CQA Consultant of HVCC, Hilversum, the Netherlands. Coaching of auditors on various levels is an on-going activity.

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1 CURRICULUM VITAE Name : Vlaskamp First name : Johanna Maria (Hanny) Title : BSc. Address : Vuurvlindermeent GZ Hilversum The Netherlands Phone : +31 (0) (mobile) Nationality : Dutch EDUCATION HBS-B, Christelijk Lyceum, Dordrecht Analytical Chemistry, Junior Laboratory Technician, Amsterdam Biochemistry, BSc, Free University, Amsterdam 1995 Certified Lead Assessor ISO 9000, BMIQA, London, UK CAREER 2015-today CQA Consultant of HVCC, Hilversum, the Netherlands During the circumnavigation, which started in June 2015, a number of audits have been conducted in Europe and Canada, including CROs and study sites. Coaching of auditors on various levels is an on-going activity Director of Hanny Vlaskamp Consulting & Coaching, Hilversum, the Netherlands Current activities covered the set-up of Quality Systems for Pharma and Biotech companies, as well as Research Hospitals, providing GxP training, auditing of CROs, providing support in streamlining Pharmacovigilance processes. Projects included: Revising an in-house quality system within a Research Hospital( this took > 2 years) System Audits, CRO selection audits and Study/Site/For Cause Audits were conducted for various companies in Europe; audit sites were located world-wide. Support and advice leading to GCLP certification. Temporary replacement of QA Manager In-company GCP and GCLP training On-the-job training of auditors Coaching of independent Quality Management Consultants Evaluation and improvement of Pharmacovigilance processes CV, version / 6

2 Improvement of Quality Management Systems and audit planning for various companies (including a software development company). General activities include consulting for Regional and Global Healthcare and Biotech Companies, covering Process Management, Quality Management, Regulatory Advice and Support for GXP, Supplier Audits and International Study Audits Director Process Improvement, Astellas Pharma Europe, Leiderdorp, the Netherlands Main responsibilities at the start included the harmonization of the SOP systems of both legacy companies from which Astellas Pharma Europe was formed. Within 6 months after employment, all R&D business processes were mapped and the harmonized processes were documented in a SOP system, which was made accessible through Intranet. All R&D employees from HQ and the affiliates were trained within 2 months. Next to that an R&D training function was implemented, covering regulatory and function related training needs. A training management system, including documentation and coordination, was established and resulted in qualified staff with documented evidence of their training. A training database was installed. Process Improvement projects (e.g. for Medical Writing, Due Diligence and in-process QC) were initiated to improve the business processes in R&D. This included the assessment of current and required processes. The analysed data was used to define the improvements, which were implemented and controlled. Support to Trans-Atlantic and Global projects was provided. A Global taskforce was chaired successfully. An improvement project on clinical study management for in-house and outsourced clinical studies was initiated June 2005 QA Manager IATEC BV, Amsterdam, The Netherlands Next to working as independent QA consultant, a part time contract was established with IATEC, CRO and Scientific Centre for clinical research studies in the field of HIV and AIDs. Main aim was to professionalize the Quality System of IATEC and to advise in the conduct of clinical research studies, including Phase I studies in compliance with regulatory requirements for Europe, Africa, South America and South-East Asia June 2005 Director Quality Management, HVQM, Hoorn, The Netherlands. Activities included internal review of Quality Systems and assistance in improvement projects for medium-sized CRO s. Training on the EU Clinical Trial Directive requirements was provided to various organisations. Worldwide systems audits of CRO s, Phase I Units and Contract Laboratories were conducted on request of global pharmaceutical companies. CV, version / 6

3 Ongoing consultancy contracts were in place with 2 international pharmaceutical companies and a medical device CRO. Audits were conducted in Europe, US, Australia, Singapore. A large independent audit was conducted in Eastern and Western Europe, requested by the EMEA for a registration study conducted by a top-ten pharmaceutical company. This audit included the sponsor office, CRO offices in several countries, central laboratory, data management at the CRO and the sponsor and 10 site audits. A Data Quality Audit was conducted on request of the FDA for a US medical device company. Round table meetings for CRAs were organised, to discuss the practical implications of ICH GCP, local regulations and the Clinical Trials Directive July 2002 Director Quality Management of IQM Healthcare B.V., Volendam, The Netherlands As a consultant to the pharmaceutical industry, the various contracts included setting up quality systems, management of quality improvement projects, systems audits at CRO s, Phase I units, Central laboratories and local affiliates, as well as study audits in many European countries including Russia, Poland, Czech Republic and Hungary. In addition in-company training was provided on ICH GCP, local law (WMO) and company SOPs to CRO s and international pharmaceutical companies. Apart from GCP projects, also GLP and GMP activities were performed Clinical QA coordinator at Yamanouchi Europe B.V., Leiderdorp, the Netherlands This function included the development and implementation of a Quality Assurance System for clinical research conducted at headquarters and the local affiliates. This also included the internal Phase I unit, which was located next to the headquarters in Leiderdorp. Full responsibility for planning and budget were covered. The harmonisation of QA systems of the European offices with the US and Tokyo offices of Yamanouchi headquarters was initiated. In this respect, the ICH3 conference in Yokohama was attended. Selection audits of CROs, Phase I units and Central Laboratories were conducted in order to create a list of preferred providers for Yamanouchi Europe. Annual training on GCP and SOPs was provided to monitors of all affiliates. A GCP representative team was installed in which all affiliates and headquarters were represented. The team discussed new authority requirements, interpretation of ICH GCP and audit findings in relation to SOPs and GCP. Participation in a taskforce of the Faster Time to Market project included active involvement in the implementation of a new organisational structure. CV, version / 6

4 International Clinical Trials Manager at Solvay Duphar Europe, Weesp, the Netherlands The set-up and conduct of a phase IIIb/IV programme for a major product was managed. Intensive training of all local monitoring staff and careful selection of CROs involved in this program resulted in compliance with GCP.Project team member for Solvay Duphar International, Amsterdam, the Netherlands A special task force of Solvay Duphar's global clinical research group compiled a Safety Dossier for a major product. This Safety dossier was submitted to the FDA. As member of the taskforce extensive project management and Quality Assurance audits were performed Project team member for Solvay Duphar International, Amsterdam, the Netherlands A special task force of Solvay Duphar's global clinical research group compiled a Safety Dossier for a major product. This Safety dossier was submitted to the FDA. As member of the taskforce extensive project management and Quality Assurance audits were performed CRA and SCRA at Solvay Duphar Europe, Weesp, the Netherlands Main task was the monitoring of international phase I, II and III studies. In addition the development of GCP SOPs was managed, which included many workshops with clinical research staff Data manager at Duphar Europe, Weesp, the Netherlands The study data of clinical trials were monitored and prepared for data handling. The involvement in improvement of this process has been of great value for future positions These years were devoted to raising two children Biochemical Research Assistant at the Free University, Amsterdam, the Netherlands As assistant to the professor, research studies with ribosomal proteins were carried out Junior Laboratory Assistant at Philips Duphar, Weesp, the Netherlands Microbiological analyses of vitamins in drugs and human serum were performed at the Biochemical Research Department. Membership: DIA (Drug Information Association), EFGCP (European Forum for Good Clinical Practice), Audit working party, DARQA (Dutch Association for Quality Assurance), BARQA (British association for Quality assurance), ACRP (Association of Clinical research Professionals), Institute of Clinical Research UK CV, version / 6

5 Special skills: Fluent in English and German Workable knowledge of French MS- Office (Word, PowerPoint, Excel, Outlook) General skills: Excellent trainer Good communication skills Flexible and Creative Efficient and effective worker Loyal team worker Excellent organiser Hobbies: Sailing (single-handed) Travelling Swimming, Skiing, Hiking CV, version / 6

6 Recent Courses and Symposia: GCLP in-company training (presenter) DARQA meetings, GCP basic and advanced in-company training (presenter) BARQA, GCP Auditing Principles and Practices, Cambridge, UK, BARQA, Annual Conference, Brighton, UK,DARQA, GMP meeting on Clinical Trial Supplies, Amsterdam, NL Clinical Trial Governance and Quality Assurance Marcus Evans Amsterdam, NL Clinical Trials in India Advanstar, UK - Change Management, Intermediar, Harry van Velthoven - Naarden Advanced GCP, Institute for Clinical Research- Efficient SOP Writing RCWG, UK PowerPoint & Excel, Broekhuis Training Group Global QA Congress, Orlando, USA, Session Chairman and Abstract Reviewer Process Improvement, Laura Brown In-company EU-CTD between the lines, the practical implication,sfg Speaker at a DARQA workshop on Quality Systems at CRO s Speaker at the annual NVFG meeting in the Netherlands, comparing quality in the Aviation Industry with Quality in the Pharmaceutical Industry. Speaker at the annual ACRP congress in Budapest, on Audits and Inspections of Clinical Programmes. Speaker at the ExpoPharma congress in Barcelona on Audits and Inspections ACRP meetings on Source Data (speaker), investigator initiated studies ACRP annual meeting, Amsterdam Validation of computerised systems, DARQA, Amsterdam DARQA meetings on Working with CROs and Quality in Clinical Research Training on a sponsor s quality system, audit management and reporting system ACRP meetings on SMOs, Clinical Trial Directive and experience with WMO Computer validation course, DARQA, Bilthoven 12th DIA Euro meeting, Nice, France Best Pharmaceutical Practices, DIA, Lisbon, Portugal Training on GLP auditing, Farma Research, Nijmegen. ACRP meetings on WMO and Personal Data Protection CV, version / 6