We spoke to Pedro Lima, Director, Global Patient Safety & Risk Management, Genzyme Latin America, during the run up to our World Drug Safety Americas Congress 2013, regarding his thoughts on the current key challenges in drug safety, below are his thoughts.
What do you see as the biggest benefit to patient safety stemming from the new EU legislation. When will we start to see this?
Transparency, with the inclusion of their participation on decisions and the need for efficiency data, with PBRERÂ improving benefit/risk evaluation.
What has been the biggest challenge in implementing the changes in the wider global market?
The need to coordinate with regulators outside ICH region their acceptance for the change in formats/documents. Currently, there should be a Global involvement in PV topics, inviting all countries to participate, even if they are no ICH region. IN fact, ICH region should be reviewed and amplified.
What are the key success factors to an effective signal detection strategy?
-Â When designing your strategy, involve representatives from the multiple entry channels of data, including affiliates.
-Â Periodic (12-18 months) re-evaluation of strategy, reviewing signals detected, their processing and outcome.
If you are interested in further discussion on the above topics then you might like to attend our World Drug Safety Congress Europe 2013 which takes place 10 – 12 September in London, UK. Download a copy of the brochure here.