e-DRA

IMPLEMENTATION OF CLINICAL IT SYSTEMS

Deep knowledge of Document Management, eSubmission, Regulatory Affairs Information Management and other GxP applications

Leader of global IT projects and teams in the biopharmaceutical industry

Ability to bring structure to complex situations like business processes, projects or system architectures

Deep knowledge of computer system validation in a GxP environment

EDMS

Electronic Document Management

EDMS Typical Systems
eSubmission Ready Document Management
SOP Management
electronic Trial Master File
Capa & Deviation Management
Records Management / Archiving
Pharmacovigilance Document Management
Labelling Systems
CMC Batch Records Archive

e-DRA Project References
Write User Requirements, select and implement an EDMS and Deviation / CAPA system (Biotech Company)
Write User Requirements and select cloud EDMS vendor (Biotech Company)
Write User Requirements for global eSubmission Ready document management system (Top 20 Pharma)
Write User Requirements for EU Clinical Document Management System (Top 20 Pharma)
Analyse EU processes / provide input to user requirements for Global Pharmacovigilance EMDS (Top 20 Pharma)
Assess if US eTMF system can be implemented in European organisation (Top 20 Pharma)
Write User Requirements for corporate EDMS (Mid-size Pharma)

Publications
Document Management in Pharma R&D, DIA Today 2007, Volume 7 Issue 1: 22- 23, Harmsen S.
R&D organisations produce, deliver and receive an increasing amount of electronic documents, reports, dossiers, emails, letters, faxes etc. In recent years they have heavily invested in Electronic Document Management Systems (EDMS). eCTD has rationalized the submission of dossiers to authorities. Still, document management remains to be a business critical issue which is not solved in an efficient way. What actions should R&D organisations take in order to meet those growing document management demands? The author Sven Harmsen discusses how R&D organisations can control the flood of documents, streamline the authoring process and reduce the number of documents. This article is based on his experience made in a European business unit of a global R&D organisation

Electronic Document Management in Clinical Research, Pharmind 2007; 70, Harmsen S.
In this article the author Sven Harmsen describes how the usage of IT systems can help to manage documents in clinical research. He shows efficient ways to prepare the documents, to manage Trial Master Files (TMF) and Clinical Trial Authorisation (CTA) packages and to capture knowledge contained in clinical research documents. The article is based on the experiences made in a European business unit of a global R&D organisation. In addition procedures and ideas from other biopharmaceutical companies were taken up. The aim of the author was to illustrate “best practices” in the area of document management in clinical research.

Presentations
eDMS in the cloud – lessons learned of a biotech company
28th - 30th November 2012 - 13th DIA Conference on European Electronic Document Management, Munich
More info at: http://www.diahome.org

Dokumentenmanagement für Regulatory Affairs
Wíntersemester 2009 - 2012, Universität Bonn - Master of Drug Regulatory Affairs
Weitere Informationen unter http://www.dgra.de

Elektronisches Dokumentenmanagement zwischen F&E und Zulassung
2009 - 2011, Forum
- Typische Dokumentenmanagementprobleme im Pharma- / Biotechunternehmen
- Gesetzlichen Anforderungen an das Dokumentenmanagement (Europa, USA)
- Dokumentenlifeycle: Vom Entwurf bis zur elektronischen Unterschrift
- Elektronisches Dokumentenmanagement System (eDMS): Einführung und Validierung
- Abteilungsübergreifende DMS-Lösungen
Weitere Informationen unter http://www.forum-institut.de

Regulatory (Clinical) Document Management - all the eSystems you need
13. April 2010, Istanbul, eCTD, current status and applications in the world & Turkey
More info at http://www.mkistanbul.com

eSubmission Dokumenten Management für Regulatory Affairs in einem multinationalen Unternehmen
27. / 28. Mai 2008, Frankfurt-Eschborn - 1. DGRA-School Elektronische Zulassung
Weitere Informationen unter http://www.dgra.de

Document Chain Management in Pharma R&D
March, 2007, Vienna, 19th Annual EuroMeeting, DIA
Session Lead
More info at: http://www.diahome.org

eSubmission

eSubmission Typical Systems
eCTD
eIND
NeeS
VNeeS

e-DRA Project References
Implement and roll-out global eCTD system, project coordination for system vendor (Top 3 Pharma)
Migrate US legacy eSubmissions to new eCTD system - project coordination for system vendor (Top 3 Pharma)
Select, implement validate eCTD system (Regulatory Service Provider)
Support selection eCTD system (CRO)
Implement system and adapt business process to submit eINDs to the FDA (Biotech Company)
Support eCTD compilation of DCP (Top 20 Pharma)
Analyse eCTD document re-use process (Generic Pharma)
Implement Veterinary NeeS eSubmission system (Animal Health company)
Implement eCTD System (Top 20 Pharma)

Publication
Einsatz eines Dossier-Management Systems in der Arzneimittelindustrie / Auswahl, Einführung und praktische Erfahrung
Pharmind 2003. 65: 511– 519, Kainz A, Harmsen S.
This paper describes the experience of Fujisawa GmbH, Munich (Germany), prior and following the installation of an electronic publishing system (dossier management system). It states reasons for investing into such a publishing system. The evaluation criteria and the implementation plan for such a system are examined, hurdles that had to be overcome during the first electronic compilation of a Marketing Authorisation Application are described. The authors discuss the challenges and limits of being compliant with the eCTD guideline and inform about the lessons learned.

Presentations
Realizing eCTD and EDMS benefits
22-24. September 2009, Warsaw - userBridge
Further information at http://www.lorenz.cc

Case Study: Select, Implement, and Validate an eCTD Management System
29. October 2008, Munich - Regulatory Symposium
More information at http://www.ndareg,com

Auswahl und Einführung eines eCTD Managementsystems
26. / 27. August 2008, Berlin - Effizientes Regulatory Document Management
Weitere Informationen unter http://www.iqpc.de

Moving away from the paper-based submission model - how to change business processes &
organisation to benefit most from eCTD
September, 2007, Nice - Userbridge - Docubridge User Conference
Further information at http://www.lorenz.cc

How to keep track of all documents and dossiers when submitting eCTDs
February, 2007, Paris, Informa Life Science, Lifecycle Management of the eCTD

Faster, Superior, More Cost Effective: Has the eCTD Delivered Its Promises? Keeping Up with Ever-changing Regulations in All Regions
June, 2006, Philadelphia, 42nd Annual DIA

Implementing an eCTD system at a global pharmaceutical company (Systems / Technical point of view)
May 2010, Mannheim - eCTD 2010 - 10 years of eCTD, Arbeitsgemeinschaft für Pharmazeutische Verfahrenstechnik e.V.
More info at http://www.apv-mainz.de

Regulatory Information

Regulatory Information Typical Systems
Regulatory Information Management
Regulatory Lifecycle Product Database
xEVMPD Gateway
Regulatory Intelligence Portal
Regulatory Datawarehouse

e-DRA Project References
Implement global RIM system (Top 20 Pharma)
Write User Requirements for xEVMPD gateway (Top 20 Pharma)
Support selection of RIM system (Mid-size Pharma company)

Publications
Auswahl und Einführung eines Regulatory Lifecycle-Systems
Pharmind 5/2011, Harmsen S.
In diesem Artikel erläutert der Autor Sven Harmsen was bei der Implementierung eines Regulatory Lifecycle Management Systems berücksichtigt werden muß. Er erläutert wie die Benutzeranforderungen an ein Regulatory Lifecycle Management System erfasst werden, wie die passende Standardsoftware ausgewählt wird, wie das Regulatory Lifecycle Management System technisch und organisatorisch richtig implementiert wird

Strategischer Einsatz von IT im Bereich Regulatory Affairs
Pharmind 2006; 68: 1047 – 1052, Harmsen S.
In diesem Artikel erläutert der Autor Sven Harmsen warum eine Produkt- bzw. Registrationsdatenbank im Mittelpunkt der IT Strategie für Regulatory Affairs stehen sollte. Er beschreibt wie durch Verknüpfung der Datenbank mit anderen Systemen aus den Bereichen F&E, Produktion und Rechnungswesen die unternehmensinterne Koordination erleichtert wird. Der Autor diskutiert die Rolle der Dokumentenmanagement- und Dossierpublishingsysteme und wie diese in die IT Strategie passen. Schließlich stellt er die Techniken dar die eine "Regulatory Intelligence" Funktion unterstützen.

Presentations
Den Überblick im Regulatory Lifecycle behalten - Möglichkeiten der IT-Untestützung
2007 - 2012, Seminar Udate Regulatory Operations , Forum
- Informationsflut Lifecycle - Termine, Korrespondenz, eCTD, PIM, xEVMPD, PSUR, Change Control...
- Zentrale Bedeutung einer Produktdatenbank
- IT gestützte Zusammenarbeit mit anderen Bereichen
- weitere Anwendungsfälle PIM, EVMPD, PSURs
- Aufbau eines Regulatory Intelligence Portal
Weitere Informationen unter http://www.forum-institut.de

Building the business case for a regulatory information system
17th & 18th April 2012, Berlin - Regulatory Information Management
More info at http://www.informa.com

IT challenges for Regulatory Affairs in Central and Eastern Europe
April 15 - 16, 2008, Budapest, Regulatory Challenges in Central and Eastern Europe, Informa

IT Strategy for Regulatory Affairs
March 3 - 5, 2008, Barcelona - 20th Annual EuroMeeting, DIA
Further information available at http://www.diahome.org

Other R&D IT

Other R&D IT Typical Systems
Drug Project Management System
Clinical Trial Management
Safety Database
Learning Management System
...

e-DRA Project References
Write User Requirements, select and implement Global Drug Project Management system (Top 20 Pharma)
Write User Requirements and select EU GCP Learning Management System (Top 20 Pharma)
Define strategy for migration of Safety Database (Mid-size Pharma company)
Write User Requirements for Clinical Trial Management System (Top 20 Pharma)