2020-12-09 2021-11-10 , Online Online, 1.590,- € zzgl. MwSt. Dr. Kirsten Plaßmann https://www.forum-institut.de/seminar/2111273-drug-device-combination-products-taking-hurdles-efficiently/referenten/21/21_11/2111273-online-training-pharma-combination-products_plassmann-kirsten.jpg Drug<->Device combination products: Taking hurdles efficiently

This training addresses the new regulatory framework for drug-device combination products. Use this opportunity to discuss the impact these changes will have on your products and how to implement the requirements. The training course will be entirely held in english.

Topics
  • Current and future regulatory framework
  • Submission and quality requirements
  • Article 117 MDR and its impact on drug-device combination (DDCs) products
  • Clinical considerations and vigilance obligations
  • Digital health and DDCs in the light of the new MDR
Aims and objectives
The regulatory requirements in the drugand medical-device sector pose numerous challenges to your products. Especially the Article 117 MDR and the draft guideline on quality requirements for DDCs will impact the industry regarding regulatory and quality-related issues, among others.
After attending this training course, you will
  • be able to classify your product in the correct product group,
  • know the consequences of current case law for the development, approval and post-marketing surveillance of your product,
  • know the impact of Article 117 MDR,
  • discuss the new quality requirements for DDCs and
  • have an idea of future digital challenges.
Who should attend

This seminar is aimed at specialists and managers in the pharmaceutical and medical-device industries. Employees dealing with borderline issues in the areas of approval, certification, clinical/medical affairs, quality assurance and vigilance, can benefit greatly from this seminar.

Online seminar - combination products

Drug<-->Device
Combination Products:
Taking hurdles efficiently

- Online training -

Benefits
  • Effective knowledge transfer
  • This expertise will benefit your company
  • Pose your questions in advance
  • This training course is entirely held in English
  • We are following the IMI quality criteria

Webcode 2111273

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Alles auf einen Blick

Termin

09. - 10.11.2021

09. - 10.11.2021

Zeitraum

Day 1: 13:00 - 17:30Day 2: 09:00 - 1...

Day 1: 13:00 - 17:30
Day 2: 09:00 - 17:00
You may dial in 30 min. before the session
Veranstaltungsort

Online

Online

Gebühr
Ihr Ansprechpartner

Dr. Birgit Wessels
Conference Manager

+49 6221 500-652
b.wessels@forum-institut.de

Details

This training addresses the new regulatory framework for drug-device combination products. Use this opportunity to discuss the impact these changes will have on your products and how to implement the requirements. The training course will be entirely held in english.

Topics
  • Current and future regulatory framework
  • Submission and quality requirements
  • Article 117 MDR and its impact on drug-device combination (DDCs) products
  • Clinical considerations and vigilance obligations
  • Digital health and DDCs in the light of the new MDR
Aims and objectives

The regulatory requirements in the drugand medical-device sector pose numerous challenges to your products. Especially the Article 117 MDR and the draft guideline on quality requirements for DDCs will impact the industry regarding regulatory and quality-related issues, among others.
After attending this training course, you will

  • be able to classify your product in the correct product group,
  • know the consequences of current case law for the development, approval and post-marketing surveillance of your product,
  • know the impact of Article 117 MDR,
  • discuss the new quality requirements for DDCs and
  • have an idea of future digital challenges.

Who should attend

This seminar is aimed at specialists and managers in the pharmaceutical and medical-device industries. Employees dealing with borderline issues in the areas of approval, certification, clinical/medical affairs, quality assurance and vigilance, can benefit greatly from this seminar.

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

Ingrid Stroo

Regulatory submissions for combination products (drug<->device)
  • Consultation and regulatory approval process
  • Communication between authorities, notified bodies and manufacturers
  • 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 break


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


More Information

How does an online seminar work?

Our online training courses are live and interactive. They are held and controlled directly by our speaker. You may take part in the seminar from anywhere using your end device. You will see the presentation and listen to our speaker's lecture using Internet telephony (VoIP) or even a normal telephone connection. And you can also ask questions live.

1. You will receive brief instructions on how to use Zoom beforehand.
2. 48 hours before the online seminar, you will receive an email with an access link and a meeting ID.
3. Use a headset, loudspeakers or the telephone for audio.
4. Listen to the speaker and follow the presentation.
5. Feel free to switch from silent to audio mode by yourself any time to ask your questions.

The benefits of an online seminar

  • Attend the training in all comfort, from wherever you like
  • There are no travel and accommodation costs
  • Ask questions live whenever you desire

Send us your individual questions

Please send us your questions concerning the seminar topics in advance.

We will be happy to forward them to the speakers, so that they know about your training requirements even better and are able to answer your questions at the seminar.

Please send your questions to b.wessels@forum-institut.de

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