WEBINAR - EU PACMP in Practice: A Smarter Approach to Post-Approval CMC Change Management

As post-approval CMC changes continue to increase in complexity and regulatory scrutiny, companies must find ways to maintain compliance while ensuring supply continuity and lifecycle agility. Under ICH Q12, the Post-Approval Change Management Protocol (PACMP) offers a structured and predictable pathway to plan and implement certain CMC changes within the EU regulatory framework, reducing uncertainty and enabling more efficient execution.

To support regulatory and CMC professionals in navigating this evolving landscape, ProductLife Group, together with its affiliate Zwiers Regulatory Consultancy, is hosting a dedicated webinar exploring how PACMP operates in practice and how it can be strategically embedded into lifecycle management to reduce timelines, fees and regulatory risk.

This PLG webinar provides practical insight into the EU two-step PACMP process, the impact of revised variation guidelines, and the alignment of PACMP strategies with global regulatory expectations. The session focuses on translating regulatory principles into actionable planning tools that support informed decision-making and long-term lifecycle optimisation.

• How PACMP operates under ICH Q12 and when it can be applied to post-approval CMC changes
• The EU two-step PACMP process and its impact on predictability and implementation timelines
• The influence of revised EU variation guidelines on PACMP strategy
• Opportunities to streamline variations, minimise regulatory risk and optimise lifecycle planning
• Alignment with global expectations, including EU, FDA and MHRA perspectives

Izabela Bedziak, Regulatory Affairs CMC Expert, Zwiers Regulatory Consultancy

🗓️ 26 February 2026 | 🕒 10:00 AM CET

📍 Format: Free online webinar held in English