Overview:
During this introductory session, delegates will gain a complete guide to the status and impact of the latest guidelines for combination products. Examples (company specific) of combination products will also be discussed to gain insights into their variety and complexities.
EU/US
The webinar will clarify the regulatory requirements of combination products and address life-cycle management.
Examining the regulatory requirements for drug device combinations in the case of a drug and a device and for integral products
Why should you Attend: This is a complex area requiring experience in both the pharmaceutical/Biotech and the medical device sector. This webinar will examine the regulatory requirements for drug device combinations in the case of a drug and a device and for integral products. This webinar will cover the basic requirements of how to stay compliant.
Areas Covered in the Session:
Regulatory Requirements
EU/US
CE Marking, 510 K and PMAs General Overview
Documentation Requirements for Combination Products EU/US
Interfacing, Development, Quality, Regulatory
Managing Third Parties and Document Control
Vigilance and Adverse Event Reporting
During this introductory session, delegates will gain a complete guide to the status and impact of the latest guidelines for combination products. Examples (company specific) of combination products will also be discussed to gain insights into their variety and complexities.
EU/US
The webinar will clarify the regulatory requirements of combination products and address life-cycle management.
Examining the regulatory requirements for drug device combinations in the case of a drug and a device and for integral products
Why should you Attend: This is a complex area requiring experience in both the pharmaceutical/Biotech and the medical device sector. This webinar will examine the regulatory requirements for drug device combinations in the case of a drug and a device and for integral products. This webinar will cover the basic requirements of how to stay compliant.
Areas Covered in the Session:
Regulatory Requirements
EU/US
CE Marking, 510 K and PMAs General Overview
Documentation Requirements for Combination Products EU/US
Interfacing, Development, Quality, Regulatory
Managing Third Parties and Document Control
Vigilance and Adverse Event Reporting
Speakers
Salma Michor,
Who Should Attend
- Regulatory Affairs
- Medical Officers
