Christina Dreher

• Global Regulatory Affairs Lead for multinational Phase II & III in clinical trials in EU countries • Accountable for CA and CEC strategy, submission and approvals • Client centered management concerning regulatory advice, strategy and documentation to receive CA and CEC approval and though hole project • Interface role between client and other internal functional area leads • Budget review of tasks within the regulatory area on contracted projects • Mentor

• Coordination, preparation and dispatch of initial, amendment, annual and EoT submission for clinical trials phase II - III to CA and EC in Germany and Switzerland according to local requirements • Management of the central/country level Informed Consent and any other documentation given to patients, ensure IP labels are in adherence to country requirements, Import requirements for Investigational Product • Interface role between GRAL, CTM and iHCRA

• Responsible for preparation and dispatch of initial, amendment and EoT submission of clinical trials phase II - III to CA, local RA and CEC/LEC in DACH Region • Ensure regulatory requirements and documents are available to activate a clinical trial sites • Submission of clinical trials to the Federal Office of Radiation Safety (Bundesamt für Strahlenschutz) and Federal Opium Agency (Bundesopiumstelle) in Germany

Charakterisierung des Tumorsuppressorproteins p53 im Merkelzellkarzinom

Neurobiologie, Humangenetik, Pharmabiologie, physiologische Chemie