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Monday, June 17 • 11:00am - 12:00pm
#104: Reporting of Pre-Market and Post-Market Safety Reports to FDA Adverse Event Reporting System (FAERS) Using ICH E2B R3 Standards

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Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-518-L04-P; CME 1.00; RN 1.00

Reporting of pre-market and post market safety reports to be submitted in ICH E2B (R3) format to FDA Adverse Event Reporting System (FAERS). The presenters will discuss system readiness, testing approach, challenges, and lesson learned for reporting premarket and post market safety reports, both from FDA’s and industry’s perspective.

Learning Objectives

Recognize that FDA will go live with E2B R3 standard early next year and will require reporting of Investigational New Drug (IND) and post market safety reports to be submitted in ICH E2B (R3) format to FAERS via the FDA Gateway or using the Safety Reporting Portal; Describe regional data elements, system readiness, testing approach, challenges and lesson learned that are key for post market, IND and IND-exempt BA/BE safety reporting, both from FDA’s and industry’s perspective.

Chair

Suranjan De, MBA, MS

Speaker

Safety Reporting to FDA Adverse Event Reporting System (FAERS) Using ICH E2B R3 Standards - Industry Prospective
Sheila M Estela, BSN, RN

Safety Reporting to FDA Adverse Event Reporting System (FAERS) Using ICH E2B R3 Standards - Industry Prospective
Subhan Ahmed Sharief


Speakers
avatar for Suranjan De

Suranjan De

Deputy Director, Regulatory Science, OSE, CDER, FDA, United States
Mr. De is the Deputy Director of CDER’s Office of Surveillance and Epidemiology, Regulatory Science Staff at FDA. He provides expert advice and technical direction on regulatory science for developing new tools, standards, and approaches to assess the safety, efficacy, quality... Read More →
avatar for Sheila M Estela

Sheila M Estela

Regional Patient Safety Head US and Canada, Novartis Pharmaceuticals Corporation, United States
I am a Registered Nurse currently working as the Regional Patient Safety Head for US & Canada at Novartis Pharmaceuticals. In this role, I lead a team of almost 70 dedicated PV professionals in the region. Additionally, I hold the position of US Country Patient Safety Head (CPSH... Read More →
SA

Subhan Ahmed Sharief

Director, ArisGlobal LLC, United States

Monday June 17, 2024 11:00am - 12:00pm PDT
Room 15AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  01: ClinSafety-PV, Session