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Publications
We author publications presenting our opinions, methodological approaches to health
products development, and our views on environment changes.

Considerations for developing EU risk management plans

February 2017
Regulatory Rapporteur - TOPRA

Obtaining orphan status – A key milestone within a development strategy

July / August 2016
Regulatory Rapporteur - TOPRA

Market Access in Europe: Bridging Regulatory and Health Technology Assessment (HTA) Gaps

April 2016
Regulatory Affairs Professionals Society

The challenges of potency assay development for cell-based medicinal products in Europe

May, 2015
Regulatory Rapporteur

Developing the relevant set of potency assays for cell-based medicinal products comes with numerous challenges due to the complex nature of the products.

Preparing a drug registration for the US and the EU: Parallel or sequential applications? – Part 2

June, 2015

Regulatory Rapporteur

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.

Keeping up with innovation: The challenge for regulators

March, 2015
SCRIP Regulatory Affairs

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

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