FDA Quarterly Briefing–July 2008 Training Course :

<strong>Course Schedule - Pre-recorded Course</strong><br/><br/>This quarter’s briefing is a careful distillation identifying the three most important new initiatives, regulatory changes and innovations from the FDA, and places them in context for the pharmaceutical, biological and device professional. This 90–minute accredited online training is divided into three sections, each section devoted to a new FDA regulation or initiative. Ample time has been allotted to answer your questions. The topics are:<br><br> <B>PUBLIC ADVERTISING GUIDELINES:<br> Congressional mandate:</b><br>   2007 Act<br> <b>Problems and value of public advertising:</b> <br>   Information dissemination<br>   Public demand, over-use<br> <b>FDA monitoring:</b><br>   Shift from FTC<br>   Expertise gap<br> <b>Emerging guidelines:</b><br>   Clarity<br>   Information without “sales pitch”<br>   Dangers and side effects<br><br> <b>GMP AND 21 CFR PART 11 REVISIONS:<br> Harmonization with EMEA GAMP4/5:</b><br>   GAMP4= cGMP+Part11<br> <b>Updating of GMPs in automated environment:</b><br>   More than ten years since last update<br>   Risk factors<br> <b>PAT:</b><br>   Automation of QA function<br>   Potential for remote monitoring<br><br> <b>POST MARKET SURVEILLANCE REQUIREMENTS:<br> Extension of FDA focus:</b><br>   Reduce NDA/ANDA pressure<br>   Increased most market surveillance<br> <b>Improved data collection and analysis:</b><br>   Active rather than passive<br>   Tracking use, side effects<br>   Possible post clinical studies (Phase V?)<br> <b>Concerns over off label use:</b><br>   Reconciling distribution volume<br> <b>Post NDA/ANDA submission and review:</b><br>   New FDA responsibility<br>   New submission guidelines<br> <b>Question and Answer Session</b>