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

How to optimally integrate a Paediatric Investigation Plan into a drug development programs, TOPRA Vol 7, No.5

Regulatory Rapporteur

For products falling under the mandatory scope of the centralised procedure, integrating a Paediatric Investigation Plan (PIP) into a company's development programme can become very challenging.

EU Compassionate use Programme (CUP) regulatory framework and points to consider before CUP implementation

Pharma Medecine Journal

For some patients, compassionate use programmes (CUPs) are the only way to access promising medicinal products that are not yet authorized and for which clinical trials are either not available or in which these patients cannot participate.

Overview of the EU CTA Regulatory Framework and Future Direction of the EU Clinical Trial directive

Pharma Bio World

Over the last few years, the European authorities have undertaken substantial new regulatory initiatives regarding the conduct of drug development activities, Clinical Trial Application (CTA) and Marketing Authorisation Application (MAA) submissions.

IIR's Partnership Debuts in the Asia Pacific

Applied Clinical trials

Representing more than a third of the world’s population, the Asia-Pacific is an attractive option for cost-effective clinical research regardless of whether the target market for the product is within or outside the region. However, if the clinical research is not conducted efficiently, or to an appropriate level of quality, the anticipated savings can in fact lead to costly mistakes.

Working as Independent Consultant

RAPS Book Chapter

An Independent Consultant is broadly defined as a person who is self-employed and works for clients in a specific field on a per-project basis. In this article, we provide a description of the general roles of a Regulatory Affairs Independent Consultant.

Defining a PIP strategy for a new medicinal product: A step by step approach,TOPRA Vol 6, No.5

Regulatory Rapporteur

A key step in the preparation of a paediatric investigation plan (PIP) for a new medicinal product is to define the PIP strategy, ie, to define how the studies/data extrapolation/waiver/deferral combination will cover, for each targeted indication, all subsets of the paediatric population.