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This Education Course provides a comprehensive overview of the regulatory requirements for the combination of medical devices with drug products (EU & US). Participants will learn and understand
“Combination Product” is a term defined by the FDA to cover various combinations of drugs, biologics and medical devices. Since 2002, there has been an Office of Combination Products (OCP) at the FDA. Alongside several historical guidances and regulations, the FDA has issued the 21 CFR Part 4 regulation on the current Good Manufacturing Practice (cGMP) requirements applicable to Combination Products, effective on July 22, 2013. In January 2015 FDA published the draft-guidance “Current Good Manufacturing Practice Requirements for Combination Products” which also brings more clarification to this topic.
In the EU, there is currently no equivalent term to “Combination Product”, a product is either considered a Medical Device or a Medicinal Product. Classification of the product is based upon the Primary Mode of Action (PMOA) and the intended use. Regulation is based upon the Medical Device Directive or the Medicinal Product Directive - however there are some recent and ongoing initiatives for change; the Medical Device Regulation, ISO 13485:2016, ISO14971, IEC 62366, ISO 9001, PS 9000 which impact the development activities within the pharmaceutical industry in future.
As a consequence, drug manufacturers who extend their development and/or manufacturing operations into delivery (Medical) devices; or vice-versa; may not only need to follow traditional cGMP approaches, but may also have to fulfil additional requirements of Regulation, Directives, Normative Standards and guidances. They will likely have to develop or enhance their quality system to satisfy these additional requirements.
The existing 21CFR820 Quality Systems Requirements (1996) defines several requirements including the Design Control development model which needs to be applied both pre- and post-production to the device constituent part of the Drug-Device Combination Products.
Additionally, the recent increase in attention to Human Factors Engineering; or Usability Engineering; has led many manufacturers into difficulties as they aim to prove high levels of intuitive use, use safety and efficacy of the drug delivery system as a whole - for a Combination Product it is no longer just about the drug. Again, regulation, directives, guidance, standards and review expectations continue to evolve in this area.
For the established pharmaceutical industry it can be a challenge to adopt new vocabulary and approaches (e.g. Design Control, Design Input, Design Output, Design Verification, Design Review, Design Validation, Design Transfer, etc.) into their existing and traditional development processes.
This Course is designed for all scientists, engineers, managers and executives from Pharmaceutical and Biotech Development Units, including Device Development, Packaging Development, Quality Assurance, Regulatory Affairs, Marketing, and Project Management, who are involved in the development, industrialisation and control of drug-device combination products.