Conference | Mixed

Event Title

Regulatory Education for Industry (REdI) Annual Conference

August 25 - 28, 2020

Date:: August 25 - 28, 2020
Time:: 9:15 a.m. - 3:20 p.m. ET

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Agenda

Presentation	Speaker
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	Renu Lal, LCDR, USPHS Pharmacist SBIA \| DDI \| OCOMM
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 Officer 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).

TOPICS

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.

Resources

CDER

CDRH

Event Materials

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