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This exciting plenary started the first in person meeting of the Centre of Excellence for Long-acting Therapeutics’ (CELT) Community of Practice for long-acting therapeutics for maternal and paediatric health (01.07.25). The Community of Practice is an international group of researchers, community group, regulators, policymakers, legislators, health care providers and more. We are dedicated to creating a pathway for pregnancy, lactation and child safety within the new scope of long-acting research. This session concentrates specifically on the importance of considering maternal health within our work, including pre-pregnancy, each trimester of pregnancy, postpartum and lactation. Each of these phases are physiologically different and we must understand them within long-acting work. While we have taken time to ensure accuracy in the captions, please understand that some mistakes may have been missed. If you spot any mistakes in the captions, please contact us on askcelt@liverpool.ac.uk. 00:00 Welcome from CELT’s Professor Andrew Owen 01:18 Chair, Dr Ethel Weld’s Introduction to Maternal Health 02:26 Professor Sharon Nachman – Priorities for research in pregnant, postpartum and lactating women 25:20 - Dr Rachel Scott – Pharmacokinetics and safety considerations for long-acting therapeutics: HIV prevention and treatment during pregnancy and breastfeeding 48:52 - Dr Adeniyi Olagunju – Long-acting therapeutics technologies and innovations: Potential applications for maternal health priorities 1:09:48 - Question and Answer session starting with a question from Dr Emily Njuguna, a paediatrician from Nairobi in Kenya 1:11:47 - A question from Mili Karina, a nurse midwife and a board-certified lactation consultant from Kenya 1:16:17 - A follow up question from session Chair, Dr Weld 1:19:07 - A question from Patrick Gad Iradukunda from Rwanda Food and Drug Authority 1:24:50 - A question from Nathaniel Nkrumah from the Ugandan Food and Drugs Authority 1:27:49 - A comment and question from Andrew Butler who is a Clinical Pharmacology Assessor at MHRA (a UK regulatory body) 1:29:36 - The last question from Dr Shadia Nakalema We extend our thanks to global health agency @Unitaid, who fund the community of practice and without whom, this meeting and all our work would not be possible. Links: Community of Practice project page - https://www.liverpool.ac.uk/centre-of... Unitaid – https://unitaid.org/about-unitaid/ Postapproval Pregnancy Safety Studies Guidance for Industry from Professor Nachman’s talk - https://www.fda.gov/regulatory-inform... DASH – https://dash.nichd.nih.gov EMA guidelines - https://www.ema.europa.eu/en/document... The EMA page - https://www.ema.europa.eu/en/ich-e21-...