Ontario Chapter Webcast: What, Why and When of Postmarket Clinical Follow-up

1.0
RAC Credits
Chapter Events Chapter Events
Thursday, 21 July 2022 (12:00 PM) - Thursday, 21 July 2022 (1:00 PM) Eastern Time (US & Canada)

PMCF is now an expectation for many medical devices. As the expectations for EU MDR become clear, PMCF can still be confusing. We will review what may qualify for PMCF, what is required, and when it is required.

A live Q&A portion with the speaker will follow the presentation.

This event is brought to you by the RAPS Ontario Chapter to encourage knowledge sharing and community development. RAC holders may claim 1.0 RAC recertification credit.


Learning Objectices

Participants will:
  • Describe what PMCF is and what is expected.
  • Learn the types of PMCF for different classes of products.
  • Learn how PMCF fits into your regulatory cycle.

Registration Fees & Deadlines

Enterprise Member: Free
RAPS Member: Free
Nonmember: $25


Who Should Attend?

Regulatory professionals and regulatory writers


How Do Webcasts Work?

For the best webcast experience, please use the Google Chrome browser. RAPS webcasts are also mobile- and tablet-accessible for your convenience. Registrants will receive instructions on how to log in 24 hours before the start of the webcast. A live Q&A portion with the speaker will follow the presentation.


RAPS Membership

RAPS membership provides vital information for regulatory professionals and a place for networking and invaluable connections. Now is a great time to explore the many benefits to RAPS membership, including the Member Knowledge Center and our award-winning, private online community, Regulatory Exchange. Find out more about RAPS membership today.


Instructors:

Angela Siebeneck

Angela Siebeneck, MSN RN
Director, Regulatory Strategy and Policy at Synchrogenix, a Certara company

Mrs. Siebeneck has over 30 years of clinical and regulatory experience beginning her career as a registered nurse in a hospital setting. She has extensive experience in regulatory strategy, clinical, and medical writing. Her experience with regulatory approvals spans Europe, Australia, the United States, and Asia. She has authored or contributed to over 100 MEDDEV 2.7/1 Rev 4 compliant Clinical Evaluation Reports(CER), as well as post-market surveillance (PMS) plans/reports, post-market clinical follow up (PMCF) plans/reports, safety and performance evaluations, clinical study reports, human factors studies, and regulatory agency responses for medical devices. Additionally, she has experience with pharmaceutical labelling and submissions including Summary Product Characteristics (SmPC), Company Core Data Sheets (CCDS) and Orphan Drug Designations (ODD). Her clinical experience encompasses several areas including vascular access, orthopedics, interventional radiology, surgical intensive care, trauma, and home care.


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 at the following the webcast.

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

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