Daniel Drogan

- Product registrations (with competent authorities) in Canada, China, Europe and USA,... - Medical Devices, Class I-II/Class A-C, Systems and Software - Regulatory Compliance and all linked Processes - Regulatory Product Documentation, Technical Documentation, Product Information File - Post-Market Surveillance - Representative person for Aesku.Group at VDGH (topic: China and USA)

Qualified advanced training in following topics: - monitoring of clinical studies (CRA) - pharmaceutical drug safety - medical devices regulation (i.e. in-vitro diagnostic (IVDR)) - quality management and risk management (QM) - drug registration/licensing (Regulatory Affairs) - product- and projectmanagement - economics, marketing

- Design and establishment of a control system and multiplexing-analysis in a microfluidic test system for POC-applications - Contribution to the establishment of testplans and -resports for product certification - Budget-Analysis for the manufacturing of molecular components - Coordination of cooperation partner (project lead) - Writing and detailing of project outlines to gain funding - Participation at meetings and processes related to regulatory affairs including clinical studies and CE-marking

Scientist in Development of Diagnostic Assays Development of monitor assays (IVD - Infectious Disease) across multiple functions, assay relevant submission documentation, working under quality requirements, write SOPs and/or lab procedures for instruments maintenance and procedures, responsible for training of new colleagues (mentorship), very good knowledge of DIN ISO 9001 & 13485 (QM) publication: https://tinyurl.com/yasdygd6 & https://tinyurl.com/y98d42b8

Scientist in Development of Diagnostic Assays Development of monitor assays (IVD - Infectious Disease) across multiple functions, assay relevant submission documentation, working under quality requirements, write SOPs and/or lab procedures for instruments maintenance and procedures, responsible for training of new colleagues (mentorship), very good knowledge of DIN ISO 9001 & 13485 (QM) publication: https://tinyurl.com/yasdygd6 & https://tinyurl.com/y98d42b8

In vitro population dynamics of HIV-1 drug resistant viruses in the absence and presence of drug publication: https://tinyurl.com/ydgd7ahb - Evaluation of kinetics in-vitro and comparing with in-vivo kinetics - Investigation of population dynamics in pre- and absence of two RTIs (3TC vs. FTC) - Identification of the increases of drug-resistant viruses depends on initial ratio of both virus variants (wildtype vs. drug-resistant virus)

Internship: research topic "Expression and Structure of LanpA" - LanpA and different mutants were grown in bacteria - Purified and analyzed by SDS-Page, co-immunorecipitation, Western Blot and mass spectrometry - Determining of structure with cross-linking experiments and X-Ray-Chromatography - Identification of monomeric, dimeric and trimeric forms of LanpA

Research herbicides proofing of protocols for testing procedures culturing and maintenace of tested plants application of substances to test evaluation of effect and impact of these substances on plants summarizing and graphical analysis of results writing of final data reports

Biology (e.g. Genetic, Microbiology, Biochemistry, Monoclonal Antibodies) Informatics (Programming, Databases, Models in Bioinformatics, Java, Parallel Programming with Java Threads)

Biology