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Agenda

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ABOUT THIS EVENT

This symposium will address drug development of products that contain nanomaterials in their formulation and how the newly finalized guidance to industry for products that contain nanomaterials can be implemented in filings to the FDA. FDA speakers will present reviewer perspectives on drug development and laboratory efforts to facilitate further understanding of challenges to manufacture products that contain nanomaterials. Two additional speakers will address safety evaluations of food contact substances that contain nanomaterials and the development of standard materials and methods for nanomaterials.

• FDA will discuss the primary Chemistry Manufacturing and Controls (CMC) and nonclinical hurdles for developing products that contain nanomaterials.
• FDA will provide case studies on the development of the COVID mRNA lipid nanoparticle vaccine products.
• FDA will present efforts to establish standards and standard methods for monitoring products that contain nanomaterials

INTENDED AUDIENCE

• Regulatory science and regulatory affairs professionals working on drug products, including biologicals, that contain nanomaterials and submit IND/NDA/BLA/ANDA applications for FDA review.
• Researchers working on applications of nanotechnology for pharmaceutical products, analytical methodology for control of pharmaceuticals that contain nanomaterials, and nonclinical studies to support human clinical trials.
• Foreign regulators who review comparable pharmaceutical products that contain nanomaterials.

TOPICS COVERED

• An overview and discussion of the recently finalized “Guidance to Industry: Drug Products, Including Biological Products, that Contain Nanomaterials”
• A contextualized discussion of the development of the COVID mRNA lipid nanoparticle vaccine products
• A nonclinical perspective of developmental challenges of products that contain nanomaterials
• The development of regulatory standards and methods for controlling products that contain nanomaterials

FDA RESOURCES

• GUIDANCE DOCUMENT: Drug Products, Including Biological Products, that Contain Nanomaterials - Guidance for Industry; APRIL 2022
• GUIDANCE DOCUMENT: Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology - Guidance for Industry; JUNE 2014
• GUIDANCE DOCUMENT: Liposome Drug Products: Chemistry, Manufacturing, and Controls; Human Pharmacokinetics and Bioavailability; and Labeling Documentation; APRIL 2018
• GUIDANCE DOCUMENT: Content and Format of Investigational New Drug Applications (INDs) for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-derived Products - Guidance for Industry; NOVEMBER 1995

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.
• 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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