Medical Device Regulatory Affairs

  • 2° EDITION: 19-23 April 2024
  • Online
  • Italian

Training overview

During the training course “Medical Device Regulatory Affairs”, key issues for those who want to operate or work in this field will be addressed in light of the changes introduced by the current Medical Devices Regulation (MDR 745/2017). Based on the lecturer’s long experience in the field of medical devices, the new obligations of the various economic actors, the new UDI traceability system and the preparation of technical documentation based on the requirements of Reg. 745/2017 will be examined.

The Medical Device Regulatory Affairs training course will explain the current regulations and provide you with the tools you need to better manage the process of obtaining CE marking for a new medical device and for managing the entire regulatory life cycle of the medical device.

Il corso affari regolatori dei dispositivi medici ti illustrerà la normativa vigente e ti fornirà gli strumenti necessari per gestire al meglio il processo di ottenimento della marcatura CE di un nuovo dispositivo medico e per la gestione di tutto il ciclo di vita regolatorio del medical device.

ARE YOU INTERESTED IN REGULATORY AFFAIRS?

Sign up for 3 courses and you’ll get a 15% discount*, while if you choose 5 courses you’ll get a 20% discount*. You may choose from these trainings:

    • Impact of variations on the site regulatory and compliance activities
    • La registrazione di un farmaco: focus sulle linee guida di tossicologia e struttura CTD per la sezione preclinica
    • Skilful drafting of technical documentation
    • Drugs registration requirements in extra-EU countries
    • Basic training in Regulatory Affairs
    • Common Technical Document (CTD) module 3: focus on the most critical aspects
    • Marketing Authorization Holder (MAH), Regulatory Affairs and Qualified Person: responsibilities and interactions for GMP compliance

(*) discounts apply to full prices and cannot be combined with other promotions. The promotion is valid for the enrollment of the same attendee in 3 or 5 courses among those proposed.

Key points of the training

  • Understand the main requirements on European medical device regulation and the changes brought about by MDR 745/2017
  • Provide the basic information for developing and drafting the technical documentation required to obtain CE marking for a new device
  • Give you the tools to ensure regulatory compliance of your medical device throughout its journey

09:00 – 13:00   COURSE SESSION
19 APRIL 2024 – MODULE 1
09:00 – 13:00   COURSE SESSION
23 APRIL 2024 – MODULE 2

Programma

MODULE 1

  • Regulatory framework: Directive 93/42 vs. Regulation 745/2017
  • Main changes introduced by Reg. 745/2017 and implementation timeline
  • Medical devices: definitions and regulatory approach
  • Roles and new responsibilities of economic operators
  • The figure of the Person Responsible for compliance
  • Classification of Medical Devices: updates introduced by Reg. 745/2017

MODULE 2

  • EC conformity: notified bodies, EC certification, declaration of conformity
  • The technical documentation: annexes II and III of Reg. 745/2017
  • The new UDI traceability system
  • The medical device vigilance system
  • The national database and the European database for Medical Devices (EUDAMED)

Regulatory Affairs, Quality Assurance, management personnel, research and development managers, production managers, process managers, managers/coordinators, complaint management and corrective and preventive actions, supervisory managers, marketing/sales managers.

The course will be carried out through live lectures. Practical examples will be showcased, providing delegates with real life examples to be applied in their daily job life.

For online trainings the access link will be sent 2-3 days before the start of the training.

5% discount for registrations within 1 month before the start of the training, 10% discount for registrations within 2 months before the start of the training. VAT not included. Please inquire for discounts for multiple registrations. Discounts are not cumulative.

Cancellation terms

In order to cancel enrolment to an event, please email info@pharmaeducationcenter.it within 2 weeks before the starting date of the event. Once this term will be expired, the entire fee will be charged.

Participant replacement

It is possible to replace a participant attendance without additional cost, simply by contacting info@pharmaeducationcenter.it. It is asked to notify the participant replacement request within 5 days before the starting date of the course/event, specifying the full name and surname of the enrolled participant as well as the full name and surname of the substitute.

Training cancellation

If the minimum number of participants is not reached, Pharma Education Center reserves the right to cancel or schedule the event for another date. Formal communication will be given within 5 days before the event date. In this case Pharma Education Center will refund the registration fee in full and without additional charges. Alternatively, the participant can request a spendable coupon for participating in another PEC event scheduled in the current year.

Speakers

Patrizia Pecin

Patrizia Pecin

Regulatory Affairs Project Manager at Pharma D&S

Graduated in 1991 in Biological Sciences at the University of Milan, she later obtained a II level Master’s Degree in Regulatory Disciplines at the University of Pavia. She has gained professional experience in the regulatory field in pharmaceutical companies and since 2005 her activity has been focused on the medical devices sector. Currently in Pharma D&S she deals with regulatory issues relating to Medical Devices; she also deals with training activities within the Pharma Education Center.

Register now

Early Bird 10%
Within 2 months before the start of the training
810€
900€
Early Bird 5%
Within 1 month before the start of the training
855€
900€
Full price

900€

Training materials available for attendees

Certificate of attendance

Senior trainers with hands-on experience

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