3rd Adverse Events Reporting, Safety Strategies and CAPA Summit -

3rd Adverse Events Reporting, Safety Strategies and CAPA Summit
December 5 - 6, 2016
Philadelphia, PA

Increase efficiency and overall safety through efficacious reporting of adverse events and effective safety strategies

3rd Adverse Events Reporting, Safety Strategies and CAPA Summit – 3rd Adverse Events Reporting, Safety Strategies and CAPA Summit

Featured MHRA Speaker

Adverse events are the pillars of pharmacovigilance and safety operations as we know them. They have been the drivers for developing safety databases, risk management plans, risk evaluation and mitigation strategies (REMS), benefit-risk assessments, and periodic reports. Their collection and reporting has been instrumental in leading to preventative actions for marketing better and safer drugs. It should come as no surprise that the pharmacovigilance space is constantly evolving — as are the needs of those who work in this area.

In order to achieve patient safety, proactively monitor adverse events and understand their impact in every phase of development, it is important to keep up to date with the latest developments from leaders in this space. The 3rd Adverse Events Reporting, Safety Strategies and CAPA Summit will offer an in-depth analysis of benefit-risk assessments, real-world data, risk management plans, signal detection, periodic reporting and solicited/unsolicited reports, all while working toward the goal of improving the safety strategies implemented by your company.

Top Five Reasons to Attend

  1. Hear from industry leaders about the latest developments in achieving regulatory compliance and optimizing safety processes and strategies
  2. Discuss ways to achieve efficient reporting of adverse events from traditional and non-traditional sources and optimize signal detection and management
  3. Explore where structured benefit-risk assessments can be used to improve decision-making and why this matters for pharma, regulators and patients
  4. Learn about measuring risk management activities for the identification and prevention of adverse events, from clinical to postmarket phases, and the comparison to REMS
  5. Hear about the impact of the European pharmacovigilance legislation and how companies are implementing it

Who Should Attend

This conference is designed for professionals from pharmaceutical, biotech and medical device companies with responsibilities in the following areas:

  • Pharmacovigilance
  • Drug Safety
  • Risk Management
  • Safety Research/Epidemiology
  • Pharmacoepidemiology
  • Medical Product Safety Assessment
  • Regulatory Affairs
  • Clinical Research
  • Safety Surveillance
  • Signal Detection
  • Clinical Safety
  • Patient/Medical Safety
  • Health Outcomes
  • Phase IV/Postmarketing Studies

This event is also of interest to:

  • Adverse Event/Case Management Service Providers
  • Safety Database Providers for Case Management
  • Clinical Research Organizations
  • Service Providers for Drug Safety
  • Healthcare/Pharmacovigilance Consultants
  • Healthcare Translation Agencies
live chat software