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Sponsored Webcast: EU IVDR: Intriguing Insights, Recommended Actions, and a Look Towards the Future

1.5
RAC Credits
Virtual Programs Virtual Programs
Tuesday, 17 May 2022 (11:00 AM) - Tuesday, 17 May 2022 (12:30 PM) Eastern Time (US & Canada)

This event is brought to you by:  

The EU IVDR is the biggest regulatory change impacting diagnostics in Europe and it has arrived in full force. With a date of application of 26 May 2022, its implementation has not without challenges. Time did almost run out before an amendment to the transition timelines resulted in a progressive roll-out of the regulation.

A lot has happened since June 2020, when notified bodies issued the first IVDR certificates. From increased post-market surveillance requirements to QMS audits and technical documentation assessments, there have been several lessons learned which will shape the future of the regulation for years to come.

In this webcast, a former notified body leader and industry subject matter experts will discuss the new IVDR timeline step by step, as well as outline key lessons learned from the early phases of IVDR implementation.

The presentation will also shine light on the most contentious topics under the IVDR. We will be taking a deep dive into the intended purpose statement, which is creating several challenges for global registrations and will also reflect on clinical evidence requirements for both legacy and new IVDs following the recent publication of MDCG 2022-2.

Finally, the presenters will uncover key regulatory hurdles around special types of products, including companion diagnostics, near patient tests, in-house developed tests & Class D devices to name a few, with a special mention of SARS-CoV-2 IVDs which have dominated headlines during the pandemic.

Leveraging notified body expertise and real life industry feedback, this webcast is designed to reflect on lessons learned under the IVDR and discuss what the future may look like for diagnostics in Europe.

Learning Objectives;

After this program, participants will:

  • Understand the impact of the new IVDR timeline on their product portfolio and plan accordingly
  • Anticipate potential notified body feedback by reflecting on lessons learned in several areas from intended purpose, clinical evidence, and post-market surveillance requirements
  • Understand expectations and the increased scrutiny mechanism for special types of products, from companion diagnostics to Class D devices
  • Be able to prepare for the future of the IVDR and adapt their transition strategy accordingly

Who Should Attend

  • Regulatory Affairs Specialists, Managers, Directors and VPs
  • Postmarket Surveillance Specialists, Managers, Directors and VPs
  • Clinical Specialists, Managers, Directors and VPs

Instructors:

Carlos Galamba

Carlos Galamba, Vice President of IVD Intelligence & Innovation, RQM+

Carlos Galamba is Vice President of IVD Intelligence & Innovation at RQM+. Carlos joined RQM+ in September 2021 after 7 years at BSI where he was responsible for managing, coaching, and developing a global team of IVD technical experts in his role as a Technical Team Manager. Among many of Carlos’s achievements he was BSI’s first in-house clinician for IVDs where he led the implementation of the BSI clinical oversight process and has made hundreds of CE marking recommendations for IVDs.

At BSI he supported and led IVDR Notified Body designations, was responsible for the development of clinical procedures, technical guidance for BSI reviewers and consulted on MDCG draft guidance prior to publication, including for example IVD batch verification, summary of safety and performance, IVD classification rules and performance evaluation for SARS-CoV-2.

Prior to BSI, Carlos has held roles at the UK competent authority, the MHRA and was a senior biomedical scientist in the UK National Health System, working for some of the largest IVD testing laboratories including Imperial College and University College of London Hospitals. Carlos has a background in haematology, clinical chemistry and haemostasis and specialises in high risk class D IVDs including those used in the fields of transfusion and transplantation.

Kristen Meany

Kristen Meany, Principal Advisor, RQM+

Kristen Meany is a Principal Advisor at RQM+ with nearly 20 years of experience in regulated industry leading global regulatory teams. She is a strategic and tactical regulatory leader with experience developing regulatory strategies and authoring regulatory submissions for new product development and post-launch changes including Pre-Submissions (Q-Subs), 510(k)s, PMAs, Technical Files and Design Dossiers (EU MDD), and Technical Documentation (EU MDR, EU IVDR) for medical devices and IVDs. Kristen has diverse product knowledge coupled with regulatory affairs expertise in medical devices, IVDs, human tissues, pharmaceuticals, and combination products in the fields of orthopedics, neurological and physical medicine, general and plastic/reconstructive surgery, cardiovascular, dental, and microbiology. She has successfully negotiated with regulatory agencies during the development and review of submissions inclusive of leading meetings with US FDA, EU Notified Bodies, EMA, TGA, and Health Canada. Kristen has also facilitated internal and external audits of regulatory documentation, clinical trials, and quality management systems to ensure continued regulatory compliance.

Kristen holds a Master’s Degree in Bioscience Regulatory Affairs from the Johns Hopkins University, completed Executive Development programs at Harvard and Northwestern Universities, obtained the RAC certification in US and EU regulatory affairs, and is a Certified Quality Auditor.

Cancellation Policy

RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation. 

All cancellation requests must be submitted in writing to raps@raps.org. RAPS is unable to accept cancellations by phone. 

To transfer a registration, email raps@raps.org with the event title, name of the original registrant and the contact information for the new attendee. 

Proof of Attendance

RAPS will send an electronic letter or a certificate of attendance following the workshop.

Questions

Contact the RAPS Solutions Center:
Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email raps@raps.org