Clinical Studies
Clinical trials play a vital role in drug development, focusing on evaluating the safety and efficacy of both new and existing drugs as well as medical devices. Läkemedelsakademin annually organizes a wide range of courses, training programs, and hot-topic events, along with offering online courses.
Course Package
Introduction to Clinical Trials – Premium Package
A course package featuring 6 courses in clinical trials that provides a solid introduction to the field. By choosing this package, you receive a 25% discount compared to purchasing the courses individually. Meets TransCelerate’s minimum criteria for ICH E6 GCP training.
Information and BookingIntroductory courses
Clinical Trials - Introduction
This beginner’s course offers a comprehensive overview of working with clinical drug trials. You’ll receive an introduction to the regulations and fundamentals of Good Clinical Practice, GCP. It meets TransCelerate’s minimum criteria for ICH E6 GCP training.
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Clinical Trials of Medical Devices and GCP
A course providing insight into clinical trials of medical devices. It covers the basics of GCP (ISO 14155:2020), other regulations, practical advice on the application processes, and expectations during an inspection.
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E-courses in Clinical Trials
GCP and clinical trials - from study start to end
This e-course covers how a clinical trial is conducted at an investigator site in Sweden and how Good Clinical Practice, GCP, is applied in the various steps. Meets the TransCelerate minimum criteria for ICH E6 GCP Investigator Site Personnel Training. Available in English and Swedish.
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GCP for Investigators
An e-course on Good Clinical Practice, GCP, covering the basics of the investigator’s responsibilities in clinical drug trials. Intended for investigators and delegated staff at trial sites. Meets TransCelerate’s minimum criteria for ICH E6 GCP training.
Information and BookingAdvanced Courses in Clinical Trials
Monitoring Investigator-Initiated Trials
A course on monitoring clinical trials in which the investigator is the sponsor. It provides essential knowledge for monitors on preparing, initiating, overseeing, and closing a trial.
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Design and Statistical Analysis of Clinical Trials
A course on study design, statistical analysis, and result interpretation for clinical trials involving drugs and medical devices. The course covers key terminology, protocol development, trial implementation, and reporting, all from an applied statistical perspective.
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Quality Assurance of Digital Tools in Clinical Trials
A course on the digitalization of clinical trials and the sponsor’s responsibility for quality assurance of computerized systems. Designed for those seeking knowledge of the requirements, their application, and the necessary documentation.
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Upcoming Course Dates
Combination Products for Pharma - Device Perspective, e-kurs
Combination Products for Pharma – Device Perspective (On-Site Session with E-course), dec 2024
2nd Nordic Conference on Computational Chemistry, March 2025
Usability Engineering in Medical Devices, april 2025
Regulatory documentation, content and format guide, May 2025
What Are Clinical Trials?
Clinical trials, also known as clinical studies, are a critical phase in the development of drugs and medical devices. These studies are conducted to determine the safety and efficacy of new treatments or to evaluate improvements in existing products. Clinical trials occur in multiple phases, from early safety studies (Phase 1) to extensive efficacy studies (Phase 3) and long-term follow-ups (Phase 4). Each phase plays a specific role in drug development and must be conducted according to strict guidelines to ensure that the generated data is reliable and meets regulatory requirements.
Conducting clinical trials requires interdisciplinary collaboration among various professionals, such as researchers, clinical physicians, research nurses/other research support staff, biostatisticians, and data managers. A deep understanding of Good Clinical Practice, GCP, is also essential; this international standard outlines the ethical and scientific quality requirements that must be followed in all clinical trials involving human participants. Furthermore, clinical trials face numerous challenges, such as patient recruitment, data collection, safety monitoring, and regulatory compliance, which require careful planning and execution.
Läkemedelsakademin provides courses on various aspects of clinical trials. Our courses are suited to both beginners and experienced professionals in the field and include both instructor-led and online options, offering diverse opportunities to tailor your learning to your needs
Boost Your Career or Make an Impact
If you work in pharmaceuticals or with medical devices, Apotekarsocieteten is your association.
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