Cengiz Tamak

Stufenplanbeauftragter according AMG §64a Informationsbeauftragter according AMG §74a EAA-QPP according IR (EU) No 520/2012

Generation & tracking of Periodic Benefit Risk Evaluation Report (PBRER) & Risk Management Plan (RMP). Preparing of Pharmacovigilance System Master File (PSMF). Review & negotiate Pharmacovigilance agreements. Searching & evaluation of literature cases. Providing of regular status & safety up-date reports. Training of internal & external staff. Communication with Agencies, National Competent Authorities & healthcare professionals. Transfer of incoming ICSRs & SmPCs to the EMA via WebTrader.

Planning, conducting and monitoring of human clinical trials in Europe. Approval and reporting procedures to national authorities, applications to ethics committees, preparation of study documents, inquiries Patient insurance, public clinical trials registry, SAE management and evaluation, Status reports to upper management, quality assurance and Pharmacovigilance.

MPG, GLP, GMP, ISO 9001, Project management, Product development of human in vitro diagnostics, Safety officer for medical devices (§ 30 MPG), Safety officer for genetic systems (S1 laboratories), CE marking and certification of in-vitro diagnostics, Participation in the preparation of patent applications, Planning and conduct of clinical trials.