Search Results for regulatory affairs

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RAPS Publishes 10th Edition of Fundamentals of US Regulatory Affairs, Plus Sector-Specific Books on Medical Devices, Biopharmaceuticals By Zachary Brousseau - Published 16 August 2017

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: HTML, Articles, Under RAPS, RAPS

Tags: regulatory affairs, text, book, Fundamentals of Regulatory Affairs

192 Earned Regulatory Affairs Certification (RAC) in Spring 2017 By Zachary Brousseau - Published 10 August 2017

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

Categories: HTML, Articles, Under RAPS, RAC

Tags: RAC, Regulatory Affairs Certification

FDA Launches New ORA Structure to Align Inspections With Expertise By Michael Mezher - Published 15 May 2017

The US Food and Drug Administration (FDA) on Monday released details on the structure of its newly realigned Office of Regulatory Affairs (ORA).

Categories: News, US, FDA, Biologics and biotechnology, Compliance, Drugs, Medical Devices

Tags: Program Alignment, Office of Regulatory Affairs, Inspections

UPDATE: RAPS Seeks Authors for EU Fundamentals Book; Deadline Extended By RAPS Staff - Published 30 March 2017

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

Categories: HTML, Articles, Under RAPS, RAPS

Tags: EU regulatory affairs, EU, European Union, Europe

FDA Office of Regulatory Affairs Realignment to Begin in May By Michael Mezher - Published 28 March 2017

The US Food and Drug Administration's (FDA) Office of Regulatory Affairs (ORA), which carries out the agency's inspection program, will officially begin a major overhaul in the coming weeks, according to FDA's Center for Devices and Radiological Health (CDRH) Director Jeffrey Shuren.

Categories: News, US, FDA, Compliance, Medical Devices

Tags: Office of Regulatory Affairs, Inspections, Jeffrey Shuren, House Energy & Commerce

Pharmaceutical Inspection Co-operation Scheme Offers New Strategic Plan Through 2019 By Zachary Brennan - Published 08 March 2017

The Pharmaceutical Inspection Co-operation Scheme (PIC/S) this week unveiled a new road map for the next two years during its February meeting in Switzerland, which was attended by representatives of 37 of its regulatory authorities.

Categories: News, Asia, Canada, Europe, US, EMA, FDA, Health Canada, MHRA, Drugs, Government affairs, Manufacturing

Tags: PIC/S, GMP guidelines, regulatory affairs

272 Pass Regulatory Affairs Certification Exams in Autumn 2016 By Zachary Brousseau - Published 10 February 2017

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: HTML, Articles, Under RAPS, RAC

Tags: Regulatory Affairs Certification, RAC

Is Regulatory Affairs Certification Right for You? By Zachary Brousseau - Published 06 February 2017

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: HTML, Articles, RAC, Under RAPS, RAC, Career Development

Tags: RAC, Regulatory Affairs Certification

UPDATE: Authors for Four US Regulatory Fundamentals Chapters Needed By RAPS Staff - Published 05 January 2017

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

Categories: HTML, Articles, Under RAPS, US, RAPS

Tags: books, publications, Fundamentals of Regulatory Affairs

Using Twitter as an Intelligence Tool: 85 Accounts Worth Following By Zachary Brennan - Published 16 November 2016

With the rise of president-elect Donald Trump, it’s become abundantly clear that Twitter matters. And it matters not just for politics. For regulatory affairs folks in in the pharmaceutical and medical device spaces, for investors, and even for the regulators themselves, Twitter is a great place to catch the day’s breaking news before the headlines are written.

Categories: News, Asia, Europe, US, Advertising and Promotion, Biologics and biotechnology, Business and Leadership, Communication, Drugs, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: Twitter, regulatory affairs, regulatory intelligence

Former Regulatory Affairs Director Charged With Insider Trading By Zachary Brennan - Published 29 September 2016

The US Securities and Exchange Commission (SEC) on Thursday charged Robert Gadimian, former senior director of regulatory affairs for Puma Biotechnology, with making more than $1.1 million thanks to non-public information linked to the company’s breast cancer treatment.

Categories: News, US, FDA, Clinical, Crisis management, Drugs, Ethics

Tags: regulatory affairs, insider trading, Puma Biotechnology

219 Earned Regulatory Affairs Certification (RAC) Credential in Spring 2016 By Zachary Brousseau - Published 30 June 2016

More than 200 regulatory professionals attained Regulatory Affairs Certification (RAC) during the spring 2016 exam cycle. Earned by passing one of four exams, the RAC is the only professional credential for regulatory professionals in the healthcare product sector.

Categories: HTML, Articles, Under RAPS, RAC, Career Development

Tags: Regulatory Affairs Certification, RAC

Updated: RAPS Seeks Authors for International Fundamentals of Regulatory Affairs Book By RAPS Staff - Published 05 May 2016

RAPS will be publishing the third edition of Fundamentals of International Regulatory Affairs later this year. We are looking for authors for chapters on general information, pharmaceuticals, biologics and other product types .

Categories: HTML, Articles, Under RAPS, RAPS

Tags: Fundamentals of International Regulatory Affairs, book, authors

Novartis Signs up for Regulatory Training Program as FDA Looks for More Participants By Zachary Brennan - Published 07 April 2016

The Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) is looking for additional participants for its Regulatory Project Management Site Tours and Regulatory Interaction Program as Novartis has already signed on to participate.

Categories: News, US, CDER, Audit, Manufacturing, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: regulatory training, regulatory affairs, Novartis, FDA regulatory training

253 Regulatory Professionals Earned RAC Credential in Autumn 2015 By Zachary Brousseau - Published 02 February 2016

RAPS has announced the names of the 253 regulatory professionals who earned Regulatory Affairs Certification (RAC) in autumn 2015. The RAC is the only professional credential specifically for the healthcare product regulatory field. 

Categories: HTML, Articles, Under RAPS, RAC, Career Development

Tags: Regulatory Affairs Certification, RAC, autumn 2015

Asia Regulatory Roundup: China Looks to End Regional Variation in Trial Oversight (22 December 2015) By Nick Paul Taylor - Published 22 December 2015

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.

Categories: News, Asia, ANZTPA, CDSCO, CFDA, IMDRF, Medsafe, MFDS, PMDA, TGA, Biologics and biotechnology, Clinical, Distribution, Drugs, Due Diligence, Government affairs, Manufacturing

Tags: Asia regulatory affairs, CFDA, TGA, CDSCO, PMDA

Book Excerpt: Fundamentals of EU Regulatory Affairs, Seventh Edition, Chapter 8: European Union Falsified Medicines Directive: Requirements and Implications for Multi-Stakeholder Healthcare Delivery By James A. Smith, B. Naughton,  A. Kramm, Graham Smith, A. Ohanjanyan, Mark De Simone, Rob Horne and David A. Brindley - Published 18 December 2015

European Union Falsified Medicines Directive: Requirements and Implications for Multi-Stakeholder Healthcare Delivery is chapter 8, excerpted from Fundamentals of EU Regulatory Affairs, Seventh Edition.

Categories: HTML, Articles, Books, Under RAPS, Europe, EMA, RAPS, Drugs

Tags: falsified medicines, Fundamentals of EU Regulatory Affairs, EU Fundamentals, sample chapter, regulatory information, regulatory resources

RAPS-National University of Singapore Certificate Program Celebrates First Graduating Class By Zachary Brousseau - Published 14 October 2015

The Medical Device Regulatory Affairs Graduate Certificate Program, a joint academic program from RAPS and the School of Biomedical Engineering at the National University of Singapore, graduated its first cohort of 31 students.

Categories: HTML, Articles, Under RAPS, RAPS Events, Asean, RAPS

Tags: Medical Device Regulatory Affairs, graduate certificate, Singapore, National University of Singapore, regulatory workforce

Get RAC Questions Answered at the Regulatory Convergence By Zachary Brousseau - Published 20 August 2015

If you are planning to attend RAPS’ upcoming Regulatory Convergence in Baltimore, 24–28 October, and you are thinking about pursuing Regulatory Affairs Certification (RAC) or have questions about the RAC, you should plan to attend one of the conference’s two scheduled RAC mini-sessions.

Categories: HTML, Articles, Under RAPS, RAPS Events, RAC, Career Development

Tags: RAC, Regulatory Affairs Certification, Regulatory Convergence, RAC min-sessions

How to Prepare for the RAC Exam By Zachary Brousseau - Published 18 August 2015

To pass the challenging Regulatory Affairs Certification (RAC) exams, even a seasoned regulatory professional will need to develop a personalized study plan and take advantage of critical exam preparation resources.

Categories: HTML, Articles, RAC, Under RAPS, RAC, Career Development

Tags: RAC, Regulatory Affairs Certification, RAC exam, exam preparation

Book Excerpt: Fundamentals of US Regulatory Affairs, Ninth Edition, Chapter 41: Regulatory Information Resources in Review By Auresa Thomas, PhD, RAC (US, Global) - Published 11 August 2015

Regulatory Information Resources in Review: This is chapter 41 of Fundamentals of US Regulatory Affairs, Ninth Edition.

Categories: HTML, Articles, Under RAPS, US, FDA, RAPS, Regulatory intelligence

Tags: Fundamentals of US Regulatory Affairs, US Fundamentals, sample chapter, regulatory information, regulatory resources

New Fundamentals of US Regulatory Affairs Book Now Available By Zachary Brousseau - Published 10 August 2015

The updated, ninth edition of Fundamentals of US Regulatory Affairs is now available. The book has been completely updated, and includes extensive, current regulatory information for pharmaceuticals, medical devices and biologics, and covers regulatory topics ranging from the history of food, drug and cosmetic laws to crisis management and FDA inspection and enforcement.

Categories: HTML, Articles, Under RAPS, US, DOJ, FDA, FTC

Tags: Fundamentals of US Regulatory Affairs, ninth editin, 9th edition, US Fundamentals, book, regulatory affairs reference

184 Earn Regulatory Affairs Certification in Spring 2015 By Zachary Brousseau - Published 30 July 2015

RAPS congratulates the 184 professionals who earned their Regulatory Affairs Certification (RAC) in spring 2015.

Categories: HTML, Articles, Under RAPS, RAC, Career Development

Tags: Regulatory Affairs Certification, RAC, spring 2015

US RAC Prep Webcast Series to Kick Off 15 July By Zachary Brousseau - Published 25 June 2015

On 15 July, RAPS will host the first of its six-part webcast series designed to help candidates for the US RAC exam fill knowledge gaps and more efficiently prepare for the exam.

Categories: HTML, Articles, RAC, Under RAPS, eCourses, US, RAC, Career Development

Tags: Regulatory Affairs Certification, RAC, Regulatory Affairs Certification exam, RAC exam, RAC (US), US RAC, RAC exam prep, RAC exam preparation, exam prep, exam preparation, webcast, RAC webcast series

RAPS, National University of Singapore Gear up for 2nd Year of Certificate Program By Zachary Brousseau - Published 23 June 2015

Last year, RAPS and the National University of Singapore launched a joint graduate certificate program in Medical Devices Regulatory Affairs for Singapore-based regulatory professionals. The program currently is enrolling its next group of students, who will begin classes in September. Applications will be accepted until the 16 July deadline.

Categories: HTML, Articles, Under RAPS, Asean, RAPS, Career Development

Tags: Medical Device Regulatory Affairs, graduate certificate, Singapore, National University of Singapore, regulatory workforce