FORUM INSTITUT
FORUM · Institut für Management GmbH
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69115 Heidelberg
Email: service@forum-institut.de
Phone: +49 6221 500-500
Fax: +49 6221 500-505
Seminar Combinationsproducts
HOT TOPICS Drug/
Device Combination
Products
2019-12-02 2020-03-03 Holiday Inn Leiden Haagse Schouwweg 10 2332 KG Amsterdam / Leiden +31(0) 71 535 5555 +31(0) 71 53 55 553

HOT TOPICS Drug/Device Combination Products

Considerations for product development and lifecycle management

This conference 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.
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
  • Drugs combined with medical apps

Aims and objectives

The regulatory requirements in the drug- and medical-device sector pose numerous challenges to your products. Especially the new 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 and
  • discuss the new quality requirement for DDCs.

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.
Your speakers
Speaker both days
Dr. Kirsten Plaßmann
PlassmannLEGAL Stuttgart, Germany

Speakers day 2
Jan Bart Hak
ProPharma Group, Leiden, The Netherlands

Prof. Dr. Bert Leufkens
University Utrecht Utrecht, The Netherlands

Frank Hermens
ProPharma Group Leiden, The Netherlands


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