Marketing Authorization
At the marketing authorization stage, regulatory authorities evaluate the complete body of evidence generated during development, including quality, non-clinical, and clinical data. The goal is to demonstrate that the ATMP meets the required standards for quality, safety, and efficacy and that its benefits outweigh any potential risks. A successful evaluation results in authorization to place the therapy on the market, enabling the next steps toward patient access and commercialization.
User guide for micro, small and medium-sized enterprises
EMA - The guide helps companies navigate the regulatory requirements and incentives available throughout a medicine's product lifecycle. It provides an overview of procedures to support research and development activities, and improves understanding of what is needed to obtain a marketing authorisation in the European Union (EU) / European Economic Area (EEA).
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.
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 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.
CAT quarterly highlights and approved ATMPs – June 2026
This report provides information on Advanced Therapy Medicinal Products (ATMPs) approvals and extension of indications of authorised ATMPs, as well as statistical data on product-related activities. The period covered by this report is: March – May 2026.
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.