M16 - Combination Product Requirements - Understanding Combination Product Regulations

About this course

A one day course aimed towards outlining the specific regulatory requirements for combination products. We explore the differences between the US regulatory requirements and those of the European Medical Devices Directives (including the impending new regulation). The course provides you with the necessary knowledge to determine what is a combination product, how regulatory agencies deal with combination products and the important interacting regulations that need to be considered for the device and the drug/biologic/combination product.

Who Should Attend

Engineers, managers, supervisors, scientists, technicians, and other personnel involved in product development, manufacturing, quality assurance, or regulatory affairs that do not have an in-depth knowledge of combination products will benefit from this course.

Course outline

This is a new course offering for Medical Devices.

For more information please call our team on +441142 541270. E-mail our training and education team at: [email protected]

Venue

Manchester - Venue to be confirmed

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Tutors

The tutors for this course are as follows:

• 

  James Pink
  Medical Devices, Vice President
  

  • [email protected]
  • +44 (0) 1143 600868
• 

  John Lang
  NSF Medical Devices, Executive Director, Regulatory Science and Product Safety
  

  • [email protected]
  • +44 (0) 1143 600868

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