This lecture will cover the main Challenges of Pharmacoepidemiological studies on Drug safety in Pregnancy and will propose potential solutions. The goal is for participants to: 1. Understand the circumstances around the discovery and management of drug safety crises affecting pregnant women and their offspring. 2. Recognize the unique methodological challenges of discovering unintended drug effects in pregnant women in pre-marketing and post-marketing studies. 3. Describe and discuss approaches to establish boundaries of safety for drugs used in pregnancy. 4. Interpret scientific evidence and critically evaluate the literature on the safety of drugs in pregnancy.