Introduzione
The In vitro diagnostics Regulation (EU) 2017/746 entered into force on May 26th 2017 as the replacement of Directive on In vitro diagnostic medical devices (98/79/EC).
This regulation will be fully applicable from May 26th 2022, with the aim to increase safety and efficiency in the EU medical device market.
This training is developed to help in vitro diagnostic medical devices manufacturers understand which is the impact of the new In vitro diagnostic regulation (IVDR), the most relevant changes against the directive and how it will impact to either medical devices already in the market and new medical devices.
Topics:
- Scope of IVDs under IVDR: What is and what is not an IVD under IVDR
- Classification and Conformity Assessment Procedures
- Concepts and rules in IVD classification
- Special additional procedures:
- Commons Specifications and EU Reference Laboratories
- Companion Diagnostics
- Economic Operators, Traceability and Registration of IVDs
- Structure and Contents of the Technical Document.
- CE marking milestones
- General Safety and Performance Requirements for IVDs
- Clinical Evidence, Performance Evaluation and Performance Studies
- Post-market Surveillance
Medical device and IVD companies, IVD designers, manufacturers, Clinical Project Managers, Quality Management, Regulatory Affairs and/or Vigilance responsible.
Participant’s experience
No previous knowledge of the IVDR 2017/746 is needed. Knowledge of the IVD Directive would be helpful.
Online training
Docente/i
Marta Rayo Lunar
Marta has a Pharmacy degree and a Specialist postgraduate degree qualification in Industrial Pharmacy and Galenic Formulation. She has over seven years’ experience in drug development in the pharma Industry as R&D Project Manager on the development of drug candidates, and over five years’ experience in regulatory affairs. As Scientific and Regulatory Affairs Associate Director at Asphalion, Marta is responsible of scientific and medical writing of regulatory documents working in regulatory strategy, regulatory roadmaps, ATMP designation, scientific advice and qualification of novel methodologies for biologicals, biomaterials, medical devices, and advanced therapies. She also manages regulatory Work Packages of H2020 projects.
Dominique Monferrer
Consultant with over 10 years’ experience, specialised in regulatory affairs for medical devices, in vitro diagnostics, borderline products, drug-device combinations and CMC aspects of medicinal products. Speaker on EU regulations for MDs and IVDs and lecturer at degrees (Bioengineering – UPF), postgraduate programs (Biotech and Pharmaceutical Industry – IQS, dHEALTH Barcelona – MOEBIO) and innovation accelerator programs for medtech entrepreneurs (CIMTI, CaixaImpulse, CRAASH Barcelona, among others). Leader of the MD team at Asphalion S.L. Prior to starting her career path in regulatory affairs, Dominique Monferrer did a PhD in Protein X-ray Crystallography at the Spanish National Research Council (CSIC). She graduated in Human Biology at University Pompeu Fabra in Barcelona (Spain).
Online Training – 2 modules
MODULE 1 | February 22nd, 2022 9:30 am – 01:00 pm CET
MODULE 2 | February 23rd, 2022 9:30 am – 01:00 pm CET
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: € 875,00* (until 22 January 2022)
Ordinary: € 1.065,00*
Freelance – Academy – Public Administration**: € 565,00*
* for Italian companies: +22% VAT
** Early Bird discount not applicable to Freelance – Academy – Public Administration fee
The fee includes: tuition, organizational office assistance, teaching materials and attendance certificate that will be sent after the training via e-mail.
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.
