Regulatory Differences Between Biopharmaceutics and Medical Devices 2013
08 Aug 2013
Webinar
Key Topics
FDA Centers: CDER, CBER, CDRH
Review of FDA regulations for biopharma vs. devices
What is the difference between the requirements for an IND vs. IDE?
What if the product is a combination product…which do I lead with?
What is needed for NDA and BLA submissions?
What are the requirements for a 510k (class I and II) and PMA submissions?
Who should Attend
Distributors or manufacturers of devices, drugs, biologics, or combination products involved in:
Documentation
Regulatory Affairs
Contract manufacturers who provide regulatory submission data for their clients
CRO personnel who are involved in regulatory submissions
Quality Assurance
Past Events
Regulatory Differences Between Biopharmaceutics and Medical Devices 2013 - 08 Aug 2013, Webinar (39675)
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Important
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