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Current Challenges and Future Developments for Drug Safety in Emerging Markets


Drug safety has never been more important. Patient's attitudes to risk have changed significantly and negative perceptions of a product can have devastating effects on the reputation of the developer.

Regulatory hurdles and rule changes on risk management have also increased the pressures on drug developers to ensure sound pharmacovigilance processes are in place.

Presented by Dr. Monica Rusu Director, Pharmacovigilance EELA, Abbott Products GmbH, at IQPC's Pharmacovigilance and Risk Management Strategies in June 2010.

Rusu discusses:

  • The local regulatory environment and expectations of competent authorities
  • Developing risk management plans to conform to differen regulatory standards
  • Challenges for the global PV systems
  • Identifying commonalities across the emerging markets for a more standardised approach to risk management

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