The workshop entitled “Anticipating the New Regulatory Landscape for Drug/Device Combinations and Companion Diagnostics:
The one-day workshop will focus on the differences between device and pharma regulations and highlight challenges facing manufacturers, who need to comply with elements of both regulatory structures. Furthermore, guidance to those who operate on the drug/device borderline where it is not immediately obvious which regulatory framework applies will be given. The workshop is particularly important given the latest discussions at European Commission on the revision of the European medical device and in-vitro diagnostics (IVD) legislations expected to be published end September 2012.
In her speech, Shayesteh will provide an overview of Commission discussions on the proposed revision of Medical Device Directives and current and changing regulatory framework for combination products in EU/US. She will also chair the session “Stakeholders’
Amanda will be chairing and speaking at the session “Regulatory requirements for companion diagnostics in the EU”, which will give attendees with an overview of the development and approval of Companion diagnostics. In her presentation, Amanda will provide an overview of Commission discussions on the proposed revision of the IVD Directive.
“Manufacturers of drug/device combination products and borderline products will be impacted by an increasingly strict regulatory environment in the EU,” commented Shayesteh. “It is essential that all stakeholders in this sector keep abreast of the changes and ensure that they remain legally compliant. This workshop will be valuable for attendees in providing information on how the new legislations are likely to change their day-to-day business.”