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Gold Award for Business Excellence

The Gold Awards for Business Excellence recognise and encourage organisations whose leadership and innovations have progressed them beyond Management System Certification to leading examples of best practice.

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The Pharmaceutical and Medical Devices Division

 

The The Pharmaceutical and Medical Devices Division

The contact for the Division is Mario Pennisi (mario@aoq.org.au)

Vision

The objectives of the Division are:

  1. To promote and contribute to the science, understanding and practice of the management of regulated research and development and manufacturing;

  2. To recognise and to advance the status of the natural persons engaged in regulated research and development and manufacturing;

  3. To disseminate knowledge of the science and practice of Regulated Research & Development and Manufacturing;

  4. To initiate, conduct, supervise, and assist in research and investigations into the science and practice of quality management, quality assurance and business excellence in regulated research and development and manufacturing;

  5. To advise AOQ and the Progressing Business Institute regarding the impact of relevant regulations on regulated research and development and manufacturing and assist AOQ and the Progressing Business Institute as required with representing these interests to the wider community;

  6. To assist AOQ and the Progressing Business Institute in the fostering of mutually beneficial relationships with relevant quality assurance and quality management organisations.

* Note: To become a Pharmaceutical and Medical Devices Division Member, please complete a Membership Application form at www.aoq.org.au/PBI-application.pdf.

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To join the Pharmaceutical and Medical Devices Division

Download a Membership Application form. If you or your company are a member of the Australian Organisation for Quality-Queensland Inc complete the personal details and the Pharmaceutical and Medical Devices Division section of the form and mail with your subscription to PO Box 15205, CITY EAST, QUEENSLAND 4002 OR email info@pbinstitute.net. If you or your company are not a member of the Australian Organisation for Quality-Queensland Inc you need to join. You can do this by fully completing the Membership Application Form for the Pharmaceutical and Medical Devices Division and mail or fax with your subscription to PO Box 15205, CITY EAST, QUEENSLAND 4002 OR email info@pbinstitute.net.

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Web Links

Organisation
Remarks
AUSTRALIA

APVMA www.apvma.gov.au

Regulator of pesticides and veterinary medicines

NATA www.nata.asn.au

Regulator of GLP (OECD), laboratories.
Many guidances for members & assessors.

TGA www.tga.gov.au

Various guidances:
Australian Clinical Trial Handbook

OVERSEAS

ANVISA www.anvisa.gov.br/eng

Brazilian regulator.
Includes guidance for BE trials.

EMEA www.emea.europa.eu

European regulator

FDA www.fda.gov

US regulator.
Many guidances for most GXPs

MHRA www.mhra.gov.uk

UK regulator - therapeutics, GLP

UKAS: www.ukas.com

UK laboratories regulator

Guidances

Not intended to be comprehensive. Difficult to order, eg:

Some regulators, such as FDA, NATA, TGA (above) have collections of guidances.

TGA note for guidance (ICH GCP with FDA notes)

Seminar

The Pharmaceutical and Medical Devices Division will conduct an annual seminar/conference.

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The Pharmaceutical and Medical Devices

The Pharmaceutical and Medical Devices Division of Progressing Business Institute.

The Pharmaceutical and Medical Devices Division leadership brings together the industry leaders who represent over 100 years combined expertise in the relevant disciplines.

The committee represents a wide range of industry groups; including professionals actively involved in Clinical Trials, Pharmaceutical Bio-analytical Processes, Veterinary Therapeutics, Good Manufacturing Practice & Regulatory Affairs and Quality Management, who also actively participate in allied industry associations including:

The Pharmaceutical and Medical Devices Division has particular interest in sharing expertise:

There are risks and benefits associated with every medication, and the Division recommends thorough investigation, definition and management of these key criteria using a number of internationally recognised quality management systems; including:

The Pharmaceutical and Medical Devices Division seeks:

Medicines design, research, development, assessment and manufacture uses sciences like microbiology, biotechnology, molecular biology, biochemistry, biophysics, pharmacy, genetics, and immunology as well as traditional learning in the attempt to develop products that can contribute to our improved quality of life, and is arguably the single largest sector employing Life Science graduates in Australia.

Over the last ~20 years there have been profound changes in medicines research, development, and manufacturing strategies. Codes of conduct have been introduced and prescribed quality standards and systems have been mandated. Significantly, the system developed in Australia, Good Manufacturing Practice has now been recognised as world's best practice, and has been adopted essentially unchanged to become the Guide to Good Manufacturing Practice for medicinal products, Pharmaceutical Inspection Cooperation Scheme (PIC/S). This system is recognised throughout Europe and Asia (essentially only the USA fails to recognise this system).

Queensland is home to a number of significant, research and manufacturing facilities in the southern hemisphere. Q-Pharm, Alphapharm, Healthworld, MediHerb, Panbio, as well a government based organisations such as TetraQ, QCTN, Biolab Incubator, and QUT's Institute for Health and Biomedical Innovation are some of the notable companies amongst them.

As well as these larger players there are a multitude of relatively unknown highly dynamic and innovative medical companies who design, manufacture and market medical products and therapeutic devices, worldwide.

Each of these companies competes in some way, whether it is for market share or more recently, for skilled employees. The Pharmaceutical and Medical Devices Division provides the forum for common ground, in the shared need for internationally recognised and regulated, Quality Management Systems.

AOQ has a demonstrable track record in providing mentors to University student programs and can provide human resources for guest lecturing and/or mentoring programs with current, relevant expertise in (for example):

The Pharmaceutical and Medical Devices Division recognises the potential for allied expertise in arenas such as Food Technology, Business Management and Environmental Technologies to be included within the scope of this industry focus.

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Past Events with Links to Presentations

Mario Pennisi, Chief Executive Officer, QCTN, Building Quality into Highly Regulated Industries, 2nd August, 2007 (This is 1.2 Mb file)

RRDM2008-2nd July, 2008

Margaret Britz, Executive Dean, Faculty of Science, QUT, The Deans Opening RemarksBio Presentation

Mario Pennisi, CEO, Queensland Clinical Trials Network (QCTN), Applying Quality Science to the Real WorldBio Presentation

Rowan Gilmore, Chief Executive Officer, Australian Institute for Commercialisation Overview on New Product DevelopmentBio or Abstract Presentation

John Styzinski, Deputy Technical Manager, NATA, NATA R&D AccreditationBio or Abstract Presentation

Brian Creese, Consultant in Preclinical Drug Development, Brian Creese Consulting, Preclinical Safety Studies of Experimental MedicinesBio or Abstract Presentation

Heather Worthey, Quality Assurance Manager, Health World Limited, GMP in Complimentary ManufactureBio or Abstract Presentation

Andrew de Jager, Manager-Analytical Development, QPharm Pty Limited, The FDA Compliant ValidationBio or Abstract Presentation and Paul Taylor, Director, Australian Bioanalytical Services Pty Ltd The Fitness of Purpose of Analytical Methods Bio or Abstract

Smith, James, Senior Lecturer, Queensland University of Technology, Faculty of Science, School of Life Sciences, Quality Systems Education within University Science, Bio or Abstract Presentation

Ted Plum, Operations Manager, Alkaloids of Australia Pty Ltd, Manufacture of API's in SugarBio or Abstract Presentation

Mario Pennisi, The AOQ/Progressing Business InstituteBio or Abstract Presentation

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