Table of Content 1. Evaluation activities for human medicines... 2

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1 20 February 2015 EMA/CAT/611200/2014 Procedure Management & Business Support Division Table of Content 1. Evaluation activities for human medicines Pre-authorisation activities Initial-evaluation activities Other specialised areas and activities Horizontal activities and other areas Partners and stakeholders Churchill Place Canary Wharf London E14 5EU United Kingdom Telephone +44 (0) Facsimile +44 (0) Send a question via our website An agency of the European Union European Medicines Agency, Reproduction is authorised provided the source is acknowledged.

2 1. Evaluation activities for human medicines 1.1. Pre-authorisation activities CAT aims to help National Competent Authorities (NCA) to build up their expertise on Advanced Therapy Medicinal Products (ATMPs) and awareness of ATMP related procedures such as evaluation of marketing authorisation applications, certification and classification. Some NCAs have reported problems when having to decide if a product would fulfil the criteria of an ATMP (e.g. in the framework of a clinical trial application). To support NCAs, CAT plans to provide training to the NCA on the criteria to apply for the classification of ATMPs. The training will be based on the experience gained by CAT with classification of ATMPs over the last 5 years, as reflected in the CAT Reflection Paper on classification. To set up a 2/3 hour webinar-training session for staff from NCAs / NCA innovation offices involved in classification questions for ATMPs. The aim of this training is to increase harmonisation of the classification outcomes throughout the EU. Identify and agree date and time for the webinar. Prepare the content of the training programme and adoption by CAT. Hold the training / webinar. 100% completion by end of 4 Q 2015 EMA topic leader: P Celis ; CAT topic leader: N Ferry Other Committee participants: E Flory, M Timon Member N Ferry France Alternate E Flory Germany Alternate M Timon Spain EMA/CAT/611200/2014 Page 2/5

3 1.2. Initial-evaluation activities Assessors in the NCA play an essential role in the evaluation of marketing authorisation applications for ATMPs, either directly when they are part of the Rapporteur or CoRapporteur teams, or indirectly when commenting upon the Rapporteur or CoRapporteur Assessment reports. Not so many ATMPs have been reviewed in the centralised system, so the experience build in the NCA might not be extensive. CAT therefore wants to assist the NCA to build up their expertise in the field and plans therefore to organise an assessor training session open to all NCAs. The training will be based on the experience gained by CAT. Depending on the topic of the training, the assessor training can also be opened to GMP and GCP inspectors in the member states. To develop and hold an assessor training for the evaluation of applications for marketing authorisation and certification of ATMPs. Identify the topic(s) of the assessor training Identify and agree date and time for the training. Ensure incorporation of the CAT assessor training in the EMA Network training initiative Activities in 2016 Hold the assessor training 100% completion by end of 2 Q 2016 EMA topic leader: P Celis ; CAT topic leader: M Menezes-Ferreira Other Committee participants: Paula Salmikangas, Martina Schüßler-Lenz, Simona Badoi Alternate Margarida Menezes- Portugal Ferreira Member Martina Schüßler-Menz Germany Member Simona Badoi Romania EMA/CAT/611200/2014 Page 3/5

4 1.3. Other specialised areas and activities Understand trends in R&D of ATMPs via the analysis of EudraCT for the years 2010 to To extract information from EudraCT for the years using the same filters as used for the analysis for the years on: the profile of sponsor of clinical trials with ATMPs, the products under development, the indications investigated, etc. Compare the results with outcome of the EudraCT analysis for Analyse and compare the profile of ATMP developers and the ATMPs under development with that in non-eu regions/countries (e.g. USA, Canada). Extract the raw data from EudraCT with the help of the EMA colleagues in charge of the EudraCT database: by end of 1 Q 2015 Data cleaning, e.g. to remove duplicate entries (e.g. multi-country trials) and trials not related to ATMPs: by end of 2 Q 2015 Analysis of data: by end of 3 Q 2015 Report to CAT and prepare a publication: by end of 4 Q 2015 EMA topic leader: P Celis ; CAT topic leader: Ilona Reisch Other Committee participants: P Salmikangas, N Ferry, R Maciulaitis, M Menezes-Ferreira, D Sladowski, E French, M Lipucci, B Gänsbacher, T Boráň Member Ilona Reisch Austria Member Nicolas Ferry France Member Romaldas Maciulaitis Lithuania Member Dariusz Sladowski Poland Member Elaine French UK Member Michele Lipucci Patients Organisation Member Bernd Gänsbacher Doctors Organisation Alternate Margarida Menezes- Portugal Ferreira Member Tomáš Boráň Czech Republic EMA/CAT/611200/2014 Page 4/5

5 2. Horizontal activities and other areas 2.1. Partners and stakeholders Provide assistance to ATMP developers via the organisation of a scientific workshop in collaboration with a scientific society. One of the long-term objective of the CAT is to strengthen dialogue with stakeholders and provide tutorial training and workshops for ATMP developers. Such workshop took place in 2011, 2013 and In 2015, CAT plans to organise a fourth CAT workshop with a scientific society. On basis of contact with learned societies, a partner for a joint workshop will be selected not later than the beginning of A programme Committee with representative of the CAT, the scientific society and the EMA will be set up to develop the programme and to identify the presenters / speakers. The draft programme will be presented to the CAT in the 2 Q The CAT workshop will be held in the 2 nd half of EMA topic leader: P Celis ; CAT topic leader: Paula Salmikangas Other Committee participants: Dariusz Sladowski, Tiina Palomäki, Martina Schüßler-Lenz Member Dariusz Sladowski Poland Member Tiina Palomäki Finland Member Martina Schüßler-Lenz Germany EMA/CAT/611200/2014 Page 5/5