4th Clinical Trials Inspection Readiness Summit -

4th Clinical Trials Inspection Readiness Summit
August 12-13, 2015
Philadelphia, PA

4th Clinical Trials Inspection Readiness Summit – 4th Clinical Trials Inspection Readiness Summit

Inspections can occur at any time and you need to be ready to act. The consequences of a failed inspection can be dire — you may face hefty fines, lost jobs and waning credibility.

Inspection readiness is more than a “one time” event. In the best companies, the inspection readiness process is driven by people who excel at thinking ahead. This means taking into account the constantly evolving variables of clinical research, including new staff, new sites and new vendors. Thinking about the problems you haven’t yet found is the key to making sure that all aspects of clinical trials are up to code and to being able to provide all required documents that prove that the trial is GCP compliant.

The 4th Clinical Trials Inspection Readiness Summit presents life science industry professionals with case studies of peers who put in place proactive measures to reduce the risk of a failed inspection. Effective clinical research documentation, FDA submissions, TMF processes and vendor management are critical to audit preparation. The professionals we bring together are the thought leaders who take inspection readiness to a higher plane. This summit will provide you with a space not only to learn, but also to network and bring your most critical challenges directly to them.

Top Five Reasons to Attend

  1. Review crucial information and analysis of regulations from around the world, with a focus on FDA, EMA, PMDA and MHRA
  2. Benchmark the success of your clinical trial with metrics for measuring the performance of CROs and trial sites
  3. Learn strategies for ensuring there is a comprehensive clinical trial storyboard so inspectors can recreate the trial
  4. Leverage process maps that can be applied to streamline TMF management and the key team members who need to be involved
  5. Innovate your inspection readiness SOPs armed with information on risk-based modeling for inspection readiness

What Past Attendees Say:

All the right people in the right place. If you are in the business of remaining inspection ready you need to be here” – Director, BIOGEN IDEC

“Very interactive, felt the real-life examples were great!” —TMF Process Analyst, Development Operations, PFIZER

“Content provides new, fresh insight to site inspections.” —Clinical Associate, Clinical Operations, INTERCEPT PHARMACEUTICALS

“Excellent and interactive speakers.” —Director, Clinical Compliance, MEDIMMUNE

Who Should Attend 

This conference is designed for professionals from pharmaceutical, biotechnology and medical device companies with responsibilities involving:

  • Clinical Operations and Affairs
  • Clinical Quality Assurance/Compliance
  • Clinical Trial Management
  • Global Compliance
  • Global Quality Management
  • Clinical Monitoring
  • Clinical Research
  • Safety and Risk Management/Operations
  • Auditing
  • Clinical Project Management
  • Trial Master Files
  • Clinical Trials
  • Clinical Development
  • Clinical Document Coordination
  • Clinical Site Management
  • Global Regulatory Affairs

This program is also of interest to clinical QA/compliance professionals involved with:

  • CROs
  • Institutional Review Boards
  • Investigative Sites
  • Data Management/Computer Software
  • Consulting Firms
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