European Regulatory Affairs Congress 2026

MODULE 1 – MAY 14th

SESSION I – NEW EU VARIATIONS GUIDELINES: SHARING OF APPLICATIONS
The EU Variations Guidelines are evolving to create a more streamlined, simplified process for updating medicine marketing authorizations. The new framework will take effect on 15 January 2026, introducing simplified variation classifications—Types IA, IB, and II—and new tools to support more efficient lifecycle management as PACMPs (Post Approval Change Management Protocols) and PLCMs (Product Lifecycle Management documents), along with mandatory worksharing.
To prepare, MAHs should comply with updated submission expectations for changes and other routine post approval variations. Early readiness will support a smooth transition and ensure continued compliance in the evolving regulatory environment.
The session will feature insights from the Italian regulatory authority representative from AIFA, while leading pharmaceutical companies will share their early experiences applying the new regulation across the product lifecycle.

Key discussion points:
• Updates on post-authorization changes and procedures for medicinal products for human use
• New challenges and first experiences of the application of this new regulation from regulatory body and pharma companies
• Implications for product lifecycle management including practical implications for planning, compliance, and strategic decision making

SESSION II – PROMOTIONAL MATERIALS REQUIREMENTS IN EUROPE: Navigating a Complex and Evolving Landscape
Ensuring compliance in the development, review, and dissemination of promotional materials for medicinal products in Europe remains one of the most intricate areas of pharmaceutical regulation. With the participation of representatives from the Italian regulatory authorities (AIFA and the Ministry of Health), this session will explore the diverse and evolving Italian and EU requirements on advertising to healthcare professionals and patients, highlighting the challenges caused by differing interpretations from regulators and industry associations.
Participants will gain insights into best practices for review and approval processes, common pitfalls, and the strategic considerations needed to maintain compliance while supporting effective product communication.

Through real world examples and expert perspectives, the session will provide practical guidance for navigating this complex regulatory pathway with confidence.
Key discussion points:
• Overview of the European regulatory landscape governing promotional materials, including EU legislation requirements, and industry codes
• Common pitfalls and compliance risks observed by regulators and industry review bodies

SESSION III – SERIALIZATION: Italian Regulatory Framework
From February 2027 onward, Italy will complete its move toward a harmonized European approach, supported by a centralized verification infrastructure managed by AIFA and the Ministry of Health.
This evolution will require Marketing Authorization Holders, CMOs, wholesalers, and pharmacies to adapt rapidly upgrading packaging lines, adjusting supply chain controls, and implementing robust data management systems.
This session will provide a comprehensive overview of the new regulatory landscape, outlining Italy’s transition from the Bollino system, the updated technical specifications for safety features (including the newly regulated carta valori support and Data Matrix requirements), and the practical challenges stakeholders face in achieving compliance.

Through expert insights and real world case examples from pilote, attendees will gain clarity on the operational impacts, enforcement timelines, and strategic preparations needed to navigate this new serialization era effectively.
Key discussion points:
• Key regulatory milestones leading to the go live of the harmonized system.
• Insights from pilot phase and common pitfalls observed during testing

MODULE 2 – MAY 21st

SESSION I – CONTENT AND DEVELOPMENT OF FIRST IN HUMAN SUBMISSION PACKAGES FOR US AND EU
This session provides a comprehensive, practical overview of how to design, prepare, and successfully deliver First in Human (FIH) regulatory submission packages for both the United States and the European Union. Participants will gain a clear understanding of the core scientific, clinical, and quality elements required for early phase regulatory dossiers—specifically INDs in the US and CTAs/IMPDs in the EU—and how these components work together to support the safe initiation of human studies.
Special emphasis will be placed on regional regulatory expectations, points of convergence and divergence across FDA and EMA/NCAs, common pitfalls observed during FIH reviews, and best practices for ensuring consistency, clarity, and scientific justification throughout the submission.
Attendees will learn how to build a robust, risk proportionate early development program that aligns with regulatory guidance, supports dose selection and starting dose rationale, and anticipates agency questions.
Key discussion points:
• Core Components of FIH Submission Packages for US and EU
• Regulatory Expectations in the US vs. EU and critical regional differences

SESSION II – HOW AND WHEN TO INTERACT WITH FDA AND EMA
Navigating interactions with major regulatory authorities is a critical factor in accelerating development timelines and ensuring the success of innovative therapies and technologies.
This session provides a clear, practical roadmap for engaging with the FDA and EMA at the right moments and in the right ways throughout the product lifecycle.
The session will highlight similarities and differences between FDA and EMA expectations, outline best practices for preparing briefing packages, and offer guidance for managing questions, timelines, and follow up commitments.
Through real world examples and common pitfalls, attendees will learn how to build a proactive engagement plan that supports smoother reviews, reduces regulatory uncertainty, and maximizes the probability of timely approvals.
Key discussion points:
• Comparing FDA vs. EMA expectations
• Regulatory touchpoints across the development lifecycle: differences between US and EMA
• Real world case examples: common pitfalls and lessons learned

SESSION III – ORPHAN DRUG DESIGNATION FOR US AND EU
Orphan drug designation is a key milestone for companies developing therapies for rare diseases. In this session, speakers will explore the core similarities and important differences between FDA and EMA processes, sharing best practices for preparing high quality applications, coordinating parallel submissions, and responding effectively to common agency questions.
Participants will also gain valuable insights directly from regulatory representatives, who will outline the pathways, criteria, and expectations for securing orphan status in both regions.
Through practical examples and real world learnings, the esperts will highlight how to avoid common pitfalls and how to integrate orphan designation into a broader regulatory strategy.
Key discussion points:
• Comparison of FDA and EMA Pathways
• Sharing of Best Practices for effective Applications