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Conference | Mixed

Event Title
Regulatory Education for Industry (REdI) Annual Conference
August 25 - 28, 2020

August 25 - 28, 2020
9:15 AM - 3:20 PM ET

Download All Slides and View CDRH Presentations





Real-world Evidence for Drugs, Biologics, and Devices

John Concato, Deputy Director
Office of Medical Policy Initiatives | CDER
Soma Kalb, Director
Division of Clinical Evaluation and Analysis 1: Clinical Science and Quality Office of Clinical Evaluation and Analysis Office of Product Evaluation and Quality Center for Devices and Radiological Health (CDRH)

Restructure of the Office of New Drugs (OND)

Judit Milstein, Chief
Project Management Staff Division of Regulatory Operations for Specialty Medicine Office of Regulatory Operations (ORO) | OND

So, Your NDA Was Approved – Now What?! Post-approval Responsibilities and Obligations

Lawrence Allan, Regulatory Health Project Manager
Business Process Operations Staff Office of New Drugs (OND) | CDER

Overview of Postmarketing Drug Safety Reporting Requirements

Kelley M. Simms, CDR, USPHS
Regulatory Policy Analyst
Office of Surveillance and Epidemiology (OSE) | CDER

Drug Shortages

Emily Thakur, Team Leader
Drug Shortage Staff CDER

Enhanced Drug Distribution Security – DSCSA Implementation Updates

Connie Jung, CAPT, USPHS Senior Advisor for Policy
Office of Compliance Office of Drug Security, Integrity, and Response (ODSIR) | CDER

CDER Export Certificate Program

William Jones, Technical Information Specialist
Exports Certificates and Compliance Team Imports Exports Compliance Branch Division of Global Drug Distribution and Policy ODSIR | OC | CDER

SBIA Program Overview


Post-Approval Submission of Promotional Materials to the OPDP

Robert Nguyen, Regulatory Review Officer
Office of Prescription Drug Promotion (OPDP) CDER

Requirement for Electronic Submission of an Application and Study Data

Jonathan Resnick
Cloud Collaboration Capability Team Division of Data Management Services and Solutions (DDMSS) Office of Business Informatics (OBI) Office of Strategic Programs (OSP) | CDER

Heather Crandall
Cloud Collaboration Capability Team DDMSS | OBI | OSP

Overview of Post-approval Chemistry, Manufacture, and Controls (CMC) Changes to an NDA

Hasmukh B. Patel
Director Division of Post-Marketing Activities 1 Office of Lifecycle Drug Products (OLDP) Office of Pharmaceutical Quality (OPQ) | CDER

Lifecycle Changes to Chemistry, Manufacture, and Controls in NDAs

Ramesh Raghavachari, Chief
Branch I Division of Post-Marketing Activities I OLDP | OPQ | CDER

Post-approval Considerations for Changes to Manufacturing Process and Facilities

Rose Xu, Quality Assessment Lead (Acting)
Office of Pharmaceutical Manufacturing Assessment (OPMA) OPQ | CDER

Questions and Panel Discussion – Post-approval CMC and Manufacturing

Hasmukh B. Patel, Ramesh Raghavachari and Rose Xu

FDA Drug Manufacturing Inspections

Russell K. Riley, Compliance
Division of Pharmaceutical Quality Operations III
Office of Regulatory Affairs (ORA)

About This Event

Interact with and learn directly from FDA’s regulatory experts in drugs and medical devices. This course is designed to provide participants with a strong, basic foundation in understanding the FDA’s drug and medical device regulatory requirements. Presentations include Q&A sessions.

Drugs Track: This year’s agenda will complete our series of the regulatory timeline which we started in REdI 2018. We will focus on “Post Approval Considerations” as we address the regulatory aspects of selected topics and utilize case studies to exemplify best practices within those areas.

Devices Track: A core theme of this program is to consider the role of risk, and risk-benefit into regulatory decisions to help advance the development of safe and effective medical devices.  This program also uses examples and specific case studies to provide a hands-on experience to reinforce the regulatory principles described. 

This event is a collaboration between the Center for Drug Evaluation and Research (CDER) Small Business and Industry Assistance (SBIA) and the Center for Devices and Radiological Health (CDRH) Division of Industry and Consumer Education (DICE).


Who should attend?

  • Regulatory affairs professionals
  • Development and preparation of submissions
  • Newcomers, managers, or directors in the drug or medical device industries
  • Research and development
  • Quality assurance and control
  • Medical device stakeholders who want to find online resources that explain premarket and postmarket regulatory framework for medical devices
  • Regulatory affairs professionals seeking to submit new or novel medical device regulatory submissions, including premarket notifications (510(k)s) and De Novos.
  • Manufacturers and researchers who are responsible for ensuring the cybersecurity of their medical devices.
  • Manufacturers and regulary affairs professionals seeking to enhance their knowledge about the FDA Quality System (21 CFR 820) and applicable subsystems
  • Global manufacturers who are seeking to harmonize their manufacturing activities to comply with multiple country regulatory bodies.




Event Materials

Title File Type/Size
REdI 2020 Agenda pdf (317.47 KB)
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