Kurse Gesundheit und Gesundheit-Pflege in Freiburg im Breisgau

The unique seminar programme provides with ten seminars key education in the biopharmaceutical-related regulatory affairs. It provides specialised degree and is available for the first time in Europe. Regulatory Affairs Manager Most future Regulatory Affairs Professionals hold a Master degree in biology, pharmacy...

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...

Regulatory procedures for clinical trial applications, marketing authorisations, variations in the EU, USA, Japan, Switzerland and China Regulatory Affairs Manager The programme is for individuals who are about to start a career in regulatory affairs or who want to continue their training in...

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...

Pharmaceutical development of biopharmaceuticals and particulars of the CMC dossier Regulatory Affairs Manager The programme is for individuals who are about to start a career in regulatory affairs or who want to continue their training in this special field.

Non-clinical and clinical development of biopharmaceuticals including biosimilars and the Module 4 and 5 requirements Regulatory Affairs Manager The programme is for individuals who are about to start a career in regulatory affairs or who want to continue their training in this special...

Specific considerations for the development and authorizations of medicinal products for children Regulatory Affairs Manager The programme is for individuals who are about to start a career in regulatory affairs or who want to continue their training in this special field.

Pharmacovigilance – Post-authorisation surveillance standards to meet regulatory requirements for product safety Regulatory Affairs Manager The programme is for individuals who are about to start a career in regulatory affairs or who want to continue their training in this special field.

The roles of the supervising authorities and the essential characteristics of quality systems Regulatory Affairs Manager The programme is for individuals who are about to start a career in regulatory affairs or who want to continue their training in this special field. ...

Scientific advice, regulatory strategy and health technology assessment Regulatory Affairs Manager The programme is for individuals who are about to start a career in regulatory affairs or who want to continue their training in this special field.

Good regulatory affairs practice: communication skills, project management and tools for the daily practise Regulatory Affairs Manager The programme is for individuals who are about to start a career in regulatory affairs or who want to continue their training in this special field....