RAPS Latest

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

2015 Regulatory Convergence Highlights: Stephen Ostroff's Keynote

Each year, the Regulatory Convergence features dozens of speakers and panelists representing global regulatory agencies, including FDA and many others. Among the highlights of the 2015 Convergence in Baltimore was the opportunity to hear a keynote address from then-Acting FDA Commissioner Stephen Ostroff.

Categories: Articles, Under RAPS, HTML, Video, RAPS Tags: Regulatory Convergence, 2015, FDA, Ostroff, FDA Commissioner
Regulatory Job Seekers, Employers to Connect via RAPS Virtual Career Fair, 23 June

RAPS will host its next Virtual Career Fair on Thursday, 23 June, from 12:00 to 4:00 pm EDT. RAPS’ Virtual Career Fairs are held regularly throughout the year. They are a convenient way for regulatory job seekers and employers looking to hire regulatory talent to connect online in real time.

Categories: Talent Recruiting, Career Search, Articles, Under RAPS, HTML, RAPS Tags: virtual career fair, regulatory career fair, career fair, regulatory jobs, regulatory job, jobs, job, regulatory career, regulatory careers, careers, career
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
Knowledge Center Provides RAPS Members With Free Content

RAPS has launched a new online Member Knowledge Center, where RAPS members can access a library of free content, including e-books, recorded webcasts and session recordings from RAPS’ Regulatory Convergence.

Categories: Articles, Under RAPS, HTML, Membership Tags: Knowledge Center, member resources, member benefits
8 Pieces of Advice for New Regulatory Professionals

A veteran regulatory pro offers 8 pieces of advice for new regulatory professionals or those changing product lines or industries.

Categories: Career Development, Articles, Under RAPS, HTML Tags: advice, new regulatory professionals, new professional, entry-level
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
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
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
RAPS DC-Baltimore Chapter to Host Career Day This Weekend

The RAPS DC/Baltimore Chapter will once again host its Mid-Atlantic Career Day this Saturday, 21 May, on the Johns Hopkins University Montgomery County campus in Rockville, MD.

Categories: Career Development, Career Search, Articles, Under RAPS, HTML, FDA, DC/Baltimore Area Chapter, RAPS Tags: RAPS Mid-Atlantic Career Day, Mid-Atlantic Career Day, career day, careers, jobs, regulatory careers, regulatory jobs, Johns Hopkins, RAPS DC/Baltimore Chapter
Disruptive Technologies Expert Ray Wang to Keynote Regulatory Convergence in San Jose, CA

R. "Ray" Wang, principal analyst, founder, and chairman of Silicon Valley-based Constellation Research will deliver the opening keynote Sunday evening, 18 September, at RAPS' 2016 Regulatory Convergence conference in San Jose, CA.

Categories: Articles, Under RAPS, HTML, RAPS Tags: Regulatory Convergence, conference, San Jose, 2016, keynote, speaker, Ray Wang
Updated: RAPS Seeks Authors for International Fundamentals of Regulatory Affairs Book

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: Articles, Under RAPS, HTML, RAPS Tags: Fundamentals of International Regulatory Affairs, book, authors
RAPS Chicago Chapter to Host 2nd Annual Midwest Career Day

Saturday, 7 May, the RAPS Chicago Chapter will host its second annual Midwest Regulatory Career Day. The event will go from 10 am to 3:30 pm at the Hilton Garden Inn in Mettawa, IL.

Categories: Career Development, Career Search, Articles, Under RAPS, HTML, Chicago Chapter, About the Profession Tags: RAPS Chicago Chapter, Chicago, chapters, careers, Midwest Regulatory Career Day, Midwest Career Day
Updated: RAPS Calls for Board Nominations; Deadline Extended to 1 June

RAPS has opened the nomination process for four open positions on its board of directors for the 2017–19 term. Nominations and supporting materials must be submitted to RAPS by 1 June 2016.

Categories: Articles, Under RAPS, HTML, Board of Directors Tags: RAPS board of directors, RAPS board, board, board of directors, nomination, board nominations
RAPS Releases Position Specification for New Executive Director

RAPS has taken the next step in its search for a new executive director, releasing the position specification, which details the qualifications, responsibilities and competencies required of potential candidates.

Categories: Articles, Under RAPS, HTML, Board of Directors Tags: RAPS, executive director
Power Up: Best Practices for Regulatory Intelligence

Regulatory intelligence allows you to use information to be proactive rather than reactive. RI has grown from a “nice to have” option that was owned and operated exclusively by large companies into a key instrument essential to every regulatory affairs practitioner’s success.

Categories: Regulatory intelligence, Articles, Under RAPS, HTML Tags: regulatory intelligence, Graematter, RIQ, Regulatory Intelligence Quotient
RAPS' New Regulatory Competency Framework Helps Organizations, Individuals Plan Professional Development, Training, Career Advancement

RAPS has released its new Regulatory Competency Framework, a tool to help design training and map professional and career development plans for regulatory professionals. The one-of-a-kind Framework is beneficial for individual professionals as well as regulatory employers and academics developing curriculum and education.

Categories: Career Development, Articles, Under RAPS, HTML, About the Profession Tags: Regulatory Competency Framework, competencies, professional development, regulatory careers
GSK's Sue James Praises RAPS' Regulatory Competency Framework

RAPS recently released its new Regulatory Competency Framework, a tool to help professionals and organizations develop regulatory training, and plan career and professional development. A few organizations have already begun using the Framework. Regulatory Focus spoke to former RAPS Chair Sue James, who is vice president of global regulatory affairs at GlaxoSmithKline (GSK) Consumer Healthcare about the Framework and its use thus far within GSK.

Categories: Career Development, Articles, Under RAPS, HTML, About the Profession Tags: Regulatory Competency Framework, competencies, professional development, regulatory careers
RAPS Seeks Applications for 2016 Fellows

RAPS is now seeking applications for the 2016 class of RAPS  Fellows. Applications will be due approximately 26 May. 

Categories: Articles, Under RAPS, HTML, Fellows Tags: RAPS Fellows, Fellows, RAPS Fellows Program
Mastering the eCTD Format Critical for Regulatory Pros

The electronic Common Technical Document (eCTD) provides a common global standard for companies to electronically submit the quality, safety and efficacy information required by regulatory agencies. It is an FDA and EMA requirement, so anyone working on drug regulatory submissions needs to understand the format well.

Categories: RAPS Events, Prescription drugs, Generic drugs, Compliance, Submission and registration, Articles, Under RAPS, HTML, RAPS Tags: eCTD, electronic Common Technical Document, Submissions, event, MDUFA, workshop, PDUFA, regulatory
RAPS Seeks Authors for Regulatory Writing Book

RAPS is planning to publish a regulatory writing handbook later this year and is seeking contributing authors.

Categories: Articles, Under RAPS, HTML, RAPS Tags: regulatory writing, book, authors, call for authors
RAPS Launches Global Survey of Regulatory Professionals' Work and Compensation

RAPS has just launched its biennial global survey of regulatory professionals who work with healthcare and related products. RAPS’ Scope of Practice & Compensation Survey of the Regulatory Profession, conducted every two years, is the largest and most comprehensive survey of professionals in this important field, vital to ensuring healthcare products are safe and effective.

Categories: Articles, Under RAPS, HTML, About the Profession Tags: Scope of Practice & Compensation, scope of practice, compensation, salary, survey, study, research
RAPS Launches Search for New Executive Director, Announces Interim Management Team

The RAPS board of directors announced today that it has initiated a search for its next executive director and that it has selected Russell Reynolds Associates as its partner in identifying a new leader.

Categories: Articles, Under RAPS, HTML, Board of Directors Tags: RAPS, executive director
RAPS DC-Baltimore Chapter Meets for Fun and Networking

Despite warnings of a massive snow storm, members and guests of the RAPS DC/Baltimore Chapter gathered for an evening meet-up 21 January at Union Jacks pub in Bethesda, MD.

Categories: Articles, Under RAPS, HTML, DC/Baltimore Area Chapter, RAPS Tags: RAPS DC/Baltimore Chapter, chapter events, networking
The Art of Saying Yes and No

Leaders of the RAPS San Francisco Chapter recently participated in a dynamic and engaging learning session covering topics in interpersonal communication and leadership including credibility, negotiation skills and meeting management skills—all with the underlying theme of how to use yes and no to better enable us to handle requests affecting our time, money or energy.

Categories: Articles, Under RAPS, HTML, San Francisco Bay Area Chapter, Communication Tags: RAPS San Francisco Chapter, chapter events, communications skills
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
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