• 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...
  • Feature ArticlesFeature Articles

    'Cafeteria-Style' Approach to Training for the Regulatory Technical Writer

    One team at Merck is implementing a flexible training methodology, referred to as the “cafeteria-style” approach to training, to provide effective, efficient instruction for onboarding regulatory technical writers. This approach provides training as needed to create an environment that facilitates writing high-quality regulatory documents. Since training is provided when needed, performing the actual job reinforces the training and helps technical writers accomplish...
  • Feature ArticlesFeature Articles

    RCOREs: African Regional Centres of Regulatory Excellence

    The African Medicines Regulatory Harmonization (AMRH) initiative mandate included the establishment of regional centers of regulatory excellence (RCOREs) in several fields. The goal was to strengthen regulatory capacity development by providing academic and technical training in regulatory science. RCOREs’ mission is training a regulatory workforce in Africa through the following routes: 1 providing academic and technical training in regulatory science applicab...
  • Regulatory NewsRegulatory News

    FDA Announces Major Regulatory Changes, With Specialization a Key Focus

    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. Background In September 2013, FDA announced to internal staff that, in response to "unparalleled challenges" posed by advances in product complexity and globalization, FDA would be forming a new "Program Alignm...
  • Regulatory NewsRegulatory News

    FDA Wants its Regulators to Learn More About 3D Printing, Other Device Topics

    The US Food and Drug Administration (FDA) announced this week that it plans to expand a program it uses to better understand the real-world challenges of the medical device industry it regulates. The ELP Program FDA's Experiential Learning Program (ELP) was announced in September 2011 as part of an ongoing effort to reform the Center for Devices and Radiological Health (CDRH) in light of criticism that the center was too out of touch with challenges faced by device manu...
  • Regulatory NewsRegulatory News

    FDA-Commissioned Report Makes Major Recommendations on How to Improve CDRH

    US medical device regulators should make several major changes to ensure that they are able to regulate products more quickly, efficiently and predictably, a new report commissioned under the Food and Drug Administration Safety and Innovation Act (FDASIA) says. Background The medical device industry has often lambasted the US Food and Drug Administration's review process as being increasingly  onerous, slow and unpredictable —a view also  shared  by government i...
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    RAPS and China's SFDA to Collaborate on Regulatory Education and Training

    RAPS and China's State Food and Drug Administration Institute of Executive Development (SFDAIED) have signed a memorandum of understanding, creating a cooperative framework to further international education and training for regulatory professionals in China and the US. RAPS is the largest global organization of and for healthcare product regulatory professionals, and SFDAIED is the arm of China's SFDA that provides education and training to the country's regulatory aut...
  • RAPS and China's SFDA to Collaborate on Regulatory Education and Training

    RAPS and China's State Food and Drug Administration Institute of Executive Development (SFDAIED) have signed a memorandum of understanding, creating a cooperative framework to further international education and training for regulatory professionals in China and the US. RAPS is the largest global organization of and for healthcare product regulatory professionals, and SFDAIED is the arm of China's SFDA that provides education and training to the country's regulatory aut...
  • Asian Regulatory Harmonization Plan Calls for Investments in Regulatory Capacity

    The Asian Harmonization Working Party (AHWP), a standards harmonization group focused on medical devices, has released a strategic framework and two proposed standards for public comment. The group, established in 1999, includes 23 countries across Asia, Latin America and the Middle East and now considers itself the, "Largest medical device regulatory harmonization body in the world." The group's forward-looking strategic framework, which it bills as the " Strategic Fra...
  • FDA Looks to Support Animal Rule With New GLP Training Program

    • 15 June 2012
    How do you ensure regulatory compliance in the world's most dangerous laboratory environments? The US Food and Drug Administration (FDA) wants to know, and is proposing to put money behind an initiative it says is aimed at supporting its 'Animal Rule' by developing an academic-based training program to educate pharmaceutical professionals working in high containment environments on good laboratory practices (GLPs). In an advanced posting of an 18 June Federal Register ...
  • EMA Launches Mandatory Training Course to Help MAHs Comply with EudraVigilance Regulations

    A new course launched by the European Medicines Agency (EMA) aims to assist Marketing Authorization Holders (MAHs) comply with new Article 57(2) EudraVigilance regulations on the submission of information on medicines. The six-part course covers the basics of the EudraVigilance system, the regulatory underpinnings of the system, which definitions are used in the system, the submission of EudraVigilance Product Report Messages and how to enter data. Successful completion...
  • CDRH Releases New Training Module for Guidance on Benefit-Risk Determinations

    The US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) released a new training module on a guidance document released by the agency that focuses on making benefit-risk determinations for medical device submissions. FDA's guidance, Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications , was released 27 March 2012. FDA noted at the time of the guidance release ...