Clinical Development
In the clinical development stage, the ATMP is evaluated in human participants to generate evidence of its safety and therapeutic benefit. Clinical studies are designed to understand how the treatment performs in patients, identify potential risks, and determine appropriate dosing and administration strategies. This stage also involves collecting data to demonstrate that the therapy provides meaningful clinical benefit (potency) while continuing to build the quality, safety, and efficacy profile required for regulatory approval.
Dastex Group GmbH
Dastex Group ensures contamination-free processes—with expert knowledge, innovative products and sustainable solutions for GMP cleanrooms. As leading provider in Europe, supporting you personally, practically and as a partner—from cleanroom clothing to cleaning solutions.
Doctoral student in Medical Science – CAR T cell therapy for B cell malignancies
Emilie in Toronto – Summer by Design
This June, Emilie Rickardsson Bergqvist participated in Summer by Design 2026 in Toronto, Canada, with support from SCALE. Emilie is a physician from Gothenburg specializing in Clinical Immunology and Transfusion Medicine.
VR as a training tool Evaluation
To better understand the potential of virtual reality as a training tool, SCALE conducted an independent evaluation of FourPlus Immersive VR training platform. Participants from both industry and academia tested laboratory and cleanroom training modules!
CTC
At CTC, clinical operations, recruitment, monitoring, data, safety and site delivery are connected within one organisation. This enables closer coordination across the study and provides sponsors with one partner across clinical trial delivery.
Vera CQ
Vera CQ is founded by colleagues who enjoy working together, every day. With a joyful, collaborative and solution-oriented approach, we provide expert support in GxP, training and audits, across the life science field.
Simsen Diagnostics
Ultra-sensitive ctDNA monitoring for your clinical trial, your laboratory, your patients. Delivered as a service from our EU lab, or run on your own instruments.
Getinge
Getinge is a global medtech company providing advanced manufacturing, cleanroom, and aseptic processing solutions that support the development and production of ATMPs, including cell and gene therapies.
Planning and conducting clinical trials of ATMPs
Welcome to a lecture regarding planning and implementation of clinical trials of ATMPs, an introduction to the special requirements, practical challenges and regulatory aspects that should be considered in clinical trials of advanced therapy drugs (ATMPs).
Introduction to ATMPs
In this course you will get a basic introduction to advanced therapies (ATMPs) based on cells, genes or tissue material. You will also get concrete examples of cell, gene and tissue therapies, which include CAR-T therapies. The course also describes what Sahlgrenska University Hospital’s and Västra Götaland Region’s work looks like today regarding ATMP therapies, market-approved ATMPs and clinical trials.
Guidelines on Good Clinical Practice specific to Advanced Therapy Medicinal Products
This training course is intended for professionals involved in conducting clinical trials with Advanced Therapy Medicinal Products (ATMPs). It complements the ICH-GCP guidelines by addressing specific requirements for clinical trials conducted with ATMP within the EU. This training course is based on the Guidelines on Good Clinical Practice specific to Advanced Therapy Medicinal Products.
Good Manufacturing Practice (GMP) for ATMPs – Practical Application
This training course is designed for individuals who will be involved in the manufacturing or handling of Advanced Therapy Medicinal Products (ATMPs) within a GMP-regulated environment. The course provides practical examples of how Good Manufacturing Practice (GMP) is applied to ATMPs and covers topics including aseptic processing, hand hygiene, cleanroom environments, gowning procedures, good documentation practices, as well as aseptic operations and cleaning in cleanrooms. The training is based on current EU GMP requirements and relevant ATMP-specific guidelines. A basic understanding of GMP, or experience working in a GMP-regulated environment, is advantageous.
Good Manufacturing Practice (GMP) for ATMP – Theory
This training is intended for individuals who will be involved in the manufacturing or handling of Advanced Therapy Medicinal Products (ATMPs) within a GMP-regulated environment. The course provides an introduction to ATMPs and the regulatory frameworks governing this field, with a focus on Good Manufacturing Practice (GMP) for conventional medicinal products and GMP for ATMPs.
ATMP, läkemedel för avancerade terapier
European Patients' Academy for Therapeutic Innovation Sverige erbjuder en gratis och webbaserad utbildning för dig som är patient, företrädare eller närstående. Här lär du dig mer om forskning och utveckling av läkemedel och medicinteknik. Du går utbildningen när det passar dig och behöver inte känna någon tidspress. Du får god kunskap om forskning och utveckling av läkemedel och medicinteknik, biobankning, precisionsmedicin, regulatoriska frågor, samt hälsoekonomiska prövningar och samverkansetik.
AstraZeneca
AstraZeneca is global pharma company with strong connection to Sweden through both big research and manufacturing sites. Their development of ATMPs includes CAR-T and TCR-T treatments, as well as drug delivery platforms. Their research as well as product development is spread out globally with over 80 000 employees over the world.
Gothia Forum
Clinical studies are essential for West Sweden to become a leading European life science cluster. We strengthen conditions for healthcare, academia, and industry to jointly develop tomorrow's treatments. Through professional research support, training, and clinical trial units, we enable research that reaches patients across the region. We are the Western healthcare region's node in Clinical Studies Sweden.
Cecilia Langenskiöld
Clinical activities focus on the application and implementation of advanced therapy medicinal products, including CAR-T cell therapies and virus-specific T-cell therapies. Work spans clinical studies, stem-cell transplantation, and the development of cellular immunotherapies for paediatric patients, contributing to the translation of emerging ATMP technologies into healthcare practice.
Laboratory methods for Advanced Therapy Medicinal Products (ATMP)
(BMA123) Ta chansen att lära dig mer om avancerade terapiläkemedel (ATMP). Kursen ger en introduktion till området och fokuserar på arbete enligt Good Manufactureing Practice (GMP) och kvalitetskontroll. Laboratoriemedicinska metoder som används för att säkerställa kvalitet, så som mikrobiologiska tester, tester av viabilitet med mera kommer går igenom. Kursen innehåller praktiska övningar och studiebesök. Föreläsningar på engelska kan förekomma.
Utveckling och användning av cell‑ och genterapier (ATMP) och dess regelverk
(ATM800) I denna kurs kommer ni att få en bred kunskap inom nya behandlingsmetoder/läkemedel som ingår inom begreppet ATMP (Advanced Therapies and Medicin Products) genom föreläsningar av specialister inom respektive fält.
Next-Generation Cell and Gene Therapies: Cancer and Beyond
The purpose of this course is to provide a comprehensive overview of next-generation cell and gene therapies and their potential to transform the treatment of cancer as well as other complex diseases. The participants will engage with the methods of cell and gene engineering through interactive toolbox sessions, facilitated in a flipped classroom format where students take the lead. Participants will gain an in-depth understanding of the principles and methods underlying cellular engineering, gene editing, and immunotherapy, while exploring how these technologies have evolved to address diverse medical challenges.
Immune, Gene and Cell Therapy
(3MG018) The course gives an overview of new and established treatments based on immune, gene and cell therapy. The course will discuss new opportunities as well as difficulties with these kinds of therapies. Some areas that will be at focus are transplantation of endocrine cells, immunotherapy of cancer and stem cell transplantation. The course is a seminar series consisting of ten meetings. The seminars will be held by scientists and/or medical doctors in the field.
Clinical Drug Development
(3KK005) This course provides you with a broad and deep knowledge of most stages in a drug's development from idea to the completed product. Special emphasis is placed on clinical trial methodology, where you will learn to plan a larger clinical trial. After completing the course, you should be able to work as a clinical trial associate or a similar position.
Pharmaceutical Protein Drug Development
Through the course, you will understand how to develop a protein-based biological drug further after the initial proposed design of the drug.
Regenerative Medicine
The course conveys the current knowledge, future potential use and development of regenerative medicine. Different stem cells, their biology and cellular programming are discussed, as well as tissue engineering, bioengineered cellular methods, next-generation biomaterials, and their applications in restoring damaged tissues and organs. Different stem cell therapies, cell and gene therapies, biobanking and in vitro differentiation of neural and myeloid stem cells will be illustrated.
GBA Key2Compliance
GBA Key2Compliance offers complete and optimised solutions within Regulatory compliance.
Verigraft
VERIGRAFT uses a proprietary patent-protected technology to make donated tissue resemble the patient’s own. This personalized tissue is tailored to the patient and can be implanted without rejection.
Drug discovery and development
ATMP session is included in this course. The course in Drug Discovery and Development aims to give you an overall understanding of the discovery and development of novel pharmaceuticals (drug discovery/development). It covers target selection, lead discovery/optimization, non-clinical in vitro/in vivo safety and efficacy studies, clinical trials, and market authorization. The course also highlights examples of existing drugs, how they have been developed, and their mechanisms of action.
Klinisk prövning av läkemedel för avancerad terapi (ATMP)
Kursen ger en översikt över relevanta regelverk för klinisk prövning av läkemedel för avancerad terapi (ATMP).
Regenerative Medicine and the Immune Microenvironment: A Synergistic Approach
(H5F6071) This advanced doctoral course offers a deep dive into the dynamic interplay between regenerative medicine and the immune microenvironment. By integrating cutting-edge insights from immunology and cell therapy, the course equips students with the tools to understand how immune responses can enhance or hinder tissue regeneration.
Drug Development
(CB2090) The lectures will cover a broad range of aspects of drug development. It will give current examples from the pharmaceutical industry and will mainly be given by invited guest lecturers.
Gene, cell and immunotherapy
The course content is based on, and is a specialisation of, previous knowledge in biochemistry, cell and molecular biology from the undergraduate programme. The course is divided into three fields, cell-, gene- and immunotherapy. The course includes diverse subjects such as Good manufacturing practice (GMP), Advanced Therapy Medicinal Products (ATMP), both viral and non-viral gene therapy, gene editing, oligonucleotide- and mRNA treatments, genetically modified cells and antibodies that influence the immune system. Diagnostics methods connected to the treatments will also be discussed.
From Research to ATMP Treatment – Process Development, Quality Assurance, Regulatory Affairs and Logistics
Take your expertise to the next level with this cutting-edge course in cell and gene therapy (ATMP) development and production. Gain a deep understanding of every step in the process, from designing and implementing standard operating procedures (SOPs) to ensuring product purity and function. Learn how to navigate the transition from pre-GMP to GMP, understand key regulatory requirements, and explore the legal landscape of ATMP products.
Lars Ny
Investigating tumor-infiltrating lymphocytes (TILs) as a personalized immunotherapy for patients with malignant melanoma. TILs are manufactured at the Cell and Tissue Laboratory, Sahlgrenska, and patients with ocular melanoma have received treatment in a completed Phase 1 HAITILs clinical trial. Process development is currently underway for the next clinical trial : Locoregional or Systemic Administration of Autologous Tumor Infiltrating Lymphocytes in Patients With Metastatic Melanoma (GoTIL-01), NCT07183852
CCRM Nordic
CCRM Nordic, based in Gothenburg, Sweden, supports academic, small, and large industrial ATMP developers to translate research and early-stage clinical programs into treatments for patients.