About

Significant regulatory changes came along with the EU Medical Devices Regulation (MDR) 2017/745 (MDR) and evolutions affecting pre-clinical and clinical modules of medical device dossiers, their market approval process and notified bodies involved in the conformity assessment.

Also, due to research and innovation, the varieties of Device-Drug and Drug-Device Combination Products is growing.

This workshop:

  • Gives you an overview of the requirements for combination products under the MDR
  • Guides you through the regulatory conformity pathways for combination products
  • Gives you a clear understanding of the regulatory requirements for devices containing medicinal substances, devices provided in combination with drug products, devices combining software and medicinal products, and devices associated with natural substances.
  • Gives hands-on insight on how to achieve compliance and the requirements for regulatory documentation and CE marking

MODULE 1
Understanding combination products

  • Definitions in device and drug regulations.
  • How are combination products classified?
  • Separate worlds, however approaching.
  • Case studies.

Medical Devices Regulation 2017/745

  • Introduction to MDR.
  • Transition for industry and notified bodies.
  • Key changes for the industry.
  • Latest updates.

MODULE 2
Device conformity assessment

  • What is conformity assessment?
  • Process for CE marking and technical dossier and changes.
  • How to demonstrate compliance to safety and performance requirements (GSPR).
  • Case study – Syringe.

Device Drug combinations

  • Guidance and conformity assessment.
  • How is the European Medicines Agency (EMA) involved?
  • Technical documentation drug part.
  • Changes to the medicinal substance.

Drug Device combinations

  • Impact of MDR Article 117 and EMA Guidance.
  • Technical Documentation and Notified Body Opinion (NBO).
  • Device data in the drug CTD.
  • Changes.

This course is beneficial for professionals from both pharmaceutical and medical devices companies working in Quality Assurance, Regulatory Affairs, Clinical Operations, Medical Writing, Research & Development, CEO / CTO.
The course will benefit to industry, pharma and biotech companies, CROs, Research Centres and Universities applied sciences and biotechnology faculties involved in development, manufacturing and sales of DDCPs.

Participant experience
Knowledge of the Medical Devices Directive (MDD 93/42) and of the Medical Devices Regulation (MDR) 2017/745 is an advantage. Newcomers are welcome.

The training includes knowledge transfer, interactive sessions, case studies and group discussions.

Lecturers
Arkan Zwick
Info

Arkan Zwick

Corporate Director Regulatory Affairs at Croma Pharma

Arkan has a master’s degree in law and PhD in European law. His role includes regulatory strategy, advice and advocacy for drug, devices, and combinations product projects as well as in house legal advice for contract management and due diligence projects. His responsibility includes global regulatory compliance and regulatory market access in the EU, Americas and Asia-Pacific for devices and combination products in ophthalmology, orthopedic and aesthetic medicine. Arkan is lecturer and trainer at the University of Applied Sciences in Lower Austria and on life cycle conferences and trainings. He is fluent in English, German, French and Turkish.


Online Training – 2 modules

MODULE 1 | 19 June 2024  9:30 am – 12:30 pm CEST
MODULE 2 | 20 June 2024  9:30 am – 12:30 pm CEST

After the registration, you will receive all details about the connection.

The course will proceed with a minimum number of participants. Should this number not be reached the registered participants will be notified one week prior to the commencement of the course.

Early Bird: € 680,00* (until 22 May 2024)

Ordinary: € 875,00*

Freelance – Individual – Academy – Public Administration**: € 445,00*

* for Italian companies: +22% VAT

**Early Bird discount not applicable to Freelance – Individual – Academy – Public Administration fee

The fee includes: tuitions, organizational office assistance, teaching materials and attendance certificate that will be sent after the training via e-mail.

Ilaria Butta
Ilaria Butta
Events & Training Manager
Printable Version
At the end of the training, you will be able to
Risultato atteso
Understand the content of the MDR and its impact on the conformity assessment of devices
Risultato atteso
Understand the requirements for combination products and the registration process to obtain CE marking and notified body option (NBO)
Risultato atteso
Understand the impact of Art. 117 MDR and gain practical experience on the life cycle of products

<p>Online interactive training on Zoom platform.</p>
<p><em>LS Academy will provide the access link to the virtual platform a few days before the training.</em></p>

Online interactive training on Zoom platform.

LS Academy will provide the access link to the virtual platform a few days before the training.

<p>Online interactive training on Zoom platform.</p>
<p><em>LS Academy will provide the access link to the virtual platform a few days before the training.</em></p>