RAPS recognizes that the current situation in Ukraine impacts our members and customers on many levels. If you are directly impacted by the current situation in the region and are challenged to meet your deadlines or obligations to RAPS, please reach out to raps@raps.org so that we can defer those challenges. Your health and safety are paramount to us.

  • Regulatory NewsRegulatory News

    ICH recaps progress made over past year, charts new topics

    The International Council for Harmonisation (ICH) announced that “significant milestones” were reached over the past year, including the adoption of the widely anticipated guideline on general considerations for clinical studies and the release of question-and-answer guidelines related to the electronic Common Technical Document (eCTD).   Other accomplishments ICH cited in a recent summary of a mid-November virtual meeting include the advancement of a guideline on qu...
  • Regulatory NewsRegulatory News

    ICH: MIDD concept paper coming by year’s end

    Regulators are increasingly interested in developing model-informed drug development (MIDD) programs, but some barriers still impede their more widespread adoption.   Among these is a lack of common understanding of MIDD between technical and non-technical experts, asserted Scott Marshall, executive director for Pfizer Research and Development in the UK, in a 15 May update on the progress being made by an International Council for Harmonization (ICH) discussion group o...