Why Regulatory Professionals Need Business Training
By William C. Putnam, PhD, RAC -
Published 02 March 2017
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: HTML, Articles, Under RAPS, RAPS Events, RAPS, Career Development
Tags: executive development, Kellogg, Northwestern, strategy, business, regulatory, training, education
Woodcock on Biosimilars: Earning the Trust of Prescribers and Patients is Key
By Zachary Brennan -
Published 07 September 2016
Similar to earning the public’s trust and confidence on generic drugs more than 20 years ago, the biosimilar industry needs to work to establish the same pattern of trust and confidence now, Janet Woodcock, director of the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research, told attendees at the Generic Pharmaceutical Association’s (GPhA) biosimilar conference in Bethesda, MD, on Wednesday.
Categories: News, US, FDA, Biologics and biotechnology, Due Diligence, Government affairs, Quality
Tags: Janet Woodcock, GPhA, biosimilars, biosimilar education
RAPS Executive Development Program Gives Regulatory Pros Needed Business Foundation
By Zachary Brousseau -
Published 27 May 2016
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: HTML, Articles, Under RAPS, RAPS Events, RAPS, Education, Career Development
Tags: Executive Development Program, executive, executive development, Kellogg, Northwestern, strategy, business, regulatory, training, education
The Four Cs of Regulatory Professional's Use of Webinars
By Meredith May, MS, RAC, Anna C. McFadden, PhD -
Published 08 December 2015
This article discusses the potential applications of webinars as an appropriate tool for use by regulatory professionals in the workplace.
Categories: Features, Career Development
Tags: Webinars, Education, Professional Development
Should You Pursue a Master's Degree or a Regulatory Affairs Certificate?
By Zachary Brousseau -
Published 28 April 2015
If you are looking to advance your regulatory career, earn more money or improve your knowledge, both master’s degrees and professional certificates are worthy of consideration. What factors should regulatory professionals consider in deciding whether to pursue a degree in regulatory affairs or a professional certificate?
Categories: HTML, Articles, Under RAPS, RAPS, Career Development
Tags: master's degree, master's in regulatory affairs, certificate, certificate in regulatory affairs, regulatory education, continuing education, RAPS Online University, Regulatory Affairs Certificate Program
FDA Announces Major Regulatory Changes, With Specialization a Key Focus
By Alexander Gaffney, RAC -
Published 08 October 2014
Regulatory functions at the US Food and Drug Administration (FDA) are set to undergo a major overhaul in the coming months after a year-long effort by the agency recommended making scores of improvements to the way the agency is structured and regulates products.
Categories: News, US, CBER, CDER, CDRH, Biologics and biotechnology, Blood, Drugs, Human cell and tissue, In vitro diagnostics, Medical Devices, Veterinary products
Tags: PAG, Program Alignment Group, ORA, Office of Regulatory Affairs, Regulatory Specialization, Regulatory Training, Regulatory Education
Answering the Call for Excellence in Regulatory Education
By Daniela Drago, PhD, Sandra Shire, DMD, MPA, Charles H. Swanson, PhD, and Jean E. Feagin, PhD -
Published 14 May 2014
The regulatory landscape has evolved dramatically in the last few decades. Today’s regulatory professionals perform key functions in their organizations, including ensuring compliance with regulations and facilitating the development and commercialization of new products. These professionals must be equipped to address the increased complexity of the modern regulatory landscape.
Tags: AGRE, MA in Regulatory Affairs, Master's in Regulatory Affairs, regulatory affairs, Regulatory Affairs Education, Regulatory Affairs Masters Degrees
Regulatory Experts Urge Caution With Communications Activities
By Zachary Brousseau, RAPS senior manager, communications -
Published 29 October 2012
During a panel discussion at 2012 RAPS: The Regulatory Convergence, regulatory professionals discussed the various ways drugmakers' missteps, small and large, could result in FDA enforcement actions against questionable promotional activities.
Categories: Under RAPS, FDA, Labeling
Tags: patient education, clinical recruitment, 2012 RAPS, advertising, promotion, social media, annual conference, The Regulatory Convergence, regulatory