Peter Sedlacek

Heading Quality Managment at Clinical R&D. Development and implementation of quality strategies to ensure continuing quality compliance at global clinical R&D Management of the audit program and of regulatory inspections

• Development and maintenance of the quality systems in clinical R&D • Management of clinical R&D training program • Performance of clinical study audits • Management of regulatory inspections • Management and qualification of contractors

• Regulatory Product Owner for vaccines and biologics • Development of regulatory strategies for clinical development programs • Management of regulatory submissions in US and Europe • Preparation of paediatric investigation programs

• Quality representative for clinical development programs • Establishment of clinical development programs, quality review and approval of CTA´s • Quality Representative for development of paediatric investigation programs • Life Cycle Management and Licensing Support Management for vaccines and biologics

Team lead of inter-facility team to establish Quality units at new plants and develop quality strategies supporting product development and licensing procedure Development of quality strategies for product development and licensing procedure Establishing of release specifications for clinical and licensed products Implementation of Design Control as an interface between R&D, Process Development, Preclinical and Clinical Manufacturing and the Project Portfolio Management Group.

• Head of Virological and Bacteriological Quality Control Laboratories (GMP) • Release of quality control test results • Responsible for GMP compliance and improvement • Training of lab technicians regarding GMP and method validation • Responsible for animal welfare (Tierversuchsleiter) according local legislation (NÖ-Tierversuchsgesetz) • Performance of internal quality audits according GxP; participation on regulatory inspections

• Perform quality control tests (biological tests) • Development, optimization and validation of QC tests and methods • Improvement of GxP status of QC laboratories

Participation in clinical research projects regarding - Immunopathology of renal insufficiency and haemodialysis - Lipidmetabolism and LDL-apheresis

• Preparation and performance of blood donation service • Preparation of blood and plasma samples

Training for professionals in Pharmacovigilance

Master Thesis: Veröffentlichung der Ergebnisse von klinischen Studien - regulatorische Änderungen im Spannungsfeld zwischen wissenschaftlichen, ethischen und kommerziellen Anforderungen; Master Thesis, JKU Linz, 2016

Training for Professionals in Drug Regulatory Affairs

Quality Manager and Certified Quality Auditor according EN ISO 9000