Discover the course
Device Drug and Drug Device Combination Products in the EU under the Medical Devices Regulation (MDR)
A targeted training to understand the regulatory pathway of device drug and drug device combinations (DDCP) in the European Union
Latest updates from the MDR 2017/745 and EMA guidance
Significant regulatory changes have come along with the EU Medical Devices Regulation 2017/745 (MDR) and evolutions affecting pre-clinical and clinical evaluation of medical devices and notified bodies. Also, due to research and innovation, the amount of Device Drug and Drug Device Combination Products (DDCPs) is growing.
- Gives you an overview of the requirements for DDCPs under the new MDR
- Guides you through the regulatory pathway of combi products
- Gives you a clear understanding of the regulatory requirements for devices containing medicinal substances and devices provided in combination with drug products
- Gives hands-on insight on how to achieve compliance and the requirements for regulatory documentation and CE marking
Module 1: Definition of combination products (DDCPs)
• Drug-Device Combinations (integral or non-integral)
• Device-Drug combinations
• Background and Guidance
Module 2: Understanding the medical devices regulation (MDR)
• Directives, regulation, Guidance and standards applicable for medical devices
• Notified body and CE marking principles
• Medical Devices Regulation (MDR) 2017/745 in a nutshell
• Labelling requirements for medical devices
Module 3: Process for conformity assessment
• Process for CE marking according to risk class
• Process for Drug-Device combination products
Module 4: Technical documentation for DDCPs
• What is required
• Structure of the dossier and the drug part
• Pre-clinical testing, Usability
Module 5: Quality requirements for drug-device combinations
• Legal basis
• Module 1,3.2
• Life cycle and post-market requirements
Case studies / Q&A
Mr. Arkan Zwick is the Corporate Regulatory Affairs Director of CROMA Pharmaceutical, Austria. CROMA is a private global pharmaceutical and surgical company with products in ophthalmology, orthopedic and aesthetic dermatology. With more than eleven years of regulatory professional experience Arkan´s role includes regulatory advocacy for drug, medical device, combi products and cosmetic compliance projects as well as in house legal advice for contract management, merger and acquisition, and intellectual property projects. He is responsible for the company’s regulatory compliance in the EU working with several notified bodies and for global market authorizations in the Americas and Asia-Pacific.
Arkan has a master’s degree in Law from the University of Vienna and a PhD in European Law. He is a lecturer at the University of Applied Sciences in Vienna and speaker on life cycle conferences. He is fluent in English, German and French.
Quality Assurance, Regulatory Affairs, Clinical Operations, Medical Writing, Research & Development, CEO / CTO´s working for medical device manufacturers, pharma and biotech companies, CROs, Research Centres and Universities applied sciences and biotechnology faculties.
Knowledge of the Medical Devices Directive (MDD 93/42) and of the Medical Devices Regulation (MDR) 2017/745 is an advantage. Newcomers are welcome.
5 training Modules
At your arrival you will find our Staff at the Welcome Desk to greet and make you feel welcome and as comfortable as possible, providing direction and all information about the meeting, seating, refreshments.
Coffee breaks and lunch will provide a pleasant moment of refreshment. Special care about the food quality, in particular to your dietary needs or preferences, from menus of local products and flavors to vegetarian dishes.
Limited number of participants to encourage networking and discussion.
All our training facilities are safe, healthy, comfortable, aesthetically-pleasing, and accessible. They are able to accommodate the specific space and equipment needs of the training program.
Depending on the seating configuration, the room may accommodate lecture-style instruction or encourage interaction in the form of roundtable discussions. Equipped for audio/visual, Free Wi-Fi to allow everyone to connect with just one click, electric sockets.
All the information necessary for learning during the course is provided. It is recommended to bring your PC to take notes (even directly on the slides provided in PDF format). The environment is important to us and that's why we try to make this meeting an experience of environmental sustainability.
Early Bird: € 880,00* (until 18 February 2020)
Ordinary: € 990,00*
Freelance - Academy - Public Administration**: € 490,00*
* for Italian companies: +22% VAT
**Early Bird discount not applicable to Freelance – Academy – Public Administration fee
The fee includes: tuitions, teaching materials, lunches and coffee breaks, organizational office assistance, attendance certificate.
Tuesday, February 18, 2020
At the end of the training, you will be able to
Understand the content of the MDR and its impact on the conformity assessment of devices
Understand the requirements for combination products and the registration process to obtain CE marking
Gain practical experience on the life cycle of products