Event Information

[Please note that this event has already taken place.]

Our EU and UK regulatory law specialist, Xisca Borrás, spoke on the second day of the EU Pharmaceutical Law Forum conference alongside fellow expert Simone Heitz, Associate General Counsel, Merck. Jamie Hatzel and Sean-Paul Brankin attended.

Session details – 22 May at 17:10:

DUAL DIALOGUE: Striking a Regulatory Balance for Companion Diagnostics: Analysing Tensions Between Pharmaceutical and IVDR Frameworks

Topics discussed include:

• Managing the conflict of IVDR with the EU Clinical Trial regulation
• Commercial and IP considerations for pharmaceuticals when combined with devices and companion diagnostics
• Practical challenges of reimbursement for companion diagnostics
• The use of hospital exemptions for companion diagnostics

For more information, see the EU Pharmaceutical Law Forum website.