Quality & Regulatory Requirements for Drug Device Combination Products

Days
Hours
Minutes
Seconds

Quality & Regulatory Requirements for Drug Device Combination Products

online live

Training features

Fully online

All sessions of this unique course online

Live interaction

Live interaction options between the delegates and trainer

On any device

Available via mobile, tablet or laptop

Course description

As delivery system technology and medical devices continue to develop, the combination of drug-device and device-drug modalities are rapidly increasing and the distinction between the modalities is becoming blurred. In some situations, it is difficult to determine as to which regulations, submission procedure and pathway to market must be followed. Correct classification is a key as in the European Union, combination products are regulated as either medicinal products or medical devices.

This course will cover the definition of combination products, EU regulatory pathways, and will explain the current state of developments as medical device manufacturers and marketing authorisation holders prepare for the new requirements.

meet the training leader
Dr. Tina Amini
Medical Device Division Director Founder, Managing Director
NDA Group AB, UK
training

Brochure

Reveal the full schedule of the training as well as key topics, course objectives, key takeaways, special features, and the trainer bio!

Quality & Regulatory Requirements for Drug Device Combination Products Training Course | Fleming
Quality & Regulatory Requirements for Drug Device Combination Products Training Course | Fleming
Quality & Regulatory Requirements for Drug Device Combination Products Training Course | Fleming
key training

Topics

Regulatory & legislative requirements for Drug Device Combination Products

Borderline classification in EU: Medical Device or Medicinal product?

EU market access for medicines with a device component

Key considerations for Combinations regulated as a medicinal product

EU market access for devices with an ancillary medicinal substance

EU MDR key changes and its impact on Drug Device Combination Products

Case study on combination products regulated as medical devices

Labelling requirements for drug device combination products

Key takeaways

Medtech and Pharmaceutical/biotech companies increasingly must stay informed about implications of the EU MDR. EU MDR came into full effect on 26 May 2021 and will encompass all integral, single-use combination products regulated as medicinal products. In the European Union, combination products are regulated as either medicinal products or medical devices.

For marketed CE Marked devices under MDD and AIMDD whether standalone or co-packaged with medicinal products, these devices must also conform to MDR.

“Substantial” device design changes of already marketed single integral combination products will require NB opinion. To ensure that operations conform with the EU MDR, pharmaceutical/biotech companies must have compliant design controls, integrated risk-management procedures, and improved processes for complaint handling. Companies must have closer oversight of their device and component manufacturers. Because compliance is an ongoing activity that lasts throughout a device’s product lifecycle, businesses are encouraged to incorporate device compliance processes into their operations as soon as possible. Given overdemand for notified bodies in the regulatory arena, an early start can make the difference between a product market freeze and full compliance for market access.

Registration

Training ticket

Online Live Stream
FROM
1396

Contact us

NEBOSH Certificate in Oil and Gas Operational Safety Maputo Training
21. - 26. March 2022
Maputo, Mozambique
Clinical Trials Quality & Inspection Updates
22. - 24. February 2022
Online Live | 14:00 - 17:30 CET
Root Cause Analysis for Oil and Gas Industry
4. - 6. April 2022
Online Live Stream
HAZID and HAZOP Masterclass
14. - 18. February 2022
Online Live Stream
Managing The Abandonment Costs For Oil And Gas Wells
26. - 28. October 2021
Online Live Stream
NEBOSH Certificate in Oil and Gas Operational Safety Maputo
15. - 20. November 2021
Maputo, Mozambique
Agility in Compliance - Yes, Please!
CONTRIBUTOR View trainer bio View trainer bio View trainer bio View trainer bio View trainer bio...
Imploded Storage Tank
CONTRIBUTOR What Happened? After cleaning with steam a tank was quenched with cold water to shorten...
Importance of a mobile banking app within a bank’s multi-channel strategy
CONTRIBUTOR View trainer bio View trainer bio View trainer bio View trainer bio View trainer bio...
Digital Banking: The Operational Backbone
CONTRIBUTOR View trainer bio View trainer bio View trainer bio View trainer bio View trainer bio...
Queens of safety inventions
Throughout history, women were underestimated and it was unbelievable for society if a woman came up with...
EHS Opportunities due to COVID-19 – seizing the “new normal”
CONTRIBUTOR On March 11, 2020, the World Health Organization officially declared the novel coronavirus a pandemic....
Jeannette Dixon
Independent GCP QA Consultancy
United Kingdom
Marcio Brochado Correia
Global Head IT Commercial Platforms
Syngenta, Switzerland
Constanze Becker
Advisor to the Local Head
Christine Kohlert
Global expert for Learning & Working Spaces
Drees & Sommer, Germany
Mattijs Kaak
Partner
Under Architects, Turkey
Burak Ünder
Founder
Under Architects, Turkey

DOWNLOAD THE BROCHURE AND REVEAL THE FULL PROGRAM DETAILS

Sophia N. Economidou | Fleming
Name
Job
Company
Bio
Name
Description
NEBOSH Certificate in Oil and Gas Operational Safety Maputo Training
21. - 26. March 2022
Maputo, Mozambique
Clinical Trials Quality & Inspection Updates
22. - 24. February 2022
Online Live | 14:00 - 17:30 CET
Root Cause Analysis for Oil and Gas Industry
4. - 6. April 2022
Online Live Stream
HAZID and HAZOP Masterclass
14. - 18. February 2022
Online Live Stream
Managing The Abandonment Costs For Oil And Gas Wells
26. - 28. October 2021
Online Live Stream
NEBOSH Certificate in Oil and Gas Operational Safety Maputo
15. - 20. November 2021
Maputo, Mozambique
Agility in Compliance - Yes, Please!
CONTRIBUTOR View trainer bio View trainer bio View trainer bio View trainer bio View trainer bio...
Imploded Storage Tank
CONTRIBUTOR What Happened? After cleaning with steam a tank was quenched with cold water to shorten...
Importance of a mobile banking app within a bank’s multi-channel strategy
CONTRIBUTOR View trainer bio View trainer bio View trainer bio View trainer bio View trainer bio...
Digital Banking: The Operational Backbone
CONTRIBUTOR View trainer bio View trainer bio View trainer bio View trainer bio View trainer bio...
Queens of safety inventions
Throughout history, women were underestimated and it was unbelievable for society if a woman came up with...
EHS Opportunities due to COVID-19 – seizing the “new normal”
CONTRIBUTOR On March 11, 2020, the World Health Organization officially declared the novel coronavirus a pandemic....
Jeannette Dixon
Independent GCP QA Consultancy
United Kingdom
Marcio Brochado Correia
Global Head IT Commercial Platforms
Syngenta, Switzerland
Constanze Becker
Advisor to the Local Head
Christine Kohlert
Global expert for Learning & Working Spaces
Drees & Sommer, Germany
Mattijs Kaak
Partner
Under Architects, Turkey
Burak Ünder
Founder
Under Architects, Turkey