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 1, we will discuss the Pregnancy and Lactation Labeling Rule, which will include a review of the new formatting and content requirements and standards for how information is presented in the pregnancy and lactation sections of labeling for prescription drugs and biological products. Experts will describe the impact of these new requirements on industry and researchers and discuss the expectations for the inclusion of additional information in the revised labeling.

Links to Remaining Series Parts

Series Part 2

Series Part 3

Series Part 4