Good Pharmacovigilance Practice: The Way Forward?
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Good Pharmacovigilance Practice: The Way Forward? Moniko Pietrek, MD, PhD, MSc Safety and Risk
Management Expert, Pietrek Associates GmbH. Germany
Rosrlird Codson, MSc, FRPhoriS Safety and Risk Management Expert. Pietrek Associates GmbH. UK
Andrzri Czorrrcki, MD, PhD, DSc Global Product Safety, Eli Lilly and Co, Lilly Research Centre. Windlesham, Surrey, UK
Key Words Phannacovigilance; Good phannacovigilance practice; Risk management; Pharmacovigilance legislation; Phannacovigilance guidance Corrrrpordrrcr Address Dr. Monika Pietrek (email: monika.pietrek@ pietrekassociates.com).
In the best interest of safeguarding public health, the science of phannacm'gilance has grown in importance over the last 30years. In the mid- l98Os, industry academia, and replators joined fmes to improve the conduct of phannacm*gilance,which d t e d in severd important initiatives including CIOMS and the ICH process. Multiple aspects of pharmamgilance have been recognized and addressed within the legai fmmework that subsequently has created numerous requirementsfor pharmacovigirance in legislation intematimalZy Also, the dayto-day nutning of phannacm*gilancehas developed into a
INTRODUCTION Over the last 30 years, regulators and the pharmaceutical industry have introduced a set of principles for quality management in drug development. These working practices relevant to the various stakeholders involved are often referred to as good X practice and include guidance on the conduct of clinical studies: good clinical practice (GCP), good laboratory practice (GLP), and good manufacturing practice (GMP), GCP being possibly the most widely known. Following national initiatives, the International Conference on Harmonization (ICH) has taken these guidances forward in order to support the marketing authorization process and the trade of pharmaceutical products globally (1). In addition, the ICH has addressed postmarketing drug safety issues, developing three major documents (2). Pharmacovigilance or the surveillance of the safety of medicinal products has become the cornerstone for ensuring patient safety, not only for marketed medicinal products but also for compounds under investigation after marketing authorization, such as new indications or dosage. While the thalidomide disaster in the
very complex business process. In recognition of these issues and the inmasing complexities of the global environment, a group of EU phannam-gilanceexperfsmet in 2oQswith thegoal of disacssinghaw to facilitate the understanding of pharmam*gilancespecijixdy dated to the conduct of good phmam*gilance pmctices. Bminstonning d e d the outline of a docum e n t / t m the table of contents, and a desaiption of the topics that should be covered for the book to become a comprehensive refmce document of good pharmam.gilance pmctice for everyone interested in undmtandingor working in thefield of phannacm'gilance.
1960s triggered relevant legislation for the regulation of medicinal products and legal requirements have continued to be tightened, general guidanc
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