IAPO attends International Conference of Drug Regulatory Authorities

Wednesday, 3 September 2014

IAPO Governing Board member Eva Maria Ruiz de Castilla attended the 16th International Conference of Drug Regulatory Authorities in Rio de Janeiro, Brazil in August 2014, and a pre-conference on 'Ensuring Quality and Safety of Biosimilars for Patients Worldwide'.


Eva Maria spoke during a plenary session at the pre-conference on 'Access to medicines and the impact of biosimilars on markets'.

The pre-conference was a forum open to drug regulators, pharmaceutical industry, academia, NGOs and international organizations. It was useful for sharing the technical details of biosimilar regulation across different industries.

Eva Maria spoke on behalf of patients and emphasised the following:

  • It is vital to ensure that all biological and biosimilar medicines are high-quality, safe and efficacious
  • Patients need to be informed of any changes made to their treatment regimes 
  • Patients need to ensure that when they are prescribed a biological or biosimilar medicine they know the brand name and where to find the batch number  
  • Robust pharmacovigilance systems and adverse event monitoring is key to ensuring patient safety 
  • Education is essential – patients need to know how and where to report adverse effects and doctors need to ensure adverse effects are reported.

Read the full intervention.

IAPO has recently published a Toolkit on Biological and Biosimilar Medicines, which is full of useful information on the topic.

The main conference was hosted by the Brazilian Health Surveillance Agency (ANVISA) and the Ministry of Health.