S2 ScienceSolutions

Patient registries may be an important source for “real life evidence” e.g. with regard to chronic and/or rare diseases or in the collection of drug utilization data. However they have be criticized on several levels including the concerning the standardization in data collection and potential competition for registered patients across registries which could create a fractured set of patient data.
PARENT (Patient Registries Initiative) is co-funded joint action by the European Commission and some member states. The overall objective is to support the EU-Member States in developing comparable and interoperable patient registries in clinical fields of identified importance thus enabling the use of secondary data for public health and research purposes in cross-organizational and cross-border setting.
The PARENT framework consists of:
__A knowledge management platform providing documents including guidelines, state-of-the-art reviews, best practices
__IT tools and models repository including software tools and links to external tolls and services relevant for patient registry implementers and holders.
__A Registry of Registries providing structured search across a number of EU Patient Registries.
The PARENT website might be a valuable source for initiators of registries as well as for marketing authorization holders seeking for existing data (e.g. within risk management planning or implementation).
Read more: http://patientregistries.eu/web/guest/parent

Patient registries may be an important source for “real life evidence” e.g. with regard to chronic and/or rare diseases or in the collection of drug utilization data. However they have be criticized on several levels including the concerning the standardization in data collection and potential competition for registered patients across registries which could create a fractured set of patient data.
PARENT (Patient Registries Initiative) is co-funded joint action by the European Commission and some member states. The overall objective is to support the EU-Member States in developing comparable and interoperable patient registries in clinical fields of identified importance thus enabling the use of secondary data for public health and research purposes in cross-organizational and cross-border setting.
The PARENT framework consists of:
__A knowledge management platform providing documents including guidelines, state-of-the-art reviews, best practices
__IT tools and models repository including software tools and links to external tolls and services relevant for patient registry implementers and holders.
__A Registry of Registries providing structured search across a number of EU Patient Registries.

The PARENT website might be a valuable source for initiators of registries as well as for marketing authorization holders seeking for existing data (e.g. within risk management planning or implementation).

Read more: http://patientregistries.eu/web/guest/parent

Pharmaceutical companies may obtain scientific advice to help with the design of clinical trials for the generation of robust data for a benefit-risk assessment from the Scientific Advice Working Party (SAWP) of the European Medicines Agency (EMA). In a 12-month pilot project starting in Q3 2015 the EMA extended this service to post-authorisation safety studies (PASS).
The service is focused on the evaluation of protocols for non-imposed PASS (category III), whereas imposed PASS still undergo a routine assessment by the PRAC or the competent authority concerned according to Art. 22a of Directive 2001/83.
This service is a voluntary option for marketing authorization holders and applicants. It follows the routine scientific advice procedure but involves PRAC experts. As with routine scientific advice fees are charged on initial as well as on follow up requests.
Read more:
http://bit.ly/European_Medicines_Agency_Postauthorisation