A Combination Product (Combo Prod) is a product composed of any combination of a drug and a device; a biological product and a device; a drug and a biological product; or a drug, device, and a biological product.
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+Validation (14)
+Pharmaceutical Engineering® Magazine
Volunteer Profile: Combination Products Community of Practice Chair - James P. Wabby, MHMS
For more than 22 years, James P. Wabby has dedicated his career to quality operations, regulatory…
Communities of Practice Profiles: Shaping the Future of the Combination Products Industry
Combination Products is one of ISPE’s newest Communities of Practice (CoPs). It started as a Special…
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Disruptive Medicine Innovation: Next Generation of Combination Product Technologies
Disruptive Medicine Innovation: Next Generation of Combination Product Technologies Complimentary…
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Medical Device Sterilization with FDA
Medical Device Sterilization with FDA Complimentary Learning Level: Intermediate/Advanced Session…
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Regulatory Responses to 503B Compounding Pharmacies
Complimentary Learning Level: Intermediate Session Length: 1 hour Most 503B compounding facilities…
iSpeak Blog Posts
iSpeak Blog
China’s Regulatory Framework for Combination Products: Ongoing Challenges and Potential Opportunities
As the world’s second largest market for pharmaceuticals and accounting for 20% of global medical…
iSpeak Blog
What is the Impact of Article 117 on the Pharma Industry?
Article 117 of the EU Medical Device Regulation (MDR), fully applying May 26, 2021, is significantly…
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Combination Products: Challenges and Expectations Training Course
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