PhD. (Dr.-Ing) Nedim Makarevic


Nedim Makarevic

Day of birth

22.11.1974

Citizenship

German

Marital status

Married

Education

Title 1: Master ( Dipl.-Ing) of electrical engineering /mechatronics
( Heilbronn/Germany) 1999

Title 2: PhD (Dr.-Ing.) in computer science.

Field: Applied informatics / „applied cryptography “

Promotion: USA / Miami 2002

Languages:

English, German, Bosnian, Croatian, Serbian

IT- project experience from

1999

Emphasis

Experiences in:

IT-projects: project management, development, consulting, maintenance,administration,validation

Fields:

Pharmacy-industry, different kind of agencies / public authorities, software producer

Operation-systems

Windows NT, Windows 2000, Windows XP

Software developing languages

C, C++, Visual Basic, Assembler, XML, HTML,

Data basis

SQL Server, Access

Project-experience

2006-2007

Task

Ministry of education –Malaysia

Project management : IT-Consulting and evaluation of diverse products required from the Malaysia-government

2005-2006

Task

DAIMLER-CHRYSLER AG

Data-base maintaining/development

2004-2005

Task

PYRAMIDE Computer GmbH

Supervising a strategic IT-project based on Ben Hur 2 appliances as a senior consultant. Responsibilities included: conducting market research, IT-Security & presales consulting, analyzing customer needs and presentation of security products

2002-2004

Task

SANOFI-AVENTIS Pharma GmbH:

Supervising a strategic global IT-projects in Aventis Pharma (Frankfurt ,Paris, Bridgewater)as a senior consultant.

Responsibilities included :Software-validation, IT-maintenance of Activity Base and the Citrix-Servers, IT-security ,Assay development, Writing the documents TraceabilityMatrix, System Prospectus etc, Preparing of the test-cases UAT/IAT and testing (considering the GLP, 21 CFR part 11 aspects).

PK/PD software (WinNonlin, WinNonmix, Trial Simulator) Installation, Troubleshooting, Documentation, WTS support, VBA-Programming, Help-Desk and User-support.

Project: WinNonLin 3.3

•PK/PD software (WinNonlin, WinNonmix, Trial Simulator) •Software-Installation

•Set of standard documents

•WTS support

•Troubleshooting

•User-support.

•Maintenance of the Citrix-Servers

•Upgrading

•Preparing the documentation for the WNL-Servers

•Writing the documents TraceabilityMatrix, System Prospectus etc.

•Validation of the whole system. (considering the GLP,21 CFR part 11 aspects)

•Collecting the user requirements

•Preparing of the test-cases UAT/IAT

•Testing

•Help-desk for Japan, USA, France and Germany.

Project: eGenoTOX

•Activity Base maintenance

•Test -Occasions-creation

•Collecting the user requirements

•Preparing of the test-cases UAT/IAT

•Testing

•VBA-Programming

•Preparing the documentation for the Activity Base-Server

•Validation of the whole system. (considering the GLP,21 CFR part 11 aspects) :

•Writing the documents :TraceabilityMatrix, System Prospectus etc. •Creation of the assay-templates such as MLA, AmesI, AmesII, VivoMNT, WTS support etc.

Project: „ILINK”

•Assistance by the Project- management of the global projects „ILINK“ (Paris/ Bridgewater/Tokyo and Frankfurt)

•Assisting the developer team in USA to create a global data ware house system.

•Setting up the Bugzilla-system in order to archive the software-bugs.

•Collecting the user requirements

•Preparing of the test-cases UAT/IAT and testing.

•Validation of the whole system. (considering the GLP, 21 CFR part 11 aspects).

•Preparing the documentation for the project ((TraceabilityMatrix,System Prospectus etc)

•User –Support

•Help-Desk activities,

Project: „Data-Exchange“(Subproject of ILINK)

Assistance by the Project- management of the global projects „Data-Exchange“ (France/ USA/ Japan and Germany

Aim was to get the effective and simple solution for the Data Exchange between Aventis DMPK and the CRO-s.

•Preparation of electronic data exchange

•Global harmonization of user processes

•Standardization of data exchange

•Validated Solution (GLP, 21 CFR part 11 aspects)

•Documentation

•Standard validation package to enable external partner to validate data exchange processes and systems

•Set of standard automated test cases

•Automated test software

•Set of standard documents

Project: „Data-Archive for DMPK“

•Evaluation of the existing archiving solutions on the market.

•Collecting the user requirements

•Writing the scripts for the data-archiving from the clients to the server.

•Preparing of the test-cases UAT/IAT

•Testing

•User –Support

•Troubleshooting

2000-2001

Task

daenetGmbH
Function: Assistance Developer

- Shareware application. Pingport and TraceServer.
Software for Network-analysis developed in C and C++ for Windows NT and Windows Sockets as Nt Service.

Project daenet Shop Template,

An E-Commerce application. Application based at: NT-Service (C/C++/ATL/COM/DCOM), OLE/DB, Visual Basic, Scriplets, Java, DHTML, XML and XSL.
Databases: Ms Access, SQL Server and Oracle.

Web server: Internet Information Server.

- Discount Engine for E-Commerce solution

Client/Server applications which aim is to count and administrate the statistics and rebates with help of the multi-dimensional mathematical functions.

Developed in VB Client and SOAP Server/COM DLL in Visual Basic. Web server IIS with SOAP Implementation.

- Currency Server, E-Commerce application. (Back office Server). NT Service developed in C/C++ with support of ATL/COM/DCOM. Implementation and input from HTTP, FTP and XML.

- Project PAPILLON, automatic generation of an Web-application from the Data Base model developed in C/C++ and VB with support from XML, SOAP, JAVA and DHTML.

- Project CONTINGATE (logistic Server for the sea freight). Developed with support of the following technologies. C/C++, ASP, VB and XML based in the ORACLE Database.

Technology

Microsoft Technologies: Client/Server, COM/DCOM, DHTML/XML/XSL, Visual Basic, Server development, C++, Server development, NT services, Web application, JavaScript, ASP, HTML,

1999 –2000

Task

„Glück und Kanja GmbH -
CryptoEx Mail Security Client. Client/Server applications, Cryptography, PublicKeyInfrastructure.

Planning, Design and Implementation of the Software-products CryptoEx , CryptoEx Key server and CA. Planning.

Design and Implementation of Algorithms for an independent OpenPGP crypto- area.

Technology

C++, Windows NT