RI SPIN: Microbiomes and new regulatory frameworks

RI SPIN: Microbiomes and new regulatory frameworks
The Regulatory Intelligence SPIN group is delighted to invite you to the webinar presentation on how can Microbiome Pioneers support the emergence of a new regulatory framework.





Date: Monday 20 March 2023

Time: 16:00-17:00 GMT/17:00-18:00 CET

Speakers:
Chrysi Sergaki, Microbiome Group Leader at MHRA 
Chrysi Sergaki has led the establishment of the first WHO microbiome reference reagents. Her group has been awarded a U.K. Regulator’s Pioneer Fund grant to develop guidelines for microbiome therapeutics and diagnostics.
Clara Desvignes, Associate Director - Drugs, Medical Devices & Microbiome-based Products, Voisin Consulting Life Sciences (VCLS)
Clara leads the VCLS Microbiome Taskforce, coordinating support activities to developers in the microbiome field across Regulatory, CMC, Nonclinical and Clinical expertise; knowledge development and sharing in expertise networks.
 

The research of the human body-associated microbes, the microbiome, can advance our understanding of human health and disease, providing new solutions for public health and allowing us to move towards personalised medicine. The complex and novel nature of microbiome therapeutics and diagnostics poses a challenge for both the regulators and companies, with the limited specific guidelines delaying the approval process and discouraging companies from starting the process in the UK – they would commonly choose to prioritize their development activities towards the USA market where more microbiome-specific guidance are established.

In the emerging Microbiome regulatory environment, gaining experience on expectations of regulators for these very specific products and having a comprehensive understanding of functioning of the Health Products regulatory environments in key markets such as the UK, the EU and the US are key assets for developers to establish an adapted development path, bridge across regions and taking into consideration the specific expectations of each Agency. 

In order to encourage innovators to invest in the UK health care, the Microbiome team from the Medicines and Healthcare Products Regulatory Agency (MHRA) Science Research and Innovation (SR&I), formerly the National Institute for Biological Standards and Control (NIBSC), aims to develop appropriate guidelines that will facilitate the regulatory process. To achieve this, the MHRA Microbiome team will collaborate with the different MHRA departments, as well as with its extended national and international network of scientists, clinicians, companies and regulators, to ensure that it can capture the views and requirements of the field. MHRA will further utilise this knowledge to deliver public communication pieces aiming to inform and educate scientists, clinicians and patients on this emerging field. The MHRA project is funded by a UK Regulators’ Pioneer Fund.

This webinar will be an opportunity to hear about the current and future regulatory environment for microbiome therapeutics.
 

Pricing

  • TOPRA Members: Free  
  • Non-member: £45 (includes 2 months TOPRA membership)

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When
20/03/2023 16:00 - 17:00
Where
ONLINE
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