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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

Date

17 March 2020

Location

Vienna

Language

English

Device Drug and Drug Device Combination Products in the EU under the Medical Devices Regulation (MDR)

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.

This workshop:

  • 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
Clinical evaluation

Module 5: Quality requirements for drug-device combinations

• Legal basis
• Module 1,3.2
• Life cycle and post-market requirements

Case studies / Q&A


Course Language

The course will be in English.
Arkan Zwick
Arkan Zwick Corporate Regulatory Affairs Director of CROMA Pharmaceutical, Austria

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. His expertise includes in house legal and regulatory consulting as well as lecturing at the University of Applied Sciences in Vienna and scientific board member and speaker on life cycle conferences and trainings. 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.


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.

5 training Modules  

Case studies  

Q&A  

Mercure Grand Hotel Biedermeier Wien

Landstrasser Hauptstrasse 28

1030 - Vienna


Upon Arrival
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.

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.



Training Room

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.



Teaching materials

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.

Fee includes
Tuition, teaching materials, lunch and coffee breaks, organizational office assistance, attendance certificate. 

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.


Brochure
Certificate of attendance

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.

Register now

Course Price

990.00 €

Early Bird

Thursday, February 27, 2020

880.00 €

Payments accepted

  • Bank Transfer
  • Credit Card
  • PayPal

Other Details

Duration

1 day

Course Type

Limited number of partecipants

You will receive

Certificate of attendance

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

Participants' Feedbacks

In each topic there was some relevance to my daily work

International and multidisciplinary profile of participants, which enriches the training

Exemples from real life situations from the workplace were very useful.

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Device Drug and Drug Device Combination Products in the EU under the Medical Devices Regulation (MDR)

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Terms & Conditions

Trainings
The fee includes: tuition, teaching materials, lunches and coffee breaks, organizational office assistance, attendance certificate. Early Bird discount not applicable to Freelance – Academy – Public Administration fee.
The course will proceed with a minimum of 8 participants. Should this number not be reached the registered participants will be notified one week prior to the commencement of the course.
For further information please contact:  e-mail: training@LSAcademy.com  telephone: +39 (0)35.515684

Conferences
The fee includes: seat at the conference, copy of presentations of Speakers who allow the distribution, informative literature for the day, networking lunch, coffee break, organisational office assistance, certificate of attendance. For further information please contact:  e-mail: events@LSAcademy.com  telephone: +39 (0)35.515684

Common Terms & Conditions

Terms of payment
Payment should be made online (by credit card) or by bank transfer, at the time of registration (only for Italian companies: + 22% VAT) to EasyB s.r.l by bank transfer or by credit card. Bank transfer payable to:

EasyB S.r.l.
Via Roma, 20 – 24022 Alzano Lombardo (Bergamo)
VAT: IT03633040161
BANCO BPM – Filiale di Carobbio degli Angeli
IBAN: IT81 F 05034 53960 000000003450
SWIFT Code: BAPPIT21AY5

Confirmation of event admission will be given on receipt of payment. Invoice will be sent following receipt of payment. EasyB reserves the right to refuse late registrations or additional registrations above the maximum accepted number of participants or registrations of roles that are not included in the target of the event.

Cancellation
Please note that refunds (70% refund of the registration fee) will only be given if cancellation is received at least one week before the event date. Cancellations will only be valid if made in writing. Transfer of registrations (or name changes) are allowed and should be made in writing within 7 days prior to the event. EasyB reserves the right to postpone or cancel an event, to change the location of an event or to alter the advertised speakers for an event. EasyB is not responsible for any loss or damage as a result of substitution, alteration, postponement or cancellation of an event due to causes beyond its control including without limitation, acts of God, natural disasters, sabotage, accident, trade of industrial disputes, terrorism, or hostilities.

Information collection and use
In accordance with the Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016, we inform you that EasyB S.r.l. (with headquarter in Via Roma 20, Alzano Lombardo, Bergamo, Italy, VAT number IT03633040161) will use your personal data voluntarily provided by you only with the consent and in compliance with the principles dictated by the European Regulations on the protection of personal data for sending newsletters, for marketing purposes (sending advertising material, market research and commercial communication) and for communication purposes to third parties (lecturers, scientific board, speakers, conferences’ sponsor), also for marketing goals. You can read the complete information, including your rights and the procedures for the exercise of the same, 
following this link.