Drug<->Device Combination Products: Taking hurdles efficiently

Detailed programme Day 1: 13:00 - 17:30
Day 2: 09:00 - 17:00
You may dial in 30 min. before the session 13:00 Welcome and introduction
13:15 - 17:30 Dr Kirsten Plaßmann Regulatory framework for different product groups

Definition, differentiation and classification: Medicinal product, medical device, combination product, drugs linked to a medical device

Case studies for classification

Advantages and disadvantages of product groups

Regulatory framework for product groups

Current legal decisions

The session includes one coffee break.

17:30 Day one ends
09:00 Dr Kirsten Plaßmann Welcome and wrap up regulatory framework
09:30 Frank Hermens Regulatory submissions for combination products (drug-device and device-drug)

Consultation and regulatory approval process

Communication between manufact-urers, notified bodies and authorities

Technical documentation requirements

11:15 Coffee break
11:30 Krysten Oates Quality requirements for combination products

Draft guideline on the quality requirements for DDCs

Quality requirements for device-drug

12:30 Dr Kirsten Plaßmann Discussion: Article 117 MDR and its impact on the industry
13:15 Lunch
14:15 Jan Bart Hak Vigilance for DDCs

What are the differences?

What are the similarities?

QMS requirements

15:45 Coffee break
16:00 Dr Dominique Monferrer Digital Health and drug-device combinations in the light of the new MDR
16:45 Concluding discussion
17:00 Seminar ends

Detailed programme Day 1: 13:00 - 17:30
Day 2: 09:00 - 17:00
You may dial in 30 min. before the session 13:00 Welcome and introduction
13:15 - 17:30 Dr Kirsten Plaßmann Regulatory framework for different product groups

Definition, differentiation and classification: Medicinal product, medical device, combination product, drugs linked to a medical device

Case studies for classification

Advantages and disadvantages of product groups

Regulatory framework for product groups

Current legal decisions

The session includes one coffee break.

17:30 Day one ends
09:00 Dr Kirsten Plaßmann Welcome and wrap up regulatory framework
09:30 Frank Hermens Regulatory submissions for combination products (drug-device and device-drug)

Consultation and regulatory approval process

Communication between manufact-urers, notified bodies and authorities

Technical documentation requirements

11:15 Coffee break
...