RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

  • Fund to Provide for England's Thalidomide Victims

    • 21 December 2012
    This year marked two important anniversaries in the regulatory community. In the US, regulators noted the 50 th anniversary of the passage of the Kefauver-Harris Amendments to the Federal Food, Drug and Cosmetic Act (FD&C Act), a piece of legislation aimed at improving regulatory oversight over healthcare products. Worldwide, regulators marked a more ominous anniversary: 50 years since the drug Thalidomide was introduced to the world . The introduction of t...
  • Feature ArticlesFeature Articles

    What RAPS' Scope of Practice Survey Tells Us About the Regulatory Talent Pipeline

    The Regulatory Affairs Professionals Society (RAPS) released the results of its biennial Scope of Practice & Compensation Survey of the Regulatory Profession in July 2012. For this research, RAPS asked those involved in the regulation of healthcare and related products to answer questions about their daily work, employment, compensation rates and background. Nearly 3,000 regulatory professionals from around the world responded. Their answers about their work experi...
  • Indian Regulators Release Draft Clinical Trial Rules

    India's Ministry of Health has released three new draft rules governing the approval of clinical trials in India , the registration of ethics committees in charge of reviewing and approving investigation protocols and the compensation payable to patients enrolled in clinical trials in the case of injury or death. Clinical trials must first be registered with India's Clinical Trial Registry before patient enrollment can proceed.  The trial sponsor or clinical tr...
  • Op-ed: New RAPS Research on the Regulatory Profession

    For several years, studies conducted by RAPS have indicated talented regulatory staff are highly valued and sought after, and they are being rewarded with increased compensation. This trend has continued over the past two decades and now confirmed in the 2012 Scope of Practice & Compensation Report for the Regulatory Profession , released by RAPS in July. The study is based on information from nearly 3,000 regulatory professionals representing 58 countries and emplo...
  • 'Job-Killing' Safety Regulations Not So Job-Killing, Claims Study

    • 18 May 2012
    A new study published in the journal Science looking at safety regulations at worksites in California shows companies making an effort to strengthen safety measures for their employees cut down on workers' compensation costs while maintaining their levels of profit. "These inspections ironically appear to be creating value for the firms that they are visiting in terms of reduced workers compensation costs and frequency of injuries," said study co-author and Harvard Pro...
  • India's Clinical Trials Attract Patients, Scrutiny

    Global pharmaceutical manufacturers have been flocking to India since 2005 when guidelines restricting clinical trials were eased.  The result: roughly 150,000 Indians participated in clinical trials in 2011-a phenomenal rise given that the country had almost no patients enrolled as of 2004. Now pushback from patients and the government are causing some to rethink that rise in clinical trial participation , writes Rama Lakshmi, as ethical lapses, adverse events, la...