The Pharmaceutical and Medical Devices Division

	Current/Future Events	Membership Joining Information	Past Events	Vision
Web Links	Guidances	The PMD Division	Seminar

The The Pharmaceutical and Medical Devices Division

The contact for the Division is Jodi Martin (president-elect"-at-"aoq.org.au)
replace"at" with @ used to help reduce spam

VisionVision

The objectives of the Division are:

To promote and contribute to the science, understanding and practice of the management of regulated research and development and manufacturing;
To recognise and to advance the status of the natural persons engaged in regulated research and development and manufacturing;
To disseminate knowledge of the science and practice of Regulated Research & Development and Manufacturing;
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;
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;
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 Devicxes Division Member, please complete a Membership Application form at www.aoq.org.au/PBI-application.pdf .

To join the Pharmaceutical and Medical Devices Division

Download a Membership Application form at www.aoq.org.au/PBI-application.pdf . If you or your company are a member of the Australian Organisation for Quality in any State complete the personal details and the RRMM section of the form and mail or fax with your subscription to PO Box 15202, CITY EAST, QUEENSLAND 4002 OR Fax: 07 3816 2288.If you or your company are not a member of the Australian Organisation for Quality in any State you need to join. You can do this by completing the Membership Application form above for membership of the AOQ and for the Progressing Business Institute Division and mail or fax with your subscription to PO Box 15202, CITY EAST, QUEENSLAND 4002 OR Fax: 07 3816 2288.

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:

Computerised systems
GCP
GLP
GMP
R&D

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.

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:

Queensland Clinical Trials Network (QCTN)
Women In Biotechnology
Australian Society of Microbiologists, (Cosmetic & Pharmaceutical Special Interest Group)
AusBiotech
International Society for Pharmaceutical Engineering (ISPE)
Association of Therapeutic Goods Consultants
Australian Society of Cosmetic Chemists etc.

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

The Pharmaceutical and Medical Devices Division regularly communicates with over 150 allied industry members, Australia wide.
The Pharmaceutical and Medical Devices Division can provide professional expertise to industry and government bodies, new players and students.
The Pharmaceutical and Medical Devices Division brings together people who are passionate about their industry

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:

GRP Good Research Practice
GCP Good Clinical Practice
GCLP Good Clinical Laboratory Practice
GMP Good Manufacturing Practice
GLP Good (Analytical) Laboratory Practice

The Pharmaceutical and Medical Devices Division seeks:

To promote and contribute to the science, understanding and practice of he Pharmaceutical and Medical Devices industry.
To recognise and to advance the status of the natural persons engaged in Pharmaceutical and Medical Devices;
To disseminate knowledge of the science and practice of Pharmaceutical and Medical Devices;
To initiate, conduct, supervise, and assist in research and investigations into the science and practice of quality management, quality assurance and business excellence in Pharmaceutical and Medical Devices;
To advise AOQ and the Progressing Business Institute regarding the impact of relevant regulations on Pharmaceutical and Medical Devices and assist AOQ and the Progressing Business Institute as required with representing these interests to the wider community;
To assist AOQ and the Progressing Business Institute in the fostering of mutually beneficial relationships with relevant quality assurance and quality management organisations.

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):

Key Criteria for Turning Research into Medicine
Good Manufacturing Practice (Therapeutic Goods)
ISO 9001 / ISO 13485 (Medical Devices Manufacture)
Clinical Trials
Implementing Quality Management in Small & Medium Businesses
Contract Manufacturing
The Role the Therapeutic Goods Administration (TGA)
The Role of the Australian Pesticides Veterinary Manufacturers Authority (APVMA)
Technical Writing, including Standard Operating Procedures (SOPs)
Auditing Quality Systems
GMP Aspects of Herbal Manufacture
Qualification & Validation
Sampling of Starting materials for medicines manufacture
Microbial Aspects of GMP Pharmaceutical Manufacture
Regulatory Aspects of Medicines Manufacture

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.

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

Gold Award for Business Excellence

The Pharmaceutical and Medical Devices Division

The contact for the Division is Jodi Martin (president-elect"-at-"aoq.org.au) replace"at" with @ used to help reduce spam

VisionVision

To join the Pharmaceutical and Medical Devices Division

The contact for the Division is Jodi Martin (president-elect"-at-"aoq.org.au)
replace"at" with @ used to help reduce spam