Only 2 weeks left! Register now for the FDA REdI Conference in Minnesota – May 17/18

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* Drugs Track Agenda *

 * Register Now *

Registration is required. This is a LIVE event and will not be webcast or recorded.

 This 2-day conference has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

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Don’t miss our Spring 2016 Regulatory Education for Industry (REdI) Conference, an FDA-led forum that brings together the regulatory educators from FDA’s Center for Drug Evaluation (CDER) and Center for Devices and Radiological Health (CDRH).

Agenda Topics Include:

 FDA Insights on Products for Rare Diseases and Pediatrics

FDA’s Role in Clinicaltrials.gov

Application of CGMPs

Increasing the Quality and Efficiency of Clinical Trials

Inspection of NDA and BLA Applications

The Drug Supply Chain Security Act

Risk and Team-Based Integrated Quality Assessment

PAI/GMP Inspection

Best Practices for Communicating with FDA

Post-Marketing Drug Safety Surveillance

Emerging Technology Team

Interactions with the FDA

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We hope to see you soon in Minnesota!

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If you are registered and are unable to attend please contact events@nakamotogroup.com

 For conference registration questions or logistical questions, contact: Nick Cane atevents@nakamotogroup.com

 For more information on:

CDER SBIA

CDER SBIA Workshops and Webinars