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Introduction to ATMPs and route to market

13 November 2023 09:00-17:00, Reading, United Kingdom


Introduction

Course Overview

This course discusses the key regulatory requirements and issues surrounding developing and translating an advanced therapeutic medicinal product (ATMP) to the clinical trial and market authorisation application.

ATMPs represent a growing number of therapeutics entering clinical development and market authorisation application (MAA). This cutting edge therapeutic area sits with an evolving area of legislation. During this one day course you will be introduced to ATMPs and their categories, key factors to consider with your process development from bench to clinic including Good manufacturing Practices (GMP), preparation and submission of Investigative Medicinal Product Dossiers (IMPD) and Investigator Brochures (IB), quality, potency and stability assessment of your product.
Venue
Online

Online, Reading Scientific Services Ltd, Reading Science Centre, Whiteknights Campus Pepper Lane, Reading, RG6 6LA, United Kingdom

Contact information
RSSL Training
Reading Scientific Services Ltd
Reading Science Centre
Whiteknights Campus
Reading
Berkshire
RG6 6LA
+441189184076
Contact us by email

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