Discover the course

WEBINAR: 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

25 - 26 - 30 June 2020

Location

Webinar

Language

English

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

Significant regulatory changes are coming along with the EU Medical Devices Regulation 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 (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 combination 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: Understanding combination products and the medical devices regulations – MDR

  • Drug-Device Combinations DDCPs - integral or non-integral
  • Device-Drug combinations
  • Directives, Regulation, Guidance and Standards applicable to medical devices
  • Notified body and CE marking principles for device market authorization
  • Medical Devices Regulation MDR 2017/745 in a nutshell

Module 2: Conformity assessment and technical documentation for device-drug combinations

  • Process for CE marking according to risk class
  • Process for Drug-Device combination products. Impact of Art. 117 MDR
  • What is required in a device technical documentation
  • Structure of the dossier and the drug part
  • Pre-clinical testing, Usability
  • Clinical evaluation

Module 3: Quality requirements for drug-device combinations 

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


Webinar language

The webinar will be in English
Arkan Zwick
Arkan Zwick Corporate Regulatory Affairs Director at 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.

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.

3 Modules 
Case studies 
Q&A  

Webinar

Webinar online - 3 modules

June 25th, 2020             10:00 am – 12:30 pm CEST
June 26th, 2020             10:00 am – 12:30 pm CEST
June 30th, 2020              09:30 am – 10:30 am 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.

Certificate of attendance

Early Bird: € 610,00* (until 4 June 2020)

Ordinary: € 685,00*

Freelance - Academy - Public Administration**: € 366,00*


*
for Italian companies: +22% VAT

**Early Bird discount not applicable to Freelance – 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.

Register now

Course Price

685.00 €

Early Bird

Thursday, June 4, 2020

610.00 €

Payments accepted

  • Bank Transfer
  • Credit Card
  • PayPal

Other Details

Duration

3 modules, 6 hours in total

Course Type

Limited number of participants

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

The limited number of participants allows a better interaction with the teachers, who can answer all the questions

International and multidisciplinary profile of participants, which enriches the training

You may also be interested in

Close Menu
×
×

Cart

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

information request

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

Webinars
The fee includes: tuition, teaching materials, organizational office assistance, attendance certificate. Early Bird discount not applicable to Freelance – Academy – Public Administration fee. For further information please contact:  e-mail: training@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 (50% refund of the registration fee) will only be given if cancellation is received at least four weeks before the event date. Cancellations will only be valid if made in writing. Transfer of registrations (or name changes) are allowed for free 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, to change its performance from residential to webinar/online. 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, hostilities, epidemics, pandemics, and / or authorities’restrictions (so-called factum principis).

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.