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

• 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.

Agenda

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