2nd Experts meeting on Microbial Strain Safety Assessment for Regulatory Approval

BaseClear, together with the Leiden Bio Science Park foundation, organises an experts meetings wherein scientists and researchers can meet, share and discuss applications and technical challenges on microbial strain safety assessment. Topics discussed at this meeting include the requirements needed for regulatory approval in both Europe (EFSA) and the USA (US-FDA). The meeting is scheduled for Tuesday April 21st, 2020.

Microbial Strain Safety Assessment

EFSA and FDA requirements for approval of food and feed additives and production organisms

Event information

  • Download Brochure Experts Meeting 21 april 2020
  • Date: Tuesday April 21, 2020
  • Organisers: BaseClear and Leiden Bio Science Park foundation
  • Chair: Dr. Radhika Bongoni, | Business Developer, BaseClear
  • Tentative number of attendees: 50 (due to the interactive nature of experts meeting, we have a limit to the number of registrations).
  • Topics: Genomics approach, technological advancements and data interpretation, EFSA vs. FDA guidelines, GM strains from food & feed industry.
  • Target group: Industrial partners, Scientists, Researchers, Start-ups, Regulatory experts, CROs and academians.
  • Location: This meetings will be hosted online.
  • Costs: 150,- euro (excl. VAT)/ participant
  • Cancellation: Cancellations are only valid if notice is received by email. For cancellations made within 1 week of the event, no refunds will be paid.


All times are Central European Time (CET).

Session 1: EFSA requirements and interpretation

  • 10.00: Welcome & Opening expert meeting
    Dr. Derek Butler | Commercial Director, BaseClear
  • 10.10: Risk assessment of feed additives of microbial origin in the European Union
    Rosella Elisa Brozzi | Scientific Officer, European Food Safety Authority (EFSA)
  • 10:30: Decoding the EFSA requirements for microbial safety and the technical challenges
    Dr. Adalberto Costessi | Product manager Genomics & Regulatory Affairs, BaseClear
  • 10.45 Panel discussion

Session 2: Food & feed applications

  • 13.00: Bringing novel microbes to market: Regulatory intelligence for current and (potential) future requirements
    Dr. Luis Gosálbez Cisneros-Miret | Managing Director – Sandwalk BioVentures
  • 13:15: Novel food applications and genetic engineering: agency requirements around the globe
    Stephen O‘Rourke, MSc. | Regulatory Affairs Manager – Jennewein Biotechnology
  • 13.30: Requirements to be met for securing the legality of use of microbial strains in food commercialized in EU, with special focus on their use as probiotics
    Dr. Tiia Asukas | Senior Regulatory Specialist – Chr. Hansen
  • 13.45: Panel discussion 2

Session 3: Regulatory framework comparison (EFSA vs. FDA) and requirements

  • 16:00: Feed Additive Regulatory framework in the EU
    Dr. Helena Oliveira | Regulatory Affairs Manager – Trouw Nutrition
  • 16:15: A look at the scientific testing requirements to meet GRAS, NPN and QPS status for a bacillus probiotic
    Dr. John Deaton | Vice President of Science & Technology – Deerland probiotics & enzymes
  • 16: 30: A look at probiotics food regulations outside of the EU and how they compare to the EU
    Solange Henoud | Regulatory Affairs Director – Lallemand Health Solutions
  • 16.45: Panel discussion 3

Registration closed

Our online Regulatory Affairs Experts Meeting is fully booked. In case you have quesitons about this event fill in the contact form below.

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Meet Radhika Bongoni!

With her passion for health and wellbeing, Radhika enjoys contributing to sustainability, and to the development of products that will benefit the end user and improve their quality of living. To this end, Radhika heads the commercial activities at BaseClear. “My diverse industry experience helps me envisage out-of-the-box solutions for our customers and to enter to new markets as a company” says Radhika. “It’s crucial that I can identify our customer needs and market trends to steer product development at BaseClear.”

Contact Radhika

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