The ENTIS Board and Scientific Committee have submitted an official communication to the EMA Pharmacovigilance and Risk Assessment Committee (PRAC) to highlight their concerns with recent updates to the Lyrica SmPC. The submitted letter can be read here. Photo by Scott Graham on Unsplash
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ENTIS affiliate member Dr Michael Ceulemans and colleagues from the Department of Pharmaceutical and Pharmacological Sciences at KU Leuven, Belgium, have published their informative results from a qualitative study investigating the experiences and perspectives of pharmacovigilance specialists at Marketing Authorisation Holders (pharmaceutical companies) towards the safety monitoring of medication exposures in pregnancy. More information can be found here. Photo by Antenna on Unsplash
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Registration is now open for the 33rd annual ENTIS conference, to be held in Bergamo, Italy from the 8th-10th September 2022. Click here to register. The early registration discount is available from 1st April until 31st May. See here for the final programme for the meeting. The organising committee and ENTIS board are really looking forward to seeing everyone there! Photo by Dom Fou on Unsplash
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The 2022 annual conference will take place in Bergamo in September. Conference delegates are invited to submit abstracts in consideration for free communication at the meeting. The deadline for abstract submission is now only one week away, Tuesday 1st March. The abstract template and submission instructions can be found here. For more information about the conference, please see here. Photo […]
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The ConcePTION project invites women, their partners, health care professionals, researchers, clinicians and representatives from companies that develop medicines and authorities that approve them to an online workshop which will focus on how we can improve the collection of information and understanding about the risks and benefits of medicine use in pregnancy and breastfeeding. The workshop will take place on […]
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A recent “consensus statement” review article published in Nature Reviews Endocrinology concluded that there is a growing body of evidence supporting the hypothesis that in utero exposure to paracetamol (or acetaminophen, APAP) impacts fetal development. This paper has been widely cited by national media organisations, some of which reported the findings in an alarming manner. ENTIS holds the position that […]
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The ENTIS Board are pleased to announce this year’s ENTIS business meeting will be held virtually on 10th November 2021, and will run from 13:30 to 16:30 Central European Time (CET). Details including the agenda and online access instructions will be posted in the members’ only section of the ENTIS website shortly. The agenda will include an update from each TIS, a case report […]
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It is with great pleasure that we are able to announce plans are underway to host the 2024 joint OTIS ENTIS meeting in Nyborg, Denmark. Meeting host and organiser, Professor Per Damkier (University of Southern Denmark and Odense University Hospital) has issued this save the date announcement. Photo by Markus Winkler on Unsplash
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In July 2019, the European Medicines Agency (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) released an updated, comprehensive assessment report on the use of ondansetron in the first trimester. The ensuing Summary of Product Characteristics (SmPC) was updated in November 2019 with important changes to section on “Fertility, pregnancy and lactation.” The SmPC now states that ondansetron should not be used […]
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