The Lachman Blog

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18
Mar

Looking for a Few Good Comments – FDA Identifies Needs for Drug Safety-Related Regulatory Science

The Center for Drug Evaluation and Research’s (CDER) Safety Research Interest Group, a subcommittee of Science Prioritization and Review Committee, is asking for organizations that may be conducting research and/or have interest in collaborating with the FDA in the 7 areas of interest identified by the Agency:

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17
Mar

Lachman Consultant Services Presents “Data Integrity: The Foundation of Metrics”

On Monday, April 20, 2015, the afternoon prior to the ISPE Quality Metrics Summit, Lachman Consultant Services will be presenting a training session on Data Integrity. The training session will be held in the Severn 1 meeting room of the Sheraton Inner Harbor Hotel in Baltimore (the same hotel as the ISPE Quality Metrics Summit), and will be followed by Q&A and a networking reception.

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12
Mar

The Beat Goes On – More On the Proposed Rule

This edition of the Proposed Rule saga covers a few more interesting issues. The rule-which was 11 years in the making (longer than the final Hatch-Waxman rule on the patent and exclusivity provisions of the Act, which was10 years in the making) really tightens up some of the long-established practices of the Agency and explains why the FDA is taking the actions that it is. Makes for good reading, but make sure you have your toothpicks ready to prop open your eyes. We are just through page 120 of the 300+ pages.

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11
Mar

Lachman Consultant Services Presents “Data Integrity: The Foundation of Metrics”

On Monday, April 20, 2015, the afternoon prior to the ISPE Quality Metrics Summit, Lachman Consultant Services will be presenting a training session on Data Integrity. The training session will be held in the Severn 1 meeting room of the Sheraton Inner Harbor Hotel in Baltimore (the same hotel as the ISPE Quality Metrics Summit), and will be followed by Q&A and a networking reception.

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09
Mar

Lachman Consultant Services Presents “Data Integrity: The Foundations of Metrics”

On Monday, April 20, 2015, the afternoon prior to the ISPE Quality Metrics Summit, Lachman Consultant Services will be presenting a forum on Data Integrity. The forum will be held in the BALLROOM NAME, the same hotel as the ISPE Quality Metrics Summit, and will be followed by Q&A and a networking and cocktail reception.

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