The Committee for Advanced Therapies' of the European Medicines Agency Reflection Paper on Management of Clinical Risks Deriving from Insertional Mutagenesis

Author:

Aiuti Alessandro123,Cossu Giulio45,de Felipe Pablo16,Galli Maria Cristina17,Narayanan Gopalan48,Renner Matthias19,Stahlbom Axel110,Schneider Christian K.41112,Voltz-Girolt Caroline1

Affiliation:

1. Gene Therapy Working Party of the Committee for Advanced Therapies, European Medicines Agency, 7, Westferry Circus E14 4HB, London, United Kingdom.

2. San Raffaele-Telethon Institute for Gene Therapy, Via Olgettina 58, 20132 Milan, Italy.

3. University Department of Pediatrics, Bambino Gesù Children's Hospital and Tor Vergata University, Rome, Italy.

4. Committee for Advanced Therapies, European Medicines Agency, 7, Westferry Circus E14 4HB, London, United Kingdom.

5. Department of Cell and Development Biology, University College London, Gower Street, London, WC1E 6BT United Kingdom.

6. Agencia Española de Medicamentos y Productos Sanitarios, Madrid, Spain.

7. Istituto Superiore di Sanità, Viale Regina Elena, 299, 00161 Rome, Italy.

8. Medicines and Healthcare Products Regulatory Agency, 151 Buckingham Palace Road, Victoria, London, SW1W 9SZ United Kingdom.

9. Paul-Ehrlich-Institut, Paul-Ehrlich-Str. 51-59, D-63225 Langen, Germany.

10. Läkemedelsverket (Medical Products Agency), Dag Hammarskjölds väg 42, 75103 Uppsala, Sweden.

11. Danish Health and Medicines Authority, Axel Heides Gade 1, 2300 Copenhagen, Denmark.

12. Twincore Centre for Experimental and Clinical Infection Research, Feodor-Lynen-Straße 730625 Hannover, Germany.

Publisher

Mary Ann Liebert Inc

Subject

Genetics (clinical)

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