Case Study Milestone 2 FD Part 2 - Development Plan

Overview of Activities for Case Study.

Recap: Product Description LAT101 & LAT202.

Manufacturing Process Development.

GMP Insights from EMA Guidance Documents.

Cell Banks (including MVS and WVS.)

Viral Safety Evaluation.

Ph. Eur. General Chapter 5.2.12 Raw materials of biological origin

Overview of EU Guidance Documents on ATMPs for clinical trails

Overview of FDA Guidance Documents for Gene Therapy INDs

Decentralised Manufacture (MHRA – UK)

Non-Clinical Program Development.

Clinical Program Development.

Clinical Aspects. ICH M4Q (R2) Step 2b – Brief Overview

The video link is attached here: Case Study Milestone 2 FD Part 2 Development Plan