Dr. Silja von Graberg

expecting

Independent editing and coordination of regulatory documents, activities, and internal approval procedures for - clinical trial applications - applications for marketing authorisations - deficiency letters with regard to pharmaceutical quality (module 3) for high-potent oral solid drug products. Set-up, optimization, and maintenance of compliance management structures for regulatory documentation concerning Corden Pharma GmbH, including appropriate administration and archiving.

Independent work on drug regulatory affairs projects: variations (national / EU), dossier update, drug substance part (32S), establishement of standard working procedures, establishemtn of life cycle management

dossier section review for registration and renewal, regulatory compliance, change control (drug regulatory aspects), management of regulatory projects

Head of laboratory in research and development for transdermal patches and oral thin films pharmaceutical formulation development, process development, process scale-up, process demonstration / qualification and process validation, wrinting of CTD-dossier / CMC parts 32P3, 32P4, 32P5, 32P7 trouble shooting for established products: manufacturing process optimization, investigations, start of change control procedure

PhD student thesis paper on heat and mass transfer in non-typical containers for freeze drying lyophilisation teaching students in pharmaceutical technology: powders, granulation, tabletting, coating, quality control testing

Cooperation between Department of Pharmaceutics in Erlangen and Miltenyi Biotec: Formulation development for active substance manufactured by Miltenyi Biotec. Process development for Miltenyi Biotec. Freeze dryer qualification for Miltenyi Biotec. standard operating procedure establishment for formulationa and freeze drying process development

Pharmacist in public pharmacy: distribution of drugs on prescription, counseling interviews with patients, merchandise management, delivery to retirement home, establishemtn of QA system (ISO 9001)

freeze drying from non-typical containers, heat and mass transfer studies, guideline for freeze drying process design in non-typical containers

Freeze Drying, Lyophilization, Heat and Mass Transfer, non-typical container systems for freeze-drying, cycle optimization, OQ http://www.freeze-drying.eu/index.html

letzte 2 Semester im Hauptstudium

Grundstudium Hauptstudium bis inkl. 6. Semester Auslandsaufenthalt (Paris XI in Chatenay-Malabry)