2^nd Annual European Combination Products Regulation Conference

We Interact Together. Innovate Together. Inspire Together.

TT Combination Products Regulation

TT Group’s 2^nd Annual European Combination Products Regulation Conference is designed to explore the most effective strategies for advancing regulatory assessment and planning. It will delve into essential topics such as Article 117, Notified Body Opinions (NBOp) requirements, cross-functional collaboration, risk management, labelling & UDI compliance, addressing regulatory complexity, borderline classification, and the application of new modalities while ensuring compliance with the MDR and European Medicines Agency’s (EMA) dual obligations. This conference brings together experts from leading regulatory bodies, manufacturers, and technology innovators, offering a unique opportunity to network with peers and gain valuable insights into emerging global trends, regulatory challenges, and evolving compliance requirements.

TT Combination Products Regulation will host engaging sessions, incorporating real-life business examples, panel discussions, Q&A sessions, and roundtable discussions facilitated by experienced professionals. Attendees will leave with actionable takeaways that enable them to navigate the ever-changing regulatory landscape for combination products and tailor approaches for global combination product portfolios throughout the product lifecycle, while seamlessly integrating regulatory requirements into a device safety plan.

Our Industry Specialists

Theresa Jeary

Principal Technical Specialist, Medicinal & Biologics

BSI Group, The Netherlands BV

Julia Frese

Director, Medical Health Services, Japan/Global Focus Business Developer, Article 117

TÜV SÜD

Petra van Leeuwen

Senior Technical File reviewer/ Project Manager

DEKRA CERTIFICATION B.V.

Abha Raveau-Violette

Associate Director, Devices and Digital Therapeutics

ASTRAZENECA

Louise Place

Director, Devices Global CMC Regulatory Affairs

GSK

Dr Nélio Drumond

Associate Director, Global Manufacturing Sciences - Drug Product

TAKEDA

Targeted Content

With our targeted attendee and speaker line-up, you can have meaningful conversations with industry-specific experts who have faced the same situations and challenges. Spark new ideas by brainstorming during our breakout sessions, informal post-session Q&As, panel debates, case studies, and workshops.

Meet Industry Leaders

Our robust screening process ensures an exclusive environment where you can focus on connecting and fostering stronger working relationships with those in the medical device field. Collaborate to find the necessary solutions to your current problems.

Customize Your Content

Get the most out of this event experience by choosing what content is most relevant for you and your company and tailoring your event experience around this decision. Learn and connect with whomever you want, whenever you want, and however you want.