PLANT SC 7250WT - Regulatory Approval for GM Plants
Waite Campus - Semester 2 - 2014
General Course Information
Course Code PLANT SC 7250WT Course Regulatory Approval for GM Plants Coordinating Unit School of Agriculture, Food and Wine Term Semester 2 Level Postgraduate Coursework Location/s Waite Campus Units 3 Contact Up to 15 hours per week for 3 weeks Assumed Knowledge PLANT SC 7225WT Course Description Plant biotechnology is widely viewed as a key tool in ensuring world food security. However, throughout the world, the use and access of the technology is subject to strict legislative restrictions and regulatory oversight. This course will examine the various requirements and processes related to commercialisation of materials generated by plant biotechnology necessary to remain compliant within regulatory frameworks. The regulatory requirements of plant biotechnology both within Australia and overseas will be covered and discussed in conjunction with related regulation on quarantine and food safety. This course will also consider the management of plant biotechnology development.
A key intended learning outcome is to develop a solid grounding in the processes and requirements imposed by the various regulatory authorities to allow the practitioners of plant biotechnology to bring a product to the market place.
Course Coordinator: Professor Mike Wilkinson
The full timetable of all activities for this course can be accessed from Course Planner.This course is a short intensive course that runs over three weeks and will be delivered by the following means:
5 lectures of 1 hour each per week
2 class exercise (6h per week total)
2 tutorials of 2h per week
Course Learning OutcomesSuccessful students will be able to:
Discuss and analyse Australian and international approaches to the regulation and management of plant biotechnology and evaluate the strengths and weaknesses of different legislative approaches.
2 Understand and evaluate the impact of international treaties, legislation and protocols on management of plant biotechnology. 3 Understanding of the scientific principles underpinning the regulation 4 Design and manage data generation leading towards the deregulation of transgenic plants 5 Apply their knowledge to practical problems in management or regulation of plant biotechnology
University Graduate Attributes
This course will provide students with an opportunity to develop the Graduate Attribute(s) specified below:
University Graduate Attribute Course Learning Outcome(s) Knowledge and understanding of the content and techniques of a chosen discipline at advanced levels that are internationally recognised. 1,2,3,4,5 The ability to locate, analyse, evaluate and synthesise information from a wide variety of sources in a planned and timely manner. 4,5 An ability to apply effective, creative and innovative solutions, both independently and cooperatively, to current and future problems. 4,5 Skills of a high order in interpersonal understanding, teamwork and communication. 4,5 A proficiency in the appropriate use of contemporary technologies. 1,2,4,5 A commitment to continuous learning and the capacity to maintain intellectual curiosity throughout life. 3 A commitment to the highest standards of professional endeavour and the ability to take a leadership role in the community. 5 An awareness of ethical, social and cultural issues within a global context and their importance in the exercise of professional skills and responsibilities. 1,2
Required ResourcesThis course will require the following texts and other resources:
ICGEB collection of Biosafety reviews
Online LearningOn-line resources (BCH, web sites of national competent authorities, OECD website, ICGEB).
Learning & Teaching Activities
Learning & Teaching ModesThis course is a short intensive course that runs over three weeks and will be delivered by the following means:
5 lectures of 1 hour each per week
2 class exercise (6h per week total)
2 tutorials of 2h per week
The information below is provided as a guide to assist students in engaging appropriately with the course requirements.This course will require approximately 156 hours comprising scheduled contact time and private study.
Learning Activities SummaryThe course content will include the following:
Week 1 Legislative context:
• Protection of germplasm and IP – Patents; copyrights; plant breeders’ rights; traditional knowledge
• Regulatory framework and requirements in Australia
• Cartagena Protocol on Biosafety and its requirements
• Regulation in other parts of the world
• International standards for dossier compilation (Familiarity, Substantial Equivalence, ERA)
• Patent searching; Accessing and utilising germplasm databases
• Description of biosafety activity in named countries based on information retrieved from Biosafety Clearing House
• Presentation on the reconstruction of the history of an event (from development to proposed introduction into a named territory) using the BCH and other internet resources
Week 2 Principles of Risk Analysis:
• Problem formulation
• Risk Assessment
• Risk Management and compliance
• Risk Communication
• Dossier compilation for submission to regulators
• Compile application for confined field trials
• Scope information needs for named deregulations
• Written report: partial dossier compilation for release of a named event in a country other than Australia
Week 3 Implementation:
• Generating risk scenarios and risk hypotheses
• Gap analysis
• Tiered risk assessment
• Dossier-relevant data gathering from confined field trials
• Effective testing of risk hypotheses
• Visit to a plant breeding program to examine its structure and management
• Visit to a food processing organisation
• Case studies: using substantial equivalence as a baseline for food safety
• Design of CFTs to optimise plant characterisation
• Written scoping plan to compile a complete deregulation dossier
Class exercise/tutorial report:
• Written report on class exercises/tutorials will be compiled by each student
The University's policy on Assessment for Coursework Programs is based on the following four principles:
- Assessment must encourage and reinforce learning.
- Assessment must enable robust and fair judgements about student performance.
- Assessment practices must be fair and equitable to students and give them the opportunity to demonstrate what they have learned.
- Assessment must maintain academic standards.
Assessment Task Task Type Weighting Learning Outcome Group Assignment 1, retracing history of an event) Formative/Diagnostic 20% 1,2 Individual Assignment (Partial Dossier report) Formative & Summative 20% 1,3,4,5 Individual Assignment (Dossier scoping plan) Summative 30% 1,2,3,4,5 Reports on class exercises Summative 30% 1,2,3,4,5
Assessment DetailGroup Assignment (retracing the history of an event using authorised internet resources): (20% of total course grade). In this problem-solving task, the students will use critical thinking and understanding of the e-resources and regulatory processes to retrace the history of a real event as if it were to be imported into a named country under the Cartagena Protocol. The students will prepare and deliver an oral presentation followed by questions and answers. The presentation will be embedded in a tutorial and they will receive instant feedback.
Individual Assignment (partial dossier report): (20% of total: 1000-1500 words). Written reports representing a section of a dossier (as compiled by notifiers) will be handed in at the end of the week and rapidly assessed for content and relevance to regulatory obligations. This report will integrate the various elements of the course (scientific basis underpinning regulation, the regulatory process and data gathering and interpretation) to assemble a key section of a dossier in a suitable form for regulatory oversight.
Students will receive written feedback within 3 days of the assessment.
Individual Assignment (Scoping dossier report 1000-1500 words):(30% of total). In this exercise, the student will compile and order all of the key elements required to assemble a complete dossier in support of deregulation of a GM crop within a named country. This will require creative thinking (problem formulation) integrated with the structural and regulatory elements required by the relevant regulatory authority. Written feedback will be given within 5 days.
Class Exercise and Tutorial Report (30% of total:1000-1500 words) : Here the students will be expected to retrieve the essential elements of each of the exercises into a coherent and integrated report relating to the vital information for inclusion in a submission dossier. Feedback will be given within 5 days of completion.
No information currently available.
Grades for your performance in this course will be awarded in accordance with the following scheme:
M10 (Coursework Mark Scheme) Grade Mark Description FNS Fail No Submission F 1-49 Fail P 50-64 Pass C 65-74 Credit D 75-84 Distinction HD 85-100 High Distinction CN Continuing NFE No Formal Examination RP Result Pending
Further details of the grades/results can be obtained from Examinations.
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