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The structure and format of applications to be submitted to regulatory authorities in the USA, Europe, and Japan has been defined within the International Conference on Harmonisation (ICH).
Administering an investigational drug to humans is subject to prior approval from regulatory authorities.
Marketing Authorization Holders are responsible for monitoring the safety of products placed on the market.
The quality of medicines and healthcare products in Europe is harmonized through different initiatives under the supervision of the European Council.
Patients invited to participate in a clinical trial (=subjects), and/or in specific circumstances their legally designated representative(s), shall be fully informed about the clinical trial in ord
Patients, and/or in specific circumstances their legally designated representative(s), are requested to give written consent before participating in a clinical trial.