Webinar on Regulatory Aspects of Advanced Therapy Medicinal Products in the EU

Advanced-therapy medicinal products (ATMPs) are medicines for human use that are based on gene therapy, somatic-cell therapy or tissue engineering. They offer groundbreaking new opportunities for the treatment of disease and injury. 

The certification procedure involves the scientific evaluation of quality data and, when available, non-clinical data that SMEs have generated at any stage of the ATMP development process. It aims to identify any potential issues early on, so that these can be addressed prior to the submission of a marketing authorization application. After the assessment, the CAT may recommend issuing a certification confirming the extent to which the available data comply with the standards that apply for evaluating a marketing authorization application. Following the CAT recommendation, the Agency issues a certification. 

Areas Covered in the Session:

• Introduction
• Committee for Advanced Therapies (CAT)
• Stem cells
• Hospital exemption
• Relevant guidelines
• Scientific recommendation on classification
• Certification procedure

Who Will Benefit:

• Senior management
• Project Managers
• Medical writers
• CRAs and CRCs
• QA / Compliance personnel
• Investigators
• Clinical Research Scientists
• QA / QC Auditors and Staff
• Consultants

Speaker Profile: