Description
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>
    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>
    hyperlinks<br><br>
<b>Question and Answer Session</b>
01/01/0001
To
01/01/0001
Training Company
The Center for Professional Advancement (CfPA)
Industry
Clinical Research Organization
Course Category
Address
90 Minute Accredited Online Training
90 Minute Accredited Online Training,
