Advances in genomic and big data analysis trends have significantly increased the interest of academia in the symbiotic relationship between the human body and its microbiome. In particular, relationship with the immune system, disease aetiology and outcome is being better articulated and continues to gain the attention of companies and investors. The regulatory terrain, however, is not yet sufficiently defined neither is the associated CMC technical aspects clearly elaborated. The webinar focusses on some of the CMC & Regulatory challenges for Microbiome development and offers solutions from the early phase of product development.

Key learning objectives:

  • Understanding the regulatory terrain for related products in key global markets
  • Key development activities towards first-in-human evaluation
  • Tips on CMC Technical & Regulatory challenges to overcome

Keywords: Microbiome; Gut microbiota; Gut bacteria; GIT; Autologous, Allogenic Faecal Microbiota Transfer (FMT); Probiotics, Prebiotics, Synbiotics; Regulatory positioning; EFSA Health Claims; cGMP; Quality Target Product Profile (QTPP); Critical Quality Attributes (CQAs)

Tim Adetona will share his experience in the regulation of microbiome related health products as a guide for product developers. The webinar will discuss the Regulatory positioning and CMC Technical challenges as well as the product development and evaluation activities of importance.

Tim Adetona, Director Drugs Biologics & nutritionals

Tim is responsible for the management of projects involving the design and implementation of global regulatory strategies for the development, evaluation and marketing of nutritional and innovative food-drug borderline products. Tim is equally well versed in regulatory engagements involved with the development of Personal, Health and Beauty Care products (cosmetics, deodorants and antiperspirants), as well as Medical Devices and OTC medicines.

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