GDP regulations and compliance are a constant challenge for professionals within the biopharmaceutical industry. Developments from the GDP, FDA, EMA and more, continue to evolve and leave the industry wondering whether its biologic shipments are properly compliant or whether biologics needs its own subsection.
Mary Foster, PharmD - USP Chair - PSD Expert Committee 2015-2020 revealed the applications of GDP to transporting biologics along with proposed changes while speaking at the BioLogistics Summit. "This is very specific to the guidance on good distribution practices that is in the Pharmacopeia", said Mary Foster.
The key points of her talk are contained in this complimentary 50-page eBook. The topics addressed include: Commercial vs. Clinical biologics, Quality Management, Environmental Conditions Management, Procurement, Risk Assessment, FDA 43 and Importation & Exportation, among others.
Jeff Carrico, Pharm.D., General Chapters-Packaging and Storage Expert Committee at USP, will provide an update on Foster's findings during his session USP's New General Chapter on Storage and Distribution of Investigational Drug Product at the upcoming 4th BioLogistics Summit this June 27-29 in San Francisco.
Experts from Pfizer, Merck, Eli Lilly & Company, Baxalta will also weigh-in on the discussion on temperature sensitive packaging, data monitoring, new regulations, and the distribution of biological based products and materials.
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About BioLogistics Summit
The BioLogistics Summit is an annual event that brings together forward-thinking professionals from biopharmaceutical companies, biobanks, wholesalers, CRO's, and CMO's whose sole focus is the storage, handling, and distribution of biological based products and materials all under one roof. The event includes interactive workshops, panel discussions, roundtable discussions, case studies, and networking opportunities. The 4th BioLogistics Summit will return to San Francisco on June 27-29.