8:00 am Welcome Coffee
8:50 am Chair’s Opening Remarks
Robust Design Control to Maximize Your Injectables’ Lifecycle
9:00 am Applying Design Control & Control Strategy to Support the Development of the Combination Drug Product
Synopsis
- Understanding design control expectations
- Establishing a control strategy to deliver safe and efficacious products
- Understanding the difference between CQAs and EPRs
- Defining your device engineering and testing parameters to ensure quality and compliance
9:30 am Creating an Effective Combination Products Risk Management Program
Synopsis
- Discussing the ‘what’ and ‘why’ of risk management for combination products
- How do you carry out a robust hazard/harm risk analysis?
- Integrating risk management into product design
10:00 am Exploring the Impact of the Changing Regulatory Landscape on the Risk Management Process for Injectable Combination Products
Synopsis
- Understanding how the complexity of regulatory expectations complicate risk management for combination products
- How can we devise a harmonized strategy for implementing risk management documents to achieve clarity with global regulators?
- How can risk management be leveraged in both premarket and postmarket phases?
10:30 am Morning Refreshments & Networking
Engaging Regulatory Bodies to Understand Best Practice in Regulatory Approval
11:30 am Overcoming Regulatory Challenges for Tapping into Global Markets
Synopsis
- Identifying the impact of the new EU device regulations (MDR and IVDR) and preparation challenges
- Aligning FDA’s expectations vs. EU MDR requirements
- Understanding the Chinese market to achieve global reach with your injectable device
12:00 pm Developing a Practical Application of Streamline Approach 21CFR Part 4 in The Pharmaceutical Industry
Synopsis
- Reviewing the necessary regulatory considerations to scrutinize in a fast-changing environment
- When can a platform approach help teams be more agile?
- Applying quality 4.0 to implement best practices in regulatory submissions
- How can you optimize the organizational culture and quality system?
12:30 pm Minimizing Failure Risks in Container Closure Integrity Testing (CCIT)
Synopsis
- Realizing the regulatory environment for container closure integrity
- Deterministic or probalistic: Which test method to choose?
- Delivering a case study that demonstrates method development and validation strategies to ensure the sterility and quality of the drug product, from product packaging to expiry
1:00 pm Understanding the Evolution of Regulatory Guidance to Reflect Best Practices in the Field of Human Factors and Usability Engineering
Synopsis
- Discussing human factors requirements within regulatory frameworks
- Exploring the changing standards relating to the usability engineering process for injectables
- Outlining future areas of opportunity for regulatory guidance based on recent combination product human factor studies
1:30 pm Networking Lunch
2:30 pm Designing a Self-Administered Injectable Device for your Patients
Synopsis
- Leveraging design innovation to enhance ease of drug delivery and patient comfort
- Discussing pain free drug delivery solutions – how might we take away the physical pain, the mental barriers, the stigma & the disposal dilemma of current needle-based drug delivery?
- Examining training and labelling best practices for self-administered injectables
3:00 pm Transforming Traditional Combination Products into Connected Injectable Devices
Synopsis
- How close are we to achieving a fully functional connected device?
- Developing a connected device through integration with your drug team
- How can connected devices accelerate speed to market through comprehensive data and validation?
3:30 pm Leveraging Digital Technologies to Design Novel Drug-Device Combination Products
Synopsis
- Applying computational modelling and simulation in combination products
- Implementing computational methodologies to model pharmacological parameters for autoinjectors
- Recognizing the significance of digital tools in supporting the regulatory submission and lifecycle analysis of injectable devices