Services: Biopharmaceuticals are special and require a special know-how during their development and during all the necessary milestones towards successful regulatory approval. EUCRAF has been founded by Dr. Gabriele Schäffner-Dallmann, an internationally renowned biotech expert, formerly in charge of approval of antibody-containing products at the German authority, the Paul-Ehrlich-Institut, in order to offer a development, regulatory affairs and business-related programme relevant for therapeutic proteins and ATMPs. The programme has been established with renowned experts from pharma companies, authorities, academic institutions and is accompanied by a scientific course committee. It is an English-speaking programme as attendees and speakers are international. The speakers are all experts in their special field providing first-hand experience and interactive seminars. Regular elements of the programme: • European pharmaceutical regulatory environment • Regulatory procedures in the EU, USA, Japan, Switzerland and China for - clinical trial applications - marketing authorisations - variations • Registration of blood products, vaccines and ATMPs • Pharmaceutical development of biopharmaceuticals and particulars of the CMC dossier • Non-clinical and clinical development of biopharmaceuticals including biosimilars • Requirements for the development and authorizations of medicinal products for children • Pharmacovigilance – Post-authorisation surveillance standards • The roles of the supervising authorities and the essential characteristics of quality systems • Scientific advice, regulatory strategy and health technology assessment • Good regulatory affairs practice: communication skills, project management and tools for the daily practice Specific topics of current interest are also offered in one-day intensive coaching events in small groups, in 2-day workshops and via webinars. In addition, specific in-house training is offered to combine training with in-house project-related discussion. Our annual conference is the go-to-event for networking, as attendees get the latest news in the biopharmaceuticals regulatory environment.

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