In late January, the U.S. Food and Drug Administration issued a Final Rule regarding current Good Manufacturing Practice requirements applicable to combination products.
If your company is involved in the manufacturing, designing, fabricating, assembling, filling, processing, testing, labeling, packaging, repackaging, transporting, or storage of combination products involving biologics, medical devices, and pharmaceuticals, there’s an opportunity to voice your concerns and questions at the March 12-14 HealthPack event in Louisville.
During HealthPack, there will be a meeting of the Institute of Packaging Professionals’ Medical Device Packaging Technical Committee. During this meeting, from 4:45 p.m. to 5:30 p.m., Wednesday, March 13, various technical subcommittees will breakout into separate sessions. One of these is the Combination Products packaging subcommittee, chaired by Healthcare Packaging Editor Jim Butschli.
At this breakout session, IoPP members are encouraged to join the subcommittee and participate with questions and ideas to advance the Combination Product subcommittee. The subcommittee is seeking for input for ideas, questions, and specific challenges you have in this area. These questions—and perhaps multiple-choice responses—will be used to formulate an online survey distributed by Healthcare Packaging. Survey results would then be reported by Healthcare Packaging and at upcoming Combination Product packaging subcommittee meetings.
Please send questions or ideas as soon as possible to Healthcare Packaging Editor Jim Butschli.
In its new technical market research report, “Global Markets For Drug Device Combinations, “ BCC Research estimates that the market value for global drug-device combination product will rise from $18.5 billion in 2011 to $30.5 billion by 2017.