Webinar: Webinar Gestion des pénuries de dispositifs médicaux

Webinar: Novel Food webinar Preview

Webinar: Key considerations when building a global PV program

IVDR Transition Period Extension – Breathing Room Amidst Persistent Challenges

While this extension offers manufacturers valuable additional time to align with the regulation, significant compliance challenges still remain. This session will explore how organizations can strategically adapt to evolving IVDR expectations while maintaining operational continuity.

Charte PP – nouvelle étape réglementaire pour les DM remboursés

La certification qualité des pratiques professionnelles devient un enjeu réglementaire majeur pour tous les acteurs impliqués dans les activités de présentation, d’information et de promotion des produits et prestations remboursés et inscrits sur la LPP.
Ce webinaire vous apportera un décodage clair et concret de la Charte de Qualité des Pratiques Professionnelles afin d’anticiper les impacts sur vos activités.

CCS nei processi non sterili: costruire una strategia vincente per qualità e compliance

Il concetto di Contamination Control Strategy (CCS) è spesso associato agli ambienti sterili, ma anche la produzione non sterile è chiamata a dimostrare un approccio strutturato, proattivo e sostenibile al controllo della contaminazione.

In un panorama regolatorio sempre più attento alla qualità globale, i sistemi produttivi non sterili rappresentano la sfida nascosta: non esistono “ricette” univoche, ma solo strategie calibrate sul rischio, sul processo e sul prodotto.

Durante il webinar, organizzato da ProductLife Group e Pharma D&S, esploreremo come trasformare il CCS da semplice requisito GMP a strumento pratico per prevenire deviazioni, ridurre i rischi microbiologici e rafforzare la compliance, con esempi reali e spunti operativi.

AGENDA:
– Perché parlare di CCS non sterile oggi
– Cosa si aspettano gli ispettori
– Dal rischio alla decisione: come costruire la strategia che fa la differenza
– I pilastri del CCS non sterile
– Conclusioni e Q&A

Soumissions réglementaires en eCTD – le cas de la nouvelle réglementation en Tunisie

Management of Variation in the new Framework

Il nuovo Regolamento Europeo sulle variazioni 2024/1701/EC, pubblicato sulla Gazzetta Ufficiale dell’Unione Europea nel giugno 2024 e applicabile dallo scorso 1° gennaio 2025, ha introdotto cambiamenti rilevanti nei processi regolatori, con implicazioni per Autorità Competenti, Titolari di AIC e produttori.

Questo webinar fornirà una panoramica delle principali novità introdotte dalla linea guida (C/2025/5045), pubblicata sulla EU GU il 22/09/2025 e che entrerà in vigore nel gennaio 2026, con la data di cut-off definita da EMA del 15/01/2026.

AGENDA
– Panoramica del contesto normativo corrente
– La nuova linea guida variazioni e la sua implementazione
– Analisi di alcune categorie di variazioni rispetto al precedente scenario normativo
– Q&A

Marketing Authorization Transfers and Considerations for successful Implementation and Integration

Learning Objectives:
– Key considerations in the regulatory and operational support services needed to accelerate
or manage licensing deals (both from the selling and acquisition perspective)
– Tips and strategies for maintaining business continuity during transitions
– How data compliance impacts need to be accounted for in the planning and execution
– Case example lessons learned and best practices

Management of Variation in the New Framework

The new European Regulation on variations 2024/1701/EC, published in the Official Journal of the
European Union in June 2024 and applicable since January 1, 2025, introduced significant changes
in regulatory processes.

This webinar provides an overview of the main updates introduced by the new guideline
(C/2025/5045), published in the EU Official Journal on September 22, 2025, and entering into force
in January 2026, with the cut-off date set by EMA for January 15, 2026.

Strategie di controllo per affrontare le Impurezze di oggi e prepararsi alle sfide di domani

Il panorama delle impurezze farmaceutiche sta attraversando un’evoluzione significativa:
da una gestione basata su linee guida consolidate come ICH Q3C e ICH Q3D, si sta affermando
un approccio sempre più dinamico, risk-based e orientato al lifecycle.

L’esperienza maturata con la gestione delle nitrosammine ha rappresentato un punto di svolta
per il settore farmaceutico, evidenziando la necessità di un sistema di gestione del rischio
strutturato e integrato nel sistema qualità aziendale.

Speaker
Sara Cretella – Italy Impurities Service Area Manager – Pharma D&S

Agenda
• Introduzione
• Impurities e valutazione del rischio
• Impurities Control Strategy
• Lessons learnt e strategie per il futuro
• Conclusioni e Q&A

IVDR Performance Evaluation IVDs, RUO & In House

Understanding the foundations of performance evaluation under the IVDR. In this 60-minute session, we break down what manufacturers really need to demonstrate, clarify what does (and doesn’t) apply to Research Use Only (RUO) products, and decode the regulatory expectations for in-house IVDs. Walk away with clarity, confidence, and practical insights to accelerate compliance and keep your portfolio on track.

In this webinar, you will learn how to:

– Build a performance evaluation strategy that satisfies IVDR requirements — without over-engineering.
– Distinguish IVDs, RUO products, and in-house devices, and understand what regulatory obligations apply to each.
– Anticipate the documentation and evidence that notified bodies expect before submission.
– Avoid common pitfalls that delay market access and impact project planning.

CMC Development of new small Molecule Products

In today’s competitive biopharma landscape, bringing a new small-molecule product to market requires more than solid science — it demands a strategic, quality-driven CMC approach.
Join our experts to learn how to integrate Quality by Design principles early in development, align with global regulatory expectations, and mitigate risk throughout the product development.
Key takeaways:
– How to build solid control strategy into small-molecule development from the start.
– Best practices for developing a strong, CMC-focused dossier across development phases and regions.
– Practical risk assessment and mitigation strategies to support smoother registration.
– Real-world case studies of how integrated CMC–regulatory planning accelerates time-to-file.

Breaking Into Europe: Regulatory and Market Access Essentials for Digital Health Companies

As a seasoned life-science leader, you understand that navigating drug and device development is just the first step — gaining meaningful access to the European market demands a different playbook. In this session, we equip you with the strategic frameworks and actionable insights needed to accelerate your digital health or digital therapeutics (DTx) venture into Europe.

Why watch the recording?
• Cut complexity, gain clarity. The European regulatory and reimbursement environment for DTx is fragmented, evolving, and high-risk outcomes can be avoided.
• Align for access and reimbursement. Reimbursement and market access are far from uniform across EU member states.
• Build competitive advantage. With our deep expertise in regulatory strategy and market access, we’ll show how you can turn Europe’s complexity into an efficiency lever—reducing time-to-market and optimizing launch readiness.

What you will learn:
1. A roadmap of key regulatory frameworks in Europe for digital therapeutics and software-based medical devices — what to know, where the traps lie.
2. Best practices to design your regulatory and evidence strategy so it supports market access.
3. Country-by-country market access realities: leading markets, fast-track opportunities and typical bottlenecks.
4. How to integrate regulatory and market access planning into your product lifecycle to create efficiency, reduce duplication and avoid surprises.
Join us to transform what often feels like regulatory and access risk into operational advantage. If you’re responsible for regulatory affairs or market access in a digital therapeutic company (or a device company pursuing digital health), this webinar will sharpen your strategy, reduce time to market and give you practical tools to execute.

La réglementation des compléments alimentaires, révolution ou pas ?

PLG vous propose un Webinaire gratuit et interactif sur la Réglementation des compléments alimentaires, révolution ou pas ? le jeudi 4 décembre à 11h (CET).

Le principe est simple : vous posez vos questions, PLG vous répond !

Ce rendez-vous mensuel est l’occasion pour vous d’être acteurs et libres de poser l’ensemble de vos interrogations à nos équipes.