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FORUM seminar: Quality Management in small Organizational Units

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FORUM seminar: Quality Management in small Organizational Units

SVPM will be speaker of the FORUM Seminar “Quality Management in Small Organizational Units” from 23.09. – 24.09.2019 in Mannheim.

Topics

Quality requirements according to ICH GCP and AMG
Development of a tailor-made QM system: Considerations on personnel, processes and interfaces
Case study – Planning a clinical trial: How to proceed step by step as a “start-up”?
Special feature of IITs: Different QM positioning necessary?

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Vakzine Projekt Management GmbH

Mellendorfer Str. 9
30625 Hannover
Deutschland

Phone: +49 511 - 169908 0
Fax: +49 511 - 169908 29
E-Mail: info@vakzine-manager.de

Contact Free First Consulting Session

Dr. Leander Grode
Phone: +49 511 16 99 08 19
E-Mail: bd@vakzine-manager.de

© 2022 Vakzine Projekt Management GmbH

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Dr. Sina Brückner

Senior Project Manager

Dr. Sina Brückner is Senior and Clinical Project Manager at Vakzine Projekt Management GmbH (VPM). She joined VPM as Project Manager.

Sina Brückner is experienced in organizing, coordinating and managing clinical trials (phases II-III) in Germany and Sub-Saharan Africa.

Key Knowledge Areas:

Infectious diseases
Clinical development
Scientific advices

Sina Brückner performed her doctoral studies at the Eberhart-Karls University Tübingen as well as at the Albert-Schweitzer Hospital in Lambaréné, Gabon. She investigated if an antihelminthic treatment has an effect on the vaccine immunogenicity in a population highly susceptible for geohelminth.

Dr. Christiane Meller

Director Quality Assurance

Dr. Christiane Meller is Director Quality Assurance at Vakzine Projekt Management GmbH (VPM).

Christiane Meller is experienced in planning and management of clinical trials within the EU regulatory framework (phases I-III). At VPM she is responsible for running the quality assurance. She consults companies in custom designing their quality management systems and acts as speaker with regard to current and future regulatory requirements.

Key Knowledge Areas:

Quality ManagementPatent
Good Clinical Practice
Teaching and Coaching

Christiane Meller studied biology and majored in molecular biology at the Ruprecht-Karls-University in Heidelberg.

Supported by a doctoral scholarship of the International Graduate College “Hannover Biomedical Research School” she accomplished her doctoral thesis at the TWINCORE, a centre for translational research in infectious diseases.

Dr. Marcus May

Medical Director

Dr. Marcus May is Medical Director at Vakzine Projekt Management GmbH. Prior to joining VPM he was senior physician and head of clinical operations at the Clinical Research Center (CRC) of Hannover Medical School. As Medical Doctor, Board Accredited Clinical Pharmacologist and Master of Health Business Administration, he has extensive clinical and administrative experience in the conduct of phase I-III clinical trials, Investigator Initiated Trials and Proof of Concept Studies.

Key Knowledge Areas:

Medicine and GCP-Regulations
Methods in clinical research
Pharmacovigilance
Healthcare economics

Based on his experience in planning and conduct of more than 70 clinical trials in various indications, with Small Molecules, ATMPs or Vaccines he is an expert in the setup of clinical development strategies for Investigational Medicinal Products. During several years as senior investigator and head of clinical operations in an academic site management organization (SMO) and later as Medical Expert and Medical Director at VPM he collected extensive expertise in ICH regulations, quality management, regulatory affairs and pharmacovigilance.

After he received his license to practice medicine in 2007, he worked in two hospitals as a resident physician in internal medicine. In 2011, he accomplished his doctoral thesis, since 2014 he is a Board Accredited Clinical Pharmacologist and since 2020 he is holding a masters degree in health economics.

Dr. Sina Brückner

Senior Project Manager

Dr. Sina Brückner is Senior and Clinical Project Manager at Vakzine Projekt Management GmbH (VPM). She joined VPM as Project Manager.
Sina Brückner is experienced in organizing, coordinating and managing clinical trials (phases II-III) in Germany and Sub-Saharan Africa.

Key Knowledge Areas:

Infectious diseases
Clinical development
Scientific advices

Sina Brückner performed her doctoral studies at the Eberhart-Karls University Tübingen as well as at the Albert-Schweitzer Hospital in Lambaréné, Gabon. She investigated if an antihelminthic treatment has an effect on the vaccine immunogenicity in a population highly susceptible for geohelminth.

Dr. Fabio Pisano

Director Project Management Office

Dr. Fabio Pisano is Director PMO at VPM and is responsible for all aspects of project management. He joined VPM as Project Manager and Quality Assurance Manager, and later specialized in product development and regulatory consulting.

Key Knowledge Areas:

Regulatory consulting
Good Manufacturing Practice (GMP)
Portfolio development

Fabio Pisano studied pharmaceutical biotechnologies at the University of Bologna, and performed his doctoral studies at the Helmholtz Centre for Infection Research in Braunschweig supported by a “Marie Curie” EU scholarship.

Afterwards, he worked as a postdoctoral researcher in the field of immunology and infectious diseases, with special focus on the virulence strategies of the enteric pathogens Yersinia and Salmonella.
After training as a Project Management Associate, he worked as Scientific Officer in the German Centre for Infection Research (DZIF).

Dr. Steffi Hansen

Director Quality Assurance

Dr. Steffi Hansen is Director Quality Assurance at Vakzine Projekt Management GmbH (VPM).

Steffi Hansen is experienced in planning, and overseeing clinical trials (phases I-III). She consults companies in custom designing their quality management system and bringing them up to date with current and future regulatory requirements.

Key Knowledge Areas:

QMS Consulting
Teaching and Coaching
Risk based clinical trial management

Steffi Hansen holds a doctorate in pharmacy from Saarland University, Germany (2009).

She held several positions in academic research including as visiting scientist at Winkle College of Pharmacy, University of Cincinnati, USA and as team leader in the field of transdermal vaccination at the Helmholtz-Institute for Pharmaceutical Research Saarland, Germany. Steffi Hansen was a freelancer for PharmBioTec GmbH and planned and conducted bioequivalence and biodistribution studies of skin products.

Dr. Gerald P. Parzmair

Chief Scientific Officer

Dr Gerald Parzmair is Chief Scientific Officer (CSO) at VPM and responsible for all R&D activities.

He serves as the first contact point for clients and provides consulting on strategic planning and regulatory affairs. In particular, his expertise includes CMC-related matters, vaccines, monoclonal antibodies, ATMPs and other biologicals. Dr Parzmair has led and supervised numerous projects and clinical trials in various indications, ranging from infectious diseases to oncology.

Key Knowledge Areas:

GMP/GCP Interface
ATMPs
Immunology

He received his bachelor’s and master’s degree in genetics at the Paris Lodron University of Salzburg. For his master’s thesis, he worked at the Medical University of Graz in the field of immunopharmacology on the immunomodulatory effects of certain cannabinoids on human granulocytes.

After graduating he moved to Braunschweig to work on his PhD thesis at the Helmholtz Centre for Infection Research on the roles of adaptor proteins in pathogen-specific immune responses and received his PhD at the Otto-von-Guericke University Magdeburg. Subsequently he participated in the TRAIN Academy for translational project management in pharmaceutical development.

Inge Martin

Director Finance and Accounting

Inge Martin is Director Finance & Accounting at Vakzine Projekt Management GmbH (VPM) and joined the company in 2002. She coordinates VPM’s financial administration department and is responsible for Human Resources. In her daily operation she is particularly involved in budgeting, public funding and contracting.

Key Knowledge Areas:

Accounting & Controlling
Projects Funding
Financial Due Diligence

Inge Martin studied English and French in Trier and is a qualified Foreign Language and Business Correspondent. In addition to her studies she got qualified for accounting and management which led into more than 20 years of experience in Finance & Accounting in national and international companies. For 7 years she worked at the Chamber of Commerce in Braunschweig in the Department of Foreign Trade & Commerce.

Dr. Leander Grode

Managing Director

Dr. Leander Grode is Managing Director (CEO) at Vakzine Projekt Management GmbH (VPM) since June 2019. Since 2013 he is Chief Scientific Officer at VPM and since April 2008 he has been responsible for Business Development.

Key Knowledge Areas:

Regulatory Affairs
Patent Strategy
Immunology

Between 2001 and 2003 Leander Grode was the coordinator of the vaccine development group at the MPI in the Department of Immunology.

He graduated in 1997 with a degree in biology at the Max-Planck Institute of Biophysics in Frankfurt/Main in the Department of Molecular Membrane Biology under Prof. Hartmut Michel. In the year 2000 he graduated as a PhD at the Max-Planck Institute of Infection Biology in the Department of Immunology under Prof. Stefan H.E. Kaufmann. The focus of his thesis was vaccine development against tuberculosis based on live carriers, such as salmonella or mycobacterium bovis BCG.

He studied biology in Giessen and Frankfurt/Main with focus on cell biology and zoology. As an exchange student, he visited the University of California San Francisco in the Department of Biochemistry and Biophysics in the lab of Prof. John Watson.

Dr. Christiane Meller

Director Quality Assurance

Dr. Christiane Meller is Director Quality Assurance at Vakzine Projekt Management GmbH (VPM).

Christiane Meller is experienced in planning and management of clinical trials within the EU regulatory framework (phases I-III). At VPM she is responsible for running the quality assurance. She consults companies in custom designing their quality management systems and acts as speaker with regard to current and future regulatory requirements.

Key Knowledge Areas:

Quality Management
Good Clinical Practice
Teaching and Coaching

Christiane Meller studied biology and majored in molecular biology at the Ruprecht-Karls-University in Heidelberg.

Supported by a doctoral scholarship of the International Graduate College “Hannover Biomedical Research School” she accomplished her doctoral thesis at the TWINCORE, a centre for translational research in infectious diseases.

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