Registry

Module Specifications

Current Academic Year 2012 - 2013
Please note that this information is subject to change.

Module Title	Professional Skills for Scientists
Module Code	BDI504
School	School of Biotechnology
Online Module Resources
Module Co-ordinator	Semester 1: Tatyana Devine Semester 2: Tatyana Devine Autumn: Tatyana Devine
Module Teacher	Tatyana Devine
NFQ level	8	Credit Rating	10
Pre-requisite	None
Co-requisite	None
Compatibles	None
Incompatibles	None

Description

In this module, students will participate in five two-day workshops in the following subject areas:1) Ethical principles and their application for the Diagnostic Industry.2) Legislation and Regulations affecting Biomedical Diagnostics.3) Research Commercialisation.4) Communication Skills for Researchers.5) An Introduction to Innovation & Entrepreneurship for Scientists.These workshops are designed:- to promote learning and discussion of these topics in detail- To demonstrate methods of practical application of the skills and principles underlying these topics- To facilitate interaction and exchange of ideas between the studentsEach workshop will be assessed by continuous assessment assignments specific to each area, including essays, patent searches, marketing plans and problem sets.

Learning Outcomes

1. Identify common types of ethical dilemmas in biomedical research and diagnostics.
2. Outline the main ethical theories and principles used to clarify and resolve ethical dilemmas, in particular, issues raised regarding diagnostic devices.
3. Outline the specific requirements and routes for obtaining approval in the US and Europe for the sale of IVD products.
4. Demonstrate an ability to use GMP in the laboratory and explain the legislation for this regarding medical devices.
5. Present multi-disciplinary scientific research effectively to both professional and lay audiences.
6. Debate some of the reasons why members of various groups of the public might be interested in being told about science.
7. Outline the fundamentals of intellectual property, including critical issues such as IP identification and protection.
8. Search for patents related to their research effectively.
9. Give an overview of the critical factors and key-decision-making criteria in the processes and pathways for successful commercialisation of technology.
10. Develop student’s creative thinking skills, in particular in the area of entrepreneurship and innovation.
11. Introduce students to the process of creativity and discovery in the science and technology field.

Workload	Full-time hours per semester
*Type*	*Hours*	*Description*
Lecturer-supervised learning (contact)	64	Workshop running time
Assignment	60	Assignments preparation
Directed learning	50	Reading material
Library	30	Literature/ Database searching
Group work	30	collaborative learning/group project
Examination	3	In-class test/ discussion
Total Workload: 237

All module information is indicative and subject to change. For further information,students are advised to refer to the University's Marks and Standards and Programme Specific Regulations at: http://www.dcu.ie/registry/examinations/index.shtml

Indicative Content and Learning Activities

Indicative Syllabus (workshop outline).
1) Ethical principles and their application for the Diagnostic Industry. Biomedical research touches people''s lives in many ways. Diagnostic devices will do more than just tell people whether they have, or are at some risk for, certain illnesses. It will force people to consider what they should do in response to this technology and the information it will produce. The realm of `should'' and `ought'' confronts people with ethical decisions: with what is right and wrong. This workshop will examine the role of ethics in health care and biomedical research. Those whose studies and careers have taken them into the sciences often have not had the opportunity to examine ethical issues and ways of making ethical decisions. This workshop provides students in the M.Sc. in Biomedical Diagnostics with such opportunities. An awareness of ethical issues will be generated through the use of literature (film clips, music, excerpts from novels, etc). This medium points to the everyday nature of ethics, the types of ethical decisions that impact everyone. Diagnostic devices and their potential impact on people will be examined to point out some of the principal ethical dilemmas they generate. This will lead into an examination of the ways arguments are presented to defend various perspectives and actions regarding these dilemmas. Principles of moral reasoning will be examined, leading to discussion of the ethical principles and theories used to organize ethical views. Case studies will be used throughout the workshop to exemplify and personalise the ethical decisions. These also will be used to give students opportunities to both reflect personally and to dialogue in small groups on the cases and issues.2) Legislation and Regulations affecting Biomedical DiagnosticsThe In Vitro Diagnostics industry is heavily regulated. As Europe and the US account for approximately 70% of the world-wide IVD market, the workshop will focus on the legislative and regulatory issues in these territories.In Europe, the In Vitro Diagnostic Medical Device Directive (VD Directive) governs the regulation of medical diagnostics across the EU and harmonises national legislation in EU member states with the objective of maintaining or improving the level of protection of its citizen''s health. In the US, the Food and Drinks Administration (FDA) is the government agency responsible for regulating IVDs. It determines whether new devices can enter the market and regulates product promotion (including product labelling). Before an in vitro diagnostic (IVD) can be placed on the market, the manufacturer must comply with a number of regulatory requirements set out by the regulatory bodies. The systems in the US and Europe differ in a number of aspects which can be critical in the development of a strategy to introduce a product into the market.Over the course of this workshop, we will examine the specific requirements of gaining approval to sell and market IVD''s in Europe and the US. The differences in the regulatory requirements in these territories will be highlighted and the specific route available and reasons for taking them will be will be investigated. In addition, the impact on the manufacturers organisation, in particular in terms of its operations and personnel will be examined. This will include an overview of quality systems including quality control and quality assurance and good manufacturing practice (GMP). In the US, clinical data may be required to support a product submission, and the requirements for this will be explored. In addition the specific requirements relating to point of care diagnostics in the US will be examined. Post-approval activities for manufacturers will also be examined - these include issues such as compliance and auditing.3) Research Commercialisation There is a growing emphasis on the commercialisation of the outputs of research.Universities are playing an increasingly important role in innovation and the transfer of new technologies into the commercial arena. Identification and protection of new technology, understanding how the technology meets a specific market need, identifying an appropriate commercialisation route and developing a strategy to achieve this are fundamental to successful technology transfer. The focus on the development of multidisciplinary research aligned with the significant increase in the level of outsourcing of corporate R&D has resulted in an increasing emphasis of collaborative research partnerships. In order for these partnerships to be successful, it is important to identify compatible partners who have appropriate, complimentary expertise and can work closely together.This workshop will provide an introduction to the fundamentals of intellectual property, including issues such as types of intellectual property (IP), identifying and protecting IP and the patenting process. In addition, it will provide an understanding of the needs and requirements relating to agreements and legal documents associated with research commercialisation such as confidentiality agreements and material transfer agreements.4) Communication Skills for Researchers(This workshop is based on research carried out the by the European Network of Science Communicators)The world of science is changing- as we make more and more discoveries that impact on people''s lives, the pressure on scientists to communicate effectively with those outside science in particular the public is increasing. We live in a time when we are constantly in contact with slick, professional communication - on the TV and radio, in newspapers, even on billboards. The stakes for communication have been well and truly raised.This does not need to be a problem. Excellent communication skills can be learned - and this is what this workshop is all about. Over the course of the workshop, we will look at the basics of good communication and try them out in a number of different contexts. Work will take place in small groups throughout- so everyone will have the chance to try out their new found skills in the safety of the workshop environment..

5: Innovation & Entrepreneurship.
This workshop will expose students to the entrepreneurial process and explore how companies and individuals take an idea from concept through to development and possible spin out formation..

Assessment Breakdown
Continuous Assessment	100%	Examination Weight	0%

Course Work Breakdown
Type	Description	% of total	Assessment Date
In Class Test	GMP training in-class test	20%	n/a
Assignment	Essay on ethical issues in diagnostics	20%	n/a
Assignment	Patent search and commercialisation problem sheet	20%	n/a
Assignment	Science communication assignment	20%	n/a
Assignment	Group case-study analysis of a Bioscience company	20%	n/a

Reassessment Requirement
Resit arrangements are explained by the following categories; 1 = A resit is available for all components of the module 2 = No resit is available for 100% continuous assessment module 3 = No resit is available for the continuous assessment component
This module is category 2

Indicative Reading List

Edward P.J. Corbett, Robert, J. Connors: 0, Classical Rhetoric for the Modern Student,
William Strunk and E.B White: 0, The Elements of Style,
John Bryant, Linda Baggott la Velle, John Searle Chichester (editors), Wiley.: 0, Bioethics for Scientists,
Ruth Ellen Bulger, Elizabeth Heitman, Stanley Joel Reiser (editors), Cambridge University Press: 0, The Ethical Dimensions of the Biological and Health Sciences,
Invent Centre, DCU: 0, Invent Commercialisation Handbook,

Other Resources

None

Array

Programme or List of Programmes

GTE

Graduate Training Elements (Non Award)

IFPBMD

Pre-Masters Intl. Foundation Programme

MBD

MSc in Biomedical Diagnostics

SHSAO

Study Abroad (Science & Health)