ACN - 101321555 Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

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Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

TGA Clinical trial arrangements0

Posted by Admin in on May 29, 2015
 

This TGA web site provides information, forms and resources relating to the TGA’s CTN and CTX schemes as well key information about the appropriate design, ethical review and conduct of clinical trials. It is essential reading for trial sponsors, clinicians, research ethics/governance officers and the members of ethics committees that review clinical trials.

Also included below are links to other useful TGA material.

Clinical trial arrangements
Human Research Ethics Committees and the therapeutic goods legislation
Access to unapproved therapeutic goods – Clinical trials in Australia

TGA Clinical efficacy and safety guidelines0

Posted by Admin in on May 29, 2015
 

The web page covers the matters discussed below.

Clinical pharmacology and pharmacokinetics
Alimentary tract and metabolism
Blood and blood-forming organs
Blood products (including biotech alternatives)
Cardiovascular system
Dermatologicals
Genito-urinary system and sex hormones
Anti-infectives for systemic use
Antineoplastic and immunomodulating agents
Rheumatology / musculoskeletal system
Nervous system
Respiratory system
Biostatistics
General
Radiopharmaceuticals and Diagnostic Agents
Allergy/Immunology

It also includes downloads and notes relating to:

Clinical pharmacology and pharmacokinetics

Alimentary tract and metabolism

Blood and blood-forming organs

Blood products (including biotech alternatives)

Cardiovascular system

Dermatologicals

Genito-urinary system and sex hormones

Anti-infectives for systemic use

Antineoplastic and immunomodulating agents

Rheumatology / musculoskeletal system

Nervous system

Respiratory system

Biostatistics

General

Radiopharmaceuticals and Diagnostic Agents

Allergy/Immunology

NOTE FOR GUIDANCE ON GOOD CLINICAL PRACTICE (CPMP/ICH/135/95) – Annotated with TGA comments0

Posted by Admin in on May 28, 2015
 

“The Note for Guidance on Good Clinical Practice (CPMP/ICH/135/95) is an internationally accepted standard for the designing, conducting, recording and reporting of clinical trials. These guidelines may be overridden by national legal requirements and the requirements of individual regulatory agencies as appropriate, to address matters relevant to local conditions or culture.

“In Australia, the National Health and Medical Research Council Act 1992 establishes the NHMRC as a statutory entity to pursue and foster issues relating to public health. The NHMRC is specifically required to issue guidelines for the conduct of medical research and ethical matters related to health. The National Statement on Ethical Conduct in Research Involving Humans (the National Statement) has been produced by the NHMRC as the Australian ethical standard against which all research involving humans, including clinical trials, are reviewed.

“The TGA has adopted CPMP/ICH/135/95 in principle, to replace the Guidelines for Good Clinical Research Practice (GCRP) in Australia, but at the same time has recognised that some elements are, by necessity, overridden by the National Statement (and therefore not adopted) and that others require explanation in terms of ‘local regulatory requirements’

The New Brunswick Declaration: A Declaration on Research Ethics, Integrity and Governance resulting from the 1st Ethics Rupture Summit0

Posted by Admin in on May 28, 2015
 

Fredericton, New Brunswick, Canada – The Ethics Rupture Summit was a gathering in October 2012 of researchers from Australia, Brazil, Canada, Italy, New Zealand, the United Kingdom and the United States, who are committed to enhancing ethical research practice, and supporting innovative alternatives to the regulation of research ethics that might achieve this end. The Declaration was developed through a consultative process following the Summit. Mark Israel and Martin Tolich from AHRECS and Will van den Hoonaard were members of the Working Party responsible for overseeing the drafting process and reaching consensus on the Declaration. Gary Allen and Colin Thomson from AHRECS were some of the many colleagues who provided feedback on the drafts.

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