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  5. Regulatory Education for Industry (REdI): Pharmaceutical Quality Symposium – Oct. 16-17, 2019
  1. CDER Small Business & Industry Assistance (SBIA)

Regulatory Education for Industry (REdI): Pharmaceutical Quality Symposium – Oct. 16-17, 2019

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SBIA Pharma Quality Symposium

 

Date and Time
October 16-17, 2019
8:30 a.m. - 4:15 p.m. Eastern
Wednesday and Thursday
Location
The Hotel at the University of Maryland
College Park, Maryland
or Online

Register Now   Agenda 

This event is FREE and open to the public.

FDA will discuss the latest developments in pharmaceutical quality and provide case studies that illustrate the most effective ways to address quality issues and interact with the agency.

In this era of globalization, engaging stakeholders is essential to furthering the overall commitment to pharmaceutical quality. FDA’s goal for this event is to share information and emphasize the critical role quality plays in assuring the safety and efficacy of pharmaceutical products.

We look forward to discussing this commitment to quality with you at this symposium.

Topics Covered

  • Manufacturing and the Quality Assessment of Applications
  • Quality Beyond Application Approval
  • Emerging Technologies in Pharmaceutical Manufacturing and Design
  • Happenings in Biologics: Biosimilars and Transition Biological Products

Keynote FDA Speakers

Patrizia Cavazzoni portrait

Patrizia Cavazzoni, MD
Deputy Center Director for Operations
CDER | FDA

Michael Kophcha Portrait 80 x 88

Michael Kopcha, PhD, RPh
Director
OPQ | CDER | FDA

Intended Audience

  • Regulatory affairs professionals (innovator and generic or biosimilar)
  • Manufacturing professionals (domestic and foreign; drug product and API)
  • Foreign regulators
  • Healthcare professionals interested in learning more about the FDA’s drug quality functions

Continuing Education Credits

This course:

  • has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.
  • is eligible for SOCRA credit 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. Candidate must provide documentation of participation.
  • has been pre-approved by SQA as eligible for 0.25 non-GCP or non-GLP units for every 1 hour of instructional time towards a participant’s RQAP re-registration.
  • is approved for ACRP research-specific continuing education at the completion of this activity. Contact hours are provided at 1 point/hour for at least 45-60 minutes of qualified material.

FDA RESOURCES

  1. Pharmaceutical Quality Resources: https://www.fda.gov/drugs/development-approval-process-drugs/pharmaceutical-quality-resources
  2. FDA’s Office of Pharmaceutical Quality: https://www.fda.gov/about-fda/center-drug-evaluation-and-research/office-pharmaceutical-quality
  3. CDER’s Quality Initiative: https://www.fda.gov/about-fda/center-drug-evaluation-and-research/cders-quality-initiative
  4. Facts About the Current Good Manufacturing Practices (CGMPs): https://www.fda.gov/drugs/pharmaceutical-quality-resources/facts-about-current-good-manufacturing-practices-cgmps
  5. Report on the State of Pharmaceutical Quality, 2018: https://www.fda.gov/media/125001/download

Technical Information

The audio for the event will be provided through your computer speakers via Adobe Connect (there will NOT be a teleconference number to dial into). We recommend that you test your PC or mobile device prior to the event and you join the event a few minutes early to address any issues.
To test your PC, please visit:
Adobe Connect Diagnostic Test

Questions

Please contact info@sbiaevents.com for all technical questions.

For Reasonable Accommodations

If special accommodations at the workshop are needed due to a disability, please email CDERSBIA@fda.hhs.gov 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.