Attestato di partecipazione
Introduzione
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 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 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 – 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
Conformity assessment and technical documentation for device-drug combinations – Part I
- Process for CE marking according to risk class
- Process for Drug-Device combination products. Impact of Art. 117 MDR.
MODULE 2
Conformity assessment and technical documentation for device-drug combinations – Part II
- What is required in a device technical documentation
- Structure of the dossier and the drug part
- Pre-clinical testing, Usability
- Clinical evaluation
Quality requirements for drug-device combinations
- Legal basis
- Module 1,3.2
- Life cycle and post-market requirements
Case studies / Q&A
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.
Docente/i
Arkan Zwick
Mr. Arkan Zwick is the Corporate Regulatory Affairs Director of CROMA Pharma, Austria. CROMA is a private global pharmaceutical and surgical company with products in ophthalmology, orthopedic and aesthetic dermatology. With more than sixteen 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.
Online Training – 2 modules
23 June 2022 9:30 am – 12:30 pm CEST
24 June 2022 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: € 660,00* (until 26 May 2022)
Ordinary: € 780,00*
Freelance – Academy – Public Administration**: € 430,00*
* 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.
Registrati
Versione Stampabile
Cosa saprai fare dopo il corso
Online interactive training on Zoom platform.
LS Academy will provide the access link to the virtual platform a few days before the training.