Module 9 2024

Module 9: Registration of Biological, Biotechnology and Advanced Therapy Products

Date: 9 - 11 September 2024

LOCATION: TOPRA OFFICE, LONDON, UK / ONLINE

Module Leader: Rhydian Howells

Date: Monday 9 th September 2024

Time

Activity

Speaker

10.30 – 10.45

Welcome & Introduction to the Module

TOPRA & Rhydian

Lecture 1: Overview of Regulation of Biologicals

Rhydian Howells, ProPharma Group

10.45 – 12.00

12.00 – 13.00

Lunch

Alison Wolfreys, UCB Celltech

13.00 – 14.15

Lecture 2: Preclinical Testing of Biologicals

Lecture 3: Clinical Development of Biopharmaceuticals

Tara Hutton, Biogen Idec

14.15 – 15.30

15.30 – 15.45

Refreshment Break

Isabelle Cludts, MHRA

15.45 – 16.45

Lecture 4: Immunogenicity Issues

16:45 – 17:00

Review of Day 1 and Close

All

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