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

Overcoming the Challenges of Establishing Expanded Access Programs in European Member States – A Regional Review

May 2017
22nd Annual Meeting of the International Society for Pharmacoeconomics and Outcomes Research

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.

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