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These seminars take place within the framework of the Cuba-European Union Expertise Exchange II programme and will also cover the evaluation of medicines
In order to provide this training, the European Union funded and FIIAPP-managed Cuba-European Union Expertise Exchange II programme has signed an agreement with the Carlos III University Foundation which will be responsible for giving these seminars in Havana.
This activity comprises five seminars focused on different topics such as statistical methods applied to clinical research, clinical trials and post-marketing surveillance, regulation in Europe, pharmacoeconomic evaluation and the transferability of the results.
Of the five workshops, one has already taken place. At this workshop, the participants got the chance to acquire knowledge of statistics applied to clinical trials and became familiar with new, practical and user–friendly software for use in their daily work.
The second of these courses will be held soon, it will discuss the most relevant aspects of European legislation for the development, authorisation and post-marketing monitoring of medicines for human use, with special focus on medicines of biological origin, including biosimilar drugs.
The accelerated development of pharmacoeconomics represents a challenge for drug developers and has an increasing impact on regulators and Ministries of Health. The Cuban biopharmaceutical industry needs to specialise in the matter and the Cuba-EU Expertise Exchange programme is supporting it in this process.