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Navigating Strategies for Postmarket Clinical Follow-up

2.0
RAC Credits
Virtual Programs Virtual Programs
Tuesday, 15 March 2022 (8:00 AM) - Tuesday, 15 March 2022 (10:00 AM) Eastern Time (US & Canada)

The introduction of the European Medical Device Regulation 2017/745 (MDR) has raised the level of regulatory requirements in terms of clinical data collection and medical evidence generation.

In particular, there are increased expectations for postmarket surveillance (PMS) and an increased scope of postmarket clinical follow-up (PMCF), which further emphasizes the need for robust postmarket processes that support ongoing compliance.

MDCG 2020-6 further details the expectations for manufacturers to provide sufficient clinical evidence for legacy devices to achieve certification under the MDR and provides guidance on the hierarchy of clinical evidence.

Regardless of whether manufacturers plan to transition their product to the MDR or phase out the device during the Article 120 transitional period, both the PMCF plan and report (described in MDCG 2020-7 and 8 respectively) are mandatory for all devices holding certification under the MDD.

This virtual program will walk you through a clear process for effectively planning your PMCF activity that fits your product portfolio, as choosing the right PMCF strategy is essential to a successful notified body audit and MDR certification.

The presentation will provide insight into how and when to leverage Real-World Evidence (RWE) studies, registries and/or surveys to collect clinical data, the associated challenges, and how to overcome them.

It will feature case studies and present the relative merits of different PMCF approaches with the goal of providing pragmatic solutions for ongoing provision of sufficient clinical evidence.

Registration Fees & Deadlines

17 January 2022 - 8 March 2022: Member $230.00 | Nonmember $270.00

Learning Objectives

Attend this live webcast to gain an understanding of:

  • Postmarket expectations of the EU Medical Device Regulation
  • How to develop a pragmatic PMCF strategies for your product portfolio.
  • When and how to use RWE as the primary source of clinical evidence to support PMCF activity
  • When and how to use PMCF surveys under the MDR

Audience Learning Level:

Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity.

Who Should Attend? 

  • Clinical, regulatory, and quality team leaders and members responsible for developing PMCF strategies for EU MDR submissions
  • Teams involved in PMCF planning and execution process
  • Decision makers responsible for EU MDR submission budget

Agenda

(All times are posted in Eastern Standard Time)

 

8:00 am – 8:45 am

PMCF for Legacy Devices Under the EU MDR - One Size Does Not Fit All

  • Post-market expectations of the new EU Medical Device Regulation, particularly in relation to PMCF
  • The relationship between risk management, clinical evaluation and PCMF requirements for maintaining existing certification during the transitional period as well as readiness for the MDR
  • How to define and implement pragmatic PMCF strategies appropriate to the device in question, to support certification during the transitional period as well as readiness for MDR certification

Adrian T. Keene, BSc (Hons), Senior Director, Global Biological Safety and Validation and EMEA Consulting Services NAMSA

8:45 am – 9:20 am

Accelerating Regulatory Success with Real world Evidence studies (RWE)

  • Use of Real-World Evidence to support post-approval study.
  • Patients Medical Records and registries as a primary source of Real-World Evidence
  • Case studies

Dr.Mikaela Dimitriu  Chief Operating Officer, EMEA, ECLEVAR

9:20 am – 10:00 am

Post Market Clinical Follow-Up (PMCF) Surveys: The Ever-Changing Landscape 

  • Understand when to utilize PMCF Surveys and their benefits
  • The differing approaches and when to use them (end user recollective surveys vs. case / patient specific surveys)
  • Recognize how existing Market Research platforms can help assist in the implementation of PMCF End-User Surveys

Marcus Torr, MDR / PMCF Lead, Purdie Pascoe

*Agenda subject to change.



Instructors:

Adrian T. Keene, BSc (Hons)

Adrian T. Keene, BSc (Hons) is senior director, global biological safety and validation and EMEA consulting services. He is responsible for global biosafety and EU regulatory and quality services at NAMSA, leveraging his broad experience of the changing EU medical device regulatory requirements to support clients worldwide. He was previously head of notified body for the UK notified body, SGS. Prior to that, he was global clinical affairs and regulatory manager for medical devices, with responsibility for conformity assessment activities of high risk (Class III) devices under the EU Medical Device Directive. Keene has more than 28 years of experience in the industry. In his current role, he combines his experience in new product development with EU regulatory requirements to provide a balanced interpretation of the needs and expectations of both competent authorities and manufacturers. He works with a broad range of devices, including drug-device combination products.

Mikaela Dimitriu, PhD

Mikaela Dimitriu, PhD is chief operating officer at ECLEVAR. She is a strategic growth-oriented executive with more than 25 years of experience in management in the areas of clinical development, medical affairs, biometry, health economics, patient engagement, regulatory and manufacturing. Dimitriu has a strong track record of managing and leading cross-cultural and cross-functional global teams in complex situations. She is recognized as an engaging, fast-moving, results-oriented leader with strong strategic thinking and execution skill from Phase I to product launch, and she has a distinct ability to generate a high-performance culture that attracts top talents and partners. Dimitriu has the ability to engage internal and external stakeholders in times of change and in challenging environments. She has background training in science with extensive management experience at the executive level. Her specialties include drug and medical device innovation and oncology.

Marcus Torr

Marcus Torr serves as postmarket clinical follow-up/Medical Device Regulation lead (PMCF/MDR lead) for Purdie Pascoe, a London-based full-market healthcare market research company. Since joining in 2015, he has rapidly gained experience and skill in both qualitative and quantitative research, progressing to become a research manager before heading up Purdie Pascoe’s growing work on the EU Medical Device Regulation (EU MDR) in 2019. The focus of this work is postmarket clinical follow-up end-user surveys, having helped many medical device manufacturers across a variety of device types implement more than 150 surveys. Torr has a first class MSci in natural sciences (chemistry with pharmacology) from the University of Bath, which included a 12-month placement working as an analytical scientist for AstraZeneca.


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. Cancellations will receive a full refund minus a 20% administrative fee. RAPS is unable to accept cancellations by phone. 

Paid registration substitutions may be accepted with written approval from RAPS for requests received before the start of the event. 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 Support Center:
Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email support@raps.org