<h2><strong>About </strong></h2> <p> </p> <p>The drug registration and listing staff is hosting a workshop dedicated to assisting industry with creating complete and accurate registration and listing submissions.</p> <p>This year will focus on the top errors and mistakes observed with submissions and highlight FDA’s newly announced process for inactivation of uncertified listings.</p> <h4>Topics Covered</h4> <ul> </ul> <ul> <li>Drug registration and listing compliance program featuring a case study of a violation</li> <li>Registration and labeler code requests</li> <li>NDC reservation, drug listing, and 503B compounder product reporting</li> <li>Listing certification and FDA inactivation of uncertified listings</li> <li>Town hall with the DRLS staff</li> </ul> <h4>Intended Audience</h4> <ul> <li>Regulatory affairs professionals working on registration and listing or who submit Structured Product Labeling (SPL) to FDA</li> <li>Members of Industry who submit Registration and Listing</li> <li>US Agents for Foreign registrants</li> <li>Importers and import agents</li> <li>Consultants and law firms representing pharmaceutical companies</li> </ul> <h4>Keynote FDA Speaker</h4> <p><em>Paul Loebach, Director</em><br /> Drug Registration and Listing Staff | Office of Program and Regulatory Operations CDER | FDA</p> <h4>FDA Resources</h4> <ul> <li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="00711a19-7a9f-4f5d-a1ad-b795a4bd527f" href="https://www.fda.gov/drugs/guidance-compliance-regulatory-information/drug-registration-and-listing-system-drls-and-edrls" title="Drug Registration and Listing System (DRLS and eDRLS)">DRLS Website</a></li> <li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="4b2a5b93-cd00-441a-b548-31198b749ecf" href="https://www.fda.gov/drugs/drug-registration-and-listing-system-drls-and-edrls/electronic-drug-registration-and-listing-instructions" title="Electronic Drug Registration and Listing Instructions">eDRLS Instructions</a></li> <li><a href="mailto:edrls@fda.hhs.gov">Email the DRLS Helpdesk</a> at <a href="mailto:edrls@fda.hhs.gov">edrls@fda.hhs.gov</a></li> </ul> <h4>Continuing Education Credits</h4> <p>This course:</p> <ul> <li>has been pre-approved by RAPS as eligible for credits towards a participant’s RAC recertification upon full completion.</li> <li>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.</li> <li>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.</li> <li>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.</li> </ul> <h4>Technical Information</h4> <p>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.<br /> To test your PC, please visit: <a href="https://concerted.adobeconnect.com/common/help/en/support/meeting_test.htm" target="_blank">Adobe Connect Diagnostic Test</a><a href="http://www.fda.gov/about-fda/website-policies/website-disclaimer">External Link Disclaimer</a></p> <h4>Questions</h4> <p>Please contact <a href="mailto:info@sbiaevents.com">info@sbiaevents.com</a> for all technical questions.</p> <h4>For Reasonable Accommodations</h4> <p>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: <a href="mailto:interpreting.services@oc.fda.gov">interpreting.services@oc.fda.gov</a>.</p> <p> </p> <p>For registration click <a href="https://sbiaevents.com/edrls2019/" target="_blank">here.</a></p>