Congress Program
08:00-08:50
Registration
Coffee, visit the exhibition, networking
08:50-09:00
Opening Welcome
Setting the scene for two days of expert discussion, shared learning and practical solutions.
09:00-10:30
Session 1: One Product, Many Owners: The Combination Product From Different Perspectives
See the combination product through the eyes of the patient, pharmaceutical and medical-device manufacturers, regulators and notified bodies. Discover where perspectives align, where they differ and why patient safety must remain the common goal.
10:30-11:00
Coffee Break & Visit the Exhibition
11:00-12:30
Session 2: Two RA/QA Frameworks, One Product: Regulatory Challenges for Combination Products
Does today’s regulatory framework adequately support both product safety and patient safety? Explore the regulatory and quality challenges arising at the interface between medicinal products and medical devices, including important developments across global markets.
12:30-13:30
Lunch Break & Visit the Exhibition
13:30-15:00
Session 3: The Bright Future for Combination Devices
Combination products are moving rapidly beyond pre-filled syringes and drug-eluting stents. Discover the technologies, product concepts and regulatory questions shaping the next generation of drug-device innovation. And see how they may be blurring the boundaries between pharmaceutical products, medical devices, software, and diagnostic information.
15:00-15:30
Coffee Break & Visit the Exhibition
15:30-17:00
Session 4: Who Owns the Benefit-Risk Evaluation? Managing Safety Across the Lifecycle
Safety must be designed into the product and maintained throughout its lifecycle. Join experts as they examine who owns the overall benefit-risk assessment, when critical decisions should be made and what evidence is needed to manage risks over time.
17:00
End of Day
08:00-08:50
Registration
Coffee, visit the exhibition, networking
08:50-09:00
Opening of Day 2
Summary of the lessons learned on Day 1 and what to look forward to on Day 2.
09:00-10:30
Session 5: Signal Detection Among Noise: Identifying Product Failure in Combination Products
A safety signal does not come with a label saying “drug”, “device” or “system”. A reported adverse event may be caused by the medicinal product, a device malfunction, an interaction between the two, or the way the product is used. Explore how pharmacovigilance, device vigilance and post-market surveillance can be connected to identify the real signal before it gets lost between systems and how the tools and systems we have can work together instead of against each other.
10:30-11:00
Coffee Break & Visit the Exhibition
11:00-12:30
Session 6: Why are the Dots not Always Connected
Detecting a signal is only the beginning. Once a potential problem has been identified, who connects the information across manufacturers, suppliers, pharmacovigilance, device surveillance, quality and regulatory functions? Explore how organisational boundaries and fragmented responsibilities can delay investigation, escalation and corrective action — and what mechanisms can prevent this.
12:30-13:30
Lunch Break & Visit the Exhibition
13:30-15:00
Session 7: Closing Panel Discussion: What Needs to be Done?
What must change to make combination products safer, and what can we do today? Our closing panel will bring together the conference’s key insights and challenge participants to identify practical actions for industry, regulators and other stakeholders.
15:00-15:30
Coffee Break & Visit the Exhibition
15:30
Close of Congress
