Team

Quality and Compliance Management

Quality & Compliance Consultant
Anders Jakobsson

Anders Jakobsson holds in total 36 years of experience in Software quality and development. Anders holds more than 25 years of experience in the pharmaceutical industry working with QA, regulatory compliance, supplier audits and QMS development and roll-out.

Anders has experience in different areas of the pharmaceutical business such as GCP, GVP, GMP, GDP and medical device. Computer systems support in areas such as Production automation, Laboratory automation, ERP incl. serialization, Pharmacovigilance, Clinical Trials, Regulatory Affairs.

SAFe 4 Agilist, ISA S88 and S95, ISO 9000, 21 CFR Part 11, GMP Training Courses: manufacturing, distribution, auditing, batch release
Quality & Compliance Consultant
Anders Winkel

Anders Winkel has 9 years of work experience doing research at the University of Copenhagen. He has had experience in using a broad suite of analytical software such as Graph Pad Prism, SensorTrace Suite, PicoLog and GIS.

In Pharma IT he is acting as assisting compliance manager and he has also led several process analysis initiatives.

GAMP 5
BenedikteMarieDueBW
Quality & Compliance Consultant
Benedikte Marie Due

More than 10 years of experience with IT compliance. Working as Validation Track Lead in IT implementation projects and as Business Consultant in system operation and maintenance.

Experience primarily with corporate GxP systems within the Regulatory, Quality and R&D area. Also experience with international projects, external vendors and offshore personnel.

Certified in Computerized System Validation/GAMP5, Certified Veeva Vault Administrator, Veeva
DanAndersenR
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
DorteJuulR
Quality & Compliance Consultant
Dorte Juul

More than 13 years of experience with IT compliance, Quality Management and System Administration within the Pharmaceutical industry. Working as Validation Track Lead in IT implementation- and upgrade projects.

Experience primarily with Corporate GxP systems within the Regulatory, Quality and R&D area. Also experience with international projects, external vendors and offshore personnel.

Certification: CISA, ITIL Foundation, Computer Validation Manager, Lead Auditor and SAFe Agilist
FieKrossdal
Quality & Compliance Consultant
Fie Krossdal

Cand. Scient. in Health Informatics.

2 years of experience within IT compliance assisting Validation Track Lead in IT implementation projects.

Experience with RPA(programming and processes) projects as well.

Certified in Computerized System Validation/GAMP5
HeidiNoerTroelsenR
Quality & Compliance Consultant
Heidi Noer Troelsen

QA and Compliance Specialist with +20 years of experiences within the Pharmaceutical industry. Hands on experienced as a laboratory Technician, IT supporter, Project Manager, IT QA, Quality Specialist, QA, IT Compliance Consultant, Auditor, QA People Manager and Quality Director.

Certified in GxP, Computerized System Validation, 21 CFR Part 11 / EU Annex 11, Quality Risk Management, Audit Management and ITIL
Quality & Compliance Consultant
Ilhem Sahnoun Østergaard

Senior Consultant with over eighteen years’ experience in the Pharmaceuticals Industry.
Active senior level professional with extensive experience in Computer System Validation (CSV) and in Test Management.
Background includes: Management of IT Compliance, IT Project Management in GXP area, Computer System Validation, IT Quality Assurance, Qualification of the GXP IT infrastructure, advising/consulting with IT associates on matters pertaining to compliance, conducting Training in GXP, Management and Administration of GXP applications.

Certified in Computerized System Validation/GAMP5
Quality & Compliance Consultant
Jesper Damborg Bendtsen

Holds more than 17 years’ experience in the pharmaceutical industry working with validation and compliance. Jesper’s experience spans IT implementation projects, validation, compliance projects, and IT system administration.

SAFe 5 Agilist, Avoiding non-Compliance in Packaging Operations; Validation of Ventilation (HVAC); QA and System Manager for GxP critical IT systems; Qualification of cooling facilities
Quality & Compliance Consultant
Lea Elsborg Olsen

Holds experience working with data, modelling and statistical analyses within the cancer research industry. Assisting Compliance Manager experience. She holds a Cand.Scient. in Health Informatics.

Foundation ISTQB Certified Tester programme, Computerized System Validation/GAMP5
Pharmacovigilance Consultant, Quality & Compliance Consultant
Maria Skou Andersen

Cand.pharm with five years of pharmacovigilance experience including strong knowledge of MedDRA coding. Successful completion of EMA’s XEVMPD knowledge evaluation. Capable of providing guidance and training to new EVWEB users for them to comply with the reporting guidelines. Capable of creating and updating XEVMPD records. Experienced with databases such as Argus, Empirica and QlikView. Currently studying Master of Pharmacovigilance at the University of Hertfordshire, UK. EDMS system expert with advanced Veeva system administrator certification and experience with Veeva implementation. Experienced with compliance tasks such as system validation within the drug safety area.

Certified Veeva Vault Administrator, Veeva
Quality & Compliance Consultant
Nini Redøhl

More than 10 years of experience with IT compliance, Quality Management and System Administration within the Pharmaceutical industry. Working as Validation Track Lead in IT implementation and upgrade projects.

Experience primarily with Corporate GxP systems within the Regulatory, Quality and R&D area. Also experience with international projects, external vendors and offshore personnel.

Certification: ITIL Foundation, Computer Validation Manager, Lead Auditor and SAFe 4 Agilist
Quality & Compliance Consultant
Sara Hamilton

Holds two years’ experience in the pharmaceutical industry working with pharmacovigilance and two years’ experience working with data, quality improvement of data and implementation projects within the hospital sector. Assisting Compliance manager experience.

GAMP (Computer System Validation), Certified Tester, Trained in risk-based testing, ISTQB foundation, Certified Veeva Vault Administrator
Quality & Compliance Consultant
Tine Falk

More than 15 years of experience with implementation projects and system operation. She is highly specialized in GxP. She has performed in roles such as Compliance Consultant and Test Manager.

Tine also have 5 years of experience as SAP System Manager in a highly complex environment.

Computerized System Validation, ISEB Foundation and ITIL Foundation
Quality & Compliance Consultant
Marianne Munck

More than 25 years’ experience in the Pharmaceutical Industry with a strong understanding of the pharma business by working in companies like Novo Nordisk, Bristol-Myers Squibb and NNIT in various areas: Quality Control, Quality Assurance, Organic Synthesis, Basic Research, Pharmacovigilance and life science IT Systems.

Computerized System Validation, Maintaining Control in Operation, Computer System Validation Master Class
Quality & Compliance Consultant
Mike Astrup Nygaard

Experience from several pharmaceutical companies, working with various compliance and test assignments within GxP. Mike is experienced in taking lead and ownership of all types of compliance tasks from user requirement specifications, to validation plans, testing and reporting.

Mike has performed the role as Compliance Consultant, Validation Lead and Test Manager on IT projects and is specialized in GxP.

Mike has hands-on experience with preparing, reviewing and ensuring the right level of compliance in documentation for GxP systems – from Validation and Quality plans, URS, Risk Assessments, protocols and test cases to reports.

He has experience from international projects and teams with different nationalities. Mike is accustomed to working with several stakeholders and communicating at all levels of the organization.

ITIL, ISPE GAMP5
Junior Pharma Consultant
Tea Mansa Larsen

Tea Mansa Larsen is Cand. pharm with 3 years’ experience in quality and compliance support within Regulatory affairs. Tea has experience with various task of creating, extracting and archiving documentation. She has been assisting in reviewing and handling submission documents and supporting the Regulatory department in various quality tasks. Tea also has teaching experience in Quality Control and Laboratory work.

Senior Pharma Consultant
Pia Nøhr Ellegaard

Pia Nøhr Ellegaard holds more than 20 years of experience with Software-, Hardware and implementation projects of which 11 years have been in the pharmaceutical industry.
She is highly specialized in GxP. She has performed in roles such as Compliance Consultant , Test Manager, Trainer and QA. She has worked within most pharma domains.

ECA Certified Computer Validation Manager, ISEB Certified Tester
Senior Pharma Consultant
Maiken Forsberg

Pharmacist with 10 years of compliance and  IT System Management experience in line with GAMP 5, 21 CFR Part 11, ISO/IEC 27000 suite for IT security, ITIL and ICH guidelines (GMP, GLP, GCP, GVP). Maiken has helped several pharma companies establishing or improving IT documentation and SOPs prior audits or inspections with good results. She has implemented as well as retired a variety of complex pharmaceutical IT systems. 

ITIL 4 Foundation Certification, LEAN (cLEAN), eTIMS, GAMP 5 - 21 CFR Part 11 Data Integrity and IT Security, GAMP 5 ISPE, TIMS training
Junior Pharma Consultant
Sara Krarup Nielsen

Junior compliance consultant Sara Krarup Nielsen is Cand.Pharm. and has experience with various tasks of protocol development, implementation, optimization and validation. She has experience with scientific writing of articles for publication and with co-supervision, training and laboratory work. Sara has also worked with data analysis.

Senior Pharma Consultant
Maria Høyer Engelhardt

Senior Pharma Consultant Maria Høyer Engelhardt holds more than 10 years of experience working in the pharmaceutical industry, working with quality, validation and processes, primarily within Quality Control. She has extensive experience within Quality Control, in particular with documentation, verification and validation of methods, set up and documentation of new processes, SOP writing and LEAN. Furthermore, she has good knowledge of QMS systems and the document structure.

Experience with development and validation of microbiological methods and  methods for raw materials.

Various cGMP courses , LEAN, Project Management
Junior Pharma Consultant
Ahmed Al-Ruba

Ahmed Al-Rubai is a junior compliance consultant with a background as cand.pharm. He has experience with GLP, GMP, documentation, laboratory work, project planning and coordination. He has also acquired experience in quality assessment of laboratory products. Furthermore, Ahmed has a strong passion and understanding of IT.

Pharma Consultant
Emil Rosenthal Jensen

Pharma Consultant Emil Rosenthal Jensen holds experience from several years in the pharmaceutical industry, working with various compliance tasks and implementations within GxP. Emil has hands-on experience with many types of compliance tasks from user requirement specifications and validation plans, testing and reporting to deviation reporting and change control.

Senior Pharma Consultant
Ole Søndergaard

Senior Compliance and Validation Consultant with +20 years of professional IT experience, quality assurance and test experience, hereof +10 year of experience with compliance, qualification and validation issues within the pharmaceutical industry. Ole has deep insight and hands on experience in all activities in the validation lifecycle – validation planning/strategy, risk assessments, requirements specification, design specification and review, build processes incl. code review and unit/integration testing, qualification testing, validation reporting and maintenance processes incl. change & configuration management and periodic reporting

SAP - GMP Compliance and Validation, SCRUM Foundation, ITQC Consultant Certificate, Computer System Validation Master Class
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)

Pharma Business Consultants

JRK 2017 BW
Business Consultant
Jannie Rosenkjær Melbye

Senior Pharma Consultant with 11 years’ experience within document/information and application management. 17 years’ of experience in the field between IT and business. Experience with GxP, application management – especially document management, functional and technical support, test and validation. Furthermore, experience within ITIL, vendor management, communication with end users, transition and application management.

Certified in ITIL, Computerized System Validation, SAFe Agilist
Business Consultant
Jeppe Resen Amossen

Project manager and Serialisation SME with 9 years of experience in project management and more than 4 years of experience in the pharmaceutical sector. Experience from Pharmaceutical Production and Engineering.

Focus on Serialisation and the many new legislations being implemented in key markets.

 

SAFe 4 Agilist
Business Consultant, Quality & Compliance Consultant
Lene Hyldgaard Jensen

Experienced Business Consultant with more than  10 years’ experience in the pharmaceutical industry working in various business partnering roles, preparing business analysis, facilitating workshops, transforming business requirements into IT development and implementation projects and delivering subject matter expert assignments, especially in the Regulatory area. Hands on Quality and Compliance experience with GxP IT systems and writing of Standard Operating Procedures.

ISPE GAMP 5, ITIL, Project Management, GLP, GCP, Veeva
Business Consultant
Luise Søgaard Rosendahl

Holds extensive experience in the pharmaceutical industry working with IT Service Management, IT implementation projects, and IT Transition and Transformation programmes. Has played pivotal roles in IT system management organisations responsible for applications supporting Product Supply. Furthermore hands on experience as Business Consultant, IT Management SME, and Track Lead as part of a Management Consultancy organization.

ITIL®V3 Foundation, ITIL®V3 Intermediate RCV, NLP Business Practitioner, SAFe Agilist
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
Business Consultant
Sara Halsskov

Holds more than 15 years of experience working in the pharmaceutical industry, working with IT systems and processes, primarily within Regulatory Affairs.  Sara has performed the role as Clinical Publisher, Regulatory Application Professional, eSubmission Manager, Senior QMS Professional/Project manager within Regulatory Affairs and Release Manager as part of System Management.

ITIL Foundation Certification, SOP Expert training, Writing effective standard operating procedures and other process documents (CfPIE), Computer Validation, Veeva
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
Senior Consultant, Architect
Nikolaj Brasen

IT Architect with vast experience within systems design, as technical lead, requirement analysis, system management, ensuring GxP-compliant documentation and planning with stakeholders to obatin the best possible solutions within the budget and timeline. Nikolaj Brasen has an eye for details, an ability to maintain overview and long-term perspectives, a firm understanding of risk, and is familiar with the latest project management tools and practices (DevOps, Agile, Scrum, and more)

Veeva Vault Platform, PRINCE2, TOGAF 9 Certified
Senior Pharma Consultant
Amalie Green
Senior Pharma Consultant Amalie Green holds more than 8 years of experience working in the pharmaceutical industry, working with GMP, optimization and processes, primarily within Finished Good Manufacturing and Quality Assurance. Subject Matter Expert from Line of Business acting as the link between business and the IT system. 
Amalie has experience as process analyst, coupling Line of Business and IT systems. She is a specialist within the area of Finished Goods manufacturing and Quality Assurance, covering handling or implementation of QMS processes.
GMP/GXP Experienced – Key2Compliance, Method 1 - Yellow belt (six sigma),

Management Consulting

CBAD 2017 BW
Partner, Management Consultant
Charlotte Bech Andersen
+ 45 61 98 27 05

IT Program/Project Manager with 15 years of experience from the IT industry within fields of Program management, Project management and IT service management. Experience from the Pharmaceutical industry and Public sector. Experience with a wide range of projects in software development, transition projects, infrastructure & operations projects and projects in service and process implementation, GxP and non GxP.

Holds a Master degree in International Business, a MITS degree from Copenhagen Business school of Executive Management Institute and courses from Henley Business School.

Project and Program Management certified in PMP, PRINCE2, ITIL and certified negotiator.
Management Consultant
Jonas Ripa

Jonas Ripa holds more than 15 years’ experience in Project and Stakeholder Management from various projects and positions. Jonas has strong experience in infrastructure projects and software development projects, but also experienced in security as well as transitions projects.

He has been heading projects for major corporations from both customer and vendor side. He is highly specialised in Pharma and GxP critical systems. Jonas works comfortably is in the commercial and stakeholder management field. With an educational background in both the technical and commercial fields, he is confident in participating in complex dialogues in both areas.

PRINCE2 Foundation, ITIL Manager, GAMP, 21 CFR Part 11, Compliance and documentation on GxP critical systems
Partner, Management Consultant
Peter-Emil Iversen
+45 28 68 78 31

More than 10 years of experience from the Pharmaceutical industry. Experienced in bridging IT Programme- and Project Management within the pharmaceutical industry. Strong references from some of the largest IT Programmes in Danish Life Science.

Experience as PM from Serialisation Projects,  SAP ATTP rollouts, Production IT projects, IT QMS implementation and as Head of PMO.

Project and Program Management certified in PRINCE2, MSP, ITIL and Standford Advanced Project Management Program (SAPM). SAFe 4 Agilist
IT Project/Program Manager
Huma Javed

Huma Javed is an accomplished and goal-driven IT Project manager offering wealth of experience planning and executing all phases of large-scale pharma IT projects. Skilled and proficient at stakeholder management, within teams as well as at steering committee and governance boards. Well-versed in the breadth of project management, incl. vendor and risk management, PMP/Scrum Master Certified. Has experience with wide range of Pharma IT projects from Regulatory (eCTD and Data Management), Research & Development, Sales & Marketing and Product Supply area. The projects have varied from software implementation, transitional and operational projects to fulfill a business case.

PMP – Project Management Professional, Scrum Master - SAFe4, CTAL – Test Manager, Business Associates Certification, ITIL foundation Certificate
JakobJuulRasmussen
Managing Director in Pharma IT, Program and Project Manager
Jakob Juul Rasmussen
+4524342655

IT Program/Project Manager with 20 years of experience with in pharmaceutical, finance and public sector. Experience with infrastructure, service delivery management, application development, SOA and SAP projects. Experience with a wide range of projects in software development, transition projects, infrastructure & operations projects and projects in service and process implementation, GxP and non GxP. Pharma process SME in multiple areas within Clinical, Regulatory and Product Supply. Holds a Master degree in Chemical Engineering.

 

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

Drug Development Consulting

Partner, Drug Development Consulting
Ea Marie Holst
+ 45 30 22 23 21

Pharmacovigilance professional with more than 14 years of experience working in both headquarters and affiliates within; Signal Detection, Risk Management Plans, PSUR/PBRER and DSUR writing; maintaining and building quality management systems; pharmacovigilance training, E2B reporting and testing, handling of individual cases. Trained user of several adverse event databases.

Data Management Consultant
Evangelos Kapris

Experienced Clinical Data Manager with experience within: CRF/eCRF design, database design, data entry, data validation, query handling, protocol deviations, SAE reconciliation, quality control, data import/export, SQL programming, data migration, CDISC SDTM standards, MedDRA/WHODrug coding, risk-based monitoring and data management oversight.

M.Sc. Data Mining
Pharmacovigilance Consultant
Kristine Kornøe

Experienced in clinical and postmarketing safety after working 6 years as a Drug Safety Advisor in a large danish HQ. Experience include: Signal Detection, PSUR/PBRER and DSUR writing and submission; Risk Management Plans; maintaining and building quality management systems; pharmacovigilance training, E2B reporting, ICSR case processing and reporting.

Pharmacovigilance Consultant
Louise Søgaard Nielsen

10 years of experience as a pharmacovigilance professional. Experience with all aspects of pharmacovigilance including; ICSR case processing and reporting, Signal Detection, PSUR and DSUR writing and submission; Risk Management Plans and maintaining and building quality management systemst a larger pharmaceutical company in the Copenhagen area.

Data Management Consultant
Jens Sørensen

Clinical Data Manager with pharmacy background and 18 years of experience from the pharmaceutical industry. Experience as both insourced and outsourced consultant with all aspects of clinical data management including; CRF/eCRF design, database design, data entry, data validation, query handling, protocol deviations, SAE reconciliation, quality control, data import/export, SAS and SQL programming, data migration, CDISC SDTM standards, MedDRA/WHODrug coding, risk based monitoring and data management oversight.

Pharmacovigilance Consultant
Mie Altermann Sørensen

Pharmacovigilance professional with 6 years of experience from the pharmaceutical industry. Experience from working in both headquarter and affiliate. Includes: Signal detection, literature monitoring, pharmacovigilance training, individual case safety report processing, including coding and narrative writing, scientific evaluation and reporting. Medical information activities; writing medical responses to health care professionals, direct costumer contact. Studying Master of Medicines Regulatory Affairs. 

Medical Writer Consultant
Kaushik Sengupta

Senior Medical Writing Consultant with over 8 years of experience from the pharmaceutical industry as a Senior/Expert Medical Writer. Has prepared numerous high-quality regulatory and research documents for leading global pharmaceutical companies. Typically, these documents have been based on Phase I–IV studies from most major therapeutic areas. Holds a Master in Dentistry from Canada and has pursued a PhD in epidemiology from Copenhagen University.

Pharmacovigilance Consultant, Quality & Compliance Consultant
Maria Skou Andersen

Cand.pharm with five years of pharmacovigilance experience including strong knowledge of MedDRA coding. Successful completion of EMA’s XEVMPD knowledge evaluation. Capable of providing guidance and training to new EVWEB users for them to comply with the reporting guidelines. Capable of creating and updating XEVMPD records. Experienced with databases such as Argus, Empirica and QlikView. Currently studying Master of Pharmacovigilance at the University of Hertfordshire, UK. EDMS system expert with advanced Veeva system administrator certification and experience with Veeva implementation. Experienced with compliance tasks such as system validation within the drug safety area.

Certified Veeva Vault Administrator, Veeva
Director of Chemistry, Manufacuturing and Control (CMC)
Torben Elhauge

Holds more than 25 years’ experience from the Pharmaceutical industry within the CMC area.

Experience working with both active pharmaceutical ingredients and medicine products for the European and American market, according to guidelines, ICH guidelines and the Pharmacopoeias (EP, PB, DLS and USP).

Broad experience within validation of analytical methods according to ICH Q2 (R1) and verification of monographs. Have been a tutor both at Pharmacon and at the MIND education under the university, lecturing in QC and analytical validation.

Experience working with registration files for the European and the American market both writing sections of the file and as an assessor within the Danish Medicines agency. Have been a part of the planning and execution of an advisory committee meeting as a part of the FDA registration process.

Experience from small development companies working in project teams and from quality control in larger setups. Always under GMP. Have also functioned as leader of an analytical development laboratory for several years.

Experienced in working with, CRO’s and Tech Tranfer.

Have held inspections both as an analytical expert within the Danish medicines agency and as a company representative. Have also functioned as an auditor for internal and external audits.

Torben holds a master’s degree in chemical engineering.

GMP, Quyality guidelines, Quality systems, HPLC, Dissolution, Analytical validation, Analytical development, Inspections, Audit,
Clinical Project and Trial Manager, Pharma Consultant
Berit Grevstad

Experienced international clinical trial manager and site manager from Clinical Research Organizations and Academia.  Experienced in start-up of multinational Phase I – IV clinical trials, including development of trial related documents such as trial protocols, risk management plans, monitoring plans and eCRFs.

Academic background as project manager in infectious disease areas (HIV, Malaria, Ebola) and working experience in infectious diseases, vaccine development, immunology, hematology, oncology, diabetes, cardiovascular, respiratory, and neuroscience disease areas.

Director, Clinical Science & Trial Operations
Birgitte Sloth

Experienced Clinical Scientist, Trial and Project Manager with more than 15 years of experience with scientific, operational and strategic parts of project and trial management, functioning as Global Study Lead and Clinical Project Scientist. Extensive experience with vendor and stakeholder management, protocol authoring, management of clinical trial teams, and clinical project management within early phase clinical development including phase I-II and phase III in a rare disease indication.

Academic background in metabolic disease area and working experience in obesity, diabetes, cardiovascular, immunology, dermatology, respiratory, musculoskeletal and neuroscience disease areas.

Experience within translational medicine, pediatric investigational plans, NDA submission.

Senior Pharma Consultant
Maria Høyer Engelhardt

Senior Pharma Consultant Maria Høyer Engelhardt holds more than 10 years of experience working in the pharmaceutical industry, working with quality, validation and processes, primarily within Quality Control. She has extensive experience within Quality Control, in particular with documentation, verification and validation of methods, set up and documentation of new processes, SOP writing and LEAN. Furthermore, she has good knowledge of QMS systems and the document structure.

Experience with development and validation of microbiological methods and  methods for raw materials.

Various cGMP courses , LEAN, Project Management
Senior Pharmacovigilance & Device Consultant
Sukhjit Gill

Senior Pharmacovigilance & Device Consultant holding 12 years of experience from several pharmaceutical companies and additionally 3 years of experience within the medical device industry. She has experience working with various pharmacovigilance development and post-market surveillance tasks such as DSUR and PSUR/PBRER writing, setting up AE/SAE flows for clinical trials as well as reconciliation and MedDRA coding, SOP writing, Pharmacovigilance training, Literature monitoring, ICSR case processing and reporting, Device vigilance complaint handling, evaluation of serious incidents, reporting of MIRs and communicating with Regulatory Authorities/Notified Body and execution of Recalls/FSCA and FSN. Has been part of implementing the new MDR regulation within device vigilance

Clinical Evaluation for Medical Devices in Europe, Medical Devices: Regulation and Life Cycle Management, MedDRA Safety Data Analysis and SMQs

Medical Device

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)
Director, Medical Device
Per Andersen

IT Project Manager/Architect with 20+ years of experience within pharmaceutical and medical device industry. Experience with infrastructure, Complex IT applications, ERP-Systems, BPM&N, WebServices, medical devices and Software as medical device software

Jira foundationals - Agile Development, Atlassian; Jama Foundationals, Requirements, Risk and Test Management; SAFé Agile / Scrum

Serialisation

Business Consultant
Jeppe Resen Amossen

Project manager and Serialisation SME with 9 years of experience in project management and more than 4 years of experience in the pharmaceutical sector. Experience from Pharmaceutical Production and Engineering.

Focus on Serialisation and the many new legislations being implemented in key markets.

 

SAFe 4 Agilist
Partner, Management Consultant
Søren Winkel
+45 26 78 02 06

IT Program/Project Manager with more than 10 years of experience running business critical projects and programmes. Søren has more than 6 years’ experience in running projects in the pharmaceutical sector.

Focus on Serialisation and the many new legislations being implemented in key markets. Project Manager of several SAP ATTP implementations.

Project and Program Management certified in IPMA level C, PRINCE2 and MSP, General Data Protection Regulation (GDPR) certified from IBITGQ. SAFe 4 Agilist

Junior Consultants - Students

Junior consultant
Elvin Iruthayam

Elvin Iruthayam is a junior compliance/student consultant currently studying a M.Sc. in Biomedical Engineering.