CPD Supplements 2020
Global regulatory frameworks for the development of gene therapy products
Gene therapies have the potential to revolutionise the global healthcare system. Some of these products may offer curative benefits to patients with devastating conditions. This continuing professional development (CPD) supplement provides an overview of the regulatory framework for the development of gene therapy products in key markets.
Gene therapy: regional assessment comparison
Axicabtagene ciloleucel (tradename YESCARTA) is an autologous chimeric antigen receptor T-cell (CAR-T) therapy that targets CD19 and is approved for the treatment of aggressive, relapsed or refractory forms of B-cell non-Hodgkins lymphoma (NHL). The active substance is composed of a patient’s cells that have undergone ex vivo modification, which causes ...
Expedited drug development regulatory pathways in the EU and the US
This continuing professional development (CPD) supplement focuses on the regulatory framework available to drug developers for expediting their products’ development and review processes in the EU and US. These mechanisms are relevant for products which address an unmet medical need in the treatment of a serious and/or life-threatening condition.
The Olaratumab experience
As highlighted within this CPD article, a conditional marketing authorisation (CMA) can be revoked in Europe. However only one occurrence has occurred since 2006 (in April 2019). Lartruvo (olaratumab), a humanised antibody, was granted a CMA via accelerated assessment on 9 November 2016 for adult patients with a locally advanced, ...
Presentation of immunogenicity-related information in regulatory dossiers
The purpose of this continuing professional development supplement is to explain how an integrated summary report can be created to consolidate the information required for assessment of immunogenicity-related risks of different types of biopharmaceuticals.
Creating an integrated summary of immunogenicity report
The purpose of this case study is to illustrate the creation of an integrated summary of immunogenicity report (ISI) that fulfils the recommendations described in current regulatory guidance for the scope of information needed to facilitate assessment of immunogenicity-related risks to support marketing authorisation of novel and biosimilar versions of ...
How to manage teams through change
Within this continuing professional development (CPD) article we introduce some practical models and tools that can be actively utilised to the benefit of any manager who is responsible for implementing change.
The psychological contract and the hierarchy of criteria
The following exercise will give some insights into people’s immediate reactions to change. This could apply to you or your teams’ reactions:
The Organisation for Professionals in Regulatory Affairs
- Issues
- Contact us
- Topics A-Z
- Contributors A-Z
- Copyright © 2023 The Organisation for Professionals in Regulatory Affairs Ltd. t/a Regulatory Rapporteur - All rights reserved