| The Regulated Research & Development and Manufacturing Division |  |
The following were elected to guide the division for 2007/08.
| Chairman | Andrew King - Manager - Quality Assurance, Q-Pharm Pty Limited | A.King"-at-"qpharm.com.au |
| Committee: | Sharon Gould - Operations Manager, Dermcare-Vet Pty Ltd | sharon.gould"-at-"dermcare.com.au |
| Paul Salm - Director, Australian Bioanalytical Services | ausbio"-at-"hotmail.com | |
| Wendy Free FAOQ - Director, Quality Matters Safety Matters Pty Ltd | talktous"-at-"qualitymatterssafetymatters.com.au | |
| AOQ-QLD Representative | Mario Pennisi - AOQ-QLD | mario"-at-"aoq.org.au |
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2008
Date |
Meeting Type |
Speaker |
Location |
| September 11-Thursday | Technical Meeting | TBA | TBA |
| November 13-Thursday | Technical Meeting | TBA | TBA |
| November 19-Wednesday | Christmas Party | TBA | Cliftons, 288 Edward Street , Brisbane |
The objectives of the Division are:
-
To promote and contribute to the science, understanding and practice of Regulated Research & Development and Manufacturing;
-
To recognise and to advance the status of the natural persons engaged in Regulated Research & 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 & Development and Manufacturing;
-
To advise AOQ regarding the impact of relevant regulations on Regulated Research & Development and Manufacturing and assist AOQ as required with representing these interests to the wider community;
-
To assist AOQ in the fostering of mutually beneficial relationships with relevant quality assurance and quality management organisations.
* Note: To become a Regulated Research & Manufacturing and Manufacturing Division Member, you must first join AOQ. Join at www.aoq.org.au/join.htm or Download a Membership Application form at www.aoq.org.au/Membership-Application.pdf.
To join the Regulated Research & Development and Manufacturing Division (RRDM)
Download a Membership Application form at www.aoq.org.au/PDF/Membership-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 RRMM Division and mail or fax with your subscription to PO Box 15202, CITY EAST, QUEENSLAND 4002 OR Fax: 07 3816 2288.
Organisation |
Remarks |
| AUSTRALIA | |
APVMA www.apvma.gov.au |
Regulator of pesticides and veterinary medicines |
NATA www.nata.asn.au |
Regulator of GLP (OECD), laboratories. |
TGA www.tga.gov.au |
Various guidances: |
| OVERSEAS | |
ANVISA www.anvisa.gov.br/eng |
Brazilian regulator. |
EMEA www.emea.europa.eu |
European regulator |
FDA www.fda.gov |
US regulator. |
MHRA www.mhra.gov.uk |
UK regulator - therapeutics, GLP |
UKAS: www.ukas.com |
UK laboratories regulator |
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)
The RRDM Division will conduct an annual seminar/conference, of which RRDM 2008 was the first on 2nd July, 2008. The theme was:
"Applying Quality Science in the Real World"
Click here for a list, and links, to the presentations.
RRDM is the Regulated Research, Development and Manufacturing Division of Australian Organisation for Quality Inc (ABN 53 322 327 143)-AOQ-QLD.
RRDM 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 RRDM Division has particular interest in sharing expertise:
- RRDM regularly communicates with over 150 allied industry members, Australia wide.
- RRDM can provide professional expertise to industry and government bodies, new players and students.
- AOQ RRDM 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
RRDM Division seeks:
- To promote and contribute to the science, understanding and practice of Regulated Research & Development and Manufacturing;
- To recognise and to advance the status of the natural persons engaged in Regulated Research & 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 & Development and Manufacturing;
- To advise AOQ regarding the impact of relevant regulations on Regulated Research & Development and Manufacturing and assist AOQ as required with representing these interests to the wider community;
- To assist AOQ 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 RRDM 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
RRDM 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)
Margaret Britz, Executive Dean, Faculty of Science, QUT, The Deans Opening Remarks Bio Presentation
Mario Pennisi, CEO, Queensland Clinical Trials Network (QCTN), Applying Quality Science to the Real World Bio Presentation
Rowan Gilmore, Chief Executive Officer, Australian Institute for Commercialisation Overview on New Product Development Bio or Abstract Presentation
John Styzinski, Deputy Technical Manager, NATA, NATA R&D Accreditation Bio or Abstract Presentation
Brian Creese, Consultant in Preclinical Drug Development, Brian Creese Consulting, Preclinical Safety Studies of Experimental Medicines Bio or Abstract Presentation
Heather Worthey, Quality Assurance Manager, Health World Limited, GMP in Complimentary Manufacture Bio or Abstract Presentation
Andrew de Jager, Manager-Analytical Development, QPharm Pty Limited, The FDA Compliant Validation Bio 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 Sugar Bio or Abstract Presentation
Mario Pennisi, The AOQ/Progressing Business Institute Bio or Abstract Presentation