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Drugs, Devices, and Biologics

Learn directly from the FDA’s regulatory experts in medical product centers: drugs, devices, and biologics. This course is designed to provide participants with a strong, basic foundation in the FDA’s regulatory requirements, and also create awareness of current activities.

NO COST Conference

Registration

Agenda

PLENARY

Federal law authorizes the FDA to collect user fees which help the FDA fulfill its mission of promoting and protecting the public health. Most major user fee programs run in five-year cycles, and the past year saw the launch of the current cycle for CDER, CBER, and CDRH. This session will take a closer look at the impact of user fee legislation, how the FDA advances programs through user fees support, and highlights of some of the exciting new efforts planned during this user fee cycle.

DRUGS TRACK

The drugs track will continue its focus on PDUFA VII commitments. Subject matter experts will provide cutting edge insights and perspectives on how several of these goals and initiatives are being implemented. Agenda topics will provide practical information and advances in bioinformatics (eCTD v4.0; ESG; data standards); digital health technologies, real-world evidence (RWE) & pilot programs.

Topics Include

• New Meeting Types, including What's New Under PDUFA, BsUFA, and OMUFA
• PDUFA VII Chemistry, Manufacturing, and Controls (CMC) Assessment Updates
• Use-Related Risk Analysis (URRA) and Human Factor (HF) Protocol Reviews: What to Submit for an Efficient Review

Intended Audience

• Regulatory affairs and other professionals working on the development and preparation of new drug submissions, drug safety and IT
• Sponsors, applicant holders, manufacturers, clinical researchers and regulatory affairs professionals wishing to gain insight on INDs, NDAs and BLAs
• Industry professionals at all levels of expertise

DEVICES TRACK

The devices track will provide an overview and highlights of how to get a new medical device to market. It will also discuss some best practices for ensuring that medical devices maintain their quality and continue to be safe and effective once on the market; and offer technical topic updates on biocompatibility, artificial intelligence, and radiological health.

Topics Include

• Artificial Intelligence and Machine Learning; FDA Medical Device Inspections & Form FDA 483
• Premarket Notification [510(k)] Program; Quality System Principles
• Tips and Best Practices for High Quality Regulatory Submissions
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Intended Audience

• A new regulatory affairs specialist wanting to learn some basics and best practices for getting started with FDA’s regulation of medical devices.
• A researcher of a medical device seeking to learn about the valid scientific evidence requirements needed to support new medical device regulatory submissions.
• An establishment seeking to understand their regulatory responsibilities for handling complaints about their medical devices.

BIOLOGICS TRACK

The biologics track will focus on the developmental and regulatory topics relevant to advanced therapies, including cellular and gene therapies, tissue-engineered and other biological products. The speakers will present updates on programmatic enhancements mandated by PDUFA-VII, including new regulatory programs, stakeholder communications and much more.

Topics Include

• IND readiness: contents of preclinical and clinical parts; Expanded Access INDs
• Product development challenges and Chemistry, Manufacturing, and Controls (CMC) Developmental Readiness Pilot program
• Estimand and Complex Innovative Design (CID) Program in application to CBER biologics

Intended Audience

• Biotechnology product manufacturers, academic sponsors, and other stakeholders working on the development of advanced therapies
• Regulatory affairs and other professionals working with submissions of INDs and BLAs to the Office of Therapeutic Products (OTP) in the Center for Biologics Evaluation and Research
• Industry and consulting professionals working with advanced therapies, cell- or tissue-based products, and devices used with biological products

FDA RESOURCES

Plenary

• Milestones in U.S. Food and Drug Law
• FDA User Fee Programs
• FDA: User Fees Explained

Drugs

• CDER SBIA Learn: Webinars, Conferences, Trainings
• Search for Regulatory References | Drugs
• CDER Offices and Divisions | FDA

Devices

• Medical Device User Fees
• CDRH Learn
• FDA’s Division of Industry and Consumer Education (DICE)

Biologics

• Interactions with Office of Therapeutic Products (formerly Office of Tissues and Advanced Therapies
• OTP Learn
• Biologics Procedures (SOPPs)

CONTINUING EDUCATION

Real-time attendance is required for the certificate of attendance which can be used in support of CEs for the following professional organizations. Certificates are only available during the two weeks post-event.

This conference has been:

• pre-approved by RAPS as eligible for a maximum of 12 credits for a two day event (appropriate to real-time attendance) towards a participant’s RAC recertification upon full completion.
• pre-approved by SOCRA who accepts documentation of candidate participation in continuing education programs for re-certification if the program is applicable to clinical research regulations, operations or management, or to the candidate's clinical research therapeutic area.
• pre-approved by SQA as eligible for 1 non-GCP or non-GLP unit for every 1 hour of instructional time towards a participant’s RQAP re-registration
• approved by ACRP for continuing education in clinical research. ACRP will provide 1 ACRP contact hour for every 45-60 minutes of qualified material.

TECHNICAL INFORMATION

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• Please contact [email protected] for all technical questions.
• If you encounter any technical issues before or during the event, please visit the Technical Issues Support.
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