Technical and Regulatory Challenges of Drug Delivery Combination Products - Prefilled Syringes, Autoinjectors and Injection Pens - March

Orlando, FL
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Duration: 1 day
Time: 8:30 a.m. - 4:00 p.m.

The course will examine the technical and regulatory challenges companies will face in the development and registration of drug delivery combination products.  The course will cover:

  • Applicable Regulatory Schemes in the US and EU and Potential Regulatory Strategies
    • Brief History and Basics of Regulatory Definitions
    • Application of Regulations and Directives to Drug Delivery
    • Differences in USA and EU Requirements
    • Regulatory Strategies
  • Partner (Vendor) Selection and Oversight
    • Product Criteria
    • Partner Criteria
    • RFP Process
  • Impact and Expectations for GMP/QSR Compliance
    • US GMPs
    • Key Quality Systems Expectations During Design
    • EU Requirements
    • Leveraging Partner's Systems
  • Technical Requirements - Creation of a Design History File
    • Unique In-Vitro and Animal Testing Requirements
      • Performance/Functional Requirements
      • Material Requirements
      • Stability Expectations
    • Risk Management and Human Factors Requirements and Expectations
      • Risk Management Requirements
      • Usability Requirements
  • Current Clinical Requirements, Expectations and Challenges
    • Current Clinical Expectations And Strategies For Clinical Bridging
  • Format, Elements and Data Requirements for Marketing Authorization Submissions

Upon returning to your company, participants will be able to initiate a gap analysis to identify the requirements and elements of a successful drug delivery combination product development program.  Proper implementation of these elements will minimize project risk.

Who Should Attend

This course will be geared towards individuals who have oversight for or actively participate on drug delivery combination product development teams. This includes project managers as well as directors or managers in marketing, regulatory affairs, quality assurance, clinical affairs and device development engineering.

More information coming soon.

Day 1

Upon completion of this course, you will be able to:

  • Discuss the basic elements and requirements behind the regulation of drug delivery combination products
  • Propose and choose appropriate regulatory strategies
  • Develop a set of criteria with which to assess and choose device partners
  • Explain the GMP/QSR expectations and responsibilities relevant to companies developing and manufacturing these products
  • Describe the expectations for robust risk management and human factors engineering systems in order to execute a successful development program
  • Identify the appropriate testing schemes and requirements specific to your products
  • Outline the contents of a clinical or marketing approval application

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Lee Leichter, President, P/L Biomedical