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.

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.

Implementing the new EU Legislation on advanced therapy Medicinal product

Informa UK Ltd

An EMA workshop in london gave an important insight into the implementation of the European regulation on Advanced Theraphy Medicinal Products (ATMPs).

Building an affordable innovative drug development chain

Express India

Every time there is a new regulation requested by the government, or generated by the industry needs, our scientific and technical contributions not only help us to remain updated but also aware of the philosophy underlying new regulations. Dr Emmanuelle Voisin, CEO, Voisin Consulting spoke on the trends in regulation and how India fits into her plans to build an affordable innovative chain, from discovery to market.

European Biotech sector struggles to survive funding crisis, Monthly, June 2009

The Center Watch

One in five European small biopharmaceutical companies faces the rick of bankruptcy by the end of 2009. the situation could worsen if the economic downturn continues into 2010, warns the European Biopharmaceutical Enterprise (EBE).

Chapter RAPS: Working as an Independent Consultant in Regulatory Affairs

RAPS Career Book

The European Regulations for Orphan Medicinal Products have been successfully implemented in the EU. Many companies have used or are using these regulations as is demonstrated by the high number of applications to the COMP. Only a limited number of products with Orphan Medicinal Product Designation have reached the market.

Update on the implementation of the European ATMP regulation


A July 2009 adoption/publication of a revised Annex I of Directive 2001/83/EC is foreseen. Discussions on how to appropriately assess combined ATMPs are advanced, with the CAT medical device experts directly involved in these discussions.