EUCRAF Ltd.
The European Centre for Regulatory Affairs Freiburg (EUCRAF) provides the opportunity of a specialized education in the area of biopharmaceutical-related regulatory affairs. It offers seminars and a unique postgraduate Master Programme on biopharmaceutical-related regulatory affairs.
The programme has been developed by distinguished experts from authorities, universities and companies.
Unsere Kurse
Besondere Kurse
POSTGRADUATE MASTER - Regulatory Affairs for Biopharmaceuticals
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...
16.300 €
Seminar 1: European pharmaceutical regulatory environment
The subject area regulatory affairs ensures that the quality, safety and efficacy of the medicinal product is in line with legal requirements for the purpose of marketing safe and efficacious medicinal products solely in the interests of public health. Regulatory affairs is primarily a specialty of the pharmaceutical industry. The function...
2.800 €
Seminar 2:Clinical trial appl.,marketing authorisation,variations
Seminar 2 provides in-depth knowledge on the procedures for marketing authorization applications, clinical trial authorisations and variations in the EU, USA, Japan, Switzerland and China. These regions are the most important markets for pharmaceutical products and the appropriate agencies such as the European national agencies, the EMA, the FDA and the...
2.800 €
Seminar 3:Registration of blood products, vaccines and ATMPs
Three unique product classes are introduced with respect to their regulation, the essential requirements for their development, their unique characteristics. Blood products stand for classical biologicals as they are manufactured from a biological source, i.e. human plasma. Their use is still required for many life-threatening and chronic diseases despite the progress...
2.100 €
Seminar 4.1: Development of biopharmaceuticals and CMC dossier
Biopharmaceuticals are special since they stem from a biological source, or the protein structure is transcribed from genetic information and is expressed by a living cell. They are usually complex and large and the quality is determined by the manufacturing process, where consistency and stability need particular attention. This has implications...
2.800 €
Seminar 4.2:Non-clin.&clinical development of biopharmaceuticals
Biopharmaceuticals play an important role in the pharmaceutical industry since they deliver an increasing number of candidates for new product developments. They are however special and require certain considerations in their pre-clinical and clinical development. They are pleiotrop and immunogenic and their non-clinical pharmacodynamic and safety characterisation is often hampered by...
2.800 €
Seminar 5: Paediatrics
The new legislation on the development and authorization of medicines for use in children aged 0
1.400 €
Seminar 6: Pharmacovigilance
Pharmacovigilance, i.e. the standard of constant monitoring of the safety of medicinal products after authorisation, is an important obligation of the marketing authorisation holder (MAH) and authorities. It requires constant exchange between companies and authorities. The EU legislation requires MAHs to provide the competent authorities with a description of their pharmacovigilance...
1.400 €
Seminar 7: Supervising authorities & quality systems
Companies manufacturing, testing or distributing active ingredients or medicinal products, clinical centres conducting clinical trials and research organisations performing studies need to follow common standards of quality system requirements. The quality system is supervised by national inspectorates who increasingly co-operate globally. If the establishment inspected is found to be compliant with...
2.100 €
Seminar 8:Scientific advice,reg. strategy,health tech. assessment
According to the records of the EMA, constantly 25% of newly developed medicinal products submitted to the centralised authorisation procedure in Europe fail. This high failure rate is remarkable taking into account all the efforts installed in Europe within the 15 years from the time the EMA had been inaugurated. Numerous...
2.100 €