Archives: Agenda

• Updates on China’s National Medical Products Administration (NMPA) regulations
• Recent reforms in drug and device approval processes
• Best practices for obtaining IND and NDA approvals in China

• 中国国家药品监督管理局（NMPA）法规更新
• 药品和医疗器械审批流程的最新改革
• 在中国获得IND（新药临床试验申请）和NDA（新药上市申请）批准的最佳实践

• How AI tools are revolutionising rare disease patient enrolment and subsequently trial success?
• Can we make rare disease trials, protocols and study design simpler with limited data and patient populations?
• Training sites and staff on new systems to maximise the benefits of the latest technology and streamline processes
• Assessing the efficiency and success of pragmatic trials for more patient-centred approaches: do they work for rare diseases?
• Leveraging digital platforms and social media outreach to identify and recruit patients

Seats available

• Uncovering the invisible: a 20-year analysis of medically underrepresented populations in clinical trials
• Benchmarking against the US census reveals structural gaps and needs
• Adopt a six-pillar architecture to embed equity from the ground up

• The heterogeneity of patients and the accuracy of the golden standards and what does that mean when studying rare diseases
• Working with a living personalized ATMP product with a limited shelf life, the logistics and the two-step release certification
• How to position your orphan treatment within standard care and what are the hurdles to overcome
• Discussions with the rehabilitation experts and the patients: what impacts the quality of life of a patient suffering a spinal cord injury best.
• A listing of the non-conformities and how to resolve this real time.

THE ROUNDTABLES WILL TAKE PLACE IN THE ONCOLOGY CONFERENCE ROOM NEXT DOOR

Interactive roundtable sessions offer a unique opportunity to come together with your peers to share best practice and develop solutions to critical challenges facing the industry as a whole. Each discussion will be led by a table moderator and will focus on a different challenge within oncology and orphan drug clinical trials. Roundtables are an exciting, interactive way to build your personal network and learn from the experience and expertise of others.

After 30 minutes, delegates will have the opportunity to swap and choose a different table, and each roundtable will run twice.

1. Discussing the increased role of China R&D in developing new products
   Hosted by Sezcan Ozturk, Vice President, Head of Europe, Luzsana Biotechnology
2. AI in clinical operations
   Hosted by Pietro Belligoli, Researcher, Former Roche
3. Running trials in low-cost countries
   Hosted by Martin Neumayer, Head Development Program Support and CRO-Vendor Management, Sandoz
4. What is the best framework of strategies, processes and pathways for pharma and patient organisations to create positive, lasting partnerships?
   Hosted by Dr. Anupoma Haque, EUPATI Fellow, Patient-Centric Public & Digital Health Expert, HTA and Policy Professional, Inclusion & Equity Trainer