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Workshop I: Building and Assuring Quality in Clinical Trials - by Karen Pinto
Why do we audit? – to build and assure quality in our clinical trials. What audit tells us is how well the trial team, being the sponsor and the site, has completed its management and conduct of a trial in accordance with the protocol and regulatory requirements. An audit can tell us which practices and systems worked correctly and well and which didn’t. Review of where, how and why, errors and problems occur provides the opportunity to further improve the quality of our clinical trials and the research data they produce. Audits are primarily learning experiences. This workshop aims to encourage participants to think about building quality in to trials upfront, hopefully then making it easier to assure quality throughout a trial.
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Workshop II: Publishing clinical research: improving your chances of acceptance - by Amitabh Prakash & David Williamson
Participants will be able to learn the rules of engagement for journal editors, what the editors are looking for, and how to avoid a negative outcome. They will be given an overview of the editorial processes involved in medical publication and asked to participate in hands-on exercises. The workshop will cover language, grammar and style in scientific writing, preparation of a structured abstract and the peer review process.
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Workshop III: How Do I Get Out of Here? - Managemet of Conflicts - by Gunther Kothen
This workshop will explore the dynamic of conflicts, unsuccessful conflict resolution strategies and what successful conflict resolution models could look like.
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Workshop IV: Designing Patient Information Sheets - Does Anyone Speak Fluent Jargon? - by Stephanie Pollard & Martin Tolich
This workshop will discuss the requirements of patient information sheets and consent forms within the context of the informed consent discussion. It will focus on providing practical suggestions and exploring current patient preference research with the aim of designing written information sheets that deliver appropriate, understandable and patient centred information.
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Workshop V: Consenting to Medical Treatment: Legal Requirements vs Medical Practice - by Carol Peters
Patient consent is a means by which healthcare providers may lawfully justify “invading” the body of another. It is of the utmost importance serving to protect both the patient and the healthcare provider.
Participants at this workshop will: Explore the basic legal principles applicable to valid consents; discover common errors made by healthcare providers; identify the biggest risk factors for healthcare providers when obtaining patient consent; appreciate the impact that occupation, clinical experience and legal training has on actual knowledge of the law; and discuss possible solutions to improve healthcare providers’ access to the law.
Friday 29 August 2008 |
0800 - 0900 |
Registration |
0900 - 0915 |
Welcome - Chris Wynne & Conference Organising Committee |
0915 - 1000 |
Prospects for Clinical Research In NZ - Barry Snow |
1000 - 1030 |
The New Strategy for the HRC of NZ - Robin Olds |
1030 - 1100 |
The CoDa Story - Better Ways to Heal Wounds - Colin Green |
1100 - 1130 |
Morning Tea - sponsored by Quintiles |
1130 - 1200 |
Made in NZ - The Journey of a new compound - Michael Copeman |
1200 - 1230 |
Publishing Safety and Clinical Data - Navigating Through the Guidelines and the Ethical Issues - Rosie Stather |
1230 - 1330 |
Lunch - sponsored by Quintiles |
1330 - 1400 |
"Back to the Future" - Re-engineering Medsafe's approach to clinical trial regulation - Stewart Jessamine |
1400 - 1415 |
Ethics: National Application Form - What to Expect - Sally Cook |
1415 - 1430 |
Medical device R&D - Gordon Macdonald |
1430 - 1500 |
Fisher & Paykel Healthcare beyond the dish drawer - Michelle Eccleston |
1500 - 1530 |
Afternoon Tea - sponsored by Quintiles |
1530 - 1550 |
Too Good to be True !? - Suspicious Data - Karin Gruber |
1550 - 1620 |
Regulatory Authority Inspections - Lessons Learned - Tomasz Kurdziel |
1620 - 1640 |
Electronic Data - Friend or Foe? - Tim Croft |
1640 - 1700 |
Summary and Close - Chris Wynne & President NZACRes |
1700 - 2000 |
Music Entertainment & Drinks and Nibbles - sponsored by Wolters Kluwer Health/Adis |