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.