WCG Announces — Understanding the Challenges of Managing Combination Product Safety Reporting, Free Webinar, Jan. 31, 2018

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Manufacturer of combination products must comply with the new post-market reporting and safety rule. Know the ins and outs of compliance and best practices when it comes to combination product safety and reporting.

Understanding the Challenges of Managing Combination Product Safety Reporting
Does the Final Rule Alleviate Post Approval Safety Reporting Confusion?
**WCG Free Webinar**
January 31, 2018 — 1:30 p.m. – 2:30 p.m. ET
http://info.fdanews.com/challenges-of-managing-combination-product-safety-reporting

Trying to figure out the nuances in applying the Final Rule on post-approval safety and reporting of combination products can be tricky. Despite the FDA guidance, there’s still a lot of confusion on where to report adverse events and what it really means to have a robust safety system in place that meets agency mandates.

But, in just 60 minutes, take a deep dive into this regulatory quagmire and emerge with a fuller understanding of how to comply with the Final Rule.

Save this date, January 31, 2018, to hear one of the leading authorities on the combination product safety explain compliance and best practices on these critical points:

  •     Detailed analysis of the new, complicated Final Rule requirements for reporting on combination products
  •     Who on the product safety staff should have the responsibility for combination product safety & reporting
  •     How to avoid receiving FDA warning letters on combination product reporting and safety
  •     How to implement real-world best practices for safety reporting, preventing unnecessary agency inspections

Take advantage of this free, timely presentation to learn the nuances of the combination product postmarket reporting and safety.

Meet the Presenter:
Angela Pitwood, Vice President of Pharmacovigilance at Vigilare, has spent years on the firing line of combination product post-market reporting and compliance. She’ll share with her secrets and tips for compliance with the Final Rule so manufacturers can avoid legal hot water.

Who Will Benefit:
This session is appropriate for organizations subject to the regulatory implementation of the Final Rule, on safety and reporting for combination products, including individuals holding these job titles:

  •     Vice President, drug or device safety
  •     Drug or device reporting specialist
  •     Regulatory affairs manager or staffer
  •     Safety manager or associate
  •     Adverse event reporting specialist
  •     Product safety assessment specialist

Webinar Details:
Understanding the Challenges of Managing Combination Product Safety Reporting
Does the Final Rule Alleviate Post Approval Safety Reporting Confusion?
**WCG Free Webinar**
January 31, 2018 — 1:30 p.m. – 2:30 p.m. ET
http://info.fdanews.com/challenges-of-managing-combination-product-safety-reporting

Easy Ways to Register:
Online:     http://info.fdanews.com/challenges-of-managing-combination-product-safety-reporting
By phone: 888-838-5578 or 703-538-7600

WIRB-Copernicus Group® (WCG):
The pioneer of independent ethical review, WCG continues to drive ingenuity in the clinical research space. Today, WCG’s solutions are built upon the foundation of ethical review, but have grown to include a suite of complementary services and technologies that expand the capabilities of the modern research professional. WCG delivers transformational solutions that stimulate growth, foster compliance, and maximize efficiency for those who perform clinical trials.

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Michelle Butler
FDANEWS
+1 (703) 538-7665
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