Several cell and gene therapy products have made it to market with many more showing scientific promise. As more ATMPs progress through development, companies must prepare the regulatory material ready for approval. ATMP regulation training is vital to ensure professionals are equipped with the knowledge to interpret the difficult FDA and EMA guidelines with proficiency.
For those seeking US approval we deliver courses on FDA regulations, so you understand the requirements of the CBER and how they differ to the EMA. If you are looking to get a cell and gene product approved in Europe, you must understand the European ATMP requirements. We provide training on ATMP regulations and guidelines, so you have the skills to gain approval in Europe.
Courses we provide on CGT regulations: ATMP guidelines | EU submissions | FDA submissions | CMC regulatory | module 3 of the CTD
We provide both online and classroom training courses to support cell and gene regulatory professionals. Whether you are new to ATMPs or an experienced professional we have training courses that can support you in your career. All courses are carefully designed to improve performance back in the workplace. Our longer online and classroom courses include post learning support to help you apply your new skills back in the workplace.
Find a course relevant for you below. Click on a course you are interested in to learn more about the agenda, delivery format, trainer and price. If you would like to join the course you must enrol and pay through the website.
We support cell and gene regulatory leaders improve the technical skills and knowledge of their employees, so they are equipped to overcome challenges and meet business objectives. Working together, we design and deliver technical training courses that align with your learning requirements and business goals. For more information about how we can support your team please get in touch.
Could your regulatory team benefit from any of the courses listed above? Or maybe a topic which is not highlighted? We would be happ to discuss your objectives and see how we might be able to help.