Combination Products: US, EU, and Japan Regulations

  • How combination/borderline products are regulated in the US, EU and Japan.
  • How to interpret and comply with current US, EU and Japan regulatory requirements for combination/borderline products (i.e., GMPs, reporting post-approval changes and safety reports); what regulations, directives, guidance and standards do and do not exist, or apply; how to manage gaps in the regulatory frameworks.
  • Format, content and submission of marketing applications submitted in the US, EU and Japan for combination/borderline products.
  • CE marking of devices that are part of a combination/borderline product and devices containing ancillary medicinal substances.
  • Quality System requirements for combination/borderline products in the US, EU and Japan and how these apply to pharmaceutical and medical device companies, constituent part and component part manufacturers.