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CliniGene - NoE

European Network for the advancement of Clinical Gene Transfer & Therapy : EC-NoE fostering interaction of all stakeholders in the field in order to facilitate and help harmonise Ethical, Quality, Efficacy and Regulatory Issues.

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    • CliniGene General Presentation
    • Technology platforms
    • Partners & Contacts
    • Publications from CliniGene partners
  • Facilities & Tools
    • GMP Manufacture of GT-Products
    • CliniGene clinical grade GMP registered partners
  • Regulation & Ethics
    • CliniGene comments on EU Guidelines
    • CliniGene publication related to regulation & ethics
    • National (member states, Israel & Switzerland)
    • US regulation
    • NIH guidance on informed consent for gene transfer research
    • EU reference texts in the area of ethics in research
    • International regulation
    • European Medicines Agency
    • CAT meetings
    • CAT Working Party
  • Quality & Safety
    • CliniGene publications related to Quality & Safety
    • Search selected Gene transfer & therapy references database
    • Search published human gene therapy clinical trials database
    • EU Clinical trials Inventory
    • Serious Adverse events related
    • GTSG – vector integration sites in chromosome
  • Meetings
    • Meetings
    • ESGCT annual meeting
    • ASGT meeting
    • Clinical Gene transfer & e-chips conferences
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Key information

EU key information

The European Commission

European Commission-Directorate General of Research

European Commission-Directorate General of Industry-Pharmacy : The European Agency for the Evaluation of Medicinal Products

The European Commission-Health and Consumer Protection Directorate General

EDQM, European Directorate for the Quality of Medicines

European Society of Gene and Cell Therapy (ESGCT)

 

US key information

American Society of Gene & Cell Therapy (ASGT)

National Institutes of Health

Office of Biotechnology Activities (NIH/OBA). National Centre for Biotechnology Information

GeMCRIS - Genetic Modification Clinical Research Information System

National Cancer Institute (NCI)-clinical trials

National Human Genome Research Institute (NHGRI)

FDA-CBER-OCTGT (Center for Biologics Evaluation & Research - Office of Cellular, Tissues & Gene Therapies)

 

International key information

ICH. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use

WHO : World Health Organization

 

EC Gene Transfer related Programmes

Baculogenes

Conticanet

Consert

DiMI – Diagnostic Molecular Imaging NoE

EVGN – European Vascular Genomics Network

Moleda

Persist

 

Literature

Cancer Gene Therapy

Current Gene Therapy

Current Molecular Medicine

Gene Therapy

Gene Therapy and Regulation

Gene Letter

Human Gene Therapy

Journal of Gene Medicine

Journal of Gene Therapy and Molecular Biology

Journal of Molecular Medicine

Journal of Virology

Molecular Therapy

Nature Medicine

Trends in Molecular Medicine

Williamsburg BioProcessing Foundation

 

Regulation

 

Please click her for more information

 

Bioethics

EGE: European Commission-European Group on Ethics in Science and New technology

IBC : Unesco International Bioethics Committee

 

IGBC : Intergovernmental Bioethics Committee

Unesco Bioethics Data-Base: The Bioethics Database was created in 1998 and is being updated since on a regular basis. It comprises more than 600 bioethics institutions (bioethics committees, commissions, training, research and documentation centres) in over 80 countries, including information on activities and publications.

 

Gene Therapy and Human Genetics Societies

American Society of Gene and Cell Therapy (ASGCT)

American Society of Human Genetics (ASHG)

Australasian Gene Therapy Society (AGTS)

Austrian Network for Gene Therapy (ANGT)

British Society for Gene Therapy (BSGT)

Dutch Society of Gene Therapy (NVGT)

European Life Sciences Forum (ELSF)

European Society for Animal Cell Technology (ESACT)

European Society of Gene and Cell Therapy (ESGCT)

European Society of Human Genetics (ESHG)

Finnish Society of Gene Therapy  (FGTS)

Francophone Society of Cellular and Gene Therapy (SFTCG)

German Gene Therapy Society (GGTS)

International Society for Cell and Gene Therapy of Cancer (ISCGT)

International Society for Stem Cell Research (ISSCR)

Israeli Society of Gene Therapy (ISGT)

Japan Society of Gene Therapy (JSGT)

Society for Molecular Imaging (SMI)

Society for the Inherited Metabolic Disorders (SIMD)

Society for the Study of Inborn Errors of Metabolism (SSIEM)

Swedish Society for Gene Therapy (SSGT)

Turkish Society of Gene and Cell Therapy

 

Gene Therapy Phrmaceuticals

Manufacture

EU academics

Please click here for more information

Commercial / Contract Companies

ACTIP : Animal Cell Technology Industrial Platform

Amsterdam Molecular Therapeutics

BioReliance

CellGenix

CellTec GmbH

Cliniporator

E.U.F.E.T.S

Eurogentec

Henogen-Novasep

Lonza

Molmed

PlasmidFactory

Qbiogene-Excell Biotech

Qiagen

Rentschler Biotechnologie

 

Quality and Safety Control - Contract Companies

Please click here for more information

 

Gene Therapy Pharmaceuticals - Pharmaceutical Products / Biotech and Pharma

Ark therapeutics

Advanced Cell & Gene Therapy-consulting

Biotechnology Industry organization (BIO)

Covance

Europa-Bio

European Biopharmaceutical Enterprises (EBE)

EFPIA : European Federation of Pharmaceutical Industries and associations

EU-Pharmakopeia : European Directorate on the Quality of Medicines (EDQM)

ICH. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use

Rentschler Biotechnologie

 

Disease-related sites

Cancer

Cancereurope/ Cancerworld : the web resource for health professionals/ the european cancer service website

Rare diseases

Orphanet : rare diseases and orphan drugs

 

Patient’s Association

Alliance Maladies Rares

BEUC : Bureau Europeen des Unions de Consommateurs

Directory of Online Genetic Support Groups

EATG : European Aids Treatment Group

ECL :European Cancer Leagues

EFNA : European Federation of Neurological Associations

EMEA/CPMP working group with patient’s organisations

EPF : European Patients’s Forum

EPHA :European Public Health Alliance

EPPOSI : European Platform for Patients’organisations, Science and Industry

Europa Donna : The European Breast Cancer Coalition

Eurordis : European Organisation for Rare Diseases

GIG :Genetic Interests Group

IAPO :International Alliance of Patients’ Organisations

 

Other Websites of interest

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    • Sixth Framework programme
      EC-09 research
      L5HB-CT-2006-010933