Dr. Bianca Scholz

ResumeSP

Contact

Welcome to SCHOLZ Pharma GmbH

SCHOLZ Pharma GmbH was founded by me in 2007 and offers business consulting and services in the field of pharmaceuticals (pharmaceutical / medical / healthcare). In addition to the core competencies of audit and inspections in the areas of GCP, GLP, GMP and GVP, I also offer customized solutions in the field of pharmaceutical management, coaching, training and document management from development to market presence.

RANGE OF SERVICES• Audits and InspectionsExecution or preparation of international audits or mock audits. Assistance with the follow-up of inspections / audits, assistance with the processing of weak points and corrective measures in all areas of the pharmaceutical industry (GCP, GLP, GMP, GVP).

• Pharmacovigilance> Project Management GVP / GCP and Interfaces (GMP, GLP, GDP, RA, QA, Marketing and Sales)> Creating or customizing process descriptions (SOPs).> Optimization of processes and update to laws and regulations> Training GVP / GCP and Interfaces (GMP, GLP, GDP, RA, QA, Marketing and Sales)> Advice on regulatory affairs / requirements

> Contract management (co-marketing, service providers)> Support in the implementation and maintenance of PV databases

• Clinical Research> Contract Research Organization> Audits of test centers> Creating and maintaining the Trial Master Files> Training for investigators, monitors> Document Management: Creating & Reviewing Study Documentation, Application Registration / EC / CA Approval, Study Design, Study Plan, CRF, Patient Information, Study Reports

• Qualitätsmanagement> ISO 9001 quality management implementation, monitoring, continuous improvement, preparation for certification> ISO 13485 medical devices

Range of Services

SCHOLZ Pharma GmbHManaging DirectorDr. Bianca ScholzErlenhauptstr. 14

D-64625 Bensheim

SCHOLZ Pharma GmbHE / scholz@scholzpharma.com

M / +49 172 6383360T / +49 6251 9826011

UST ID DE 298411134Registriergericht Dramstadt

HRB 93890

Competencies

Personal Information Professional Vitae

Software

Language Skills

Social Skills

Date of birthJanuary 2nd,1973 in Stuttagrt / GER

Nationalitygerman

Marital statusMarried, three children

SCHOLZ Pharma GmbHsince 01/2015

SCHOLZ ConsultingBensheim

since 10/2007

Baxter Germany10/2010 - 10/2012

01/2004 - 09/2006

07/2002 - 12/2003

Bären Pharmacy Heidelberg07/1998 - 06/2002

Clinic Pharmacy Sindelfingen05/1997 - 06/1998

Consulting & Project Mgmt. Pharma:Production, Pharmacovigilance, Clinical Trials, Audits & Inspection Preparation & Postprocessing GMP, GLP, GCP, GVP, GDP etc.

Founding / OwnerQuality Management, Pharmacovigilance, Clinical Trials, Regulatory Affairs

Quality Manager & AuditorPharmacovigilanz / Clinical Trials / Regulatory Affairs / Manufacturing & Supply Corporate Compliance Services

Quality Manager & AuditorDrug Safety / Medical Affairs / Medical Information for Europe

Quality Manager & AuditorDrug Safety / Medical Affairs / Medical Information for Deutschland

Employee, Dissertation

Practical year pharmacist training

MS OfficeMS Project

VISIOTrackwise

GermanEnglisch

FrenchSpanish

Audit PharmacovigilanceProjectmanagment

Clinical Studies ISO 9001

ISO 13485Regulatory Affairs

GMPGLP

Curriculum Vitae

Team PlayerMotivated

InvolvedAccurate

CommunicativeAmbitiousLoadable

Reliable

European Org. for Quality 07/2017

Landesapothekenkammer BaWü 10/2008

European Org. for Quality 03/2005

European Org. for Quality 09/2004

European Org. for Quality 07/2003

DGQ dt. Gesellschaft f. Qualität 06/2003

Landesapothekenkammer BaWü07/2002

Universität Heidelberg 04/1996

Uni. Heidelberg, Kinderklinik 06/1999 -11/2001

Fachapothekerin f. Arztneimittelinformation

Lead Auditor EOQ

Quality Auditor EOQ

Quality Systems Manager EOQ

Quality Management Technician EOQ

Quality Manager and Auditor DGQ

Fachapothekerin für Offizin-Pharmazie / Allgemeinpharmazie

Apotheker Approbation

Dissertation Neonatology and Gynecology Interleukins (IL-1a. GE, IL-6, IL-8, MCP-1, MIP1a) as predictive value for preterm delivery and neo-natal infections

Professional Competencies• DGQ Dt. Gesellschft f. Qualität e.V.• DGParMed- Dt. Gesellschaft f. Phar-

mazeutische Medizin• DGGF- Dt. Gesellschaft f. gute

Forschungspraxis (GQMA)• Leiterin Arbeitsgruppe Pharmak-

ovigilanz DGGF• Wissenschatl. Leitung Heidelberger

Herbstkongress LAK• Referentin ChemAcademy, CH• Referentin Akademie f. Fortbildung,

Heidelberg• Referentin Concept Heidelberg

Memberships & Associations

Publications

• Pharmazeutische Medizin. 1-2016 März, Inspection Readiness in der Pharmakovigilanz - so erreichen wir unser Ziel!

• pharmind 2015, Nr. 6, Seite 844 Pharmakovigilanz - Inspektionen- Anforderungen an das phar-mazeutische Unternehmen.