Combination products

Lecturer: Dr. Hagit Marchaim

Date: 19 May 2019
Location: Psagot, Hamada 8, Rehovot
General Information
Duration: 1 - Day Course
Hours: 9:00 – 17:00
Price: 1,850 NIS+VAT
Credit Points: 1
SKU: 191010
Course Language: Hebrew
About the Course
US
  • What it a combination product?
  • Classification and jurisdictional information
  • Examples and regulatory pathway
  • Request for designation and a pre-request for designation
  • Human factors studies
  • cGMP requirements
  • Submissions for post-approval modifications
EU
  • Definitions of a drug, device and combination or borderline products
  • Regulatory route as a drug or as a device
  • Different types of combination products and the consultation procedure
  • Major changes in the new MDR with regards to combination products
  • Innovation Task Force (ITF)

Who should attend
    Combination products
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