In this podcast, Dr. Milligan makes the case for studying drugs in pregnant and lactating women on an ongoing basis to understand long-term efficacy and safety, as well as effects of concomitant medications on these women. Sandy believes that the entire ecosystem--regulators, policymakers, governments, physicians, healthcare systems, and industry, need to have a conversation around improving the under-met and unmet needs of women, which includes understanding the unique experiences of women with conditions such as pre-term labor, menopause or endometriosis.
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.