Meetings with stakeholders and other organisations

The Committee for Advanced Therapies (CAT) engages in active dialogue with its stakeholders in the field of advanced therapies, including industry, developers of medicines, academia, patients and clinicians.

This allows the exchange of scientific views and the further development of the regulatory framework for the authorisation of advanced therapy medicinal products (ATMPs). The Committee recognises the importance of dialogue and working relationships with its interested parties, in order to implement the ATMP legislation successfully.

Ad-hoc meetings and scientific workshops

The CAT organises ad-hoc meetings and workshops with academia, experts and developers to discuss and reflect on scientific and regulatory considerations and challenges for novel products and technologies in the fast evolving field of ATMPs.

The CAT held workshops or ad-hoc expert meetings on the following topics:

• Expert meeting on genome editing technologies used in medicine development (18/10/2018)
• Expert meeting on scientific and regulatory considerations for adeno-associated viral vector (AVV)-based gene therapy (6/9/2017)
  • Meeting report: Scientific and regulatory considerations for AAV-based gene therapy
• CAT workshop on genetically modified cell-based cancer immunotherapies (15 – 16/11/2015)
• CAT workshop in collaboration with Biologics and Cell-therapy Working Party on Stem cell-based therapies (10/5/2010)

Interested parties

The CAT has established a list of its interested parties as a permanent forum for interaction between the Committee and its stakeholders.

The Committee interacts with these organisations in a variety of ways, such as:

• allowing their participation in CAT hearings, such as an annual general hearing or ad-hoc topic-specific hearings;
• consulting with them proactively on guidelines under development.

The CAT's interested parties are defined as not-for-profit, European or international organisations in the field of advanced therapies. They include organisations representing industry, research groups, academia, patients, consumers or healthcare professionals, and can be general umbrella organisations or organisations with a focus on a specific disease, therapeutic area or category of ATMPs, such as gene therapy, cell therapy, tissue engineering, regenerative medicine or stem cells.

Meetings with interested parties

The CAT holds general hearings with interested parties. It also hosts focus group meetings with its interested parties:

• Minutes of the CAT Interested Parties meeting with industry  (26/10/2021)
• Report from CAT meeting with interested parties (11/12/2014)
• Report from CAT Interested Parties' Focus Group on non-clinical development of ATMPs (11/10/2012)
• Action plan on activities proposed by CAT-IP Focus Group on non-clinical development of ATMPs (24/9/2012)
• Report from CAT Interested Parties' Focus Group on incentives for academia, hospitals, charities developing ATMPs (15/9/2011)
• Report from CAT Interested Parties' Focus Group on system to navigate guidelines for ATMPs (12/5/2011)
• Report from CAT-Interested Parties' Focus Groups on non-clinical development of ATMPs (9/2/2011)

How to get involved

Any organisation is welcome to express its interest in participating in the activities of the CAT. Successful applicants will be added to the list of interested parties to CAT.

The CAT has developed a questionnaire to collect the information necessary to evaluate the eligibility of organisations:

• Download the questionnaire on eligibility to become an interested party to CAT .

All organisations applying must provide supporting information on their legitimacy, mission, objectives, activities, representation, structure, accountability and consultation modalities, and transparency.

The Agency will send an acknowledgment of receipt for each questionnaire, together with a timeframe for the evaluation of the request.

Other workshops and meetings

• CAT workshop in collaboration with German Society for Transfusion Medicine and Immunohaematology and German Stem Cell Network (11/9/2014)
• Council of Europe's European Directorate for the Quality of Medicines and Healthcare (EDQM) and European Medicines Agency joint meeting on raw materials used for the production of cell-based and gene-therapy products (2/4/2013)
• CAT workshop in collaboration with the Translational Centre for Regenerative Medicine Leipzig (23/10/2013)
• CAT workshop in collaboration with European Society of Gene and Cell Therapy (27/10/2011)
• First EMA Workshop on ATMPs (2/4/2009)