We are thrilled to let you know that from March 19th 2018, we have become fully operational out of our new facilities! Same building, same floor, but expanded, more inspirational and better equipped to serve even better our present and future customers. You keep ON trusting us, we keep UP with our commitment to support you!

FEDRA receives an award from @asLAN association

FEDRA (the Spanish Agency database containing all notifications of adverse reactions produced by medicines) has been awarded by the association @asLAN in the category “Improvement in communication with the citizen”. Congratulations!

Q&A on Cosmetovigilance updated in the Spanish Agency website

AEMPS has updated its website section Q&A on Cosmetovigilance in order to better identify all the new regulations and indications applicable to consumers, distributors and healthcare professionals regarding the communication and transmission of undesirable adverse events. More info at AEMPS

EMA’s recommendations on ‘Dos and Don’ts’ for Eudravigilance users

The EMA has distributed some clarifying ‘Dos and Don’ts’ to be observed for ICSR reporting to Eudravigilance, based on additional operational experience with the system since November 2017. These simple but crucial indications will surely improve the quality of the system.

AEMPS: Recommendations for drug distributors regarding unusual sales and drug misuse

The Spanish Agency has released some recommendations in order to facilitate that drug distributors comply with specific obligations, related to the detection, investigation and notification of unusual sales patterns. This document concerns the need to put in place a specific procedure to communicate unusual sales that may constitute a diversion or misuse of medicines. More info at: https://bit.ly/2IXgEfi

Food supplements: additional substances regulated in Spain

Regarding food supplements in Spain, substances other than vitamins and minerals have been added to the list of ingredients allowed in the preparation of these products, in alignment with similar regulations in other EU member states. Check the full list of substances at: http://bit.ly/2HLgoP2

New office

We are thrilled to let you know that from today, March 19th 2018, we have become fully operational out of our new facilities! Same building, same floor, but expanded, more inspirational and better equipped to serve even better our present and future customers. You keep ON trusting us, we keep UP with our commitment to support you!

EMA Public hearing on quinolones

Highly committed in empowering citizens to express their views and experiences, the PRAC has proposed a new upcoming public hearing to take place at the PRAC meeting in June 2018 on quinolone and fluoroquinolone antibiotics as part of its ongoing safety review.

Keep an eye on http://bit.ly/2wNdDKU for further information and have a look at this explanatory video https://www.youtube.com/watch?v=l5y2Qrlo8mI.

Signal detection: product-related risk logs

Since long ago we have been hardly working in developing accurate and updated risk logs for every product, to better conduct the signal detection activity. It is a crucial step and we are happy to be ready at the time we have started the EVDAS pilot period, since it allows a clear methodology and assures a positive approach even with the increased workload. Should you need some help for this challenging activity, do not hesitate to contact us, we will be happy to help you.

New NCA filter in EVWEB – ICSR download

We really appreciate the new filter criterion now available in EVWEB download!

MAHs can now filter and download ICSRs based on the sender organisation type, so ICSRs received from National Competent Authorities can be easily identified.

Eudravigilance Release 5.0

On 14-Feb-2018 Eudravigilance release 5.0 will be launched. Most relevant enhancements will be the possibility of viewing attachments to ICSRs submitted in E2B(R3) by using the EVWEB workspace area, the elimination of the limit of maximum 50 rows from the Excel report and the use of coded fields rather than free text fields in the tree view of the “Create and send ICSRs” section. The updated EVWEB user manual will be available on that date.

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Services

Bussiness development
Regulatory
Pharmacovigilance
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Location

Av. Ernest Lluch, 32-TecnoCampus
Tower TCM2 6th floor
08302 Mataró – Barcelona (Spain)

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Connect

+34 93 169 65 51
info@eignapharma.com