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  5. Regulatory Education for Industry (REdI) and CERSI Workshop: Current State and Future Expectations of Translational Modeling Strategies to Support Drug Product Development, Manufacturing Changes and Controls – Sep. 23-25, 2019
  1. CDER Small Business & Industry Assistance (SBIA)

Regulatory Education for Industry (REdI) and CERSI Workshop: Current State and Future Expectations of Translational Modeling Strategies to Support Drug Product Development, Manufacturing Changes and Controls – Sep. 23-25, 2019

Date and Time
September 23-25, 2019

8:30 a.m. - 6:00 p.m. Eastern

 

Agenda  Background

Physiologically based biopharmaceutics modeling (PBBM) can facilitate the incorporation of clinical relevance in product quality from initial development through marketing approval to lifecycle management, thereby minimizing the need of additional in vivo BE studies, leading to reducing cost in product development and supporting regulatory decisions. The purpose of this workshop is to identify and begin to fill the gaps in knowledge on the use of PBBM for drug product quality (e.g., to study in vivo impact of formulation and manufacturing changes).

The workshop will provide a forum for regulators, drug developers, and academicians to:
1) identify biopharmaceutics and modeling strategies (including model development, verification, and validation) to facilitate formulation development and to enhance risk management of bioperformance over the product’s life cycle;
2) demonstrate the rewards and challenges of coupling biopredictive dissolution testing with translational PBBM; and
3) identify knowledge gaps, and a path forward to advance the application of PBBM.

This workshop is a collaboration between FDA's Division of Biopharmaceutics, Office of Pharmaceutical Quality in the Center for Drug Evaluation and Research (CDER), CDER Small Business and Industry Assistance (SBIA), the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI).

Intended Audience

This workshop is open to the public. The intended audience includes:

  • those with an interest in PBBM and its application in the incorporation of clinical relevance in product quality and for drug product lifecycle management;
  • those with a background in pharmaceutical science, chemistry, clinical pharmacology, pharmacometrics;
  • regulatory agencies, academic institutions, and the pharmaceutical industry.

Registration

Registrants will receive confirmation when they have been accepted. There will be no on-site registration. Seats are limited, and registration will be on a first-come, first-served basis. There will be no webcast of this workshop.

Continuing Education

  • This event is RAPS (Regulatory Affairs Professional Society) eligible for credit towards a participant’s RAC (Regulatory Affairs Certification) recertification.
  • SOCRA (The Society of Clinical Research Associates) 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.
  • This event is SQA (Society of Quality Assurance) approved for 0.25 non-GCP or non-GLP units per 1 hour towards RQAP re-registration
  • ACRP (Association of Clinical Research Professionals) provides continuing medical education for the completion of this educational activity. Contact hours are provided at 1 unit for at least 45 minutes of qualified material.
  • Attendance certificates are only available during the two weeks after the event. Attendance is required.

For More Information and Questions:

Contact Sandra Suarez Sharp, (301) 796-2158, Sandra.Suarez@fda.hhs.gov

For Reasonable Accommodations:

If special accommodations at the workshop are needed due to a disability, please email Ann Anonsen (aanonsen@umd.edu) at least 7 days in advance of the workshop date. Requests for sign language interpretation or Computer Aided Realtime Translation (CART)/captioning should be made 2 weeks in advance of the workshop and should be sent directly to the FDA Interpreting Services Staff email account: interpreting.services@oc.fda.gov.

 

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