Marketing Authorization Transfers: Planning and Operational Considerations for Successful Implementation

Marketing Authorization Transfers (MATs) are increasingly common in today’s biopharma industry, whether driven by product divestitures, outsourcing licensing, or strategic licensing deals. While often perceived as a regulatory formality, MATs actually generate a broad set of regulatory impacts and product development impacts that require careful planning and operational excellence. 

Successful Marketing Authorization Transfers demand cross-functional coordination. Beyond regulatory filings, they affect: 

• Product development impacts, including continuity of clinical and CMC data 

• Regulatory impacts, with differing global and domestic frameworks to navigate 

• Pharmacovigilance and quality system transitions 

• Supply chain continuity to avoid product shortages 

• Data compliance and IT system integrations 

Without proactive planning, companies risk compliance gaps, delayed launches, or business disruptions. 

This session — the first in a three-part series on Marketing Authorization Transfers — will equip participants with strategic and operational insights to handle both the regulatory and business dimensions of licensing transitions. 

• Understand key regulatory impacts and operational considerations to accelerate licensing deals 

• Explore strategies for outsourcing licensing effectively while maintaining compliance 

• Identify risks, dependencies, and hidden complexities through robust due diligence 

• Gain practical tips to ensure business continuity and product supply 

• Review case examples of successful MATs and lessons learned 

Our panel will feature ProductLife Group specialists with hands-on experience supporting global pharma companies through complex MATs and licensing transitions: 

• Philip Smith, Global Business Unit Head of Regulatory Affairs & Operations 

• James Crook, Staff & Performance Director, Regulatory Affairs & Operations 

• Nick Larsen, Data Migration Lead 

• Chetan Javia (to be confirmed), Director, Sales Enablement & Operations 

🗓 Date: 9 October 2025 
🕒 Time: 3:00 PM CET 
📍 Format: Online | Free registration