, Under RAPS, HTML, RAPS Tags: Virtual Career Fair, jobs, careers
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