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Course for professionals

MRCRM Seminar Series - February 2024

Welcome to this year's first MRCRM seminar, where the key personnel from the Section for Cell-based Medicinal Products (CMP) at Helse Bergen HF will present the Ex vivo clean room facility at Helse Bergen HF. Delve into the process, milestones achieved, and the final steps needed to secure a manufacturing license for Advanced Therapy Medicinal Products (ATMPs). Enjoy the insights over coffee, tea and cookies with your peers in Aud. 4 at BBB this Tuesday afternoon.

Passed
20.
February
2024
  1. 20. Feb 2024, 2:30 PM - 3:30 PM

Time and place

When

  1. 20. Feb 2024, 2:30 PM - 3:30 PM

Event type

Fagseminar

Organizer

Mohn Research Centre for Regenerative Medicine (MRCRM)

Where

Auditorium 4, BB-Bygget
Jonas Lies vei 91
5009 Bergen

Title

How to obtain a manufacturing license according to current good manufacturing practice (GMP) regulations.


Abstract

Key personnel at Section for cell-based medicinal products (CMP) will present the Ex-vivo clean room facility at Helse Bergen HF. The talk will include the process so far and the remaining work to be done before being able to obtain a manufacturing license for advanced therapy medicinal products (ATMPs). A brief overview of the facility and how it is qualified, tested and maintained will be followed by main points regarding establishment and validation of both the production processes and quality controls crucial for releasing the products for patient treatment in clinical trials.

 

About the speakers

A group of women in white lab coats
From left to right: Elin Strand (QC Manager), Kimberley Hatfield (Qualitifed Person and Section Leader) and Petra Vogelsang (Production Mananger).

Photo Credit: Øystein Fykse, Helse Bergen HF

Elin Strand, PhD, is the Head of Quality Control (QC).

Kimberley Joanne Hatfield, PhD, is head of Section for CMP, head of Quality assurance (QA) and Qualified Person (QP).

Petra Vogelsang, PhD, is the Head of Production.

Contact