Annual Pharmacovigilance & Risk Management Strategies Summit
05-06

February 2015

Germany

Berlin

Hilton Berlin

Mohrenstraße 30, 10117

About

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 drugs safety and efficacy.

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Who Should Attend

Professionals with intermediate to advanced knowledge of, and experience in, clinical safety and who are involved in:

  • Pharmacovigilance
  • Risk Management
  • Regulatory affairs
  • Data analysis
  • Medical information
  • Drug Safety
  • Medical product safety assessment
  • Clinical research
  • Pharmacoepidemiology
  • Health outcomes

It is also designed for professionals who work for:

  • Industry: pharmaceuticals and biologics
  • Academic Research Centers
  • Clinical Research Organizations
  • Regulatory Agencies
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. Frank Schippers

Global Safety Evaluation

Boehringer Ingelheim GmbH

Dr. Magnus Nord

Safety Medical Director

AstraZeneca

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