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The EU-Innovation Network announces a pilot project for simultaneous national scientific advice (SNSA) to strengthen early regulatory support for innovation. The pilot project kicks off with developing a best practice model starting 1 February 2020.
The FAMHP has created an online form for healthcare professionals to notify any adverse effects of medicinal products for human use. This new format incorporates the patient notification form for that has been online since March 2019. From now on, anybody can notify adverse effects of medicinal products using simplified online forms available at a single address: www.notifieruneffetindesirable.be or www.eenbijwerkingmelden.be.
In its capacity as the competent national authority, the FAMHP is actively engaged at a European level. In the context of its international activities, the agency keeps developing its network of European partnerships.
May employees of companies making, importing or distributing medical devices be present in the surgical area? Yes, but only under certain conditions.
L’Amérique du Nord connait depuis plusieurs années une « épidémie » d’abus, de surdosages et de décès liés aux opioïdes. Dans une moindre mesure, ces dernières années l’utilisation d’opioïdes en Europe a fortement augmenté, entre autres pour faire face au syndrome de la douleur chronique. Bien que s’inscrivant dans le cadre de l’amélioration de la prise en charge de la douleur, l’utilisation accrue d’opioïdes est remise en question au vu des risques associés à leur abus. L’accent est donc mis sur la prévention de la dépendance et des abus, et sur l’importance de l’usage rationnel des opioïdes.
The European Medicines Agency (EMA) is performing further research after a recombinant strain containing two living attenuated Porcine Reproductive and Respiratory Syndrome Virus (PRRSV) vaccines was identified in Denmark. The recombinant strain was associated with clinical symptoms of PRRS, such as reduced fertility in sows, increase in the number of rejections, increased in piglet mortality, reduced appetite and respiratory conditions in young pigs.
Quality defects in medicinal products can impact patients’ health or make it difficult for healthcare professionals to administer them. Quality defects can be reported via the FAMHP website.
Based on the evolution of the pilot project for the new Clinical Trial Regulation, the FAMHP made an update on the guidance document to assist clinical trials sponsors as part of the pilot project for clinical trials.