News Items

Dear Interested Parties to the Committee for Advanced Therapies (CAT),

As some of you may be aware, at the end of each CAT plenary, the CAT Secretariat drafts a Meeting Report where it disseminates key elements of the work of the CAT. We wanted to make you aware of this document in order to aid you with the attainment of up-to-date information on the decisions made by the CAT. Please click here:

http://www.emea.europa.eu/pressoffice/cat.htm

You may consider keeping the above webpage in your favourites section for rapid access.

On 15 September last year, a joint meeting between TOPRA, EFPIA, EBE and The European Medicines Agency on Paediatric Medicines took place in London, UK.

This meeting was set up to address the fact that the need to submit paediatric investigation plans (PIPs) has been a requirement for around 2 years and there have been many new procedures and processes to master to prepare a PIP and then to follow it through. This practical workshop enabled members of the paediatric committee (PDCO) to share with Industry through case studies what should be considered when preparing and writing a PIP.

The framework for the regulation of medicines grows more complex every day. The development of new product types, the harmonisation of requirements and the addition of new countries to the EU all have resulted in an environment where it’s becoming increasingly hard to predict how the regulatory agencies will view applications.

At the same time we see more and more information becoming available.

The European Medicines Agency has published a Questions and Answers document on Gene therapy (EMA/CHMP/GTWP/212377/2008), which is available on the following webpage:

http://www.ema.europa.eu/pdfs/human/genetherapy/21237708en.pdf

This document will be regularly updated on the basis of received comments and questions. Should you have any, please send them to GTWPsecretariat@ema.europa.eu

The prestigious international Regulatory Affairs Awards, organised by a sub-committee of TOPRA’s STAR Panel, will take place on 5 October this year. Over the coming months this Awards logo will become very familiar to members and many other regulatory professionals. The Awards signify TOPRA’s commitment to recognise individuals, teams and organisations who have demonstrated excellence in regulatory affairs. Entry is open to any individual, organization or company working in the healthcare regulatory sector wherever they are based.