August 25th – August 26th 2022
The compatibility and joint performance of the drug product and the delivery device are vital to patient safety and product quality. However, in early development, when the drug formulation and dosage have not been finalized, it might be difficult to determine device inputs and choose the right regulatory/clinical strategy. Consequently, the successful development of combination drug-device products presents technical and regulatory challenges.
In our online meeting drug delivery experts and device development engineers will be sharing multiple views on drug product and delivery device compatibility and functionality, aligning design controls with Quality by Design, device inputs in early development, material compatibility and safety, regulatory pathways and QMS, essential performance requirements, design verification & validation, risk management challenges, device conformity and essential performance requirements, compatibility and clinical evaluation.
Decisions made in the early stages of product development can have a significant impact in terms of time to market and costs. Join us to share and collaborate across the critical factors of successful drug-device integrated development!
WE WILL BE FOCUSING ON
- integrated development: synchronizing device and drug development processes and timelines
- regulatory and quality systems requirements for combination products development
- overcoming cultural differences between drug and device development teams
- comparing Design Controls and Quality by Design (QbD) – how are they different?
- proactive risk management for combination products development and lifecycle management
- clinical strategy early in the development, design input requirements to meet intended needs
- human factors, usability engineering and safety considerations in product design
- design controls and essential performance requirements in drug/device development
WHO IS IT FOR?
CxO, VP, Directors, Heads, Managers of
- Combination Products/ Medical Devices
- Drug Delivery/ Delivery Systems
- Device Development/ Device Engineering/ Device Manufacturing
- Device Design/ Design Verification/ Design Validation/ Design Controls
- Human Factors/ Usability Engineering/ User Experience
- Formulation/ Biopharmaceuticals
- Regulatory Affairs/ CMC
- Packaging/ Materials Development
- Risk Management/ Quality
- Research & Development
- Business Development