With regulations evolving rapidly around the world, how can drug/ device developers ensure a robust and thorough technical documentation for regulatory approval filing? What should you include and what do regulatory agencies expect from you?
This workshop session will give you a step by step guide in:
• Coordinating with multiple drug/device teams to draft a detailed submission plan for your combination products
• Ensuring quality control and quality assurance
• Anticipating changes and regulatory agencies’ expectations: from the FDA to EMA
• Common pitfalls and tips for best practice
Workshop Leader: Patty Kiang, Principal, Kiang Consulting Services
As human factors regulations advance, drug and device developers need to incorporate formative studies as early as possible. A well thought-through and integrated human factors program will also help drive commercial competitiveness and enhance patient experience. This doesn’t just relate to device design but also labelling and packaging.
This workshop is designed to help attendees:
• Build a comprehensive E2E human factors program with other device functions
• Extrapolate meaningful data and establish a feedback loop to enhance usability and functionality of device
• Deliver beyond regulatory expectations and ensure smooth approvals from the FDA and EMA
• Post-launch management to drive next gen products and increase product life
Workshop Leader: Joely Gardner, Chief User Researcher, Human Factors Research; Professor, UCSD Graduate Business School
Having a quality systems and risk management program is critical to a compliant device/ combination product. That said, regulations are changing very rapidly, and as your device evolves, how confident are you that they still fit with regulatory framework? And what are the parameters you should consider?
This workshop session will involve scenario-based exercises and discussions to help you:
• Stay up to date with the latest ICH Q9 and ISO 14971 risk management standard
• Revise your existing framework and approach to avoid common pitfalls
• Collaborate with your vendors to ensure transparent dialogue and implement a first class QA/risk management program
Workshop Leader: Edwin Bills, Principal Consultant, ELB Consulting