2012 Sydney Preliminary Programme by ARCS Australia

SYDNEY Sydney Convention and Exhibition Centre 6-7 June 2012

| 31 sessions | 90 speakers | 5 streams • Asia Pacific • Clinical Research (including Study Coordinators) • Medical Affairs • Medical Information • Medical Writing • Pharmacovigilance • Workplace Management

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The changing face of therapeutics |

Sydney 2012 PRELIMINARY PROGRAMME & REGISTRATION Information Booklet

2 12 ARCS Scientific Congress

6-7 June, Sydney Convention and Exhibition Centre, Sydney

WELCOME The Changing Face of Therapeutics On behalf of the ARCS Conference Committee, the Board and the Business Office, I invite you to attend one of the foremost conferences for therapeutic development in Australia, the ARCS Annual Scientific Congress. 2012 sees a return to the Convention Centre venue at Darling Harbour and us again facilitating a very comprehensive programme of over 90 speakers and chairs for five concurrent sessions over the two conference days. These include many international and local speakers from industry, government, academia and hospitals, including key opinion leaders from hospitals and industry, state and federal government representatives, as well as specialists and consultants from the Pharma and Medical Devices industries. This year, we have continued to increase the breadth of offerings with streams of content for Clinical Research (Australia and Asia), Study Coordinators and Data Managers, Medical Affairs, Pharmacovigilance, Medical Writing, and Management. We had a strong increase in attendance last year and this year we hope to attract 700 of your peers and colleagues; it will definitely be the place to be! What is great about this event, is the value and engagement equation. ARCS congresses, through a process of selection and peer-review, seek to bring together a variety of speakers, sometimes with differing views and we offer all of our speakers and participants a neutral forum for the exchange of information to foster professional development. With ARCS being a not-for-profit charitable association, the value that we provide is high and to further this, we encourage you to register early or in groups to take advantage of the great early bird and group conference rates. I think that you will agree that this Preliminary Programme already looks fabulous, and we look forward to seeing you, your friends and colleagues on 6-7th June. Adrian Bootes, ARCS CEO

KEY DATES 26 March 2012 Extra Earlybird Discount Closes 16 April 2012 Earlybird Discount Closes 30 April 2012 No cancellations after 24 May 2012 Normal Registration Closes 28 May 2012 Congress 6-7 June 2012 Registrations Open

Exhibition Hours Wednesday 6 June 2012 Thursday 7 June 2012 Networking Function Wednesday 6 June 2012

8.30am – 7.00pm 8.00am – 3.30pm 6.00pm – 7.00pm

REGISTRATION FEES COB 16 April COB 30 April Extra-EarlyBird EarlyBird

COB 24 May Registration

24 May – 5 June Late Registration

Member 2 Day $945 $995 $1070 $1300 1 Day $695 $735 $800 $945 Student or Retired Member 2 Day $645 $685 $745 $995 1 Day $445 $480 $545 $680 Non-Member† 2 Day $1205 $1255 $1350 $1580 1 Day $870 $910 $985 $1135 Government, Hospital, Researcher, Coordinator or Academic Employee†* 2 Day $695 $735 $795 $1045 1 Day $495 $530 $595 $730 † Price includes ARCS membership. * Members and non-members employed in their primary role by a Government or Academic organisation are eligible for this rate.

SOCIAL PROGRAM

Masquerade Ball Date: Time: Venue:

Wednesday 6 June 2012 7.00pm – 11.00pm Sydney Convention and Exhibition Centre

Cost:

Included in both one and two day registrations. Please ensure you indicate if you will be attending this event when completing your online registration. Masquerade The theme for this year’s Gala Dinner will be masquerade, wear your finest mask to be in the running for one of the best dressed prizes. This fantastic evening of Venetian decadence will include a two course dinner, band and entertainment; do not miss out on the ARCS Sydney networking and social event of the year.

Dress: Details:

2 12 ARCS Scientific Congress

6-7 June, Sydney Convention and Exhibition Centre, Sydney

KEYNOTE SPEAKERS Professor Phil Aylward, Director of the Division of Medicine, Cardiac & Critical Care Services, Flinders Medical Centre

Monash University School of Public Health and Preventive Medicine and Chair, Alfred Ethics Committee

Chief Executive at Clinical Education and Training Institute NSW, Clinical Professor at University of Western Sydney and University of Sydney

Office of Product Review, TGA

Director of Regional Medical Affairs for Asia Pacific, Biogen Idec (Singapore) Pte Ltd

Professor John McNeil, Head,

Professor Steven Boyages,

Dr Jane Cook, Office Head,

Dr Werner Katzmann, Senior

Associate Professor Libby Roughead, School of Pharmacy and Medical Sciences, University of South Australia

Dr Brendan Shaw, Chief Executive, Medicines Australia

Siân Slade, Group Director, Global Core Content & Knowledge Management Bristol Myers Squibb USA

Deborah Monk, Director Innovation and Industry Policy, Medicines Australia

Dr Adrian Thomas, Head Global Market Dr Clive Morris, Head, Research Group, NHMRC

Access and Commercial Strategy Operations, Johnson and Johnson USA

Peter Wills AC, Chair NSW

Dr Tony Gill, Director,

Dr Harry Rothenfluh, Office

Experimental Products, TGA

Health and Medical Research Strategic Review

Head, Office of Medicines Authorisation, TGA

Dr Nik Zeps, Research Group

Dr Annette Katelaris, Editor,

Leader, St John of God Hospital Subiaco

Medical Journal of Australia

REGISTRATION INCLUSIONS Group Registrations Both Two & One Day Registrations Register five or more staff from the same organisation for any mixture of Congress registrations and receive 10% off Congress registration fees (excludes Membership fees where selected). Register twenty or more staff for a 15% discount. Delegates must work for the same organisation and pay on the one invoice. Please read the Registration Procedure information below for details of how to register as a group. Non Member Registration When registering for Congress at the Non-Member rate, delegates may elect to join ARCS Australia at no further cost. Membership to 30th June 2013 is included in a 2-day registration, and to 30th June 2012 in a 1-day registration.

Two Day Registration

One Day Registration

• Access to all Congress presentations (permission permitting) on the ARCS website • Admission to all Scientific Sessions • Admission to Trade Exhibition • Admission to the Congress Welcome Reception and Gala Dinner (Dinner RSVP required) • Delegate Satchel • Morning, Afternoon Tea and Lunch daily • Membership till 30th June 2013 (if selected)

• Access to all Congress presentations (permission permitting) on the ARCS website • Admission to all Scientific Sessions (for specified day) • Admission to Trade Exhibition (for specified day) • Admission to the Congress Welcome Reception and Gala Dinner (Dinner RSVP required) • Delegate Satchel • Morning, Afternoon Tea and Lunch (for specified day) • Membership till 30th June 2012 (if selected)

Changes To Your Registration Details Changes to your session preferences can be made on-line once you have completed your registration. A password will be emailed to you as part of your immediate confirmation. If you require changes for the social function then please contact the ARCS Business Office on 02 8905 0829. Please consider your registration preferences carefully during registration as sessions may fill.

For details on how to register please visit www.arcsconferences.com 26 March 2012 Registrations Open

To register please visit www.arcsconferences.com

PRELIMINARY PROGRAMME Time

7:30 - 8:30am 8.30 - 9.00am 9:00 - 11:00am

Day 1 Wednesday 6th June 2012

Session Information

Registration, Welcome Coffee & Trade Exhibition Welcome and opening of Sydney ARCS Congress W1 The changing face of therapeutics The local and global landscape for research, development and usage of new therapies is changing. A global ageing population, convergent and expensive technologies, slow global recovery, limited research dollars, evolving regulatory needs and other social and economic pressures are forcing many to evolve. This will require Global companies and Australian personnel to reconsider processes, access new fields and embrace change. This plenary session brings together leading figures who will discuss their observations of how people and processes are being harnessed to adapt to these challenges. Session chair: Adrian Bootes ARCS Australia

11:00 -11:30am 11:30 - 1:00pm

W3 eMedical Records - from theory to implementation Electronic Medical Records (EMR) are now standard in the majority of Australian public hospitals. At this session we will explore the progress of Electronic Health Record adoption in each Australian health jurisdiction and its implication on the source documents used in clinical trials. This session will also give participants an awareness of the quality requirements for electronic source data, privacy principles requirements and strategies to address noncompliance. Session chair: Tim Croft Take Control Technical Services Pty Ltd

W4 Investigational site hot topics Hot topics of interest to investigational sites covered in this session include, (1) integrating clinical research into already busy hospitals and working more effectively with other departments (2) a new system ensuring the smooth and easy transfer of images and documents to a central review system and (3) implementing a patient registration website to engage and recruit patients for clinical trials. Session chair: Miriam Dwyer Gallipoli Medical Research Foundation

W5 Is GCP relevant for device trials? This session will explore how the principles of GCP are applied in medical device trials under the ISO guidelines. When CRAs and PMs move from drug to medical devices trials they often try to apply ICH-GCP unaltered which can lead to roadblocks. In this session we will explore the main differences between ISO 14155:2011 and GCP, and how to address these roadblocks to ensure the success of device trials. Session chair: Cliff Spong MTAA

W6 The yin yang of trust: eight practical actions to enhance trust in clinical research from the Asia-Pacific region. Without trust in clinical research, patient care will not advance as it should. Trust in research from the Asia-Pacific region can be viewed in two ways; people trust it because they believe they should (the yin of trust) or because they know they can (the yang of trust). This session will highlight eight practical ways to increase the yang of trust. Session chair: Dr Renee Granger Eli Lilly Australia

1:00 - 2:30PM

Peter Wills AC, Chair NSW Health and Medical Research Strategic Review

Dr Adrian Thomas Head Global Market Access and Commercial Strategy Operations, Johnson and Johnson USA Prof Steven Boyages Chief Executive at Clinical Education and Training Institute NSW, Clinical Professor at University of Western Sydney and University of Sydney

Morning Tea & Trade Exhibition W2 Risk Management Plans - The Australian specific annex; what you need to know about Risk management plans (RMPs) have been implemented in Australia since April 2009. Recently the TGA has provided guidance on their expectations of the management of RMPs in Australia. This session will explore how specific companies have implemented the TGA requirements including the submission of the Australian specific annex. In addition, the TGA will provide feedback to Industry on their review of RMP submissions, highlighting specific areas of interest to the Australian regulator. Session chair: Karen Whitelock Novartis Pharmaceuticals

2:30 - 4:00PM

Speaker Information

Simon Little Novartis Pharmaceuticals Minhaj Obeidullah Sanofi Aventis Dr Jane Cook Office Head, Office of Product Review, TGA

NEHTA Representative GCP Auditor (Invited) Peter Maccallum Cancer Centre Representative

Cindy Hall Princess Alexander Hospital Deidre Cornes Trans-Tasman Radiation Oncology Group

Miriam Dwyer Gallipoli Medical Research Foundation

Catherine Bourgeois St Jude Medical Natalie Ruffles Medtronic Christy Thiel Smith & Nephew

Dr Julie Ely Proscribe Medical Communications

Dr Julie Newman Bristol-Myers Squibb Prof Karen Woolley ProScribe Medical Communications, University of Queensland, and University of the Sunshine Coast

Lunch & Trade Exhibition W7 Pharmacovigilance responsibilities one year post registration This session aims to be a stimulating discussion around adverse event (AE) reporting mechanisms, responsibilities and functions. Amgen recently launched two products into the Australian market and the safety department reviewed the AE reporting one year post launch. There was a wide variation in reporting of AEs by Health Care Providers (HCPs) and responding to information requests. This session aims to foster discussion and debate about mechanisms and explores three perspectives- the regulator, a quality use of medicines perspective and the role of the GP/clinician. Session chair: Dr Pat Thomas Amgen Australia

W8 “How do you decide when to monitor a clinical site? “What do I need to consider?” “What tools and how – face to face or remotely?” The paradigm shift to Risk Based Monitoring presents unique challenges for the monitor, the manager and the site staff. This session includes strategic approaches that have been implemented by different organisations to monitoring and data that supports the decision to monitor on or off site. The session also includes the investigational site perspective and ends with practical examples on how to implement in a study situation. Session chair: Katrina Campion GSK Australia

A/Prof Libby Roughead School of Pharmacy and Medical Sciences, University of South Australia Dr Gerard Cudmore General Practitioner, Northwest Health Dr Jane Cook Office Head, Office of Product Review, TGA

Sarahjane McIntyre, Quintiles Shannon Uren Peter Maccallum Cancer Centre

Sponsor perspective (Invited) Helen Monaghan George Clinical

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Session Information

Time Time

Day 1 Wednesday 6th June 2012

W9 Ethics roundup This session will focus on the current status of ethics in Australia and includes an update on the implementation of the Memorandum of Understanding, the role of the Australian Health Ethics Committee (AHEC) and the relationship to institutional HRECs and an overview of the functioning of a private ethics committee. Session chair: Despina Engwall ARCS Australia

Speaker Information Dr Nik Zeps Research Group Leader, St John of God Hospital Subiaco

Imelda Lynch Bellbery Limited MOU Representatives: Anne O’Neill NSW Ministry of Health Melissa Hagan Queensland Health Dr Suzanne Hasthorpe Department of Health Victoria

W10 To compare clinical trial capabilities between Australia and a number of Asian countries With the increasing role of Asia in early phase trials, this session explores the advantages and disadvantages of clinical trials in Australia and the Asia Pacific region and looks at ways that Australia could capitalise on advantages it has over Asia. During this session data from a recent survey will be presented and will conclude with a panel discussion on the capabilities of Australia and the Asia region in performing clinical trials. Session chair: Bernard Yau Synthes Asia Pacific

W11 What we've got here is a failure to communicate: how to improve your document review process The aims of this session are to explain why a strategic document review process is critical for document development, to define what a strategic document reviewer does, to explain how to create and adopt a style guide, and to provide some highly practical tips on how to improve your (and your organisation’s) document review process. If you have ever wondered what you should be doing when asked to review a document or felt frustrated by a review process, then this session is for you. Session chair: Dr Serina Stretton ProScribe Medical Communications

4:00 - 4:30pm 4:30 - 6:00pm

Kym Short Clinical Research Consultant Dr Lil Edis Novotech Dr Werner Katzmann Senior Director of Regional Medical Affairs for Asia Pacific, Biogen Idec (Singapore) Pte Ltd

Dr Serina Stretton ProScribe Medical Communications

Dr Rebecca Lew ProScribe Medical Communications

Dr Chris Wichems CSL Dr Harry Rothenfluh Office Head, Office of Medicines Authorisation, TGA

Session Informa

Afternoon Tea & Trade Exhibition W12 Paediatric research - what is different? Conducting clinical trials involving infants, children and young adults presents some unique ethical and operational challenges. Australia is currently involved in only a small proportion of paediatric research, conducted internationally, presenting an opportunity for growth. This session will provide some insight into paediatric trials with a view to increasing understanding of the ethical, consent, recruitment and operational considerations when running clinical trials involving this population group. Session chair: Dr Janelle Bowden The Children’s Hospital Westmead

W13 I wonder what happens to my trial data and what is my role in this beyond GCP compliance? This session will provide an insight into processes involved in registering a therapeutic product including providing an understanding of the quality and regulatory inputs involved in compiling a registration dossier together with the clinical evaluation process at the agency. It also aims to give an understanding of some of the key data elements in a clinical trial which have a major impact on the clinical evaluation of a drug and its eventual registration. Session chair: Dr Anne Altmann University of Melbourne

W14 Poster session For the first time within an ARCS Congress program, this poster presentation session will highlight examples of local research being undertaken by your colleagues. Each poster will be accompanied by a short presentation from the author followed by an opportunity to walk around and review the posters and speak to their authors. Session chair: Lukas Litewka St Vincent’s Hospital

W15 Understanding and managing different generations Understanding and managing the different generations has become such a hot topic with most workplaces having three generations of employees (the Baby Boomers, Gen X and Gen Y) working side-by-side. This session includes perspectives from manager from each generation, who will share and discuss the standard workplace traits attributed to their generation, and impart their experiences and lessons learned in managing and working with all three generations from their perspective. Session chair: Paula Mumby DOCS Global Resourcing

W16 Hot topics in therapeutics development This session will cover recent updates in therapeutics, with a summary of the research development task force outputs. We will hear from Medicines Australia about the new indemnity and clinical trial research agreements. We will also hear about the progress of building and working with clinical trial networks in Australia. And finally, we will catch up with the development of the clinical trial portal. Session chair: Dr David Lloyd Southern Star Research

6:00 - 7:00pm 7.00pm - 11.00pm

Welcome Reception & Trade Exhibition Congress Gala Dinner

Pathma D Joseph The Children’s Hospital at Westmead and Sydney Medical School

Righa Saroo Sydney Children’s Hospital Network Human Research Ethics Committee Dr Merle Spriggs Health Ethics & Policy and the Children’s Bioethics Centre, Murdoch Children’s Research Institute, Melbourne

Natasha Shackell Oracle HSGBU CSL Representative (Invited) Dr Anne Altmann University of Melbourne

Posters to be announced at a later date

Catherine Hubert Eli Lilly Dr Tamara Miller ICON Clinical Research Dr Marisa Petersen George Clinical

Deborah Monk Director Innovation and Industry Policy, Medicines Australia

Dr David Lloyd RDTF Taskforce Margaret Corcoran Department of Industry, Innovation, Science, Research and Tertiary Education

PRELIMINARY PROGRAMME Session Information

Time

Speaker Information

Registration, Welcome Coffee & Trade Exhibition

8:00am 9:00 - 10:00am

Day 2 Thursday 7th June 2012

Sub Plenary Ensuring public confidence in research results Public trust in medical research is essential. Without trust, why should the public fund research? Without trust, why should the public expect advances in patient care? In this session, two highly regarded speakers will share their views and evidence on research integrity and research governance. There are many steps in the research pathway where integrity can be compromised. The research community has put protective measures in place, but high profile cases of fraud and misinterpretation of data reinforce that these measures are insufficient. What more can be done and who should do it? Attend this session to find out, debate the concerns, and discuss the additional safeguards that might be coming our (your) way. Session chair: Karen Wooley ProScribe Medical Communications, University of Queensland, and University of the Sunshine Coast

10:00 -10:30am 10:30 - 12:00pm T2

Building the critical infrastructure in Australia for the conduct of clinical research

What new managers need to know (Part 1) Often people are promoted to management because they performed well in their specialist role, only to find that managing people requires a whole different set of skills, many of which they have not used before. This session will focus on the transition from being in a specialist role to that of a people manager. We will address the role of the manager (versus the role of the specialist), selecting staff leading, delegation, motivating your team, obligations of a manager under Australian law and how to prepare yourself for a management role. Session chair: Samantha Flynn ICON Clinical Research

Biologicals and biopharmaceuticals – an increasing role as therapeutic products Biological and Biopharmaceutical products are increasingly being introduced into the clinic as treatments for a broad range of indications. These products which include peptides, antibodies and cellular products raise significant issues in terms of development, manufacture, validation and regulatory approval. This session aims to provide an overview of the extent to which Biopharmaceuticals and Biologicals already play a role in patient treatment, and the complexities surrounding their delivery into the clinic. Session chair: Dr Belinda Kramer The Children’s Hospital Westmead

Strengthening thought leader (TL) engagement in a challenging environment This session will focus on opportunities to enhance thought leader engagement through a mutually beneficial relationship between the industry and the scientific/clinical environment. This session includes a strategic approach to TL engagement, compliance, TL engagement in the absence of new data and developing and maintaining relationships over time. We will also explore publication planning and address how to develop local publication plans that answer scientific questions and align to the overall global publication strategy. Session chair: Greta James Bayer Pharmaceuticals

12:00 - 1:00pm 1:30pm - 3:00pm T6

Clinical trial patient recruitment partnerships

Influence and negotiate with your project team members This session is focused on how to influence your global team, your sponsor, your site, your CRAs to achieve the best outcomes for the study and/or your site. Learn how to quickly identify the nature of resistance and be able to influence and negotiate with integrity and build great business relationships. It will include case studies focusing on a sponsor/CRO and site perspective. Session chair: Terri Davies ICON

School of Public Health and Preventive Medicine and Chair, Alfred Ethics Committee

Dr Clive Morris Head, Research Group, NHMRC

Dr Tony Gill Director, Experimental Products, TGA

A/Prof Lisa Askie NHMRC Clinical Trials Centre, Sydney Medical School, University of Sydney

Catherine O’Mahony On Q Recruitment Melanie Gentgall Pain and Anaesthesia Research Clinic

Amanda Jubb George Clinical Robert Kent St Vincent’s Health Andrew Taylor Roche Louise Hogan INC Research Nicola Chapman Boehringer Ingelheim Penny Field Bioregulatory Consulting Richard Makin Sydney Cell and Gene Therapy

Dr Belinda Kramer The Children’s Hospital Westmead

Dr Nicol Kurstjens Novartis Pharmaceuticals

Joel Barolsky Barolsky Advisors Dr Amanda Lowry Eli Lilly

Lunch & Trade Exhibition It is widely recognised that improving clinical trial patient recruitment is key for Australia to continue to be at the forefront of global clinical research. This session will highlight the “customer” requirements with the emphasis on hearing from patients and clinical trial site staff requirements in clinical trial recruitment. The session intends to provide a deeper understanding of stakeholder needs when planning for and executing recruitment plans and strategies. Session chair: David Wilks Bristol-Myers Squibb

Journal of Australia

Prof John McNeil Head, Monash University

Morning Tea & Trade Exhibition Ensuring Australia has the right infrastructure to conduct and attract clinical research has been the focus of a number of Federal and State based initiatives. This session including (1) Information on key NHMRC initiatives (including (HoMER) which impact researchers and sponsors in Australia (2) The new eCTN system being implemented by TGA (including a demonstration of the new system and guidance on its completion) and (3) An update on the use of the Australian New Zealand Clinical Trials Registry (ANZCTR) and its ongoing development. Session chair: Dr Joseph Badolato ARCS Australia

Dr Annette Katelaris Editor, Medical

What new managers need to know (Part 2) Continuation of session T3. Session chair: Samantha Flynn ICON Clinical Research

Barbara Yeung The Kirby Institute A/Prof Rupert Leong Concord and Bankstown Hospital

Cancer Voices NSW Representative

Diane Gatto Performance Leaders

Day 2 Thursday 7th June 2012 Time T9

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Session Information

Speaker Information

Globalising medical information - the changing world of medical information: one company’s experience

Bristol Myers Squibb speakers: Siân Slade Group Director, Global Core

Medical Information departments in Australia and worldwide have a responsibility to provide an immediate interface with the external world to healthcare professionals seeking information about company products. In this global world of ever increasing focus on health reform and immediate delivery of information whether by phone, online or through smart phones, it is imperative that companies are able to respond quickly to ensure factual knowledge transfer and ensure safe & appropriate use of medicines. During this session we will describe development of a Global Centre of Excellence with focus on developing foundational capabilities to ensure robust regional and market support and delivery in these changing times. Session chair: Rebecca Mascarenhas Pfizer

T10 Investigator initiated studies – their role and impact in a product lifecycle Pharmaceutical companies approve and fund investigator initiated studies (IIS) to achieve a number of clinical and company objectives, while building strong relationships with key opinion leaders (KOLs). The ultimate goal is publication to advance a drug’s — and the company’s — profile and credibility. This session will look at how companies align IIS with their strategy, manage risk and ethical considerations, as well as building collaborations with KOLs. Session chair: Andrew Corbett Eli Lilly Australia

3:00pm - 3:30pm 3:30 - 5:00pm

Content and Knowledge Management

Isobel Reid Director, Medical Information and Pharmacovigilance, Emerging Markets and Asia Pacific Mike Burman Director, Global Contact Centre

Dr Deon Gouws Janssen, Pharmaceutical Companies of Johnson and Johnson

Nicola Leaney Roche Products Prof Paul Mitchell Austin Health Melbourne (Invited)

Afternoon Tea & Trade Exhibition

T11 Research governance – what you can do to speed up your next approval Research governance over the last few years, has become a rate limiting step during the crucial start-up phase of clinical trials. In this session, we will set a hypothetical scenario of a study undergoing governance review. We will then hear from the different departments and stakeholders on their point of view on this study and what factors/issues they are looking at. Speakers will include those who fill the following positions: Hospital RGO, CRC, Pathology, Pharmacy, Sponsor and lawyer Session chair: Cindy Hall Princess Alexander Hospital

T12 Cardiology – what the future holds Heart failure treatment is one of the great success stories of the new millennium, but there is still a long way to go. This talk will outline achievements so far in heart failure management and what still needs. Advances and commercial success have not been realised due to not understanding heart failure. Acute Coronary Syndromes (ACS) includes a broad spectrum of cardiac conditions that represent one of the most common causes of acute medical admissions. Management of patients in the immediate and chronic phases of ACS has been in development for a number of years, but, what else can be done? Session chair: Kieran Loder Boehringer Ingelheim

T13 Developing people and managing individuals and team performance Managing employees and teams are universally cited by both new and experienced managers as the most challenging and rewarding aspects of their role. This session will cover increasing the level of engagement of your team, setting clear and inspirational direction, reducing the chance of underperformance in the first place and improving performance. Session chair: Liga Hegner GSK Medicines Research Unit

T14 How to manage operational change in the local sector; what factors to consider in dealing with impending change in the Medical Information sector. If you are a manager looking to maintain “business as usual” during mergers and redundancies or an employee taking control of your career, this session covers dealing with change. The processes, hurdles and learning from the restructure of two medical information departments will be discussed as a case study in change management. The data from 2012 ARCS Medical Information Interest Area survey data will also be presented (including insights and changes to the medical information sector). Session chair: Lisa Kalman Celgene, ARCS MI Interest Area Committee Co-Convenor

T15 Medical affairs hot topics Part 1 - The Sunshine Act- will it make it to the sunny shores of Australia? In 2013 new legislation, referred to as the Sunshine Act will come into full effect in the United States, requiring pharmaceutical, biotechnology and medical device companies to declare all payments and hospitality provided to doctors. This session will explore the potential impact of the Sunshine Act in the Australian setting and what would it mean for companies, the medical profession and most importantly patients?

Part 2 - Free online tools for identifying therapeutic area experts and target journals – ‘Do you get what you pay for?’ Within industry and academic environments, identifying therapeutic area experts and target journals is becoming increasingly important. This session will review the results from a study that compares six free online search tools. It will review the strengths and limitations of each tool and present results from a statistical analysis on the consistency among the tools for identifying leading experts and journals. Session chair: Karen Raines Medical Affairs Consultant and ARCS Trainer

5:00pm

Scientific Congress

Closing drinks

A selection of representative speakers from the following roles: Governance office Clinical research co-ordinator Sponsor Laboratory Pharmacy Legal

Dr Jo-Dee Lattimore Royal Prince Alfred Hospital

Prof Philip Aylward Director of the Division of Medicine, Cardiac & Critical Care Services, Flinders Medical Centre

Rod Matthews Impact Human Performance Technologies

Ameeta Nelson Sanofi Ryan Chang Astra Zeneca Amanda Jachowski ARCS Medical Information Interest Area Committee Co-Convenor

Dr Brendan Shaw CEO, Medicines Australia

David Herd GlaxoSmithKline, Australia Dr Julie Monk ProScribe Medical Company

The changing face of therapeutics

GENERAL INFORMATION VENUE: SYDNEY CONVENTION & EXHIBITION CENTRE, Darling Drive, Darling Harbour, Sydney The Sydney Convention and Exhibition Centre is located in the Darling Harbour area. A thriving precinct on the edge of Sydney’s central business district, Darling Harbour is home to some of Australia’s most significant tourist attractions as well as a myriad of restaurants, shops and hotels.

PUBLIC TRANSPORT: The Sydney Convention and Exhibition Centre can be accessed by monorail, lightrail, road or on foot from the city. The nearest train stations are Town Hall or Central Station and both stations are approximately a 10 minute walk from the venue. For more information about how to access the venue, visit www.131500.com.au.

PARKING: The Exhibition Centre car park is

FLIGHTS: If you are travelling from interstate

conveniently located off Darling Drive, underneath the Centre’s adjacent exhibition halls. The car park has direct access to the venue and the many attractions and facilities available in Darling Harbour. An all day pass is $32.00.

we recommend you visit the domestic airline websites of Qantas, JetStar and Virgin Blue. These carriers often have sale fares which could make your trip to Congress all the more affordable. Book early as flights can become expensive closer to the travel date.

ACCOMMODATION: ARCS Congress delegates should take advantage of the special rate we have with the Ibis at Darling Harbour by contacting the Reservations Department on +61 2 9288 7180 or 1757@accor.com and quoting ARCS050612. Rooms start at $159 a night for those that get in quick! A comprehensive list of hotels to suit a range of budgets are located within walking distance from the Sydney Convention and Exhibition Centre and can be found on the ARCS website under Conferences.