Live eLearning - PDA 615.1 Injectable Combination Product Integrated Development

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The regulation of combination products continues to evolve in the US and Europe with new practices that have greater scrutiny for safety and performance. The effectiveness and compatibility of the delivery device with the drug product is critical to patient safety. However, it is difficult to define the device inputs in early development when the drug formulation and dosing is not yet final. Pharmaceutical companies, device engineers, and suppliers have a common goal to identify risks to combination product quality with early planning to enable parallel development.

The aim of this training course is to bring together multiple viewpoints with a line of sight to finished combination product from early development through commercialization. A background on the requirements from different regulatory branches will be given, with a focus on Design Controls and Quality by Design alignment. Interactive discussion across various disciplines will bring to light the importance of early planning to address potential failures. There will be examples of making informed decisions about suitable performance and safety data at the right time in order to guide application information. This training course will provide practical experience on understanding the role of human factors, recognizing essential performance requirements, and qualifying primary container systems.

  1. Explain the concept for integrated injectable drug-delivery system/device
  2. Merge aspects of Design Controls (DC) with Quality by Design (QbD)
  3. Identify considerations for contact material compatibility and safety
  4. Build line of sight data packages for delivery systems performance starting at development through regulatory approval
  5. Recognize goals for a total product life cycle (TPLC) model with feedback loops from inception

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Standard Pricing

Standard Member Price

$600

GovernmentMember Only

$600

Health AuthorityMember Only

$600

AcademicMember Only

$600

Non-Member

$600

See Qualifying Criteria for Member Types.

Day 1

Welcome and Introduction (15 min)

The Evolving Regulatory Landscape for Combination Products (35 min)

Alignment of Quality by Design and Design Controls / Knowledge Management (40 min)

Break (10 min)

The Role of Human Factors and Patient Focused Design (80 min)

Day 2

Opening Remarks / Combination Products: Risk-Based Assessments for Product Quality & Patient Safety (50 min)

Development of an Injectable Combination Product (30 min)

Break (10 min)

Case Studies and Regulatory Initiatives (90 min)

  • Risk for Method Development
  • Risk for Excipient Interactions with Primary Package Components
  • Bridging Drug Device and Biologic Device
  • Product-Specific Guidance PSG for Complex Generics

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