Clinical development

For all disciplines within development and research

Expand your current skills and knowledge

If you work in clinical development and research, e.g. as a clinical project nurse, clinical trial manager, investigator, CRA/monitor or responsible for contracts between the different research parties – and whether you are inexperienced or seasoned in your work – you can find courses and training that expand your current skills and knowledge here.

FOCUSED COURSES

You will find courses that are focused on Good Clinical Practice (GCP) and GCP training and courses that focuses on specific subject areas, such as generation and value of Real World Evidence (RWE) or Risk-Based Monitoring. We also offer courses on outsourcing and insourcing contracts and vendor management. Some courses can be applied to specific diploma degrees and some courses offer a certificate upon completion.

Introductory course:
Introduction to clinical drug research

Basic GCP course:
Certificate in basic Good Clinical Practice

Diploma programme:
Diploma in ICH-GCP managed trials

Advanced courses:
Certificate in advanced Good Clinical Practice 
Risk management and risk based monitoring in a clinical research setting 
Site audits and inspections
Contracts in clinical trials 
Generation and value of Real World Evidence (RWE)

TAUGHT BY CLINICAL RESEARCH EXPERTS

Our clinical development and GCP courses have been developed by a team of experts from the pharmaceutical industry, The Danish Medicines Agency, the public healthcare sector and The National Committee on Health Research Ethics. The faculty comprises experts from the pharmaceutical industry, authorities and universities.

Learning activities include class teaching, self-studies, interactive discussions, case studies and workshops. The diploma courses are concluded with an examination approximately 4 weeks after the course.

ADVISORY BOARD

INDUSTRY (SPONSOR)
Anette Bedsted Toft, MSc Pharm, Director Clinical Trial Supply Management, Ascendis Pharma A/S, Denmark
Connie Brendstrup, Affiliate Process and Training Manager, PDG Country Clinical Operations, Roche a/s, Denmark
Kit Maria Schøning, Competency Development Specialist, Trial Management Anchor, Novo Nordisk A/S, Denmark

INDUSTRY (CRO)
Erik Carp, Head Clinical Operations Europe, Navitas Life Sciences A/S
Lisbet Vandvig, Vice President, Clinical Trial Services & Pharmacovigilance Services, Klifo A/S, Denmark

DANISH MEDICINES AGENCY
Lisbeth Bregnhøj, Medicines Inspector, Danish Medicine Agency, Denmark


ACEDEMIA
Tia Vetterli Sjøgren, Senior Study Coordinator, Clinical Research Unit, Hematology (H-KFE), Aarhus University Hospital, Denmark


NATIONAL COMMITTEE ON HEALTH RESEARCH ETHICS (NVK)
Karen Kiilerich, Special legal adviser, National Committee on Health Research Ethic (NEC), Denmark
Mette Luise Nielsen, Legal advisor, National Committee on Health Research Ethics (NEC), Denmark

NATIONAL EXPERIMENTAL THERAPY PARTNERSHIP (NEXT)
Britta Smedegaard Andersen, Project Director, NEXT, Denmark

   

Want to know more?

Contact Programme Director Gitte Hornemann Møller at +45 39 15 09 20

Send an email