Dir 116 Risk Assessment and Risk Management Plan



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Abbreviations


ACT

Australian Capital Territory

the Act

Gene Technology Act 2000

APVMA

Australian Pesticides and Veterinary Medicines Authority

BHK21

immortalised baby hamster kidney cell line number 21

CCI

Confidential Commercial Information as declared under section 185 of the Gene Technology Act 2000

CD

Cluster of Differentiation

CTLA-4

Cytotoxic T-Lymphocyte Antigen 4 (also known as CD152)

CTN

Clinical trial notification

CTX

Clinical trial exemption

DAFF

Department of Agriculture, Fisheries and Forestry

DIR

Dealings Involving intentional Release

DNIR

Dealings Not Involving intentional Release

DNA

Deoxyribonucleic Acid

EEV

external enveloped virus

fowlpox

Fowlpox virus

FSANZ

Food Standards Australia New Zealand

GM

Genetically Modified

GM-CSF

Granulocyte macrophage-colony stimulating factor

GMO

Genetically Modified Organism

GTTAC

Gene Technology Technical Advisory Committee

HREC

Human Research Ethics Committee

HIV

Human immunodeficiency virus

IATA

International Air Transport Authority

ICAM-1

Intercellular adhesion molecule-1 (also known as CD54)

ICH

International Conference on Harmonisation

ICH-GCP

International Conference on Harmonisation Good Clinical Practice standard

IL

interleukin

IMV

internal mature virus

ITR

inverted terminal repetitions

kb

kilobase(s)

LFA-1

Leukocyte function associated antigen-1 (also known as CD18)

LFA-3

Leukocyte function associated antigen-3 (also known as CD58)

LGA

Local government area

Mac-1

macrophage adhesion ligand-1 (also known as Integrin alpha M (ITGAM), complement receptor 3 (CR3) and CD11B)

ml

millilitre

mRNA

Messenger Ribonucleic Acid

NHMRC

National Health and Medical Research Council

NSW

New South Wales

NICNAS

National Industrial Chemicals Notification and Assessment Scheme

NYCBH

New York City Board of Health

OGTR

Office of the Gene Technology Regulator

PC2

Physical containment level 2

PCR

Polymerase Chain Reaction

PPD

Pharmaceutical Product Development Australia Pty Ltd

PROSTVAC-F

Recombinant fowlpox virus that expresses human genes encoding B7.1, LFA-3, ICAM-1 and modified PSA (also referred to in this document as GM fowlpox)

PROSTVAC-V

Recombinant vaccinia virus that expresses human genes encoding B7.1, LFA-3, ICAM-1 and modified PSA (also referred to in this document as GM vaccinia)

PSA

prostate-specific antigen

QLD

Queensland

Q-PCR

Quantitative Polymerase Chain Reaction

RARMP

Risk Assessment and Risk Management Plan

the Regulations

Gene Technology Regulations 2001

the Regulator

Gene Technology Regulator

REV

Reticuloendotheliosis virus

RNA

Ribonucleic acid

SA

South Australia

TGA

Therapeutic Goods Administration

TNFα

Tumor necrosis factor alpha

TRICOM

Triad of co-stimulatory molecules

USA

United States of America

UV

Ultra violet

VIC

Victoria

VIG

Vaccinia hyperimmune gamma-globulin

vaccinia

Vaccinia virus

WA

Western Australia

WHO

World Health Organisation



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