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Professional Development in Therapeutics

CANBERRA

National Convention Centre

27-28 September 2012

80 speakers 30 sessions • • • • • •

Prescription Medicines OTC Medicines Medical Devices Regulatory Affairs Health Economics Quality and GMP

PRELIMINARY PROGRAMME & REGISTRATION

Information Booklet


27-28 September, National Convention Centre, Canberra

KEY DATES 25 June 2012 20 August 2012 3 September 2012

Regulatory, Health Economics and Quality Congress Canberra Convention Centre 27-28 September 2012 On behalf of the ARCS Conference Committee, the ARCS Board and the ARCS Business Office, I invite you and bid you welcome to our regulatory, health economics and quality congress for 2012, held once again at the Canberra Convention Centre. In the traditional of past years, and with the help of our volunteer experts, we have pulled together a strong programme for your consideration. Sessions include: - Multiple streams on regulatory matters for medicines and devices, local, regional and global - A strong health economics medicines and devices programme - A GMP/quality programme. Some of our many Australian and international confirmed speakers are as follows: - Dr John Skerritt the new National Manager, TGA - Dr Stewart Jessamine, Group Manager, Medsafe, NZ - Dr Suzanne Hill, Chair, PBAC - Prof Robyn Ward, Chair, MSAC - Mr Michael Gropp, Vice President Global Regulatory Strategy, Medtronic and Co-chair of the Global Medical Technology Alliance (GMTA) - Ms Jacqueline Minor, Director of Consumer Affairs, DG SANCO, European Commission - Mr Laurent Sellés Deputy Head of Unit Cosmetics and Medical Devices, European Commission - Mr Rico Schoeler, Manager, Analysis and Assessment, Pharmac, NZ - Mr Shane Porter, Assistant Secretary, Medicare Financing and Listing Branch, DoHA Overall we have approximately 80 speakers and 30 sessions, once again at not-for-profit rates, and over the next few weeks we will be adding some further details. We hope that you take advantage of these sessions and networking opportunities. On behalf of the Conference Committee and ARCS I also wish to invite you to the special conference dinner on the Thursday evening 27 September, which should be entertaining and a further great opportunity for networking! We hope to see you there.

21 September 2012 27-28 September 2012 3 September 2012

Thursday 27 September 2012 8.30am – 6.30pm Friday 28 September 2012 8.00am – 3.00pm Thursday 27 September 2012 5.30pm – 6.30pm Friday 28 September 2012 2.30pm – 3.00pm

REGISTRATION FEES COB 20 August Extra-EarlyBird

COB 3 September COB 21 September EarlyBird Registration

Member 2 Day $945 $995 $1095 1 Day $645 $685 $755 Student or Retired Member 2 Day $695 $745 $845 1 Day $445 $495 $565 Non-Member† 2 Day $1,245 $1,295 $1,395 1 Day $920 $960 $1,030 Government or Academic Member†* 2 Day $695 $745 $845 1 Day $445 $495 $565

22-26 September Late Registration

$1320 $965 $1,070 $765 $1,620 $1,240 $1,070 $765

† Price includes ARCS membership or associate membership where eligible. * Members and non-members employed in their primary role by a Government or Academic organisation are eligible for this rate.

Adrian Bootes, ARCS CEO

Professional Development in Therapeutics

To register please visit www.arcsconferences.com


27-28 September, National Convention Centre, Canberra

KEY NOTES Dr Richard Bartlett, First Assistant Secretary Medical Benefits

Professor Andrew McLachlan, Associate Dean (Research), Faculty of

Dr Jane Cook, Office Head, Office of Product Review, TGA

Pharmacy, University of Sydney and Chair, National Medicines Policy Committee

Professor Borje Darpo, Professor Cardiology, Karolinska Institute,

Sweden Elizabeth de Somer, Manager, Regulatory Affairs, Medicines Australia Judy Develin, Group Coordinator, Market Authorisation Group, TGA Dr Tony Gill, Director, Experimental Products Section, Office of Scientific

Evaluation, Market Authorisation Group, Acting Principal Medical Adviser, TGA

Jacqueline Minor, Director of Consumer Affairs DG SANCO, European

Commission Shane Porter, Acting First Assistant Secretary, Medicare Financing and

Listing Branch, Department of Health and Ageing Dr Harry Rothenfluh, TGA Rico Schoeler, Manager, Analysis and Assessment, PHARMAC

Michael Gropp, Vice President Global Regulatory Strategy, Medtronic and

Dr Deon Schoombie, CEO, ASMI

Co-chair of the Global Medical Technology Alliance (GMTA)

Laurent SellĂŠs, Deputy Head of Unit, Cosmetics and Medical Devices,

Jenny Hefford, Chief Regulatory Officer, TGA

European Commission

Dr Sue Hill, Chair PBAC

Dr John Skerritt, National Manager, TGA

Dr Stewart Jessamine, Group Manager, Medsafe

Professor Robyn Ward, Professor, Faculty of Medicine, UNSW, Chair of

Dr Larry Kelly, Chair, IMDRF

MSAC and member of PBAC

REGISTRATION INCLUSIONS

To register please visit www.arcsconferences.com


GENERAL INFORMATION VENUE: The National Convention Centre is the largest purpose-built meetings and events facility in the ACT. The Centre is conveniently located between Sydney and Melbourne and is a great destination for delegates with easy access via plane, bus, train or car.

PARKING: Parking for more than 400 cars is

REGISTRATION DESK: The Registration Desk will be located in the Main Foyer of the National Convention Centre and will be open from 8.00am to 5.00pm each day. Upon arrival on your first day, please report to the Registration Desk to receive your delegate satchel, name badge and social event ticket/s.

ACCOMMODATION: Crowne Plaza

available beneath the National Convention Centre currently at a cost of $13 per vehicle per day, or $7 per four hours or part thereof. The National Convention Centre car park can be entered off Constitution Avenue. Canberra is pleased to offer preferred accommodation rates to delegates attending the ARCS Conference. The following rooms are available at special rates: • Superior King Room Non Smoking, including full buffet breakfast for one $240

CONTINUING PROFESSIONAL EDUCATION (CPE) POINTS: Names will be recorded as you enter sessions to enable CPE points to be added to your record – please ensure you are wearing the correct name badge! See the Registration Desk for assistance.

PUBLIC TRANSPORT BUSES: Murrays coaches offer over 100 services a week from Sydney to Canberra. Go to www.murrays.com.au for more information or call 13 22 51. AIR: The National Convention Centre, situated in the city centre is just a ten-minute drive from the airport. We recommend you visit the domestic airline websites early to secure a cheaper fare. TRAINS: CountryLink offers two daily XPLORER rail services from Sydney to Canberra.

• Superior Twin Room Non Smoking, including full buffet breakfast for one $240 • Deluxe King Room Non Smoking, including full buffet breakfast for one $290

PRIVACY: ARCS is bound by the National Privacy Principles (NPPs) set out in the Privacy Amendment (Private Sector) Act 2000. ARCS will collect information provided in the Registration Form for the purposes of enabling us to register your attendance at the ARCS Scientific Congress (ASC), to assist with administrative purposes and for future planning and development of ARCS events, to facilitate your requirements in relation to the ASC and to allow the compilation and analysis of statistics. The information provided in the Registration Form and information provided at any other time during the ASC, including without limitation any feedback obtained during the ASC, will be used by ARCS to offer, provide and continue to improve its events and services. ARCS will publish information that is collected in the Registration Form in the Congress Delegate Listing available to delegates, sponsors and exhibitors at the conference. The information published will be limited to your name and organisation unless you indicate on the online application that you do not want this information shared. ARCS will not otherwise, without your consent, disclose your personal information for any purpose unless it would reasonably be expected that such purpose is related to the provision and improvement of ARCS events or where such purpose is permitted or required by law. DISCLAIMER: All information printed in this brochure is correct at the time of printing. This is a preliminary programme and some speakers and topics will be changed as it is finalised. ARCS Australia reserves the right to change the program and contents as necessary.

• Deluxe Twin Room Non Smoking, including full buffet breakfast for one $290 To make a booking please call 1300 662 218 1300 662 218 or 02 6247 8999 02 6247 8999 (dial zero and ask for In-house Reservations) Monday to Friday 9.00am – 5.00pm and quote the reservation code “ARD”. Reservations can also be made via reservations.cbrbs@ihg.com. Alternatively, for a comprehensive list of accommodation near the Centre please visit the Centre website at www.nccc.com.au/canberra/accommodation.html

EXHIBITORS AMS Laboratories/Lotus Technology Drink Bottle Sponsor

ARCS Australia Biotech Regulatory Solutions Digital Print Services eCTD Office Healthcare Placement Solutions OnQ Recruitment

Note Pad and Pen Sponsor

OPTUMInsights Pharmaceutical & Medical Professionals PharmOut Thomson Reuters

SPONSORSHIP, EXHIBITION AND ADVERTISING OPPORTUNITIES Would you like to see your company’s name associated with this event? Sponsorship, Exhibition and Advertising Opportunities are still available. For a copy of the Sponsorship and Exhibition Brochure please visit the ARCS Australia website at www.arcsconferences.com or call Berta Brein on 02 8905 0829.

Suite 802, 28 Clarke Street, Crows Nest NSW 2065 Phone: 02 8905 0829 Fax: 02 8905 0830 Email: asc@arcs.com.au Web: www.arcsconferences.com


PRELIMINARY PROGRAMME Session Information

Time

Speaker Information

Day 1 Thursday 27th September 2012 8:30 - 9.45am

Registration, Welcome Coffee & Trade Exhibition Welcome and opening remarks Adrian Bootes, ARCS Australia

9.45am

10.00 - 11:00am T1a Medsafe and the TGA – update and future directions Dr John Skerritt, the new TGA National Manager, speaks to ARCS members for the first time on both the progress of reforms and the future direction of the TGA. Dr Stewart Jessamine has kindly agreed to make a welcome return with a perspective and update on Medsafe from across the Tasman. The progress with ANZTPA will also be discussed. Session chair: Ailsa Surman Eli Lilly Australia

11.00 - 11.30am 11:30 - 1:00pm

T1b Access to medicines, devices and benefits - a fair and equitable balance

Session chair: Patrick Tung Merck Serono Australia

1:00 - 2.00pm

Dr Sue Hill, PBAC Dr Richard Bartlett, 1st Assistant Secretary Medical Benefits (invited) Peter Chesworth, Pharmaceuticals Industry Strategy and Environment Section, DIISRTE (invited) Prof Andrew McLachlan, National Medicines Policy

Lunch & Trade Exhibition T2

T3

Packaging and labelling of medicines - is a regulatory solution going to deliver what is desired?

Anne Mackenzie, Consumer Advocate,

The request from consumers, prescribers, and academics is to reduce the number of avoidable medication errors that are directly caused by inadequate manufacturers labelling and packaging. Is this an achievable goal and what are the multi factorial causes of medication error? Where do we start and where to next i.e. dispensing labelling practices? Session chair: Michael Parker Astra Zeneca

Rebecca Doolan, TGA Elizabeth de Somer, Medicines Australia

Immunogenicity of therapeutic peptides: regulatory science implications

Penny Field, Bioregulatory Consulting Dr Jill Conner, Teva Pharmaceutical USA, Nena Waight-Sharma, TGA

This session aims to demonstrate the potential for, and causes of, unwanted immunogenicity of therapeutics, including proteins/peptides and non-biologic complex drugs. It will also illustrate risks of inadequate clinical/preclinical testing of immunogenic peptides; and review and interpret available guidelines for supporting product approval Session chair: Dr Dianne Jackson-Matthews ERA Consulting (Australia)

T4

Update from PHARMAC This session will provide a description of health economics policy and its practical application in seeking reimbursement for pharmaceuticals in New Zealand. A speaker from PHARMAC will describe the statutory background of PHARMAC, its processes and remit. The applicant’s perspective will be provided by a New Zealand based consultant with many years of New Zealand and Australian reimbursement experience. Session chair: Brenda Pote Roche Products

T5

MSAC Submissions: a way forward. Evidence requirements - ideal versus reality, the current situation The most common reason for a negative recommendation for MBS listing is ‘insufficient evidence’. In 2012, the Medicare Financing and Listing Branch, DOHA will make the long anticipated Guidelines for MSAC Submissions available. If the evidence requirements for MSAC Submissions continue to be a major hurdle to the introduction of new medical technology, what impact will this have on the administration of hospitals? This session will cover the new guidelines for MSAC Submissions, especially the evidence requirements within these guidelines. The session will also look at the impact of these evidence requirements on hospitals and medical device companies. Session chair: Jenny Pollack Covidien

3:30 - 4.00pm 4.00 - 5.30pm

Medsafe

Morning Tea How do we strike a balance to provide the right environment to ensure access and appropriate utilisation of medicines, devices and services, whilst conserving an appropriate environment for the medicines and devices industries. Leading speakers will discuss this balance in their decision making processes and considerations.

2.00 - 3:30pm

Dr John Skerritt, TGA National Manager Dr Stewart Jessamine, Group Manager,

UWA

Rico Schoeler, PHARMAC Dr Richard Milne, Health Outcomes Associates

Shane Porter, Acting 1st Assistant Secretary, Medicare Financing and Listing Branch, DOHA Carol Bryant, Macquarie University Hospital Kevin Ryan, Device Technologies Australia

Afternoon Tea T6

T7

Validation in manufacturing – now and in the future

Brad Roberts, Seerpharma Ashley Isbel, PharmOut TGA speaker from the Office of

The relevance and effectiveness of traditional qualification and validation activities in GMP regulated industries are currently being challenged by recent guidelines. This session will look at the impact of recently published regulatory and industry guidance as well as provide insight into the statistical tools that can be used to analyse and provide evidence of validation of equipment and processes. Session chair: Deb Cooper ARCS Australia

Manufacturing Quality (invited)

Successful approval of risk management plans in Australia

Dr Jane Cook, Office Head, Office of

Hear from the TGA about their expectations regarding RMPs in Australia, their experience to date and proposed streamlining of the RMP process. Industry speakers will provide their perspective on preparing RMPs for Australia and their experience of negotiating RMPs as part of the streamlined submission process. This session will be presented from a regulatory affairs perspective. Session chair: Ailsa Surman Eli Lilly Australia

Product Review, TGA

Industry speaker (invited)


Session Information

Time T8

Time

Speaker Information

The challenges of medicines derived from nature

Dr Dianne Jackson-Matthews, ERA Naturally-derived medicines can have their own unique regulatory challenges compared to their Consulting (Australia) synthetic counterparts. This session is intended to show that the fate of naturally-derived products Dr James Aylward, Oncolin depends on identifying, early on, not only commercial feasibility, but also the regulatory hurdles TGA speaker (invited) associated with the desired claims and indications. We aim to explore this topic from the perspective of the innovator and the regulator, considering local and global approaches. Session chair: Mary Nteris INC Research Australia Session Information Speaker Inf

T9 Educational topics in medicines reimbursement – Session 1 A checklist of uncertainties for PBAC decision making. The objective of this session is to propose a taxonomy of uncertainties for PBAC decision making to help the industry and decision makers evaluate uncertainty consistently, to understand possible mechanisms for reducing uncertainties and who should or could be responsible for establishing those mechanisms. The increased prominence of DUSC in reviewing actual utilisation and feeding this back to the PBAC and the Department. The utilisation of AMT and the impact that this will have upon industry will also be discussed. Session chair: Dominic Tilden (TBC)

T10 MSAC Submissions: a way forward. Evidence requirements - ideal versus reality, closing the gap University is the traditional home of research; however, the collection of data and the training of doctors are often left to Industry. Registries have recently become more prominent as a possible partial solution to the evidence requirements for MSAC Submissions, either pre or post. There is an urgent need to develop cost-effective ways of generating ‘appropriate’ evidence. The answer has to be, as least partially, generated in partnership between industry and hospitals, universities and government. This session will explore some of the initiatives in addressing the unique evidence requirements for medical technology (excluding pharmaceuticals) and the associated procedures. Session chair: Andrew Wiltshire Medtronic

T11 Managing compliance concerns and behavioural GMP Have you ever considered how human behaviours impact on GMP compliance? Does your company have an effective organisational change management strategy and methodology that is designed to model and change behaviours to execute the company strategy in a holistic manner? Can the relationship between company strategy and GMP behaviours can be managed in a similar manner to Sales and Marketing and commercial targets? These questions and more will be addressed in this enlightening session which will provide the attendee with an understanding of behavioural GMP as a way of life, versus something different to the norm. Session chair: Lucy Dias Elanco

Dominic Tilden, THEMA Consulting DUSC, PEB Speaker, Department of Health (invited)

NEHTA Speaker (invited)

Professor Simon Foote, Australian School of Advanced Medicine, Macquarie University Professor Ian Caterson, Boden Institute of Obesity, Nutrition, Exercise & Eating Disorders, Sydney Medical School, the University of Sydney Associate Professor Sue O’Malley, Macquarie University and Medical Intelligence

Brad Roberts, Seerpharma John Montalto, PharmOut Rai Karklins, Independent consultant

Session Informa

5:30 – 6.30 Pre-Dinner Drinks & Trade Exhibition 6:30 – 10:00 Conference Gala Dinner (including entertainment)

Day 2 Friday 28th September 2012 8:00 – 8:30

Registration, Welcome Coffee & Trade Exhibition Day 2 Sub Plenaries

8:30 – 10:00am F1

Building on the TGA business reform – optimising the Streamlined Submission Process Using industry case studies and making comparisons with other international agency processes, the session will investigate the effectiveness and robustness of the new Streamlined Submission Process to date and explore opportunities to build on and improve this process. Session chair: Mandy Cooke GlaxoSmithKline Australia

F2

Global device IMDRF regulatory update The IMDRF meeting comes to Australia in the preceding few days, so we kindly welcome Dr Larry Kelly, chair of the IMDRF and European IMDRF representatives to speak on the very latest on international device regulation. Dr Minor will speak on the proposed reforms to the European Medical Devices Directive and Laurent Sellés will discuss the international approach to Unique Device Identifiers (UDI). Michael Gropp will discuss the international changes impacting upon the medical devices industry and the perspective of the GMTA, a global alliance of industry associations.

F3

10:00 – 10:30

Jenny Hefford, TGA (invited) Damien Gallagher, Ascent Pharmaceuticals Dr Stewart Jessamine, Medsafe Judy Develin, Market Authorisation Group, TGA (invited)

Tony Whittaker, Commercial Eyes Dr Larry Kelly, Chair, IMDRF and TGA Jacqueline Minor, Director of Consumer

Session chair: Dr Larry Kelly Chair, IMDRF and TGA

Affairs DG SANCO, European Commission Laurent Sellés, Deputy Head of Unit, Cosmetics and Medical Devices, European Commission Michael Gropp, Vice President Global Regulatory Strategy, Medtronic and Co-chair of the Global Medical Technology Alliance (GMTA)

Co-dependency and reimbursement

Professor Robyn Ward, Faculty of

Increasingly bringing a medicines and IVD to market concurrently is critical for patients, health professionals and industry. We welcome Dr Robyn Ward, chair of MSAC, Dr Sue Hill, chair of PBAC, Dr George Koumantakis of Roche Diagnostics and Susan Phillips of GSK will discuss the process of putting together a HE submission for co-dependents, the challenges to the decision analytic protocol (DAP) and the progress and learnings from the pilot through PBAC and MSAC during the course of 2012. Session chair: Carlene Todd Roche Products

Medicine, UNSW, Chair of MSAC and member of PBAC Dr Sue Hill, Chair PBAC Dr George Koumantakis, Roche Diagnostics Susan Phillips, GSK

Morning Tea & Trade Exhibition


PRELIMINARY PROGRAMME Time 10:30 – 12:00pm F4

Session Information

Speaker Information

Electronic Consumer Medicines Information (CMI) and the patient/pharmacist perspective

Dr Jacky Arkell, Roche Products Diana Aspinall, Patient Lachlan Rose, Pharmaceutical Society of

Don’t miss this chance to enhance your skills to produce high quality CMIs which will benefit patients and pharmacists and contribute to the Quality Use of Medicines. This session aims to stimulate those that write & update CMIs to think about the impact on the patient. Session chair: Dr. Sylvia Roins Regulatory Consultant

F5

Non-prescription medicines regulatory affairs update The regulatory environment for non-prescription medicines is currently undergoing enormous change. In this critical update for everyone associated with non-prescription medicines you will hear the industry, pharmacist and consumer perspectives on the new packaging and labelling requirements for non-prescription medicines. The session will go on to look at the evidence required to support indications for listed medicines. Session chair: Industry OTC Manager

F6

HTA: a local and global perspective In 1993, Australia became the first country in the world to adopt a system of mandatory health economic evaluation for new medicinal products seeking listing on the Pharmaceutical Benefits Scheme (PBS). Nineteen years later the trend towards economically rational reimbursement is well and truly entrenched. This session will provide a comparative overview of the drug reimbursement and pricing systems in a range of international markets, including those of countries in the Asia-Pacific region. This session will also discuss issues that pharmaceutical manufacturers of new health care technologies face when developing evidence that meet the needs of both regulators and payers. Prof Ward will complement the session with a perspective on HTA and how it may influence clinical practice in Australia and other countries. Session chair: Giao Tran Roche Products

F7

Class I to III device conformity for assessment explained Confused about Medical Device conformity assessment? You are not alone! The Australian Medical Device Regulation framework is based on the European Medical Device Directive, and requires that the TGA conduct an evaluation of conformity assessment documentation. An application for a Medical Device registration can use an EU Notified Body Certificate for Conformity Assessment evidence, but this certificate and the level of assessment it represents is often confusing. This session will explain key concepts, the reason behind them, the meaning of the different Parts or Annexes and how they are applied to choose the correct path for successful registration medical devices. The session will also include the common pitfalls that cause rejection as well the general submission requirements for class III medical devices. Session chair: Julia Guinan Link Pharmaceutical Group

F8

Pharmaceuticals in the environment Ecotoxicologists and health experts alike are calling for a concerted effort to better understand how pharmaceuticals behave in the natural environment and controls to limit exposure. This session will include discussion of the background concerns and issues, methods for risk assessment, potential mitigation strategies, and current regulations in Australia. It will also look at the impact of the European Guideline on the Environmental Risk Assessment of Medicinal Products for Human Use which requires an environmental risk assessment to be included in all new applications for marketing authorisation. Session chair: Judy Bingham Easington

12:00 - 1:00pm 1:00 – 2:30pm

Australia

Dr Deon Schoombie, ASMI Judy Develin TGA Quality Use of Medicines speaker (invited)

Andrew Manton, Commercial Eyes Eugene Salole, Pfizer Michael Wonder, Wonder Consulting Professor Robyn Ward, Faculty of Medicine, UNSW, Chair of MSAC and member of PBAC

Garry Burgess TGA Mike Flood, Locus Consulting,

John Frangos, Golders & Associates Dr Mike Williams, CSIRO Regulatory expert (invited)

Lunch & Trade Exhibition F9

Medicines shortages and supply chain management Are medicines shortages avoidable? Why do they occur and what can the industry and/or the government do to mitigate the impact of these issues. What can be and needs to be done to assist in securing the supply chain in multiple situations such as: single source suppliers, natural disasters that interrupt delivery (national and/or international), pandemic or other major health crises. Session chair: Susan Alexander Roche Products

F10 OTC BPR and quality non-prescription medicine applications With the BPR for OTC medicines fast approaching, it will become increasingly important to ensure applications are ‘right first time’. This session will begin with an update on the status of the BPR for OTC medicines. This will be followed with the evaluators’ perspective looking at the common deficiencies observed in non-prescription regulatory applications. Get ahead of the game by learning about the processes and issues faced with non-prescription applications. Session chair: Industry OTC Manager

F11 Educational topics in medicines reimbursement Research will be presented examining submissions for orphan drugs considered by the PBAC from Dec 1999 to Nov 2011 for listing on the PBS and LSDP. Was the recommendation rate for submissions for orphan drugs (which included orphan indications of non-orphan drugs) any greater or less than that for submissions involving non-orphan drugs/indications and is the average time from PBAC recommendation to PBS listing for orphan drugs any different to a representative sample of non-orphan drugs . This session will also examine ICER thresholds compared with those published internationally. The research aim being to examine the indicators of success in reimbursement application in Australia made by the PBAC, and the underlying rationale, clarifying the basis of decision making and the impact of economic evaluations. Session chair: Industry HE manager

Dr Simon Quilty, University of Sydney Elizabeth de Somer, Medicines Australia, Dr Tony Gill, Market Authorisation Group, Acting Principal Medical Adviser, TGA

Dr Harry Rothenfluh, TGA Dr Susan James, Regulatory Affairs Consultant

Geoffrey Chin, Novartis Pharmaceuticals Michael Wonder, Wonder Consulting Kelly Makarounas-Kichmann, Monash University and KMC Health Care


Session Information

Time

F12 Hot topics in medical device regulation - Part 1 This not to be missed session will cover current hot topics in medical device regulation locally, regionally and globally. This will include an Australian manufacturer and exporter’s perspective on the trend toward greater regulatory scrutiny for medical devices and perceptions and inconsistencies in international regulatory review of devices. Also an outline of the concepts of clinical evidence contained in the GHTF guidance on clinical evidence for IVDs and an update on the implementation of the GHTF model globally will be presented. Lastly, join us for an update on the status and requirement of the regulation of devices in selected Asia Pacific countries. Session chair: Alex MacTavish Biogen Idec

F13 Pharmacogenomics and personalised medicine Genetic variation can make an important contribution to interindividual variation in drug response, with consequences for both the efficacy and safety of drugs in individual patients. Personalised medicine aims to tailor drug treatment for a particular patient (e.g. choice of drug and dose prescribed) in order to ensure a therapeutic response is achieved and adverse drug reactions are avoided. This session will provide a general background on pharmacogenomics and personalised medicine, including an overview of general concepts and examples of therapeutic relevance. The current application of these principles to clinical practice in Australia will be described and future perspectives considered. The role of pharmacogenomics in the safety of medicines will be discussed in detail with a focus on current examples of clinical relevance such as abacavir and antipepileptic drugs. This session will also discuss the economic and regulatory challenges posed by recent developments in pharmacogenomics and personalised medicine. Session chair: Annette Gross GlaxoSmithKline R&D

2:30pm - 3:00pm 3:00 - 4.30pm

Speaker Information Lora Allemeier, Head Regulatory Affairs, Cochlear

Shelley Tang, Stellar Consulting Mike Flood, Locus Consulting

Professor Andrew Somogyi, University of Adelaide

Professor Elizabeth Phillips, Murdoch University

Professor Ross McKinnon, Flinders University

Afternoon Tea & Trade Exhibition

F14 Recalls – all you ever wanted to know Managing the quality of therapeutic goods is imperative for the safety of healthcare for all Australians. As a Regulatory Affairs or Quality professional, do you really understand the recall process and your critical role within it? Is your company continually improving its processes to align with latest developments? With the advent of unique and unambiguous global product and location identification, we now have a more electronically enabled system to assist in managing recall notifications, aiming to improve the speed and accuracy of the therapeutic goods recall process. Session chair: Mark Brommeyer National E-Health Transition Authority (NEHTA)

F15 Regulatory Affairs in Asia – 3 Cs: culture, changes and challenges Increasingly, organisations in Australia are now working or expanding their coverage into Asia. There are new learnings and experiences into cultural and requirements differences. Along with unique and, in some cases, more complex regulatory requirements and environment in Asia than working under the Australian regulatory environment. The aim of this session is to provide insight into the current and future trends in the evolving regulatory environment in key Asian economies including China, South Korea, Taiwan, India and Singapore. Session chair: Dr Mary Nteris INC Research Australia

F16 Update from the PEB

Lisa Steinberg, CSL Biotherapies, Tania Snioch, GS1 Australia, Industry speaker (invited)

Allen Chu, Eli Lilly Australia Rodney Turner, iNova Pharmaceuticals (Australia)

Various speakers from the PEB (invited)

Back by popular demand! Key staff from the Department of Health will present information about the most recent developments at the department as they relate to PBAC submissions and post- PBAC processes (including AMT and price disclosure). There will be opportunity for delegates to ask questions of PEB representatives in attendance. Session chair: Alena Strizek Janssen-Cilag

F17 Hot topics in medical device regulation – Part 2 Off label use of medical devices We are all aware of the Special Access Scheme and Clinical Trials in medical devices, but have you heard of the EPS? The Experimental Product Section (EPS) of the TGA is the section that should be contacted for approval and regulatory requirements related to off label use of devices. These areas handle research and direct patient use of currently approved products by surgeons who propose to use devices outside their approved intended purpose and can also include a HCP who manufactures medical devices for a specific patient. This session will update the audience on the how, what and why of the process in the context of the Medical Device regulations. Session chair: Victoria Evans Clear Vision Consulting

F18 Mechanisms, clinical trials and regulatory evaluation of drug-induced QT/QTc prolongation Don’t miss this unique opportunity to hear from local and global experts. This session will provide an overview of the mechanisms leading to drug-induced QT/QTc prolongation and the design of clinical trials in which ECG safety, particularly QT/QTc prolongation liability, is assessed. It will enable regulatory professionals to contribute to clinical research strategies for ECG assessment and analysis to meet regulatory expectations. Dr Borje Darpo was deputy topic leader representing pharmaceutical industry in Europe (EFPIA) on the Implementation Working Group for the ICH E14 document. Session chair: Professor John McNeil Monash University

4.30pm

Closing drinks

Dr Tony Gill, Market Authorisation Group, Acting Principal Medical Adviser, TGA Additional speakers to be confirmed

Professor Terry Campbell, UNSW Professor Borje Darpo, Karolinska Institute, Sweden (by video link) Dr Harry Rothenfluh, TGA


2012 Canberra Preliminary Programme