2nd Annual Pharmacovigilance and Risk Management Strategies Summit
18-19

February 2016

Germany

Berlin

Hotel Riu Plaza Berlin

Martin-Luther-Straße 1, 10777

About Summit

With concerns occurring across the board in relation to PV auditing, companies face the challenge of understanding the key considerations when presenting to auditors. Unravel the challenges in compiling and presenting the new PSUR to external regulatory bodies and determine what these regulatory bodies have learnt in the wake of its recent introduction. The introduction of the new legislation has led to a significant change in how companies present there data and safety studies to external regulatory bodies. This has ultimately led to a lack of...

With concerns occurring across the board in relation to PV auditing, companies face the challenge of understanding the key considerations when presenting to auditors. Unravel the challenges in compiling and presenting the new PSUR to external regulatory bodies and determine what these regulatory bodies have learnt in the wake of its recent introduction. The introduction of the new legislation has led to a significant change in how companies present there data and safety studies to external regulatory bodies. This has ultimately led to a lack of understanding in what is expected upon data presentation. Attend this fantastic forum to discuss the format and content of Periodic Safety Update Reports and how data integration and additional modules are incorporated into this documentation to provide a far more comprehensive overview of a drug safety and efficacy.

more info
Who Should Attend

CEOs, Directors, Department Heads & Managers of Leading Application Creators & Suppliers from:

  • Pharmacovigilance
  • Risk / Safety management
  • Patient Safety
  • GPvP
  • Signal Management
  • Safety evaluation
  • Regulatory affairs
  • Assurance and Compliance
  • Pharmacoepidemiology
  • Drug Safety
  • Safety Surveillance
  • QPPV
  • Inspection and Audit
  • Clinical Trials
  • Medical product safety assessment
  • Clinical research
  • Data analysis
  • Medical information

From Industries Including: 

  • Pharmaceuticals
  • Hospital
  • Biotechnology
  • Clinical Research Organizations
  • Regulatory Agencies
  • Health Care
  • Medical Practice
  • Biologics
  • Academic Research Centers
Key Practical Learning Points of the Summit

An update on the implementation of the new pharmacovigilance legislation with a particular emphasis on the regulatory aspects
New features of the pharmacovigilance legislation and their impact on regulatory activities
New pharmacovigilance legislation and how it is impacting drug development
Drug safety management across a product`s lifecycle
Risk management and monitoring effectiveness of risk minimalisation
Latest innovation and trends in drug safety
Big data & Pharmacovigilance
Panel discussion on impact on drug development and approval
Speakers
Dr. Magnus Nord

Senior Safety Medical Director, Patient Safety RIA/I/V

AstraZeneca

Dr. Heike Schoepper

Head of Global Drug Safety Regions

Merck Serono

Saad Shakir

Director

Drug Safety Research Unit

Annual

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