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Agenda

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ABOUT THIS EVENT

Pharmaceutical quality assures the availability, safety, and efficacy of every dose of medicine. Everyone deserves confidence in their next dose of medicine. Problems with pharmaceutical quality can impact the availability of medicine to patients and consumers. The mission of CDER’s Office of Pharmaceutical Quality (OPQ) is to assure quality medicines are available to the American public. This symposium, held every two years, will explore topics related to pharmaceutical quality regulation, supply chains, and advanced manufacturing technologies. Attendees will become familiar with the regulatory quality assessment, inspection, policy, surveillance, and research activities that impact the pharmaceutical supply chain and assure drug quality.

Learn more about the FDA’s pharmaceutical quality toolbox. OPQ’s quality assessment of drug applications uses tools that streamline risk assessment and knowledge management. OPQ policy conveys the most current thinking on pharmaceutical quality topics to enable manufacturers to provide high-quality drugs. Market surveillance and enforcement tools work to support the health of pharmaceutical supply chains while protecting the public. Programs focused on advanced pharmaceutical manufacturing provide tools for regulators and drug developers so that patients and consumers can benefit from promising new technologies. This pharmaceutical quality toolbox helps assure that quality medicines are available to the American public.

INTENDED AUDIENCE

• Manufacturing professionals focused on drug products, including new drug applications (NDAs), abbreviated new drug applications (ANDAs) and biologics license applications (BLAs) marketed in the U.S. and regulated by CDER
• Regulatory affairs professionals interested in FDA’s pharmaceutical quality policy and surveillance programs
• Foreign regulators and other international bodies interested in pharmaceutical quality harmonization
• Healthcare professionals and others interested in medicine quality, the U.S. supply chain, and advanced pharmaceutical manufacturing technologies

TOPICS COVERED

• Quality assessment of drug product marketing and licensing applications and how it relates to FDA innovations and facility evaluations
• Pharmaceutical quality policy and how new domestic and international efforts drive toward improved quality outcomes for patients and consumers
• Pharmaceutical supply chains and how FDA market surveillance activities help to assure drug quality
• Advanced pharmaceutical manufacturing technologies and how FDA is preparing for industry’s use of technologies such as AI for pharmaceutical manufacturing

FDA RESOURCES

• FDA’s Office of Pharmaceutical Quality
• CDER’s Drug Quality Sampling and Testing Programs
• 2022 Report on the State of Pharmaceutical Quality
• Pharmaceutical Quality Resources
• Framework for Regulatory Advanced Manufacturing Evaluation
• Emerging Technology Program

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 course 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.
• 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.
• 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.
• 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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