Juraj Sestak

• Responsible Person for Wholesale Distribution in Germany according to §52 Abs. 2 Nr. 3 AMG and §2 (1) HandelsV • Develops, improves and maintains Quality Management System • Manages quality incidents (deviations, observations, findings) and CAPAs • Controls and approves labels in accordance with AMG, AMWHV and FMVO • Information Officer Substitute (“Informationsbeauftragter” accord. to §74a AMG) • Internal Data Protection Coordinator (Regulation (EU) 2016/679 (EU GDPR))

Leads the planning and maintenance of drug supply study plans • Creates the packaging design • Manages the randomization, packaging, labeling and distribution of clinical supplies • Leads interactions with third party CROs / CMOs • Manages the procurement, labeling and distribution of reference/comparator products • IRT - develops the specification • Actively engages during inspections and audits • Plans and manages costs utilization, performs and oversee the budget planning

• Provides support to drug supply activities and interface with clinical team, CRO and any other internal or external partners in the operational study conduct • Performs invoice and budget tracking management for clinical studies • Tracks and coordinates the evaluation of temperature excursions in clinical trials • Tracks and process contracts, work orders and other key trial documentation • Coordinates and leads subprojects related to process improvement initiatives

Mein Verantwortungsbereich war ziemlich breit – von der Erstellung und Einreichung von Studiendokumenten an Ethikkommissionen und das Gesundheitsbehörde, durch die Koordinierung der