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© 2022 MJH Life Sciences and BioPharm International. All rights reserved.
© 2022 MJH Life Sciences™ and BioPharm International. All rights reserved.
Julie Barthuet is head Regulatory CMC&D Vaccines at Sanofi Vaccines.
Change of lot or extension of reference standard shelf-life is considered low
risk and should be downgraded from prior-approval to being managed in the Pharmaceutical Quality System (PQS) only based on a science and risk-based approach.