8:00 am Welcome Coffee

8:50 am Chair’s Opening Remarks

  • David Morra Director, Devices & Digital Health, Merck

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

  • Ajit D’Souza Director, Pharmaceutical Product Development, Kiniksa Pharmaceuticals

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

  • Raihan Hossain Former, Director, Drug, Device & Combination Product Quality, Bill & Melinda Gates Medical Research Institute

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

  • Olivia Wong Director, Quality, Device & Combination Products, Gilead Sciences

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

  • Kirsten Paulson Executive Director, Global CMC-Medical Device Lead, Pfizer

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

  • Leo Vanegas Director, Clinical Product Quality, Alexion

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)

  • Rakesh Khilwani Principal Device Development Engineer, Teva Pharmaceuticals

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

  • James Leamon Director, Biologics Device Development, Jazz Pharmaceuticals

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

  • David Morra Director, Devices & Digital Health, Merck

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

4:00 pm Chair’s Closing Remarks

4:45 pm End of Summit