• RAPS' LatestRAPS' Latest

    RAPS Seeks Authors for Regulatory Writing Book

    • 25 February 2016
    RAPS is planning to publish a regulatory writing handbook later this year and is seeking contributing authors. Chapters will be due in late summer. If you or a colleague have expertise in any of the available topics and would be interested in sharing that knowledge, please contact Senior Editor Pam Jones at pjones@raps.org with the specific topic and a CV. Available topics are: Policies, Codes and Guidance for Industry Overview of ICH guidelines for regulator...
  • RAPS' LatestRAPS' Latest

    RAPS Seeks Authors for Global Device Strategy Book

    Do you have multinational experience with medical devices, throughout the lifecycle, and want to give back to the profession by authoring chapters for a new book? This new publication entitled, Global Strategy for Medical Devices , will help your colleagues develop and implement a strategy to successfully bring their devices to the global stage. To be considered, please submit your interest to Pam Jones by 10 April 2014. Global Strategy for Medical Devices Chapters ...
  • EU Science Agency Calls for Experts, Information on Host of Medical Device Safety Issues

    The European Commission's Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) has published seven announcements calling for information and experts on a host of emerging and established regulatory issues related to several classes of medical devices. The 8 August announcements come in response to several requests that it update earlier scientific opinions or issue new ones where no earlier opinion exists. Nanomaterials and Metal-on-Metal Hip Imp...
  • EMA Tightens Conflict-of-Interest Policies

    The European Medicines Agency (EMA) announced it will, effective immediately, be tightening its conflict-on-interest policies for scientific experts and members of advisory committees. The policy was announced 3 April after being endorsed by EMA's Management Board on 22 March 2012. "The updated policy gives clearer guidance on the involvement of experts in academic trials and publicly funded research," explained EMA in a statement. "It aligns restrictions for the differ...
  • FDA Seeks to Standardize CDER's Telephone Availability

    A new manual of policies and procedures (MAPP) released by the US Food and Drug Administration's (FDA) Office of Management (OoM) dictates how the Center for Drug Evaluation and Research (CDER) must maintain adequate and consistent phone coverage to allow regulatory professionals and the public to reach the agency during normal business hours. "As Federal employees and public servants, CDER employees must be responsive to the needs of the public," writes OoM. "The public...