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

 
  • Regulatory NewsRegulatory News

    Convergence: EMA close to finalizing guidance for advanced therapies

    The European Medicines Agency is on the verge of releasing revised guidance for advanced therapy medicinal products containing genetically modified cells, which includes chimeric antigen receptor (CAR)-T cell therapies. The “Guideline on quality, non-clinical and clinical aspects of medicinal products containing genetically modified cells” was originally issued in 2012 but underwent revision and consultation from July 2018-July 2019. The revised version is expected to...
  • Regulatory NewsRegulatory News

    Medical cannabis regulation is a global patchwork

    (Editor's note: this article was updated to clarify which products made from cannabis or hemp plants fall under Health Canada's Natural Health Products category.) The framework for regulating cannabis as a pharmaceutical product varies widely across the world, though increased clinical research into cannabis products means more approvals are likely under any scenario.   “It’s currently a complex patchwork of approaches,” Michael Craig, a principal consultant at Pa...
  • Regulatory NewsRegulatory News

    How to build a professional brand in a virtual world

    CEOs are not the only people who need to worry about their professional branding, attendees of RAPS Convergence 2020 heard during a plenary session. All regulatory professionals should establish a professional brand online and take the time to maintain it.   “How you are perceived is how you succeed,” said Elena Kyria during the 15 September plenary session.   What is a professional brand? It is your professional reputation and it precedes you, surrounds you, and f...
  • Regulatory NewsRegulatory News

    Embracing disruption: Convergence plenary stresses compassion, innovation

    The COVID-19 pandemic has turned daily life upside down around the globe and presented unique challenges for regulatory affairs professionals. In the kickoff plenary session of RAPS 2020 Convergence, regulatory experts and business leaders shared how they have coped with the unprecedented disruption and offered insights about how the pandemic may be accelerating industry-wide changes. The conversations were facilitated by Kimberly Belsky, vice chair for Convergence and ...
  • Regulatory NewsRegulatory News

    FDA updates PK guidance for patients with impaired renal function

    The US Food and Drug Administration (FDA) has updated its draft guidance for the design and analysis of trials to assess how impaired renal function impacts the pharmacokinetics and pharmacodynamics of investigational drugs. The guidance , issued on 03 September 2020, provides an update to a previous draft issued in March 2010. Specifically, the new document offers updated advice on when a standalone pharmacokinetic study is necessary, the appropriate study design, con...