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Addressing Challenges in Developing Drug Delivery Systems: Navigating Regulatory Requirements in the US



 
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Product Code: WB-7007
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About the Product
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Innovative drug delivery systems are one of the fastest-growing sectors within the pharmaceutical industry with revenue forecasted to reach $100 billion by 2016 in the US alone. This particular sector is also beginning to see more sophisticated therapies that often combine a drug or biologic with a device in order to overcome the drawbacks of conventional dosage forms such as vial and syringe. The FDA regulates these products as either a drug or biologic as opposed to a device based on their primary mode of the action. However, meeting FDA requirements and obtaining approval can be a complex and ambiguous process.
  • Overview of drug delivery systems and US and global drug delivery markets
  • Current FDA guidance applicable to the development of drug delivery systems
  • Requirements for demonstrating safety and efficacy for products that contain already approved drugs
  • Managing conflicts between drug and device regulatory requirements
  • Determining the impact of device changes throughout development of the product

Speaker:

Alan Smith PhD.
Vice President, Clinical, Regulatory & Operations
4P Therapeutics


Target Audience

  • Regulatory Affairs
  • Delivery Device Development
  • Drug Delivery R&D
  • Business development
  • Strategic product development
  • Pharmaceutical Development
  • Drug Formulation Novel Drug Delivery Technologies

Target Industry
  • Drug Delivery Systems
  • Pharmaceutical Manufacturers

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