The objectives of the Guide are to raise awareness of the magnitude of the drug safety problem and to convince health professionals that reporting of adverse reactions is their moral and professional obligation.

The purpose of this document is:
• to present the case for the importance of pharmacovigilance,
• to record its growth and potential as a significant discipline within medical
science, and
• to describe its impact on patient welfare and public health.

This booklet aims to provide practical guidelines and information for the setting up of new Pharmacovigilance Centres.

amending, as regards pharmacovigilance of medicinal products for human use, Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, and Regulation (EC) No 1394/2007 on advanced therapy medicinal products. (Text with EEA relevance)

amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use.
(Text with EEA relevance)

Das Thema Outsourcing steht schon seit einigen Jahren im Focus verschiedener Veroeffentlichungen der Fachpresse. War es noch vor kurzem uueblich, dass pharmazeutische Unternehmer, die in Deutschland Arzneimittel vertreiben wollten, eine deutsche Niederlassung gruuendeten, wird aktuell vermehrt von der Moeglichkeit Gebrauch gemacht, ohne deutsche Niederlassung direkt von EU-Ausland den deutschen Markt mitzuversorgen. In dem folgenden Beitrag wird gezeigt, dass es sinnvoll ist, Arbeiten im Bereich MedWiss, Qualitaetsbeanstandungen, Pharmakovigilanz und Zulassung an einen sog. „local contact point“ zu uuebergeben.

People working in Pharmacovigilance strive to implement the regulations - but can they
be confident that the output of their activity is translated into more informative and
useful product information for the prescriber or patients? How have things improved
over recent years? Has the increase in information sources and case report numbers
had a positive effect? What could be the way forward to improve provision of accurate
and helpful safety information?

How can genomics have an impact on the management of your clinical trials? With the growing understanding of genetic code within personalised medicine, could this signal a change in the size and scope of clinical trials? What does this mean for the pharmaceutical industry and the patient?