Product Safety Management

ProductLife's involvement in Safety and Efficacy issues

 

To ensure safety and enhance know-how, industry professionals are now required to invest more resources to manage Safety and Efficacy data within the context of an increasing burden of proof.

 

The first consequence of this requirement is a substantial increase in the number of studies to be conducted. Portfolio management tools have now become necessary in order to track these studies (clinical, epidemiologic studies, etc). Within this context, ProductLife has been involved in defining and selecting tools as well as in drafting and establishing best practices. Similarly, ProductLife has carried out an examination of the harmonisation of clinical and Pharmacovigilance databases including the tools and practices involved in preparing the reporting of adverse events.

 

A second consequence of safety requirements is the increasing complexity of the studies that are conducted and the sharp rise in the volume of data generated. In order to facilitate the exchange of information with third parties or with the relevant Authorities, ProductLife has been involved in the implementation of electronic CRFs (eCRFs), and more generally in all new approaches to exchanging data sets. The same also applies to understanding, interpreting and adopting exchange standards such as the now mandatory CDISC standard (Clinical Data Interchange Standards Consortium).

 

Material published by ProductLife:

With the aim of achieving overall improvements in the processes and information systems in this area, ProductLife has played a key role in a joint examination with Authorities on the subject of fraud and misconduct in therapeutic trials and has co-authored a book on the subject entitled "Fraud and Misconduct in Biomedical Research", edited by Frak Wells and Michael Farthing and published byt the Royal Society of Medicine Press.

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