ISoP Symposium
ISoP ā ENTIS Training Course 20016
2-3 June | Berlin, Germany
Organiser: ISoP / ENTIS
Risk assessment of drugs used during pregnancy and lactation.
The International Society of Pharmacovigilance (ISoP) in co-operation with the European Network of Teratology Information Services (ENTIS) will hold a joint training course on 2nd to 3rd June 2016 in Berlin, Germany. This training course will address the specific areas of drug use during pregnancy or breastfeeding and pharmacovigilance. Experts working on these fields either in hospitals or community settings, drug agencies, pharmaceutical companies or in academia are the target audiences. Items in the programme will address basic and specific aspects of teratology, some epidemiologic tools to monitor drug use during pregnancy or breastfeeding, and communication about risks in this specific setting.
Through this meeting, ISoP is pleased to partner with ENTIS on provision of education material in the important field of problems of drug use during pregnancy or breastfeeding and how pharmacovigilance will help manage these risks. This two days course is targeted at physicians, scientists, regulators and industry, with a focus on problems in medical care during pregnancy.

Main Topics
- Maximising the potential of established sources in pharmacovigilance: spontaneous reporting systems and observational studies
- Embryology and causes of adverse pregnancy outcomes
- Pharmacoepidemiology of drugs during pregnancy
- Specific diseases and drugs during pregnancy, e.g.: Hazardous intrauterine infections: example CMV Thyroid diseases and iodine deficiency Maternal obesity and diabetes Vitamins and supplements Epilepsy and anti-epileptics: valproate and safer alternatives Depression and antidepressants Autoimmune diseases and immunomodulatory drugs
- Infantās mental development after intrauterine exposure
- Drug exposure during breastfeeding
- Risk perception and risk communication
The faculty for this course consists of international and national experts in teratology, pharmacovigilance, and communication.
ISoP ā ENTIS Training Course Berlin on āRisk assessment of drugs used during pregnancy and lactationā accredited for CME credits
The āISoP and ENTISā symposium āRisk assessment of drugs used during pregnancy and lactation.ā is accredited by the European Accreditation Council for Continuing Medical Education (EACCME). The course āRisk assessment of drugs used during pregnancy and lactation.ā is designated for a maximum of 12 hours of European external CME credits.
Certificates can be handed over at the end of the course on 3 June.