White Paper
Navigating the EU Pharma Package

This white paper was developed by Project Farma experts focused on helping pharmaceutical and biotechnology organizations navigate evolving regulatory landscapes and assess the broader business and operational implications of changing global requirements. Lisa Hawkins and Armen Nahabedian bring extensive experience supporting regulatory strategy and market planning across complex pharmaceutical environments. 

The insights presented in this paper outline key strategic and regulatory considerations organizations should evaluate as proposed changes to the EU Pharma Package continue evolving.

What Our Experts Share

  • Key proposed updates within the EU Pharma Package and why they matter.
  • How changes to market exclusivity frameworks may affect development and commercialization strategy.
  • Considerations for global launch sequencing and market planning.
  • Evolving expectations surrounding medicine shortage monitoring reporting.
  • Strategic areas organizations may want to evaluate as requirements continue developing.

 

EU Regulatory Updates - Cover

Featuring Insights From

Lisa Hawkins - Blue Suit

Lisa Hawkins
Associate Practice Area Lead, QA/RA

With more than 35 years of experience in quality and regulatory compliance, Lisa supports Project Farma clients across GMP, change management, and quality systems initiatives. She helps organizations navigate regulatory submissions and post-market processes, and operational readiness while strengthening compliance and regulated environments.

Armen Nahabedian

Armen Nahabedian
VP, Technical Operations

Armen brings more than 40 years of experience in biotechnology and pharmaceutical manufacturing, supporting Project Farma clients across technical operations, tech transfer, cleaning, validation, and manufacturing readiness initiatives. He has held leadership roles at large-scale manufacturing facilities, helping organizations strengthen operational performance, compliance, and commercialization efforts for complex biologic therapies.

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