• Brief outline of the requirements of PRRC
• What does it mean?
• What does it involve?
• Understanding what questions you should be asking
• Learning how your companies should be supporting you

Speakers:

Elem Ayne
President
TEAM PRRC EU Association

Anne Jury
Vice-President
TEAM PRRC EU Association

As the revised EU MDR deadline approaches, manufacturers are still in the dark on key aspects of meeting the general safety and performance requirements as, currently, harmonized standards under MDR are still yet to be published. This leaves manufacturers unclear about key areas including quality and risk management, requiring resources to be set aside for everything from processing additional paperwork up to and including running additional time consuming and costly tests.

In this webinar, we will explore the history of EU MDR implementation, assess the challenges faced by manufacturers, and look at how careful gap analysis and testing can support compliance with state of the art, including strategies to mitigate risks.

Speaker:

Liliana Omar
Regulatory and Quality Project Director
Covance Medical Device and Diagnostic Solutions

In this session, we will cover:

• Explaining what NB expectations are for clinical evaluations during dossier review and audit
• Elements observed in successful submissions
• Highlighting the common errors in Clinical evaluation documentation

Speaker:

Dr. Melania Battistella
Global Manager Aesthetic Products
TÜV SÜD

Modernizing clinical trial operations is a top priority among life science companies, as indicated by the 98% of respondents in the Veeva 2020 Clinical Operations Survey.

While this is an industry-wide priority, progress can be hindered by legacy systems and processes that slow study execution, limit visibility, and make data sharing and collaboration difficult.

Cook Research (a Cook Medical company) is among those leading the way to a unified approach. Cook Research took the steps to modernize its clinical operations and data management by implementing new solutions including eTMF, CTMS, and Payments in order to improve compliance, streamline operations, seamlessly manage trials, and improve overall study performance.

Even when COVID-19 presented challenges, Cook Research was able to keep existing studies on track and speed new studies to gain a competitive edge.

Join this session to hear Jennifer Kerr, President of Cook Research, share:

• Reflections and learnings from COVID-19 disruption
• Industry trends to improve clinical study performance
• Factors that accelerate implementation
• Achieving visibility, oversight, and collaboration
• Quantifying value of unified clinical operations

Speakers:

Stéphanie Flipo
Director Strategy
Veeva MedTech

Jennifer Kerr
President of Cook Research
Cook Research

• Understanding the requirements for clinical investigations
• Assessing how to meet the requirements set for successful investigations
• Outlining the data set and pool to run your clinical investigations
• Ensuring your clinical investigations match your intended use statement

Speaker:

Shelley Jambresic
Clinical Evaluation Manager
Geistlich Pharma

The Medical Device Regulation calls for much stricter clinical data and a continuous process of clinical evaluation. Based on analyses of MDR 2017/745, understanding state of the art (SOTA) is important, as it supports the entire clinical evaluation process. Systematic review of the scientific literature have a lot to offer when it comes to getting the right SOTA information for your device.

This webinar will discuss:

• Importance of the state of the art (SOTA) as defined in MDR 2017/745
• How SOTA can help in critical benefit-risk assessment of your device
• Best practices for formulating a systematic literature search for finding the right clinical evidence

Speaker:

Dr. Carlos Rodriguez Del Rio
Product Manager Embase
Elsevier B. V.