The EU General Data Protection Regulation was made effective on the 25th of May 2018. Pharma IT offers several services in respect to the implementation of GDPR in pharmaceutical companies.

EU GDPR Implementation

If you haven not already done so we recommend that the following activities are planned and executed:

  • Create a process overview of departments handling personal data
  • Map the personal data processed into the process overview
  • Map the existing security measures and compliance to the GDPR
  • Identify gaps to the GDPR in the created process and data flow overview
  • Create Data Protection Impact Assessment document based on the above collected information
  • Initiate project/tasks to close the identified gaps (if any)

In many cases, existing systems and process will be sufficient and compliant with GDPR, but the full process and IT systems will still need to be reviewed in the view of GDPR and where gaps are identified these should be closed.

Data Protection Officer

The GDPR states that a data protection officer shall be designated in any case where the core activities of the controller or the processor consist of processing operations which require regular and systematic monitoring of data subjects on a large scale (article 37).

This role can be outsourced and it’s a service we are already providing.

Meet the EU GDPR team:

Senior Pharma Consultant
Bettina Kok

Bettina Kok holds more than 15 years’ experience in the medical device industry working with a broad selection of projects in QMS, IT QMS, QA, Pharma IT projects and GDPR. Bettina holds in total 17 years’ experience working under various standards and directives with compliance and documentation, in highly regulated industries. Experience as a Compliance Manager, RA Consultant, Compliance Architect, Vigilance and Complaint Specialist and Track Lead (URS) on IT projects. Hands-on experience with IT and QMS documentation, process mapping, design and implementation of quality processes, to improve and secure compliance requirements.

Bettina has several years of experience with QMS systems preferred in medical device/pharma, ISO 13485 and ISO9001 compliant businesses. Such systems are for example: HIQMS, DOORS, ENOVIA, Track-Wise, Sharepoint, Improve, Veeva and Lotus Notes.

Risk Management, Document Management, Quality Management, Auditor, MDD 93/42 Compliance, EU GDPR, Data Protection Impact Assessment (ISO/IEC29134), Information Privacy Manager (IAPP)
Business Consultant
Steen Lindebjerg

IT Program/Project Manager and Senior Pharma Consultant within Identity Management and GDPR with more than 20 years of experience from the IT industry within Pharmaceutical, Finance, Food and Public sectors. Experience with wide range of projects and operation in Infrastructure, IAM & Security, Application development, process optimization and IT service management.

SAFe 4 Agilist, PRINCE2, ITIL, GDPR Practitioner, CIPP/E and Certified Engineer in Microsoft Infrastructure MSCE and Nowell Network CNE
Quality & Compliance Consultant
Dan Andersen

30 years of pharma experience from multiple area of business and levels of responsibility with a constant focus of delivering compliant solutions. Hands on experienced as a Security Manager, QA, Compliance Specialist, Validation Specialist, Project Manager and Process Technician.

Certified in CISSP (IT security), CISA (IS Audit), CISM (Security Manager), GxP, Computerized System Validation, 21 CFR Part 11 / EU Annex 11, LEAN and ITIL, Veeva
Senior Pharma Consultant
Peter Noes

Information technology professional with more than 15 years of experience from the pharmaceutical industry. Extensive business understanding and experience from IT projects mainly within the areas of Regulatory Operations – eSubmission/eCTD, Regulatory Information Management Systems (RIMS), Electronic Documents Management Systems (EDMS), XEVMPD and IDMP. Broad experience with project management, system administration and system implementation and with establishing and optimizing business processes within GxP areas.

Veeva White Belt Certification, Computerized System Validation/GAMP5 and GDPR Foundation
Partner, Management Consultant
Jakob Juul Rasmussen
+ 45 24 34 26 55

IT Program/Project Manager with 16 years of experience within the pharmaceutical industry, finance and the public sector. Experience with infrastructure, service delivery management, application development, SOA and SAP projects

Project and Program Management certified in IPMA level A, PMP, MoP, PRINCE2, MSP and Professional SCRUM master