European Regulatory Affairs Congress 2026 – INTERNATIONAL CONFERENCE

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

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 Italian 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 Italian legislation requirements, and industry codes
• Common pitfalls and compliance risks observed by regulators and industry review bodies

From February 2027 onward, Italy will complete its move toward compliance with the Falsified Medicines Directive (FMD – 2011/62/UE), supported by a centralized verification infrastructure managed by AIFA and the Ministry of Health, for a harmonized approach with the other European countries.
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, with the participation of General Manager of NMVO Italia and the sharing of experiences of companies taking part in the “Pilot Project”, attendees will gain clarity on the operational impacts, enforcement timelines, updated technical specifications requirements for safety features (Data Matrix and anti-tampering measures) 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
• NMVO’s Pilot Project: updates, insights and sharing of experience observed during testing

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 approach the FIH submission, 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
• Real world case examples: common pitfalls and lessons learned

Orphan drug designation is a key milestone for companies developing therapies for rare diseases. In this session, speakers will explore the core similarities and key differences in the regulatory
frameworks for US, EU and UK 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 experts and regulatory agencies representatives, who will outline the pathways, criteria, and expectations for securing orphan status in the different regions.
Through practical examples and real world learnings, the experts will highlight how to avoid common pitfalls and how to integrate orphan designation into a broader regulatory strategy.

Key discussion points:
• Comparison of FDA, MHRA and EMA Pathways
• Sharing of experiences and best practices for effective Applications