What Will it Take to Build Global Regulatory Capacity?
View a 2014 RAPS panel discussion about the importance of building regulatory capacity around the world, and how regulatory and healthcare leaders can go about building that capacity.
Categories: RAPS Events, Under RAPS, Video
Tags: 2014 RAPS, The Regulatory Convergence, regulatory capacity
FDA’s Woodcock Talks About Advancing Innovation at 2014 RAPS
CDER Director Janet Woodcock told 2014 RAPS attendees about how FDA is helping to get important new therapies to patients more quickly.
Categories: RAPS Events, Clinical, Under RAPS, FDA
Tags: 2014 RAPS, The Regulatory Convergence, FDA, Woodcock
2014 RAPS Keynote Examines Future of Healthcare in Complex World
2014 RAPS keynote by David Bosshart, PhD, CEO of the Switzerland-based think tank the Gottlieb Duttweiler Institute, discusses the future of healthcare.
Categories: Under RAPS, About the Profession
Tags: 2014 RAPS, The Regulatory Convergence
Introducing Some New Voices (and Changes) Here at Regulatory Focus
Focus is teaming up with several trusted content providers to offer you unparalleled access to breaking news, unique data-based insights and regulatory events.
Categories: Under RAPS, About Regulatory Focus
Tags: Regulatory Focus
2014 RAPS Closing Plenary Will Touch on Benefit-Risk, Risk Mitigation in Global Healthcare
Attendees at the 2014 RAPS Convergence closing plenary session will hear from four respected thought leaders about the global regulatory healthcare market. One issue likely to come up during the session is how different healthcare models deal with benefit-risk and risk mitigation strategies.
Categories: Drugs, Ethics, Under RAPS, RAPS
2014 RAPS Opening Keynote to Address Global Healthcare Evolution, ‘Simplexity’
David Bosshart, PhD, CEO of the Gottlieb Duttweiler Institute, will speak 29 September at the opening plenary session of 2014 RAPS: The Regulatory Convergence. Regulatory Focus recently had a chance to speak to Bosshart about his talk, “The Future of Healthcare: Trends, Disruptions and Scenarios” in a globalized market.
Categories: RAPS Events, RAPS
10 Sessions We Can't Wait to Attend at 2014 RAPS
Among the sessions at 2014 RAPS: The Regulatory Convergence are some that stand out to me, your Regulatory Focus editor, as particularly exciting—sessions that cover important topics, emerging trends, new developments and the critical aspects of actually being a regulatory professional.
Categories: RAPS Events, Under RAPS, US, FDA, EMA, RAPS
10 Ways to Make the Most of Your 2014 RAPS Experience
Attending 2014 RAPS: The Regulatory Convergence is not just an opportunity to get out of the office for a few days and see the inside of a new and different convention center. It’s an investment in your job, your career and your regulatory knowledge. But to get the most out of it, you will want to think a little bit about how best to spend your precious time in Austin.
Categories: Under RAPS, US, FDA, EMA, EC, Health Canada, MHLW, PMDA, CFDA, RAPS
Earning the RAC Means Better Pay and More
RAPS’ 2014 Scope of Practice & Compensation Survey found that US-based regulatory professionals who have earned their Regulatory Affairs Certification (RAC), on average, earn 10.6% more than their peers without the credential. At some levels, the salary differential is even more significant, with base salaries for regulatory associates holding the RAC at 17% more than their non-certified colleagues.
Categories: Career Development, Under RAPS, RAC
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
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
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
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
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
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.
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.
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.
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.
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.