1. If you can't see this message pleas e us e this linkpleas e us e this link FDAs Expedited Programs for Serious Conditions - Drugs and Biologics Friday, September 12, 2014 | 10:00 AM PDT | 01:00 PM EDT | Duration : 120 Minutes | Register Now Register Now This webinar will discuss four FDA programs intended to facilitate and expedite development, review and approval of new drugs to address unmet medical needs in the treatment of serious and life- threatening conditions. This includes FDAs newest expedited program Breakthrough Therapies Designation. Besides Breakthrough Therapies Designation also discuss will be Fast Track Designation, Accelerated Approval and Priority Review Designation. These programs are intended to help ensure that therapies for serious conditions are approved and available to patients as soon as it can be concluded that the therapies benefits justify their risks. Criteria for each expedited program will be reviewed so a judgment can be made relative to your new drug. Also definitions for serious condition and unmet medical need will be covered. Instructor: with all aspects of the FDA approval PRO versionpdfcrowd.com Are you a developer? Try out the HTML to PDF APIHTML to PDF API Albert A. Ghignone Albert A. Ghignone, MS, RAC is the CEO of AAG Incorporated. For more than 30 years his focus has been on FDA related matters in regulatory affairs, quality assurance and clinical affairs. He has expertise in dealing

2. A must attend webinar for those personnel that require an understanding of the FDAs expedited programs for serious conditions. Areas Covered in the Session : FDAs Expedited Program system Definitions for serious condition and unmet medical need FDAs Breakthrough Therapy Designation Program FDAs Fast Track Designation Program FDAs Priority Review Designation Program FDAs Accelerated Approval Program Who Will Benefit: Upcoming Webinars: Regulatory Affairs Personnel Quality Personnel Clinical Personnel Research Personnel Laboratory Personnel Manufacturing Personnel Legal Personnel Clinical Research Associates Personnel who require a general understanding of the FDAs Expedited Programs for serious conditions Drugs and Medical Devices Available Recorded Webinars: Register Now Root Cause Analysis and Corrective Action Good Laboratory Practice Regulations process for drugs, biologics, medical devices and generic drugs. He has worked in every major segment of the industry-research, quality assurance, regulatory affairs, manufacturing and clinical. He lectures throughout the world on numerous FDA related matters. He is a consultant to FDA and trains FDA Field Force (those who conduct FDA inspections) on GCP, GLP and GMP). In recent years he has filed numerous FDA drug, biologic and medical device submissions for product approval. Quality by Design (QbD) Across the Product Lifecycle How to Implement HIPAA Requirements in GxP Regulated Establishments Risk Management Principles FDA Adverse Event Reporting forFDA Adverse Event Reporting for PRO versionpdfcrowd.com Are you a developer? Try out the HTML to PDF APIHTML to PDF API

3. It would be really nice if you can share this mail to all your colleagues who can get benefit from this training. Home Home | About Us | Contact Us | Terms of Use | Priv acy PolicyAbout Us Contact Us Terms of Use Priv acy Policy Call Us : +1 416-915-4458 | Email us : events@compliancetrainings.comevents@compliancetrainings.com Uns ubs cribe About Compliance Trainings: Compliance Trainings focuses on providing regulatory and quality based trainings to industry professionals across the globe. Compliance Trainings strive to educate and enhance the knowledge and broaden the horizons of regulatory professionals as well as professionals from the HR, Healthcare and many other industries. Compliance Trainings intends to establish both, a strategic and significant hold in the training industry by providing the highest level of quality trainings and consulting. To achieve our goal, Compliance Trainings uses the latest technology to make trainings both affordable as well as relevant to the industries professionals who work in an ever changing and highly regulated environment. 10 Steps to Perfect SOPs: FDA10 Steps to Perfect SOPs: FDA Acceptable SOPs made Easy Sign Up with Us to get:Sign Up with Us to get: Weekly Newsletters Regular updateson Trending topics and discussions Onlinetrainingsessions by Industry Experts PRO versionpdfcrowd.com Are you a developer? Try out the HTML to PDF APIHTML to PDF API