Regulatory Affairs
Regulatory Affairs guides the ATMP development process by ensuring that activities align with regulatory requirements and expectations. Working across the product lifecycle, RA supports regulatory strategy, interactions with health authorities, and the preparation of submissions required to advance development milestones. By helping teams navigate an evolving regulatory landscape, RA facilitates efficient development and supports the generation of the evidence needed for clinical development, market authorization, and patient access.
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).
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).
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.
GBA Key2Compliance
GBA Key2Compliance offers complete and optimised solutions within Regulatory compliance.
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.