Formulation, Development & Delivery In-Depth Focus 2021

Discover how to plan for post‑market clinical follow-up compliance under the new EU Medical Device Regulation (MDR), and formulate live biotherapeutic products to enhance their effects in this in-depth focus.  

  • Maintaining EU MDR certification: a spotlight on post‑market clinical follow-up
    Celeste Maksim, Chief of Staff, Clinical and Post-Market Practice, RQM+ advises on strategising for PMCF compliance, highlighting areas to prioritise to ensure an efficient process.
  • Developing and delivering live biotherapeutic products
    The microbial content of the gut has a well established role in health and disease. In this article, European Pharmaceutical Review’s Hannah Balfour explores the development and formulation of live biotherapeutic products (LBPs), an emerging treatment modality that seeks to capitalise on the interaction between the microbiota and host in order to treat disease. Commenting on this new class of treatments is Duncan Peyton, Chief Executive Officer of 4D Pharma – a pharma company that develops LBPs.

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