Position statement: Live vaccine use following in utero or lactation infliximab exposure

In March 2022 the European Medicines Agency’s (EMA) published a direct healthcare professional communication (DHPC) regarding the use of live vaccines in infants exposed to infliximab in utero or during breastfeeding. The DHPC stated that live vaccines (e.g. BCG vaccine) should not be given to infants less than 12 months after birth following in utero infliximab exposure, and that administration […]

» Read more

Case report of bosentan and sildenafil use in lactation and medication disposition in breastmilk.

ENTIS affiliated researchers from the Department of Pharmaceutical and Pharmacological Sciences, KU Leuven have published a case report of bosentan and sildenafil use in lactation. This report, from the IMI ConcePTION project, presents the clinical and pharmacokinetic data of a single mother-infant pair exposed to bosentan and sildenafil for the treatment of pulmonary arterial hypertension (PAH) during lactation. More information […]

» Read more

Experiences and perspectives of Marketing Authorisation Holders towards the monitoring of medication safety in pregnancy

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

» Read more

33rd Annual Conference 2022; REGISTRATION NOW OPEN

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

» Read more

Annual conference 2022; Final reminder for abstract submission

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 […]

» Read more

REGISTER NOW: ConcePTION Workshop – Moving pregnancy pharmacovigilance into the 21st century

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 […]

» Read more

OFFICIAL ENTIS POSITION STATEMENT: Paracetamol (acetaminophen, APAP) use in pregnancy

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 […]

» Read more
1 2 3 4 5 7