Regulatory - Applied Clinical Trials

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Regulatory

Schulman Associates IRB Establishes Itself in Canada

October 28, 2009

REMs: Battling the Unknowns

October 22, 2009

Why knowing a drug's risk and preparing for a risk evaluation mitigation strategy early on will considerably benefit a drug's development.

European Medicines Agency Implements Internal Reorganization

October 5, 2009

Keys to Drug Development in Latin America

October 1, 2009

The region and its regulatory agencies try to keep up with the rapidly growing clinical trials market.

FDA Promotes Integrity and Compliance

October 1, 2009

Stiffer enforcement of research standards aims to restore the public's confidence in agency actions.

Working Toward a Better Future

October 1, 2009

The EU struggles to get over its regulatory hurdles in an effort to further R&D success.

Pressure Mounts for ICH GCP Revisions

October 1, 2009

The ICH GCP guideline continues to age and while members of the Institute of Clinical Research voice the need for its revision, industry debates whether changes are necessary.

Business and People Update

October 1, 2009

Industry news focusing on the people and organizations who work in the clinical trials profession

BSI Launches New CE-Dedicated FastTrack Program

September 24, 2009

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