RAPS Latest

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

2014 RAPS Takes the Regulatory Convergence to Austin

Next month, Austin will play host to regulatory professionals from around the world attending 2014 RAPS: The Regulatory Convergence, RAPS’ signature annual event and the world’s largest annual gathering for the healthcare product regulatory profession. The conference will draw approximately 2,000 participants to the Austin Convention Center, 27 September–1 October, to learn about and discuss important developments in medicine and healthcare technology, and the myriad regulations that help ensure their safety and effectiveness for patients and consumers across the globe.

Categories: RAPS Events, Under RAPS, US, RAPS Tags:
What Can Employers Do to Attract and Retain Top Regulatory Talent?

A recent report on workplace trends has sparked renewed concern within pharmaceutical companies about employee turnover and retention.

Categories: Talent Recruiting, Career Development, Career Search, Under RAPS, About the Profession Tags:
Regulatory Salaries Up; Position, Experience and Credentials Drive Compensation

The results of the 2014 Scope of Practice & Compensation Report for the Regulatory Profession, consistent with past surveys, show regulatory careers continue to offer good pay, growth opportunities and challenging and diverse work.

Categories: Career Development, Under RAPS, About the Profession Tags:
MDRA Faculty Discuss Importance of Regulatory Knowledge, Goals of Program

The Regulatory Affairs Professionals Society (RAPS) and the National University of Singapore (NUS) recently launched a joint Graduate Certificate in Medical Devices Regulatory Affairs (MDRA) program in Singapore. The program was developed in partnership with the government of Singapore to help cultivate an industry-ready regulatory workforce. The Singapore Workforce Development Agency recently announced it will provide funding for 70% of the registration fee to qualified Singapore citizens or Singapore permanent residents upon successful completion of the program.

Categories: RAPS Events, In vitro diagnostics, Medical Devices, Under RAPS, Asia, About the Profession Tags:
RAPS Announces 2014 Board Nominations

The RAPS Nominating Committee has announced the slate of candidates to serve as officers and directors of the RAPS board of directors for the 2015–17 term. 

Categories: Under RAPS, RAPS Tags:
Mobile-Friendly Upgrades Coming to Regulatory Focus

Regulatory Focus will soon adopt responsive design, which will make RF content easy to read and navigate on any device.

Categories: Under RAPS Tags: Regulatory Focus
RAPS Taiwan Chapter Becomes First in Asia

RAPS announces the establishment of a new chapter in Taiwan, its first in Asia.

Categories: Under RAPS, Asia, Taiwan Tags: RAPS chapters, global
RAPS Seeks Fellows Candidates

RAPS is seeking applicants who want to make a difference in the regulatory profession as members of the 2014 Class of RAPS Fellows.

Categories: Under RAPS, Fellows Tags: RAPS Fellows
Embracing Change in EU Medical Device Regulation: The Notified Body Perspective

Change is underway in the EU and the medical device industry needs to be ready sooner than anticipated.

Categories: Under RAPS, RAPS Tags: RAPS San Fransisco, RAPS Chapter Even, AIMDD, MDD, EU, medical device
RAPS Seeks Authors for Global Device Strategy Book

RAPS is seeking professionals with multinational experience with medical devices, throughout the lifecycle to authoring chapters for a new publication, Global Strategy for Medical Devices.

Categories: Under RAPS, Medical Devices Tags: call for authors, Publication, strategy, book, global, regulatory
Survey of Regulatory Pros Draws Increasingly Global Response

RAPS' biennial research survey of the regulatory profession, launched at the end of January and continuing through Monday, 31 March, has garnered well over 2,000 responses to date, with 29% from outside the US.

Categories: Under RAPS Tags: workforce, Salary, Scope of Practice, compensation, regulatory affairs, profession, regulatory
Book Excerpt: How I Got Started in Regulatory

This chapter, How I Got Started in Regulatory, is an excerpt taken from the book Choosing the Right Regulatory Career, available from the RAPS Store.

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RAPS Launches Global Survey of Regulatory Professionals

RAPS today launched its survey of professionals around the world who are involved with the regulatory process for healthcare products.

Categories: Tags: Salary, Scope of Practice, compensation, regulatory affairs, profession, regulatory
New RAC Eligibility Requirements, Deadlines, Application Fees Coming in 2014

The Regulatory Affairs Certification Board has approved a number of changes to Regulatory Affairs Certification (RAC) eligibility, deadlines and fees that will go into effect in 2014.

Categories: RAC Tags: regulatory affairs certification
Call for Authors: Regulatory Focus Wants You

Writing for Regulatory Focus is a rewarding experience that can place your work in front of a substantial segment of the regulatory profession.

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Book Review: FDA Requirements for Prescription Drug Promotion

The pharmaceutical and biotech industry in the US is very heavily regulated under the Food, Drug and Cosmetic Act (and other laws). FDA Requirements for Prescription Drug Promotion is a thorough compilation of current topics, historical references, FDA enforcement, etc., and provides a robust overview of applicable laws and regulations.

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Understanding FDA Expectations Critical, Some Direction on Social Media Exists, Says Drug Promo Expert Driscoll

John Driscoll, author of FDA Requirements for Prescription Drug Promotion, talks about about the book and its subject matter, including common compliance issues, best practices, gray areas and the challenge of drug promotion online and on social media.

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Business Skills Crucial to Regulatory Professionals’ Success

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RAPS Board Nominations Update

The RAPS Nominating Committee has announced nominees to serve as RAPS officers and directors for 2014-16.

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Former NY/NJ Chapter Chair Gosda Dies of Cancer

Former chair of the RAPS New York/New Jersey Chapter, Andrea Grace Gosda (née Parisse), died on Sunday, 11 August 2013, at Overlook Medical Center in Summit, NJ, after a seven-month battle with cancer.

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Book Review: Fundamentals of US Regulatory Affairs, Eighth Edition

Edward Tabor reviews the new, eighth edition of Fundamentals of US Regulatory Affairs, RAPS' flagship guide to how drugs, biologics and medical devices are regulated in the US.

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Focus Feedback: Let us Know How We're Doing

Categories: Under RAPS Tags: Focus, Feedback, Regulatory Focus
RAPS Congratulates 223 Regulatory Professionals Who Earned RAC in Spring 2013

RAPS has announced the names of the 223 regulatory professionals who earned their Regulatory Affairs Certification (RAC) during the spring 2013 RAC exam period.

Categories: RAC Tags: RAC EU, RAC CAN
Regulatory Systems Critical to Global Health, Says Harvard Dean and 2013 RAPS Opening Keynote Speaker, Julio Frenk

Harvard Health School Dean Julio Frenk, who also served as Mexico's minister of health and will be the 2013 RAPS keynote speaker, talks about global health challenges and the importance of regulatory systems in addressing them.

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RAC-exam Prep Webcast Presenters Give Advice for RAC Exam Takers

Regulatory Focus recently asked presenters for RAPS' RAC (US) Exam Preparation Series for their advice on how to prepare for the RAC exam. While there is no one right way to prepare for the exam, experience, dedication, identifying study resources and creating a personalized plan are all important elements.

Categories: RAC Tags: regulatory affairs certification
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