[Free White Paper]

Pharmacovigilance and Risk Management Consideration for Rare Disease Gene Therapies

The development of a pharmacovigilance and risk management system to support a gene therapy for a rare genetic disease requires consideration of the specific challenges and nuances that novel therapies present throughout the lifetime of the product.

Within this White Paper we will explore:

  •    The extent of rare genetic diseases
  •    The challenges of pharmacovigilance and risk
       management for rare disease gene therapies
  •    US (FDA) and EU (EMA) approaches to gene therapy


Pharmacovigilance Rare Disease Gene Therapies


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