Continuing Education credits are not available for the On Demand offering.
Part A - Broadcast time: 36 minutes
Part B - Broadcast time: 48 minutes

Series Overview: This 4-part webinar series is designed to introduce the recent revisions to the Pregnancy and Lactation Labeling Rule, discuss resulting policy decisions, and describe different approaches for proactively gathering relevant data. This series will follow the 2015 DIA Annual Meeting, and content will continue discussion of ideas generated at the 2015 Annual Meeting forum on methodologies to increase availability and understanding of the safety information for products used by pregnant and lactating women. The series will culminate in a workshop/forum at the DIA 2016 Annual Meeting on multiple and complementary approaches for collecting and sharing safety data on medications used by pregnant and lactating women.

The format for this webinar series is a panel discussion including industry and academic experts, government and regulatory authorities and other stakeholders, promoting a lively discussion and exchange of ideas.  A question-and-answer session will be offered for the live webinar audience. 

In Part 2, we will discuss the challenges of conducting postmarketing studies in pregnant women. Key messages from the 2014 FDA public meeting and 2015 DIA Annual Meeting Workshop will be presented and discussed. Experts will discuss implementation of pregnancy registries as well as methodological considerations. Experts will discuss the current thinking and experiences in the approaches to postmarketing data collection in pregnant women, including complementary approaches for collecting data for labeling and decision-making purposes, highlighting the advantages and limitations of each.

Links to Remaining Series Parts

Series Part 1

Series Part 3

Series Part 4