Clinical Testing Plan and Submissions – a TWO Part Course Training Course :

<strong>Course Schedule - November 6 and 11, 2008 at 11:00 a.m. - 12:30 p.m. (EST)</strong><br/><br/>The FDA procedures for the clinical testing of drugs, potentially leading to the filing of an NDA or ANDA, are evolving rapidly. This <b>two-part, <i>accredited</b></i> program examines the steps involved in designing and filing for permission to conduct the clinical tests (the IND); the FDA issues and concerns in reviewing IND applications; the details of the pre-IND FDA meeting; and the procedures for electronic IND filing. Registration for both sessions is required. The course is divided into two 90-minute sessions, each in turn divided into three modules.<br><br> <b>Participants <i>MUST</i> Attend Both Parts<br><br> <u>SESSION 1: Planning the Clinical Study and IND Filing<br><br> Module 1:</u> Overview: Clinical Testing Concerns</b><br>   • QbD<br>   • Post marketing clinical testing<br>   • Phases of Clinical Testing<br><br> <b><u>Module 2:</u> Steps</b><br>   • Planning the Clinical Testing Process<br>   • Pre-clinical<br>   • IND filing<br>   • Pre-meeting<br>   • Design<br>   • Research<br>   • Investigator's Brochure<br>   • IRB approval<br>   • Format<br><br> <b><u>Module 3:</u> FDA Criteria and Concerns</b><br>   • Foreign studies<br>   • Design issues<br>   • Safety and IRB review<br>   • Study Size<br>   • Blood/brain barrier<br><br> <b>Question and Answer Session</b><br><br> <b><u>SESSION 2: Dealing with the FDA Pre-IND Meeting and Details of Electronic Filings<br><br> Module 1:</u> Quality Issues in Clinical</b><br>   • Clinical Team pre-IND meeting with FDA<br>   • Focusing on the important issues and meta-issues<br>   • Evaluating research facilities and strategies<br>   • Ethical issues<br>   • Protection of the safety, rights of persons participating<br><br> <b><u>Module 2:</u> Prep for the Pre-IND Meeting</b><br>   • Early interactions with FDA staff to help to prevent clinical <br> &nbsp&nbsp&nbsp issues from arising<br>   • Selection of appropriate CROs and Investigators<br>   • The Mock-Meeting: managing expectations<br>   • Efficient use of FDA resources<br><br> <b><u>Module 3:</u> Electronic INDs</b><br>   • Evolving process<br>   • Industry guidance and FDA guidelines<br>   • e-Forms<br>   • Alternatives: paper, paper with electronic index, paper with<br> &nbsp&nbsp&nbsp hyperlinks<br><br> <b>Question and Answer Session</b>