Evenement

Advanced Therapy Medicinal Products (ATMPs) are groundbreaking treatments for humans that harness the power of genes, tissues, or cells. These cutting-edge therapies offer new avenues for treating diseases and injuries that were previously beyond our reach. On September 27^th 2024, DARQA will organize a day dedicated to ATMPs . Experts will share their experience in non-clinical, clinical and production of these innovative therapies and address some of the issues that can be challenging compared to the development of other pharmaceutical products. There will also be plenty of opportunity to ask your questions and to find out more about these novel products.

Remember, ATMPs represent a paradigm shift in healthcare, offering hope for conditions that were once considered untreatable. As we explore these frontiers, it’s crucial to ensure rigorous regulation and safety to protect patients and promote scientific progress. Don’t miss your chance to learn more!

Program –  ATMPs; what makes them different?

• Welcome -Eveline Krijger (DARQA Chairperson)
• Introduction to ATMPs- Christine Mitchell (ChrisalisQAdvice)
• Decoding the complexity of non-clinical ATMP assessment- Ion Tcacencu (Venn Life Sciences)
  • Break
• Challenges for assessing ATMPs using flow cytometry in a regulated environment  – Marie Geerlings (Ardena)
• Good Manufacturing Practices and Beyond: Essential Regulatory Insights for ATMPs – Thilo Buck (Progress-Experts in Life Sciences)
  • Lunch
• ATMP drug development and production – Marc Kamp (Kite Pharma)
• Clinical studies with ATMPs – what are the differences? – Katie Brock (Kite Pharma)
  
  • Break 
• Clinical studies with ATMPs – what are the quality challenges? – Eveline Krijger (Acerta Pharma)
• Q&A panel discussion – All Speakers
• Closing remarks – Hans de Koning  (Progress-Experts in Life Sciences)

Deelname
Deelname voor DARQA leden is gratis.

Aan dit evenement kunnen niet-DARQA-leden deelnemen na overschrijving van € 100,- op de bankrekening van DARQA NL 61 ABNA 0245 9984 46 o.v.v. naam deelnemer en GCP270924. De overschrijving van € 100,- moet uiterlijk woensdag 25 september 2024 ontvangen zijn door DARQA.

Niet-DARQA-leden die een bewijs van betaling willen ontvangen kunnen daartoe een verzoek per email versturen aan penningmeester@darqa.org.

De presentaties, die gedeeld mogen worden, zullen na de themadag op het ledengedeelte van de DARQA-website beschikbaar worden gesteld voor download.

At the end of the day the audience should understand what ATMPs are, and what makes ATMP different to the standard GLP, GCP and GMP product life cycle?