RAPS Latest

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

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
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
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
RAPS to Host First Virtual Career Fair of 2016 This Week

RAPS will host its first Virtual Career Fair of 2016 on Thursday, 11 February, from 12:00 to 4:30 pm EST.

Categories: Talent Recruiting, Career Search, Articles, Under RAPS, HTML Tags: virtual career fair, regulatory career fair, career fair, regulatory jobs, regulatory job, jobs, job, regulatory career, regulatory careers, careers, career
253 Regulatory Professionals Earned RAC Credential in Autumn 2015

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: Career Development, Articles, Under RAPS, HTML, RAC Tags: Regulatory Affairs Certification, RAC, autumn 2015
4 Reasons to Invest in Regulatory Intelligence

Justifying the need for regulatory intelligence investments is uniquely challenging—so where do you even begin to convince your organization that RI has value? Here’s what your organization may not know.

Categories: Regulatory intelligence, Articles, Under RAPS, HTML Tags: regulatory intelligence, ROI, Graematter, RIQ, Regulatory Intelligence Quotient
RAPS Southeast Regional Career Day Educates Participants on Regulatory Careers

The 2015 RAPS Southeast Regional Career Day, held at Georgia Tech, brought together those interested in regulatory careers, veterans of the field and regulatory employers for panel discussion on regulatory careers and networking.

Categories: Career Development, Career Search, Articles, Under RAPS, HTML, Atlanta Chapter Tags: RAPS Southeast Regional Career Day, Southeast Career Day, career day, careers, jobs, regulatory careers, regulatory jobs, Atlanta, RAPS Atlanta Chapter
Sherry Keramidas: An Interview With RAPS’ Outgoing Executive Director

Regulatory Focus sat down Thursday with Sherry Keramidas, PhD, FASAE, CAE, who for the past 20 years has run the Regulatory Affairs Professionals Society (RAPS) as executive director but will be signing off at the end of January.

Categories: Under RAPS Tags: RAPS
Handling Regulatory Challenges: Responding With Grace Under Pressure

During a recent interactive webcast based on a popular session at the RAPS 2015 Regulatory Convergence in Baltimore last October, participants voted on the best solutions to some challenging regulatory scenarios while a panel of seasoned regulatory experts share their insights.

Categories: Crisis management, Articles, Under RAPS, HTML, Business and Leadership, Communication Tags: Regulatory Convergence, 2015 Regulatory Convergence, webcast
Book Review: The FDA Clinical Submission Survival Manual

A regulatory professional's primary role is communication with FDA, other regulatory agencies and internal stakeholders in the written and oral form. The quality of a regulatory professional's communication skills can make or break a company. "The FDA Clinical Submission Survival Manual" contains useful tips and processes to improve FDA communication. It contains specifics on how to plan, develop and test strategy and key messages for a marketing application, with a focus on clinical data.

Categories: Drugs, Clinical, Regulatory strategy, Under RAPS, US, FDA, Communication Tags: The FDA Clinical Submission Survival Manual
Book Excerpt: Fundamentals of EU Regulatory Affairs, Seventh Edition, Chapter 8: European Union Falsified Medicines Directive: Requirements and Implications for Multi-Stakeholder Healthcare Delivery

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: Drugs, Books, Articles, Under RAPS, HTML, Europe, EMA, RAPS Tags: falsified medicines, Fundamentals of EU Regulatory Affairs, EU Fundamentals, sample chapter, regulatory information, regulatory resources
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