In response to popular demand, we are pleased to announce the upcoming 3rd course of the CMC and GMP for Biomanufacturing; Biologics and ATMPs which will be held in Amsterdam, The Netherlands.

This 2-day (19-20 June 2024) training course will explore two essential aspects of biomanufacturing: CMC (Chemistry, Manufacturing, and Controls) and GMP (Good Manufacturing Practice). These concepts are crucial for the development and production of biologics and ATMPs (Advanced Therapy Medicinal Products).

Compliance with GMP regulations is essential to guarantee the safety, efficacy, and quality of biologics and ATMPs. It helps minimize risks, prevent contamination, and ensure batch-to-batch consistency. GMP guidelines are enforced by regulatory authorities such as the FDA (Food and Drug Administration) in the United States, the EMA (European Medicines Agency) in Europe, and other relevant agencies worldwide. Throughout this workshop, we will delve deeper into CMC and GMP principles, discuss case studies, and explore the latest advancements in biomanufacturing for biologics and ATMPs. We hope this knowledge will empower you to contribute effectively to the field and advance the development of innovative therapies.

Contact: Stephen Meade at stephen@globalengage.co.uk for further inquiries and group discount.

Key Topics:

1

AN INTRODUCTION TO CMC

2

(BIO)CHEMISTRY

3

MANUFACTURING

4

CONTROL

5

INTRODUCTION TO THE PARADIGM SHIFT IN GMP CONSIDERING

6

CONTROL STRATEGIES

7

PROCESS RISK MANAGEMENT

8

PRINCIPLE GMP CONTAMINATION OF CONTROL MEASURES AND MONITORING

9

FILL AND FINISH OF BIOLOGICAL PRODUCTS AND ATMPS

Trainers

David Murray

Principal Consultant Parexel

James Drinkwater

Head of the PHSS Aseptic processing and Annex 1 focus groups, PHSS

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