Description

The Drug/Device Combination Products event will examine the current US and global regulatory environments for combination product development and approval, including new FDA regulation and guidances, and late-breaking information on implementation of the EU Medical Device Regulation. This event will provide a better understanding of both regulatory and practical aspects of developing drug-device combinations, as well as the management of combination products across the total product life cycle.

The global drug-device combination products market was valued at $81,374 million in 2017 and is projected to reach $139,193 million by 2025 at a CAGR of 6.9% from 2018 to 2025. The growth of the Global Drug-device Combination Products Market is driven by rise in incidence of chronic diseases such as diabetes, cancer, and respiratory problems, increase in casualties owing to accidents and trauma, rise in geriatric population, growth in home-based healthcare market, and technological advancements such as development of prefilled syringes. However, factors, such as unnoticed complications of drug-device combination products, number of product recalls, and stringent government regulations, hamper the market growth. Conversely, rise in healthcare infrastructure and high market potential in untapped emerging economies are expected to provide lucrative growth opportunities for the market.

Combination products bring together generic or biologic drug and medical devices to more effectively deliver treatments to patients. They are still relatively new delivery systems for the healthcare market. During the past few years new regulations and legal developments have improved the framework for combination product development and evolved the technology. Therefore that process increased technological requirements, as well as quality systems and lifecycle management.

Key Practical Points

  • Development of Combination Products from Initial Studies Through Post Market Management
  • EU MDR Compliance for Commercial Combination Products
  • Regulatory Pathways and Control Strategies
  • Life Cycle Management and Platforming
  • Implication for Combination Products
  • Digitalization Trend in Combination Product Use and Design
  • Approach and Strategy in Developing Drug/Biologic/Device Combination Products
  • Wearable Devices in Drug Delivery and Combination Product Development
  • Application and Characterization of Biodegradable Polymers as a Drug Delivery Conduit in Combination Products
  • Application of Mathematical Modelling in Design and Validation of Drug/Biologic/Device Combination Products
  • Real World Challenges for a Pharmaceutical Organization
  • A System-Wide Approach to Stability of Combination Products
  • Translation of User Research to Actionable Product Specification
  • Integrated Development and Risk Management Process for Combination Products
  • Driving innovations to extend your combination product lifespan.
  • Connected digital technologies and next generation combination products.
  • FDA Considerations for Speedy Product Approval & Continued Compliance
  • Impact Of International Market Challenges Including EU MDR
  • Practices to demonstrate design control compliance
  • Key clinical study design considerations for connected combination products including unique endpoints and instrumenting for RWE collection
  • Describe challenges and opportunities in lifecycle management programs for complex Combination Advanced Therapeutic Medical Products (CATMPs)
  • Registering DDC products across the globe.
  • LCM strategies and regulatory considerations.
  • Platform selecting and engaging the right stakeholders in the product development process.
  • Addressing the differences and gaps between drug and device development plans.
  • Streamlining a quality management system to support sustainable LCM.
  • Identifying essential performance requirements and associated control strategies.
  • Integration of design control throughout LCM. Design verification and process validation.
  • Risk-based approaches to design and development of drug delivery systems.
  • Utilizing human factors in combination products risk management.
  • Clinical evaluation for combination products.
  • Drug/device compatibility, safety evaluation and testing for combination products.
  • Best practices for post approval changes.
  • Assessing post market surveillance to support effective lifecycle management.

Who should attend?

  • CMC
  • Compliance
  • Design Controls
  • Device Development & Manufacturing
  • Drug Delivery & Devices
  • Human Factors
  • Packaging
  • Risk Management
  • eClinical
  • Regulatory Operations
  • Research and Development
  • Submissions
  • Combination Products
  • Controls & Robotics
  • Device Design
  • Device Engineering & Design
  • Formulation Sciences
  • Pre-filled Syringes
  • Quality Assurance / Control
  • Validation
  • Consulting
  • Legal, Government Affairs
  • Quality Assurance and Control
  • Clinical Research
  • Research & Development
  • Usability Engineering
  • Inhalation Products
  • Parenteral Products
  • Product Quality
  • Regulatory Affairs
  • Biopharmaceutical
  • Generics, Biosimilars, Device, and Combination Product R&D and Development
  • Business Development
  • Policy