RAPS Latest

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

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
RAPS Seeks Applications for 2017 Fellows

RAPS is seeking applications for the 2017 class of RAPS Fellows. Since 2008, the RAPS Fellows program has recognized senior-level regulatory professionals for continued significant contributions to, and leadership in advancing, the global regulatory profession.

Categories: Articles, Under RAPS, HTML, Fellows Tags: RAPS Fellows
Why Regulatory Professionals Need Business Training

Because regulatory decisions have a direct impact on business outcomes, regulatory professionals need to have a comprehensive understanding of business, such as the business acumen provided by extensive on-the-job training, professional development programs or formal business training.

Categories: RAPS Events, Career Development, Articles, Under RAPS, HTML, RAPS Tags: executive development, Kellogg, Northwestern, strategy, business, regulatory, training, education
Remembering RAPS Founder Richard Greco

RAPS Founder Richard E. Greco died last week near his home  outside of Buffalo, NY. He was 87 years old.

Categories: Articles, Under RAPS, HTML, RAPS Tags: Richard Greco
RAPS Seeks Board Nominations

RAPS has begun the nomination process for openings for the 2018–2020 term of its board of directors, and is now accepting nominations for president-elect and up to four director positions.

Categories: Articles, Under RAPS, HTML, Board of Directors Tags: board of directors, nominations, RAPS leadership
272 Pass Regulatory Affairs Certification Exams in Autumn 2016

Another 272 regulatory professionals passed one of four challenging exams last autumn to attain Regulatory Affairs Certification (RAC). The RAC is the only professional credential for regulatory professionals in the healthcare product sector. Currently, more than 4,000 individuals around the world are RAC-credentialed.

Categories: Articles, Under RAPS, HTML, RAC Tags: Regulatory Affairs Certification, RAC
Is Regulatory Affairs Certification Right for You?

The decision to pursue Regulatory Affairs Certification (RAC) is a personal one with many variables to consider—from the amount of regulatory experience you have and the potential value of having the credential to how much time you can devote to studying. So while there is no one-size-fits-all answer to the question ‘Is the RAC right for me?,’ there are some important factors to take into account.

Categories: Career Development, Articles, Under RAPS, HTML, RAC, RAC Tags: RAC, Regulatory Affairs Certification
Regulatory Intelligence, Leading Edge Technology, Compliance Strategy, Scientific Research and a Preview of February

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

Categories: Biologics and biotechnology, Drugs, Medical Devices, Compliance, Regulatory intelligence, Submission and registration, Features, US, Canada, Europe, China, FDA, EMA, Health Canada, CFDA Tags: Regulatory Focus, Feature Articles, Feature Summary
RAPS Celebrates National Puzzle Day With Regulatory Crossword

RAPS has created a crossword puzzle just for regulatory professionals. The answers to RAPS’ Regulatory Word Challenge include words from the areas of pharma, biotech and medical devices. If you see yourself as a "regulatory nerd," download the puzzle and see if you're up to the challenge.

Categories: Articles, Under RAPS, HTML, RAPS Tags: Regulatory Word Challenge, crossword, puzzle
UPDATE: Showcase Your Expertise at Regulatory Convergence; Proposal Deadline Extended

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: Articles, Under RAPS, HTML, RAPS Tags: Regulatory Convergence
RAPS' New Board of Directors Begins 2017 Term

The 2017 term for the board of directors of the Regulatory Affairs Professionals Society (RAPS) began officially on 1 January. For the new term, Todd Chermak of Abbott Established Pharmaceuticals takes over as chairman. In addition, Susumu Nozawa of BD assumes the role of president; Don Boyer, formerly of Health Canada and currently of BOYER@RegulatorySolns, steps in as president-elect; and Salma Michor of Michor Consulting e.U, continues to serve as treasurer. Two new directors also have joined the board: Gert Bos of Qserve Group and Michael Morton of Medtronic.

Categories: Articles, Under RAPS, HTML, Board of Directors Tags: board of directors
UPDATE: Authors for Four US Regulatory Fundamentals Chapters Needed

RAPS currently is seeking authors for chapters to be published in the 10th edition of Fundamentals of US Regulatory Affairs.

Categories: Articles, Under RAPS, HTML, US, RAPS Tags: books, publications, Fundamentals of Regulatory Affairs
Biosimilar Drug Development, Complex Medicinal Products, Medical Device Regulations, Research and Technology and a Preview of January

The following is a summary of feature articles posted throughout December with links and a preview of what's to come in January.

Categories: Biologics and biotechnology, Drugs, Medical Devices, Features Tags:
RAPS Holiday Schedule Announced

RAPS wishes all our members, readers, customers and the entire global regulatory community a healthy and happy holiday season and new year.

Categories: Articles, Under RAPS, HTML, RAPS Tags: 2016 holiday schedule
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