June 20-22, 2018
Boston, MA
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How Early Should I Think About My Regulatory Strategy for My Microbiome Projects?

In this webinar, Dr. Magali Cordaillat-Simmons, Scientific and Regulatory Affairs Director at the PRI will address the importance of considering the regulatory status of a future microbiome-based product at every stage of the development including the early developments carried out in the academia.

Indeed, regulatory aspects are often considered as only relevant for the industry but for microbiome-derived drug products, as well as any other pharmaceuticals, the constrains associated with a pharma development should be taken into account as early as the proof of concept studies.

Throughout the session, Dr. Cordaillat-Simmons will discuss:

  • How different are microbiome-based products from other biologics?
  • What are the regulatory struggles for microbiome-based products?
  • What are the impacts of regulatory guidelines for academic research?
  • How early should I think about the regulatory status of my future product?
  • How will regulatory status influence future product development within microbiome related research?

Webinar Details

Duration: 30 minutes

Date: Wednesday May 16, 2018

Time: 12:00pm – 12:30pm Eastern Time/ 18:00pm – 18:30pm Central European Time

Registration link: https://attendee.gotowebinar.com/register/297546928529215234

Speaker Details

Name: Magali Cordaillat-Simmons

Job Title: Scientific and Regulatory Affairs Director

Company Name: PRI