Timo Kretzschmar. Inspector. Head of Quality Assurance. Sales (mobile devices) Sales Manager. Freelancer. Curriculum vitae PERSONAL INFORMATION

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1 Curriculum vitae PERSONAL INFORMATION Timo Kretzschmar WORK EXPERIENCE September 2016 Present Inspector BASG - Bundesamt für Sicherheit im Gesundheitswesen (Austria) Inspections in the field of GLP and Bioequivalence as well as inspections on GxP relevant computerised systems (Trainee program) at AGES Medicines and Medical Devices Agency, in behalf of BASG (Austrian Federal Office for Safety in Health Care) April 2003 August 2016 Head of Quality Assurance pharm-analyt Labor GmbH (Austria) GxP in an (bio-)analytical service provider (CRO) o QA programme based on GLP and GMP regulations o Legal compliance with appropriate regulations o Regulatory affairs concerning GxP and pharmaceutical processes / systems o Internal auditing / self inspections o External vendor auditing o Training of the staff on QA / GxP matters o Management of demand documents like SOPs (review and revisions) o Management of on-site audits conducted by authorities and sponsors o Management of corrective and preventive actions (CAPAs) o Supervision of and support to (assessment of) validation / qualification processes of IT systems and other technical equipment as well as facility o Definition and execution of regulative processes and systems o Cooperation with Management, IT and project managers (like GLP study directors) o Cooperation with sponsors and external QAs in multisite studies / projects o Participation as QA auditor in clinical studies (to observe sampling as interface to analytical part), if pharm-analyt was involved o Management review concerning deviations and CAPAs o Member of the internal LIMS project team ( ) and steering group ( ) June 2001 February 2003 Sales (mobile devices) Thermo Electron Austria (Austria) o Responsible for sales / technical marketing of OE (optical emission) and XRF/XRD (X-ray fluorescence/diffraction) spectrometers (brand ARL mainly) in Austria and partly CEE o Officer for dangerous goods + radiation protection o Intensive training in English language because English was the corporate language February 2001 April 2001 Sales Manager Cool Structures Production & Sales GmbH (Austria) o Responsible for preparation of product launch of computer CPU (and similar) cooling equipment o Responsible for business plan January 1999 February 2001 Freelancer Esolution (freelance work) (Austria) o Trade agency for chemical, environmental and safety products (selling of industrial cleaning 24/9/16 European Union, Page 1 / 5

products for specific purposes) o Engineering office for technical chemistry (consultant in the field of environmental and safety technology, also preparation of case studies etc.

Since end of 1993 main concerns in the field of major hazard accident protection ( Seveso ), but also in the field legal compliance of industrial sites o Consultant in the field of environmental /

2 products for specific purposes) o Engineering office for technical chemistry (consultant in the field of environmental and safety technology, also preparation of case studies etc.) September 1993 December 1998 Head of division Environment/Energy/Traffic TÜV Austria (Austria) o In 1993 starting with environmental measurements in the Institute for Environmental Technology o Since end of 1993 main concerns in the field of major hazard accident protection ( Seveso ), but also in the field legal compliance of industrial sites o Consultant in the field of environmental / industrial safety technology / management o Holding lectures / training courses for safety specialists on safety management for TÜV Austria Academy o Since January 1996 head of (new) division Environment/Energy/Traffic, responsible for 35 employees, department budget, sales, project management o Responsible person for accreditation of the environmental part of the devision as test and inspection body based on ISO EDUCATION AND TRAINING September 1995 June 1996 Special Course for Employees on Quality Management and Quality Technique TGM (technical college) Vienna (Austria) o Quality Management (QM Systems, Quality Controling, TQM (with assessment for TQM systems), Audit Methods, Laboratory "Realisation of QM" [inclusive project management, staff management in QM, tools of QM, documentation of QM systems, computer based QM (CAQ), performance of audits, testing/calibration, certification, accreditation (new appoach of EU, CE marking), use of measurement and test/monitoring devices], modern tools of QM: FMEA, POKA-YOKE, KAIZEN, corrective and preventive strategies) o Quality Technique (Technical Statistics, Random Test Systems, Statistical Process Control (SPC), Statistical Methods of Reliability Management, Statistical Test Methods, Industrial Trial Methods, Laboratory Measurement-Technological Projects, corrective and preventiv strategies) o Quality Technique (QII) examination (introduction of statistical methods in QA, random test systems, statistical process control - SPC I, evaluation methods, reliability tests) with DGQ, March 30, 1996, Leipzig September 1991 August 1993 Dr. techn. Technical University Graz (Austria) Doctorate program in technical chemistry at the Institute for Chemical Technology of Organic Materials. Subject: "Investigations on the explanation of the rubber-metal bonding". September 1986 August 1991 Graduate Chemist (Diplomchemiker) Technical University Leuna-Merseburg (Germany) September August 1991: Master program in macromolecular chemistry Subject: "Permeation - Flow Analysis on Polymer Networks". Title "Diplomchemiker" was accredited in Austria in 1993: Diplomingenieur. September 1986 August 1990: Certificate programme in bases of chemistry and process chemistry (included: February May 1990 industrial placement at BUNA-Werke AG Schkopau near Halle/Saale, Germany. Subject: Optimisation of synthetic latex products). 24/9/16 European Union, Page 2 / 5

3 ADDITIONAL INFORMATION Expertise Publications o GLP in Austria, T. Kretzschmar pharm-analyt Labor GmbH, DGGF News News of the Society of Good Research Practice (DGGF e.v.), Issue No. 48, October 2007 Projects Memberships Memberships: o German Society for Good Research Practice, member no. 589, since 10/2004 o Society of Austrian Chemists (GÖCH) since 11/2000 o Society of German Chemists (GDCh) since 1990 Own Presentations / Trainings, partly combined with participations: o Inhouse GLP training at FINI Institute of Neurointervention at Paracelsus Medical University (PMU) Salzburg at SALK (Salzburger Landeskliniken), Salzburg, 22 April 2016 o Keeping Conformity and Compliance to Analytical Part of GLP / GCP in Borderline Cases QA Experience in a Bioanalytical CRO (Stream GLP, Session 4), Ulm, 25 Sept. 2015, Int. Meeting 2015 o IIR Forum Pharma: The Validation of Computer Based Systems, Lecture on 19 March 2015: Field Report on Electronic Archiving as exercised by a GLP compliant Laboratory, Schlosspark Mauerbach near Vienna, March 2015 o Effective and Dynamic Management of Documents and Documentations: a Report from Practice, lecture in the General Conference Laboratory Optimising in behalf of Concept Heidelberg at PharmaLab 2014 Analytics, Bioanalytics and Microbiology Congress & Exhibition, 19 November 2014, Swissôtel Düsseldorf/Neuss o Documentation on Sample Preparation for Analysis How Deep is Necessary and How Deep is Meaningful? Is there Rising a New Area of Conflicts between Laboratory and Authority? (Stream C: Analytics / Information Technology Analytic Session), Magdeburg, 19 Sept. 2014, Int. Meeting 2014 o Understanding GLP for Inspection Readiness, 1 day in house training at an UK Healthcare Company in behalf of pti (Pharmaceutical Training International) London, London, 12 August 2014 o Generation of user requirements specifications to establish a tailored GxP compliant LIMS for a typical bioanalytical CRO Highlights and pitfalls (Stream D: Information Technology), Bonn, 26 Sept. 2013, 1st European QA Conference o GLP training at Institute of Dermatopathology Hannover (Dr. med. Rolf Rüdiger Meliß), Hannover, 27 May 2013 o IIR Clean Room & Laboratory Forum 2013: Quality Enhancement in Analytical and Pharmaceutical Laboratories, Ehat amounts to a successful Laboratory?, Vienna, 12 March 2013, 3 lectures hold and chairman (Laboratory Forum) o Infancy problems regarding implementation of EM(E)A Guideline on bioanalytical method validation (GLP Analytics) and CAPA for SME without getting lost in Preventions, with and groupware (GMP), both Dresden, 20 / 21 Sept. 2012, Int. Meeting 2012 o GMP Webinar Quality Assurance / Quality Control GMP meets GLP a practical approach (hold in German and English) at Concept Heidelberg, Heidelberg, 23 April 2012 o IIR Clean Room and Laboratory Forum 2012: Compliance by Laboratory Automation More Overview, Quality and Safety, Vienna, March 2012, 4 lectures hold and chairman on the 2. day o FDA Claim 0 Re-Integration Concerning Chromatograms, Berlin, 22 Sept. 2011, Int. Meeting 2011 o In-house training Computer Validation (QA tasks), at GAT Microencapsulation AG, Ebenfurth / Lower Austria, 7 July 2011, on behalf of IIR Austria ( o Lectures (from QA background) Annex 11: Role and Responsibilities + Data Management 24/9/16 European Union, Page 3 / 5

4 Requirements + Access Protection, Audit Trail, Vienna, 27 June 2011, IIR Conference Computer Validation based on Annex 11 ( o Practice and Error Sources during Introduction of a Combined GLP/GMP QA System in a Pharmaceutical Laboratory, Königswinter, 08 April 2011, Meeting WG GMP of DGGF o Assay Validation, Königswinter, 23. Sept. 2010, Int. Meeting 2010 o Lecture within Practice forum GxP and on Method Validation under GLP and under GMP Analytics based on "Guidance for Industry - Bioanalytical Method Validation, FDA, May 2001" (and succeeding docs), EMEA-Draft Guideline on Validation of Bioanalytical Methods and ICH Q2 (R1), Vienna, 13 April 2010, IIR-Conference Quality Assurance in Analytical Laboratories ( o How much GxP needs a Laboratory?, Vienna, 15 Oct. 2009, Clean-Room Technology Day 2009 o e-archiving of Analysis Raw Data and official acceptance in the view of QA an Exercise Report, Dresden, 24 Sept. 2009, Int. Meeting 2009 o GMP in the Laboratory, Graz, 24 June 2009, European Lab Design Convention 2009 Conferences, Courses, Seminars etc. (as participant only, others see above) o January 29-31, 2013, Electronic GMP Systems Implementation Validation Maintenance, European Compliance Academy (ECA), Budapest / Hungary o September 26-28, 2007, Int. Meeting of DGGF 2007 (GLP stream), Darmstadt / Germany o November 7-8, 2006, Project Management in the Practice of Computer Validation, PTS Training Service, Wiesbaden / Germany o September 27-29, 2006, Int. Meeting of DGGF 2006 (GLP stream), Darmstadt / Germany o Mai 16, 2006, 6th DGGF Working Group Meeting Archiving, Biberach / Germany. o September 22-23, 2005, Int. Meeting of DGGF 2005 (GLP stream), Berlin / Germany o September 22-23, 2004, Int. Meeting of DGGF 2004 (GLP stream), Darmstadt / Germany o October 08-12, 2003, Seminar FDA Compliance in the Quality Assurance GMP Academy / Concept Heidelberg, Heidelberg Other Relevant Information Additional activities as lecturer (at universities), besides main employments: Since September 2016 University of Applied Sciences Campus Vienna, Vienna o Lectureship on QM (basics, basic GxP), course Molecular Biotechnology Since September 2012 at University of Applied Sciences Wiener Neustadt, Campus Tulln, Tulln/Danube o Lectureship on "QM Systems in Biotechnological und Pharmaceutical Industries", master course Biological Technologies (MBIO), content: mainly GMP, GCP, GLP and ISO accreditation. Since April 2012 at Postgraduate Center of the Vienna University, Vienna o Lectureship on the module "Applied Laboratory Practice (GLP)" within the University course "Pharmaceutical Quality Management" (education of qualified persons) Since autumn 2010 University for Applied Sciences Campus Vienna, Vienna o Mentoring of Bachelor theses, concerning GMP/GLP topics, in the course Molecular Biotechnology at University of Applied Sciences Joanneum, Graz o Guest-Lectureship on Basics of Polymer and Building Chemistry within the lectureship "Material Science 2" in the course Production Technology and Organisation Since 2009 (May / June) at Institute of Chemical Technology of Materials (ICTM), TU Graz, Graz o Guest-Lectureship on safety of industrial facilities / QRM, part of the course "Process Technology" Since November 2008 University for Applied Sciences Campus Vienna, Vienna o Lectureship on GLP/GMP (basics, validation / qualification, QRM), course Molecular Biotechnology and (only 2008) also course Bioengineering March-May 2005 University of Applied Sciences IMC Krems, Krems/Danube o Guest-Lectureship on Instrumental Chemical Analysis (held in English) within the Master Degree Programme Medical & Pharmaceutical Biotechnology December 2004 January 2005 Vienna University, Vienna 24/9/16 European Union, Page 4 / 5

5 o Guest-Lectureship on Processes in the pharm. Industry (QA part), VO , WS04, 2 h. April - June 2001 University of Applied Sciences Vienna, Vienna o Lectureship on Environm. Management, course Entrepreneurship for Medium Sized Companies. November and December 2000 College of Building, Vienna o Lectureship for building chemistry at the Department of Building Engineering and Management , each March May University of Applied Sciences Vienna, Vienna o Lectureship on Environmental Technology in the course Production Technique and Automation June 1997 and June 1998 at Institute of Chemical Technology of Organic Materials (ICTOS), TU Graz, Graz o Lectureship on Environmental Technology with Additional Aspects of Quality / Environmental Management Additional activities as consultant, besides main employments: January 2009 to June 2010 Trumpet GmbH, Vienna: o Responsible Person for REACH introduction o Concerning with REACH and GHS / CLP to establish the registration for crude oil products imported from outside EU January December 2006 at BioDiesel Technologies GmbH, Vienna: o Free Consultant for technical chemistry o Concerning with chemical part of construction of continuous biodiesel production units Other courses with Graduation o November 26-30, 2001, Radiation Protection Academy of Austrian Research Center Seibersdorf (ARCS), Seibersdorf, Training for Appointees for Radiation Protection (basis and special training for radiation equipment for non-medical purposes and encapsulated sources) - expired. o February 24, 2000, examination for licence of adviser of dangerous goods (ADR), Brunn / Gebirge - expired. o April 15, 1999, examination for concession to open an engineering office for technical chemistry, in St. Pölten at government of Lower Austria. Preparatory course for the examination on the concession to work as engineering office for technical chemistry, organised by Austrian Economic Chambers and performed in January and February /9/16 European Union, Page 5 / 5

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