ATMP

Results: 20



#Item
11Research / Health / European Union / Directive 2001/83/EC / Medicinal product / Medical device / European Directive on Traditional Herbal Medicinal Products / Clinical Trials Directive / Clinical research / Pharmaceuticals policy / Medicine

IN GENERAL Comment 1: The ATMP Regulation should urgently be revised to focus on delivering affordable therapies to all those who are in need, without necessarily “placing these products on the European market”. The

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Source URL: ec.europa.eu

Language: English - Date: 2013-10-09 09:02:50
12Pharmacology / Pharmaceutical industry / Biologic / Cell therapy / Marketing authorization / ATMP / Alternative medicine / Gene therapy / Regulatory requirement / Biology / Biotechnology / Pharmaceuticals policy

Public consultation on the regulation on advanced therapy medicinal products – Contribution from Biofarmind (Netherlands association of Biotechnological, Pharmaceutical and Life Sciences Industry) Biofarmind appreciate

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Source URL: ec.europa.eu

Language: English - Date: 2013-10-09 09:02:50
13Biotechnology / Pharmaceutical industry / Pharmaceuticals policy / European Medicines Agency / Cell therapy / Gene therapy / Alternative medicine / Supplementary protection certificate / Biology / Clinical research / Research

Responses from the ATMP Manufacturing Community (amc) to the Public Consultation Paper on the Regulation on Advanced Therapy Medicinal Products (Ref. Ares[removed][removed])

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Source URL: ec.europa.eu

Language: English - Date: 2013-10-09 09:02:20
14Clinical research / Pharmaceutical industry / Stem cells / Cell therapy / Validation / Food and Drug Administration / Tissue engineering / Clinical trial / Medical device / Biology / Cell biology / Biotechnology

EC REVIEW OF THE ATMP REGULATION – CELL THERAPY CATAPULT RESPONSES 1 Introduction It is clear from the very small number of MAA approved to date that the registration process for ATMPs is complex and not easily satisfi

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Source URL: ec.europa.eu

Language: English - Date: 2013-10-09 09:02:18
15Cell therapy / Pharmaceuticals policy / Clinical research / Biology / Biotechnology / Cell biology

EC REVIEW OF THE ATMP REGULATION – Scottish National Blood Transfusion Service / National Services Scotland RESPONSE

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Source URL: ec.europa.eu

Language: English - Date: 2013-10-09 09:02:48
16Health / Pharmaceuticals policy / Pharmaceutical industry / Design of experiments / Pharmacology / Clinical trial / Microdosing / ATMP / Cell therapy / Clinical research / Research / Biology

EMA Consultation on ATMP Comments from the Board of the European Society of Gene and Cell Therapy (ESGCT) by Luigi Naldini (President), Nathalie Cartier, Len Seymour. 2.1 MAA requirements As more ATMP may reach MAA it ma

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Source URL: ec.europa.eu

Language: English - Date: 2013-10-09 09:02:38
17Research / Pharmaceuticals policy / Pharmaceutical industry / European Medicines Agency / Pharmacovigilance / ATMP / Food and Drug Administration / Directive 2001/83/EC / Advances in Theoretical and Mathematical Physics / Pharmaceutical sciences / Pharmacology / Clinical research

[removed]BPI Comments Public Consultation ATMP Regulation

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Source URL: ec.europa.eu

Language: English - Date: 2013-10-09 09:02:18
18Biotechnology / Pharmacology / Clinical research / Pharmaceutical industry / Cell therapy / Clinical trial / Gene therapy / Pharmacovigilance / Alternative medicine / Biology / Medicine / Science

public consultation on ATMP regulation_AP-HP contribution

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Source URL: ec.europa.eu

Language: English - Date: 2013-10-09 09:02:31
19Research / Science / Pharmaceuticals policy / Pharmaceutical industry / Pharmacy / Clinical trial / Directive 2001/83/EC / Clinical research / Pharmaceutical sciences / Pharmacology

Co-ACT response to the European Commission’s invitation to submit comments as part of the public consultation on Regulation[removed] (“ATMP Regulation”) Co-ACT welcomes the initiative of the European Commission an

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Source URL: ec.europa.eu

Language: English - Date: 2013-10-09 09:02:34
20Transplantation medicine / Hematology / Hematopoietic stem cell transplantation / Lymphatic system / Surgical oncology / Biologic / Medicine / Biology / Stem cells

EBMT Contribution to Public Consultation ATMP[removed]

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Source URL: ec.europa.eu

Language: English - Date: 2013-10-09 09:02:34
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