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  • RAPS' LatestRAPS' Latest

    Knowing Regulations Not Enough, Says Expert who Will Help Guide RAPS Exec Program Participants

    RAPS' long-running Executive Development Program , which brings rising regulatory leaders to the Kellogg School of Management at Northwestern University for four days of intensive business training, has been consistently popular because it fills an increasing need. Most regulatory professionals come from science- or engineering-oriented backgrounds, with relatively few having had business training or experience. The growing recognition of the strategic importance of regu...
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    Are You a Rising Regulatory Leader? Learn Business Skills at RAPS Executive Development Program

    As William C. Putnam, PhD, RAC, argues in a  Regulatory Focus  thought piece  on the need for business skills within the regulatory profession, "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."  Regulatory Strategy Critical for Business Success The reasons for this are pretty clear. Regulatory issues can ...
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    Why Regulatory Professionals Need Business Training

    You are the senior regulatory professional in the board room overseeing a major development program. The program looks promising and all you need to be concerned about is the most expeditious and risk-free regulatory path to approval, right? Unfortunately, that is not the case. The regulatory development path is typically much more complex and there are many business factors that drive the ultimate development strategy design. The most successful development programs tak...
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    When Pfizer Needed Customized Training, The Enterprise Member Company Turned to RAPS

    When about 60 Pfizer employees convened last November at the company’s New York headquarters for a customized on-site, two-day training session, one of the key goals was establishing a common language. Attendees represented several groups with different, but related, roles within the company. Some were part of a pilot program of “core strategists,” a new role combining expertise in regulatory and chemistry, manufacturing and controls (CMC). Another group was made up...
  • Regulatory NewsRegulatory News

    ICH Details Pilot Training Programs for 2017

    The International Council for Harmonization (ICH) has released details for five upcoming training programs in the US, Germany and Japan. The training programs are part of a pilot initiative agreed to at ICH's management committee meeting in Osaka, Japan in November 2016, where members of the management committee launched the year-long pilot and set out criteria for the program. Under the pilot, the ICH Training Subcommittee has partnered with a small group of training p...
  • Regulatory NewsRegulatory News

    CDRH Seeks Participants for Staff Training Program

    Medical device companies and other stakeholders have until 30 April to apply to be a part of the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) Experiential Learning Program (ELP), which is meant to help agency staffers better understand medical devices.  The training program, which is not intended for FDA to inspect, assess, judge, or perform a regulatory function (e.g., compliance inspection), is "is intended to provide CDRH ...
  • Regulatory NewsRegulatory News

    FDA Calls on Pharma Companies to Join Manufacturing Inspection Program

    The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) on Tuesday announced the launch of the 2017 CDER Office of Pharmaceutical Quality (OPQ) Staff Experiential Learning Site Visit Program, which is meant to help OPQ staff learn more about industry’s drug development and manufacturing processes. The program, which aims to bring groups of OPQ staff to observe operations of commercial manufacturing, pilot plants and pharmaceutical test...
  • Regulatory NewsRegulatory News

    Novartis Signs up for Regulatory Training Program as FDA Looks for More Participants

    The Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) is looking for additional participants for its Regulatory Project Management Site Tours and Regulatory Interaction Program as Novartis has already signed on to participate. The tours and program are part of efforts by CDER to train and develop its regulatory project management staff to further enhance review efficiency and quality by providing the staffers with a better understanding ...
  • Regulatory NewsRegulatory News

    FDA Begins Training Hundreds of Indian Regulators

    The push to get India’s pharmaceutical and medical device regulators up to speed with international norms and the US Food and Drug Administration’s (FDA) regulations is progressing with new cooperative training sessions. Recently, in Ahmedabad and Bengaluru, India, FDA officials conducted training sessions for about 200 Indian regulators, the majority of which were new inspectors, representing the Central Drugs Standards Control Organization (CDSCO) and some state drug c...
  • Regulatory NewsRegulatory News

    FDA Lays Out New Areas of Interest for Training Device Review Staff

    The US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) on Friday invited industry, academia, and health care facilities to participate again in a program that helps train medical device review staff. The 2015 Experiential Learning Program (ELP) General Training Program, which was first launched in September 2011, is intended to provide CDRH staff with a better understanding of the policies, laboratory practices and challenges of t...
  • Feature ArticlesFeature Articles

    Out of Africa: Six Regulatory Articles that Span the Continent

    Africa has a rapidly growing populace and demand for safe, effective and trusted medical products. Different geographic areas of Africa are developing their medical products submission and approval systems at varying rates of sophistication dependent, in part, on internal resources. Exclusively for RAPS members comes this valuable collection of articles exploring important regulatory differences in five major geographic/economic regions of Africa: East and Southe...
  • Feature ArticlesFeature Articles

    Writing Skills for the Regulatory Professional

    Later this year, RAPS will publish a new book, Regulatory Writing, co-authored and edited by Mukesh Kumar, PhD. Kumar has been a teacher, practitioner, innovator and researcher in the healthcare regulatory and scientific professions for 18 years. This article is an introductory overview of his upcoming book. Regulatory professionals have to write highly technical documents for a variety of audiences. These documents include clinical study reports, protoco...