Day Five – 14 June 2024Friday, 14 June 2024 - CEST (Cent Europe Summer, GMT+2)

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Project Management Training Course

08:45 - 08:55

Chairperson’s Opening Remarks: Regulatory Project Management

08:55 - 10:25

Development stages

Regulatory considerations in early development
Access publicly available databases early on
“Can you sell me this pen?” Three easy steps to develop an initial regulatory, quality, and clinical strategy and then sell it to senior management.
Establishing and initiating the project
- Mapping out timelines, responsibilities, and management
- Records management and documentation
- Identify ways to incorporate quality planning into a project
Common myths, best practices, and tools – Lessons learned

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Project Management Training Course

11:10 - 11:55

Regulations and standards in project management for medical devices

Which regulations and standards apply to your device?
Establishing and monitoring standards in medical device project management
Incorporating regulatory requirements and considerations throughout the medical device lifecycle (clinical evaluation, safety, and risk management)
Additional regulatory considerations for project management (quality system requirements, design control, vendor control)
Common myths, best practices, and tools – Lessons learned

11:55 - 12:25

Incorporation of clinical evaluation in project management

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Project Management Training Course

13:25 - 13:30

Chairperson’s Afternoon Remarks: Regulatory Project Management

13:30 - 15:15

Establishing risk management in project management

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Project Management Training Course

15:45 - 17:00

Managing medical device project cycles

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