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

Overview: 

Advanced therapy medicinal products are human cells and tissues or products with a genetic mode of action; they generate huge expectations but are also associated to new significant threats including tumorigenicity, cell (de)differentiation, and patient integration.

The ATMP Regulation 1394/2007 aims to facilitate the patient access to these products and to foster the competitiveness of European pharmaceutical companies in the field, while guaranteeing the highest level of health protection for patients. ATMPs are pharmaceuticals with high complexity linked to their development, manufacturing, or administration process. The Regulation addresses the following points:

• Definition: ATMPs are gene therapy, somatic cell therapy, or tissue-engineered medicinal products.
• For Marketing Authorizations, the centralized procedure is mandatory. Because of the complexity of ATMPs, a Committee for Advanced Therapies (CAT) has been created. The CAT’s main responsibilities are:
• The evaluation of MA applications by providing opinions to the Committee for Medicinal Products for Human Use (CHMP); the CHMP may adopt or refuse the CAT opinion.
• The optional scientific certification of quality and non-clinical data of a proposed ATMP-compound in development.
• The optional scientific recommendation on ATMP-classification, prior to their clinical development.

Why should you Attend: 

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. 

As this is a new area, early contacts with the regulatory authorities are particularly important. There are a number of procedures available during the development of these products. These procedures are explained in this webinar. Companies can apply to the European Medicines Agency to determine whether a medicine they are developing is an advanced-therapy medicinal product (ATMP). The procedure allows them to receive certification that a medicine, based on genes, cells or tissues, meets the scientific criteria that define ATMPs. The European Medicines Agency's Committee for Advanced Therapies (CAT) provides a certification procedure for advanced-therapy medicinal products (ATMPs) under development by micro, small and medium-sized enterprises (SMEs). This is an opportunity for SMEs to get an assessment of the data they have generated and check that they are on the right track for successful development. 

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: