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Accelerated CMC and regulatory efficiency tools can be used to support the approval of medicines in early access programmes, such as emergency medicines and medicinal products for unmet medical need…
Over recent years, an increasing number of medicines have been developed for orphan indications and for treatment of unmet clinical need. The abbreviated development times associated with such clinical programmes has required sponsors to expedite CMC activities…
The EFPIA Biomanufacturing Working Group is a cross-company industry team working to aid the development of biological products for patients. Through areas of special interests, the group supports and develops cutting edge science and technology strategies…
Digitalisation is already transforming industries and its application in the world of regulatory assessment is on the horizon. Multiple recent efforts have focused on digitalisation and its potential to increase efficiency in submission and review, for both industry and agencies…