Watch Basics of the IND Event Streaming Online

Date(s) And Time(s): April 30, May 1, 2, 7, 8, 9, 2012 12:00PM - 2012 1:30PM ET Overview: Learn about FDA regulations and expectations for the content, submission, and review of INDs and the importance of regulatory strategy. What you will learn Activities and submissions required The fundamentals of the Investigational New Drug Products Preparation Content Strategy to maintain an IND Special Regulatory Considerations for Clinical Development Agenda Part 1 April 30, 2012: 12-1:30 pm Part 2 May 1, 2012: 12-1:15 pm Part 3 May 2, 2012: 12-1:15pm Part 4 May 7, 2012: 12-1:00pm Part 6 May 8, 2012: 12 -1:30pm Part 5 May 9, 2012: 12-1:15 pm Unless otherwise disclosed, the statements made by speakers represent their own opinions and not necessarily those of the organization they represent, or that of the Drug Information Association. Speakers, agenda and CE information are subject to change without notice. Recording of any DIA educational material in any type of media is prohibited without prior written consent from DIA. Learning Objectives: At the conclusion of this activity, participants should be able to: · Explain the importance of incorporating regulatory strategy into the drug development plan · Identify FDA review processes for evaluating INDs · Plan and prepare an IND, and know the reporting requirements for IND amendments · Identify regulatory mechanisms to facilitate development of new therapies Target Audience: · Regulatory affairs professionals new to the IND process · Clinical development professionals · Biostatisticians · Basic researchers · Quality and manufacturing professionals · Medical writers · Business and marketing professionals · Clinical research academicians Event Code: 12458 Contact Information: For registration questions, please contact Elizabeth Espich at +1-215-293-5802 or Elizabeth.espich@diahome.org For agenda details, please contact Susan Berkelbach at +1-215-442-6183 or Susan.Berkelbach@diahome.org. more