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Webinar Replay: “FDA User Fees – What Have They Done For You Lately?”

Weinberg-admin — Fri, 27 Apr 2012 18:21:47 +0000

A Webinar Presented by The Weinberg Group
April 25, 2012

FDA user fees have been fact of life for regulated industry for nearly two decades. As you continue to comply by paying the fees, you should understand what the revenue does for you. This webinar will provide a history of the Prescription Drug User Fee Act (PDUFA) from its inception to its latest reauthorization (PDUFA V). We will discuss the various PDUFA mandates that FDA has described over the years and how well the Agency is doing in achieving their PDUFA goals. We will also cover the pending Generic Drug User Fee Act (GDUFA) and the potential impact it may have on the industry.

Marla Scarola, M.S., Senior Consultant, discussed the following topics:

▪  Remembering a pre-PDUFA world
▪  History of PDUFA and achievements to date
▪  Goals of PDUFA V
▪  What is GDUFA and what are its potential benefits?

To watch full replay please click here.

CEO Matthew Weinberg Presents at FDA Clinical Trials Hearing

Weinberg-admin — Mon, 23 Apr 2012 21:07:58 +0000

April 23 – The Weinberg Group CEO, Matthew Weinberg, presented today at FDA’s hearing titled “Modernizing the Regulation of Clinical Trials and Approaches to Good Clinical Practice.” Mr. Weinberg presented on the mandatory need for audits and audit independence. A full copy of his presentation can be found here.
For more information on The Weinberg Group’s independent clinical auditing services, please contact
Jeff Antos, Vice President, at jeff.antos@weinberggroup.com or 202.280.0815.

The Weinberg Group to Sponsor and Participate in Linking Leaders Roundtable Series

Weinberg-admin — Thu, 01 Mar 2012 21:11:19 +0000

Linking Leaders’ Clinical Quality roundtable series provides pharmaceutical and biotech executives a forum to share insights and experiences, benchmark progress, and collaborate on solutions with like-minded peers facing similar industry obstacles in a closed-door, invitation-only setting. This unique forum brings together an exclusive community of executives engaged in Clinical Quality Assurance, Compliance, Risk Management and more to discuss collective challenges and collaborate on new ways to spearhead innovation in executing quality in clinical trials.

The Weinberg Group is sponsoring the 2012 quarterly roundtable meetings with Amy Hansen, Director of GCP Services, joining the pharma executive network members at the boardroom table. For more information please visit www.linkingleaders.com.

Webinar Replay: “Understanding What FDA is Looking for in Postmarket Safety Assessments: Going Beyond AERS”

Weinberg-admin — Wed, 08 Feb 2012 14:47:45 +0000

As we know, getting a drug approved by FDA is hardly the last step. FDA’s oversight continues well past approvals and over the years, has become more vigilant regarding safety and efficacy. This greater focus means postmarket safety assessments are playing a growing and increasingly critical role within your regulatory group. During this webinar, Dr. Bob Roth will explain how to get the information FDA is looking for, and how to communicate this information, both good and bad, to FDA.

Please join Bob Roth, Ph.D., M.D., Vice President and Worldwide Medical Director, as he discussed:

VigiBase, the international equivalent of AERS
Drug Abuse Warning Network (DAWN)
National Poison Data System (NPDS)
Useful analyses and data presentations
Application to special risk settings

To watch full replay please click here.

The Weinberg Group Launches its Blog

Weinberg-admin — Wed, 14 Dec 2011 16:28:31 +0000

The Weinberg Group is excited to announce the publication of its new blog, Weinberg on FDA. The blog will act as a forum for discussion among our experienced consultants and the regulatory community. Each week, Weinberg on FDA will feature opinions and discussion on FDA news and regulatory decisions from some of our most senior consultants, including Nick Fleischer, Joel Falk and Bob Roth.

As we continue to provide clients with exceptional service and results, we believe this blog will allow the public to become familiar with The Weinberg Group, our knowledge and our work. We have also joined the discussion on Facebook and Twitter and look forward to sharing company activities, announcements and thoughts with our followers on a daily basis.

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