Click Here to View This Year's Event!

Following the success of ExL Pharma’s inaugural Proactive GCP Compliance conference in March 2010, there emerged a clear need for industry to reconvene to share experience and exchange solutions around the GCP compliance issue of clinical vendor oversight. At a time when the FDA and global regulatory agencies are shining a spotlight on quality oversight of clinical trials and sending Warning Letters not only to Sponsors but also to CROs, it is imperative to align your quality efforts when outsourcing clinical trial work.

At the Quality Oversight of Clinical Vendors conference, we have gathered together Quality Assurance and Clinical Operations professionals from over 15 pharma/biotech companies to provide practical experience and case studies focusing on inspectional experience, vendor qualification and contracting, study set-up and quality management of outsourced work. These industry experts are joined by several esteemed quality consultants, well versed on these same issues from a cross-industry perspective. Finally a panel of clinical vendors weighs in on their important role in ensuring quality of clinical trials.

As clinical outsourcing continues to increase as a way to gain efficiencies, ensure that your internal and external clinical and quality teams are communicating effectively, documenting expertly and aligning roles, responsibilities and expectations around quality oversight. We look forward to greeting you on October 12th in Arlington, VA.

 “ FDA regulations require that sponsors, or CROs to whom such responsibilities have been transferred, ensure proper monitoring of clinical investigations.”
– Division of Scientific Investigations, Office of Compliance, Center for Drug Evaluation and Research, FDA

Take Advantage Of In-Depth Half-Day Workshops: