Regulatory affairs and quality assurance: ipm's regulatory affairs team oversees the monthly dapivirine ring regulatory process, providing leadership in dossier preparation, filings, and post-approval maintenance in Europe, the United States, south Africa, and other target african countries, where ipm is preparing for the market introduction of the ring. This division also supports all regulatory efforts for other ipm products on the product development pathway; this support includes submission and maintenance of investigational new drug (ind) documentation and conducting regulatory agency interactions related to new protocols for upcoming clinical trials. Importantly, in 2021, the regulatory affairs team managed all post-authorization measures related to the ema's positive scientific opinion of the monthly dvr. Additionally, the team completed the necessary activities to secure world health organization (who) prequalification (pq) and a recommendation from the who as an additional HIV prevention choice for women as part of combination prevention. The monthly dvr is now under regulatory review in african countries. These efforts were then leveraged, and the dvr dossier was submitted to numerous african countries for review and approval. By the end of 2021, the monthly dvr had received approval from 5 african countries. The monthly dvr remains under regulatory review in additional african countries.In partnership with the regulatory affairs team, the quality assurance (qa) team ensures ipm's product development and clinical studies are conducted in compliance with all applicable drug and safety laws. Audits are conducted during clinical trials to assure protocol compliance and compliance with an international conference on harmonization of technical requirements for registration of pharmaceuticals for human use (ich) guidelines, good clinical practices (gcp), and all applicable regulations. Vendor audits are also conducted where ipm's clinical, preclinical, or cmc work is conducted.

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