The Pharmacovigilance Final Rule Summit on IND Safety Reporting

Systematic Approaches for FDA Investigational New Drug Applications and Safety Reporting Submissions

August 16, 2016

Alexandria, VA

McGuireWoods Senior Counsel, Brian Malkin, spoke on new FDA Guidance at two sessions entitled “Develop Strategies to Successfully Implement the New Guidance” and “Determine Potential Compliance Obstacles and Financial Penalties to Avoid Unanticipated Delays” at The Pharmacovigilance Final Rule Summit on IND Safety Reporting.

With the recently released FDA Final Rule for IND Safety Reporting Requirements, it is critical for industry sponsors to implement systematic approaches for detecting and reporting serious and adverse event to ensure the safety of patients in clinical trials. Attendees will now be able to demystify this final rule, learn to accurately and rapidly report to the FDA, minimize uninformative reports and enhance the reporting of meaningful and interpretable information.

Who Should Attend:

You will benefit from attending this event if you are a manager, director or executive at a bio/pharmaceutical or medical device company with responsibilities or involvement in the following areas:

  • Safety Monitoring
  • Safety Reporting
  • Clinical Research
  • Epidemiology
  • Biostatistics
  • Clinical Pharmacology
  • Pharmcoepidemiology
  • Regulatory
  • Drug Safety
  • Pharmacovigilance
  • Risk Management

This conference will also benefit CROs, Consultants, legal firms, technology vendors and companies providing services to the above audience.

For more information please click here.