The number and market value of medicinal products that require delivery by a medical device have increased exponentially over the last ten years. These products bring an increased level of complexity to the development and approval process. Also, the way these products are addressed by the regulatory agencies has changed and continues to evolve. This course will contain a combination of presentations, open discussions and hands-on exercises to enhance the knowledge and skills of the attendees.
Who Should Attend
This course will be geared towards individuals that have input to; oversight for; or actively participate on; drug delivery combination product development teams. This includes the following practitioners, managers and directors in medical device, pharmaceutical or consulting companies:
- Project Management
- Marketing
- Regulatory Affairs
- Quality Assurance
- Clinical Affairs
- Human Factors Engineering
- Device Development Engineering
- Design Verification Department
- Packaging Development
- Testing Laboratories
- Quality Engineering
- Manufacturing
- Formulation
Learning Objectives
Upon completion of this workshop you will be able to:
- Explain the basic elements and requirements behind the regulation of Drug Delivery combination Products in the USA and EU
- Plan, propose and choose appropriate regulatory strategies
- Understand requirements of Design Controls (USA) /Product Realization (EU) including Risk Management, Human Factorsand Clinical Requirements
- Develop a set of criteria with which to assess, choose and manage Device Partners
- Develop a set of criteria with which to verify device design, including Functional Requirements
- Identify the appropriate testing schemes and requirements specific to their products
- Learn about Post Market Requirements, including Complaints, Reportable Events, Customer Service, Change Management, and Non-conformances including Recalls