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AGENDA

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ABOUT THIS EVENT

In this symposium, FDA will provide an overview of CDER experience with approving several solid oral drug products which benefited from the continuous manufacturing technologies. We will also provide case-studies of intramural and extramural research in the areas of nanomaterials and continuous manufacturing, to further encourage the innovation and adoption of continuous manufacturing. Lastly, we will discuss ways in which industry, academia and other regulatory agencies can collaborate and engage with FDA in advancing the field of nanotechnology and continuous manufacturing.

INTENDED AUDIENCE

• Regulatory science and regulatory affairs professionals working on IND/NDA/BLA/ANDA etc.
• Researchers working on nanomaterials, drug delivery system, gene delivery systems, liposomes, lipid nanoparticles, biologics or continuous manufacturing
• Consultants focused on early- and late- stage product development and manufacturing
• Foreign regulators

TOPICS COVERED

• CDER experience in approving solid oral drug products utilizing continuous manufacturing
• FDA extramural research on various types of continuous manufacturing technologies for liposomes and lipid nanoparticles
• FDA intramural research on characterization of drug products containing nanomaterials
• Regulatory considerations on nanomaterial drug products
• Ways to engage with FDA on regulatory science research

FDA RESOURCES

• Drug Products, Including Biological Products, that Contain Nanomaterials - Guidance for Industry.
• Q13 Continuous Manufacturing of Drug Substances and Drug Products.
• FDA Emerging Technology Program.
• Adam F et al. An audit of pharmaceutical continuous manufacturing regulatory submissions and outcomes in the US. International Journal of Pharmaceutics, (2022), 622, 121778.

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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