Advanced therapy medicinal products (ATMPs) belong to a rapidly developing, state-of-the-art field of science and technology in the EU. Due to the complex nature of ATMPs involving gene and cell therapy products, product development can be challenging. Regulatory...

Early access programs (EAP) provide unauthorized medicinal products prior to marketing authorization and commercial launch for life-threatening, chronically or seriously debilitating diseases, which can not be treated satisfactorily by an authorized medicinal...

This article aims to share some key considerations when defining the strategy for the preparation of a risk management plan (RMP). The RMP is required to be submitted when applying for an EU marketing authorisation application (MAA). Advice is offered to applicants...

This article describes the regulatory frameworks and incentives associated with orphan drug designation (ODD) in the EU and the US, as well as capturing key strategic considerations needed to achieve successful orphan drug product development and registration in...

This article introduces the roles of HTA bodies within the EU member states healthcare system and provides key elements to consider for manufacturers, which would like to enter such geographical market, on key elements to consider. In addition solutions to maximize...

Developing the relevant set of potency assays for cell-based medicinal products comes with numerous challenges due to the complex nature of the products. This paper highlights several approaches to consider when designing the potency assay strategy in the framework...

This article, the second in a two part paper highlights the main challenges faced by marketing authorisation applicants for the conversion of a dossier from one region to another, and deciding between a sequential and a parallel preparation.

Nathalie Boeglin...

Big data, mobile health and synthetic biology: An overview of some of the changes and measures were taken by regulators as they strive to keep up with the latest developments.

Habib Zalila and Emmanuelle Voisin

This article was published in Scrip...

Application of industrial biotechnology has changed dramatically over the past decade. Stainless steel process equipment has largely given way to disposable systems, facilitating easier and quicker process configurations and up-scaling. Suppliers generally made...

An overview of the main challenges faced by marketing authorisation applicants for the conversion of a dossier from one region to another, and deciding between a sequential and a parallel preparation.

Nathalie Boeglin, Alice Rolland, Frederic Pailloux and...

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