Anna Nowocin

Company: Medicines & Healthcare Products Regulatory Agency (MHRA)

Job title: Head of Cellular Immunology

Seminars:

Biological Standardization & Development of Reference Reagents & Bioactivity Assays for Extracellular Vesicles 9:00 am

Bioactivity/potency testing considerations for complex Biotherapeutics and ATMPs Bioactivity reference materials development Process optimisation for manufacturing of MSC-EVs bioactivity standards BRAND NEW SESSIONRead more

day: Conference Day Two

Roundtable Discussion: Harmonizing the Exosome & Extra-Cellular Vesicle Regulatory Landscape Towards Better Definitions, Practices & Guidelines for Therapeutic Success 9:30 am

What are the current gaps in knowledge of submissions, and what can we learn from current therapeutic progress in the clinic? How does the current regulatory guidance provide clarity on CMC changes for exosome-based therapeutics? How can the exosome biopharma industry and regulators continue to support each other to ensure global harmony and better therapeutics…Read more

day: Conference Day Two