EUCRAF provides the opportunity of a specialized education in the area of biopharmaceutical-related regulatory affairs.
The subject area Regulatory Affairs ensures that the proof of the quality, safety and efficacy of the medicinal product is demonstrated to be in line with legal requirements for the purposes of marketing safe and efficacious medicinal products solely in the interests of public health.
The unique seminar programme "Regulatory Affairs for Biopharmaceuticals including ATMPs" provides with ten seminars key education in the biopharmaceutical-related regulatory affairs. This seminar programme also allowing to receive a specialised degree based on the attendance of the whole course is available for the first time in Europe.
It meets the requirements of the pharmaceutical industry and of the agencies regulating medicinal products, in particular biopharmaceuticals and advanced therapy medicinal products (ATMPs). It focuses on biopharmaceutical-related regulatory affairs relevant for European procedures but also offers knowledge on regulations and procedures valid outside the EU.