Clinical Development
and Good Clinical Practice

For all disciplines within clinical development and research

Expand your current skills and knowledge

If you work in clinical development and research - and whether you are inexperienced or seasoned in your work – you can find courses and training that expand your current skills and knowledge here.

A practical approach

There is an increased demand in the pharmaceutical and biotech industries for qualified professionals in clinical development. Our courses are designed to meet this demand, offering you a specialised understanding of Good Clinical Practice (GCP), based on the issues you meet in your daily work and formed by a practical industry and academic approach.

Differentiated levels of education

We offer life long learning from basic to expert level, because we know that the need for upgrading competences changes throughout your career.

Focused courses

Our courses cover key stages of a drug’s development cycle and aim to satisfy the educational need of practicing clinical research professionals.

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 Clinical Trial Management, Risk-Based Monitoring and Site Audits & Inspections. Other courses look into the complexity of outsourcing and insourcing contracts and vendor management. Others again, focus on how to generate and utilize Real World Evidence.


Clinical Project Management
We have designed a clinical project management programme for you who wants to become a better clinical project manager and strengthen your understanding of the methods used when working on clinical development projects. Read more


Introductory course

Introduction to Clinical Development

Introduction to Personalised Medicine (online)

Vendor Management and Oversight (basic)


Advanced courses

Challenges for project nurses in 2023

Risk Based Quality Management in Clinical Trials

Contracts and Insurance in Clinical Trials

Driving Decentralised Clinical Trials

New Standards for Investigational Medicinal Products (IMP) in clinical trials (online)

Regulatory medical writing

Vendor Management and Oversight (advanced)


Diplomas

Clinical Project Management - Manage your Project (Module 1)

Clinical Project Management – Lead your Project Team (Module 2)

Diploma in ICH-GCP Managed Trials

Examination and certification

When you have completed a course at Atrium, you will receive a certificate of completion.

Our diploma courses are completed with an examination approximately four weeks after the course. When you have passed the exam, you will receive a certificate of exam and a diploma.

Taught by clinical research experts

Our courses within Clinical Development will provide you with an up-to-date and in-depth knowledge of the most important theoretical and practical aspects within clinical development.
Our courses have been developed by a team of experts from:

  • The pharmaceutical industry
  • CROs
  • The Danish Medicines Agency
  • The public healthcare sector
  • The National Committee on Health Research Ethics

Expand your network

Network and exchange of experience is a big part of Atrium. The participants come from a wide variety of academia, CROs and the pharmaceutical industries. We do our best to take advantage of this by incorporating different experiences, viewpoints and nuances into the training sessions. The many practical exercises and discussions are great opportunities for you to strengthen your network.

Advisory board

At Atrium we believe it is of the utmost importance that stakeholders from the entire Life Science sector, being in contact with clinical research one way or another, also represent Atrium’s professional anchor. Here you can see the members of our clinical development advisory board:

Industry (Sponsor)

Camille Birgitte Claudius, Senior Medical Director, Head of Medical Affairs, Astellas Pharma

Morten Pedersen, Vice President, Head of Clinical Operations, Lundbeck

Lene Eskildsen, Head of Quality Assurance, Vicore Pharma

Anette Erbod Auscher, SSO Country Manager, Novartis Healthcare A/S

Michala Gauguin, Manager Safety Surveillance, Novo Nordisk

Tina Spang Hjorth, CEO, ClinOps Consult

Trine Danø Klingberg, Head of Clinical Process Management, Leo Pharma

Kashifa Ahmad Wichmann, VP Global Clinical Operations, Ferring Pharmaceuticals


Academia

Pernille Ask Aabo, GCP Coordinator, M.Sc.Pharm, GCP-enheden, Frederiksberg Hospital


Industry (CRO)

Erik Carp, Director, Operations Management, Syneos Health


What is GCP and ICH-GCP?

Good Clinical Practice (GCP) is an international quality standard for clinical trials and includes both scientific and ethical guidelines.

In clinical trial trials in the EU, compliance with GCP is a legal requirement that e.g. helps to safeguard the subjects and their rights as well as a valid data collection that complies with the Helsinki Declaration.

GCP is a common standard for the EU, the USA and Japan, just as the guidelines take into account standards in Australia, Canada and under WHO auspices. Therefore, trials conducted under the requirements of GCP can be approved by the authorities of most countries.

Good Clinical Practice describes guidelines for all phases of clinical trials such as the design, planning, implementation and reporting of trial results.

GCP is described in the “ICH Harmonized Tripartite Guideline for Good Clinical Practice”, from which the abbreviation ICH-GCP also derives.

Want to know more?

Contact Client Manager Christina Spangsberg at +45 39 15 09 22

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