European Medical Device Post-Market Clinical Evaluation Planning Conference

October 29-30, 2019 | Frankfurt, Germany
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“I thought the conference was excellent!  Having a conference tailored to one discipline made each panel and contact relevant.”

Director, Compliance & Legal Affairs
Orexigen

“Great insight to hear payer perspective in contracting and account management and the changing healthcare landscape.”

Channel Liaison
Biogen

“It was definitely an excellent well-rounded opportunity to meet new people, get new ideas, and get an in-depth education on what’s to come with the FDA collaborations.”

Quality Engineer
Centurion Medical Products

“It was very well organized event and high quality, the fact to have an IVD track was also interesting. Thanks, I will recommend the Q1 event!”

Regulatory Affairs – EMEA Regional Head
BIOMERIEUX

“The organization and support staff were fantastic! I’m looking forward to next year.”

Global Business Project Lead
Genentech

About the Conference:

As medical device manufacturers navigate the changing industry landscape in preparation for the European Medical Device Regulation, one of the most pressing requirements facing clinical research executives is the enhancement of post-market clinical follow-up, surveillance, and reporting strategies. Placing a major focus on real-world evidence, the MDR presents professionals in clinical research with numerous challenges as they seek to provide an accurate representation of each device’s performance and safety once on the market. While the volume and sources of data that will be required by competent authorities and notified bodies to support each device’s continued market presence remains uncertain, leaders in the field recognize the urgency of developing and implementing compliant plans for the collection of relevant and sufficient data while working to contain costs.

The Q1 Productions EU Medical Device Post-Market Clinical Evaluation Planning Conference will provide insight into practical solutions implemented by medical device firms to determine the appropriate level of evidence needed, and to develop plans to meet enhanced post-market clinical follow-up requirements. Focused working groups and peer-to-peer discussion will allow for the sharing of strategies to optimize cost-effective data collection while addressing challenges relating to registry data ownership, privacy concerns, physician motivation, and much more. Industry leaders seeking proactive methods by which to demonstrate device safety under the new requirements of EU MDR will find this conference a must-attend educational event.

Core Topics to be Addressed

  • Exploring factors to define the level of clinical evidence deemed sufficient under MDR
  • Proactively aggregating a thorough body of evidence to meet PMCF requirements
  • Examining the pros & cons of various cost-effective data-gathering methodologies
  • Optimizing the cohesive reporting of PMCF, PMSF & clinical evaluation data
  • Aligning internal teams during development & implementation of the PMCF plan
  • Insight into challenges & solutions in post-market clinical interventional trials
  • Effectively communicating PMCF requirements to executives to promote buy-in
  • Managing the transition of pre-market clinical trials into the post-market phase
  • Maximizing the use of registries: appropriate timelines & relevant data goals
  • Obtaining datasets from hospitals while ensuring compliance with privacy requirements
  • Promoting the rapid collection of quality data through increased physician motivation
  • Practical considerations in seeking ethics committee approval regarding registry use
  • Leveraging PMCF findings for the improvement of device design, safety & function
  • Incorporating device complaints data into the clinical evaluation reporting process

Audience

75 Attendees

All attendees come directly from a medical device companies

Distinguished Presenters

Speaker recruitment in process

Networking

Networking time is built into the agenda to allow industry peers to connect and exchange ideas

Open Dialogue and Group Share

Each presentation is followed by 10-15 minutes of open dialogue for questions and exchange of best practices

CONTACT US
Q1 Productions
500 N. Dearborn Suite 500 | Chicago, IL 60654
Chicago, IL 60654
T: 312.822.8100
F: 312.873.3969
marketing@q1productions.com

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