SAFETY AND INNOVATION ACT (FDASIA) TO THE PROTOCOL 2013 - FDA ? Alternative Strategies in Dealing with the Agency to Develop and Gain Approval of Drugs and Medical Devices By compliance2go

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Category Medical Device ; Pharma

Deadline: February 20, 2013 | Date: February 21, 2013

Venue/Country: Houstan, U.S.A

Updated: 2013-02-08 19:46:21 (GMT+9)

Call For Papers - CFP

In tackling the challenge of developing a drug or device product for FDA approval, a common assumption is that the effort will take years and cost the budget of a small city. And, then, when you file at FDA, you worry that you will have to wait forever for a decision. While there is some truth in that hyperbole, the reality is that there are a number of programs available at FDA that are designed to speed the development and approval process. In this webinar, we will explore those mechanisms for both drug (and biologic) and device (incuding diagnotics) products.

Ranging from the new “breakthrough drug” provisions of the 2012 Food & Drug Administration Safety and Innovation Act (FDASIA) to the protocol assistance requirements of the 1983 Orphan Drug Act to the Special 510(k) process, we will review how to qualify for these programs, their benefits, and their burdens, all with aim of helping you, where possible, get your product to the market faster while still satisfying the legal requirements for approval.

Areas Covered In the Seminar

Benefits of programs

Eligibility criteria for programs

How they compare

Strategies in deciding which to use when multiple may be available

Who should attend

Executives (VPs, Directors, Managers) and other professionals involved in developing and executing the strategies to secure approval/clearance of FDA-regulated drugs, biologics, and medical devices and diagnostics. In particular, professionals from these functional arenas:

Regulatory, Research & Development, Compliance, Quality Assurance, Medical Affairs, Clinical Affairs, Clinical Operations, Legal

About Speaker

Michael Swit has been addressing critical FDA legal and regulatory issues since 1984. Before recently joining Duane Morris LLP as a Special Counsel in its San Diego office, Mr. Swit served for seven years as a Vice President for The Weinberg Group, a premier FDA regulatory consulting firm headquartered in Washington, D.C., where he developed and ensured execution of a broad array of regulatory and other strategies, compliance and enforcement initiatives, recalls and crisis management, submissions and related traditional FDA regulatory activities, labeling and advertising, and clinical research efforts for drug, biologic, device, IVD, and other life sciences companies, as well as those in the food, cosmetic, and dietary supplement industries.

Mr. Swit has taught and written on a wide variety of subjects relating to FDA law, regulation and related commercial activities, including, since 1989, co-directing a three-day intensive course on the generic drug approval process and editing a guide to the generic drug approval process, Getting Your Generic Drug Approved. A former member of the Food & Drug Law Journal Editorial Board, Mr. Swit also has been a prominent speaker at numerous conferences sponsored by such organizations as RAPS, FDLI, and DIA.

Speaker : Michael Swit

Product ID : F62185

Schedule Date :

Thursday, February 21, 2013

duration : 02:00 to 03:00 PM EST

https://compliance2go.com/index.php?option=com_training&speakerkey=50&productKey=212