PRELIMINARY PROGRAMME & REGISTRATION

Information Booklet

89 speakers 31 sessions• Prescription Medicines• OTC Medicines• Medical Devices• Regulatory Affairs• Health Economics• Quality and GMP

Professional Development in Therapeutics

CANBERRA National Convention Centre 27-28 September 2012

STOP PRESS.......F19 LATE BRE

AKING SESSION

with Bill Turner and Bob Trib

e

Go to www.arcsconferences.com

for details

27-28 September, National Convention Centre, Canberra

KEY DATES25 June 2012

20 August 2012

3 September 2012

21 September 2012

27-28 September 2012

3 September 2012

COB 20 August COB 3 September COB 21 September 22-26 September Extra-EarlyBird EarlyBird Registration Late Registration

Member

Student or Retired Member

Non-Member†

Government or Academic Member†*

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

REGISTRATION FEES

2 Day $945 $995 $1095 $13201 Day $645 $685 $755 $965

2 Day $695 $745 $845 $1,0701 Day $445 $495 $565 $765

2 Day $1,245 $1,295 $1,395 $1,6201 Day $920 $960 $1,030 $1,240

2 Day $695 $745 $845 $1,0701 Day $445 $495 $565 $765

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

Professional Development in Therapeutics

To register please visitwww.arcsconferences.com

Regulatory, Health Economics andQuality Congress

Canberra Convention Centre 27-28 September 2012On behalf of the ARCS Conference Committee, theARCS Board and the ARCS Business Office, I inviteyou and bid you welcome to our regulatory, healtheconomics and quality congress for 2012, held onceagain at the Canberra Convention Centre. In thetraditional of past years, and with the help of ourvolunteer experts, we have pulled together a strongprogramme for your consideration. Sessions include:- Multiple streams on regulatory matters formedicines and devices, local, regional and global

- A strong health economics medicines and devicesprogramme

- A GMP/quality programme.

Some of our many Australian and internationalconfirmed speakers are as follows:- Dr John Skerritt the new National Manager, TGA- Dr Stewart Jessamine, Group Manager, Medsafe, NZ

- Dr Richard Bartlett, 1st assistant Secretary, MedicalBenefits

- Dr Suzanne Hill, Chair, PBAC- Prof Robyn Ward, Chair, MSAC- Mr Michael Gropp, Vice President GlobalRegulatory 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 Cosmeticsand Medical Devices, European Commission

- Mr Rico Schoeler, Manager, Analysis andAssessment, Pharmac, NZ

- Mr Shane Porter, Assistant Secretary, MedicareFinancing and Listing Branch, DoHA

Overall we have approximately 80 speakers and 30 sessions, once again at not-for-profit rates, andover the next few weeks we will be adding somefurther details. We hope that you take advantage ofthese sessions and networking opportunities.

On behalf of the Conference Committee and ARCS I also wish to invite you to the special conferencedinner on the Thursday evening27 September, which should beentertaining and a further greatopportunity for networking!

We hope to see you there.

Adrian Bootes, ARCS CEO

27-28 September, National Convention Centre, Canberra

To register please visitwww.arcsconferences.com

Dr Richard Bartlett, First Assistant Secretary Medical Benefits

Dr Arthur Brandwood, CEO, Brandwood Biomedical

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

Professor Borje Darpo, Professor Cardiology, Karolinska Institute,Sweden

Elizabeth de Somer, Director, Health Policy and Research, MedicinesAustralia

Judy Develin, Group Coordinator, Market Authorisation Group, TGA

Dr Tony Gill, Director, Experimental Products Section, Office of ScientificEvaluation, Market Authorisation Group, Acting Principal Medical Adviser,TGA

Michael Gropp, Vice President Global Regulatory Strategy, Medtronic andCo-chair of the Global Medical Technology Alliance (GMTA)

Dr Sue Hill, Chair PBAC

Dr Stewart Jessamine, Group Manager, Medsafe

Dr Larry Kelly, Chair, IMDRF and TGA

Professor Andrew McLachlan, Associate Dean (Research), Faculty ofPharmacy, University of Sydney and Chair, National Medicines PolicyCommittee

Jacqueline Minor, Director of Consumer Affairs DG SANCO, EuropeanCommission

Adriana Platona, Assistant Secretary, Pharmaceutical Evaluation Branch

Shane Porter, Acting First Assistant Secretary, Medicare Financing andListing Branch, Department of Health and Ageing

Rico Schoeler, Manager, Analysis and Assessment, PHARMAC

Dr Deon Schoombie, CEO, ASMI

Laurent Sellés, Deputy Head of Unit, Cosmetics and Medical Devices,European Commission

Dr John Skerritt, National Manager, TGA

Professor Robyn Ward, Professor, Faculty of Medicine, UNSW, Chair ofMSAC and member of PBAC

KEY NOTES

REGISTRATION INCLUSIONS

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

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

VENUE: The National Convention Centre isthe largest purpose-built meetings and eventsfacility in the ACT. The Centre is convenientlylocated between Sydney and Melbourne and is agreat destination for delegates with easy accessvia plane, bus, train or car.

REGISTRATION DESK: The RegistrationDesk will be located in the Main Foyer of theNational Convention Centre and will be openfrom 8.00am to 5.00pm each day. Upon arrivalon your first day, please report to theRegistration Desk to receive your delegatesatchel, name badge and social event ticket/s.

CONTINUING PROFESSIONALEDUCATION (CPE) POINTS: Names willbe recorded as you enter sessions to enable CPEpoints to be added to your record – pleaseensure you are wearing the correct name badge!See the Registration Desk for assistance.

PUBLIC TRANSPORT

BUSES: Murrays coaches offer over 100 servicesa week from Sydney to Canberra. Go towww.murrays.com.au for more information orcall 13 22 51.

AIR: The National Convention Centre, situatedin the city centre is just a ten-minute drive fromthe airport. We recommend you visit thedomestic airline websites early to secure acheaper fare.

TRAINS: CountryLink offers two dailyXPLORER rail services from Sydney to Canberra.

PARKING: Parking for more than 400 cars isavailable beneath the National ConventionCentre currently at a cost of $13 per vehicle perday, or $7 per four hours or part thereof. TheNational Convention Centre car park can beentered off Constitution Avenue.

ACCOMMODATION: Crowne PlazaCanberra is pleased to offer preferredaccommodation rates to delegates attending theARCS Conference. The following rooms areavailable at special rates:

• Superior King Room Non Smoking, includingfull buffet breakfast for one $240

• Superior Twin Room Non Smoking, includingfull buffet breakfast for one $240

• Deluxe King Room Non Smoking, including fullbuffet breakfast for one $290

• Deluxe Twin Room Non Smoking, including fullbuffet breakfast for one $290

To make a booking please call 1300 662 2181300 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 quotethe reservation code “ARD”. Reservations canalso be made via reservations.cbrbs@ihg.com.

Alternatively, for a comprehensive list ofaccommodation near the Centre please visit theCentre website atwww.nccc.com.au/canberra/accommodation.html

PRIVACY: ARCS is bound by the National Privacy Principles (NPPs)set out in the Privacy Amendment (Private Sector) Act 2000. ARCSwill collect information provided in the Registration Form for thepurposes of enabling us to register your attendance at the ARCSScientific Congress (ASC), to assist with administrative purposes andfor future planning and development of ARCS events, to facilitateyour requirements in relation to the ASC and to allow thecompilation and analysis of statistics. The information provided in theRegistration Form and information provided at any other time duringthe ASC, including without limitation any feedback obtained duringthe ASC, will be used by ARCS to offer, provide and continue toimprove its events and services. ARCS will publish information thatis collected in the Registration Form in the Congress DelegateListing available to delegates, sponsors and exhibitors at theconference. The information published will be limited to your nameand organisation unless you indicate on the online application thatyou do not want this information shared. ARCS will not otherwise,without your consent, disclose your personal information for anypurpose unless it would reasonably be expected that such purpose isrelated to the provision and improvement of ARCS events or wheresuch purpose is permitted or required by law.

DISCLAIMER: All information printed in this brochure is correct atthe time of printing. This is a preliminary programme and somespeakers and topics will be changed as it is finalised. ARCS Australiareserves the right to change the program and contents as necessary.

GENERAL INFORMATION

Drink Bottle Sponsor

Note Pad and Pen Sponsor

EXHIBITORSAMS Laboratories/Lotus Technology

ARCS Australia

Biotech Regulatory Solutions

Digital Print Services

eCTD Office

Healthcare Placement Solutions

OnQ Recruitment

OPTUMInsights

Pharmaceutical & Medical Professionals

PharmOut

Regulatory Concepts

Thomson Reuters

PRELIMINARY PROGRAMME

Time Session Information Speaker Information

Day 1 Thursday 27th September 2012

8:30 - 9.45am Registration, Welcome Coffee & Trade Exhibition

9.45am Welcome and opening remarks Adrian Bootes, ARCS Australia

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

11.00 - 11.30am Morning Tea

11:30 - 1:00pm T1b Access to medicines, devices and benefits - a fair and equitable balanceHow do we strike a balance to provide the right environment to ensure access and appropriateutilisation of medicines, devices and services, whilst conserving an appropriate environment for themedicines and devices industries. Leading speakers will discuss this balance in their decision makingprocesses and considerations.

Session chair: Patrick Tung Merck Serono Australia

1:00 - 2.00pm Lunch & Trade Exhibition

2.00 - 3:30pm T2 Packaging and labelling of medicines - is a regulatory solution going to deliver what is desired? The request from consumers, prescribers, and academics is to reduce the number of avoidablemedication errors that are directly caused by perceived inadequate manufacturers labelling andpackaging. 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

T3 Immunogenicity of therapeutic peptides: regulatory science implicationsThis session aims to demonstrate the potential for, and causes of, unwanted immunogenicity oftherapeutics, including proteins/peptides and non-biologic complex drugs. It will also illustrate risks ofinadequate clinical/preclinical testing of immunogenic peptides; and review and interpret availableguidelines for supporting product approval.Session chair: Dr Dianne Jackson-Matthews ERA Consulting (Australia)

T4 Update on pharmaceutical reimbursement in New ZealandThis session will provide a description of health economics policy and its practical application inseeking reimbursement for pharmaceuticals in New Zealand. A speaker from PHARMAC willdescribe the statutory background of PHARMAC, its processes and remit. Then a consultant withmany years of New Zealand reimbursement experience will provide an applicant’s perspective. Session chair: Brenda Pote Roche Products

T5 MSAC Submissions: a way forward. Evidence requirements - ideal versus reality, the current situationThe most common reason for a negative recommendation for MBS listing is ‘insufficient evidence’. In2012, the Medicare Financing and Listing Branch, DOHA will make the long anticipated Guidelines forMSAC Submissions available. If the evidence requirements for MSAC Submissions continue to be amajor hurdle to the introduction of new medical technology, what impact will this have on theadministration 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 impactof these evidence requirements on hospitals and medical device companies.Session chair: Jenny Pollack Covidien

T6 Validation in manufacturing – now and in the futureThe relevance and effectiveness of traditional qualification and validation activities in GMP regulatedindustries are currently being challenged by recent guidelines. This session will look at the impact ofrecently published regulatory and industry guidance as well as provide insight into the statistical toolsthat can be used to analyse and provide evidence of validation of equipment and processes.Session chair: Deb Cooper ARCS Australia

3:30 - 4.00pm Afternoon Tea

4.00 - 5.30pm T7 Successful approval of risk management plans in AustraliaHear from the TGA about their expectations regarding RMPs in Australia, their experience to dateand proposed streamlining of the RMP process. Industry speakers will provide their perspective onpreparing RMPs for Australia and their experience of negotiating RMPs as part of the streamlinedsubmission process. This session will be presented from a regulatory affairs perspective. Session chair: Ailsa Surman Eli Lilly Australia

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

Dr Sue Hill, PBAC Dr Richard Bartlett, 1st Assistant SecretaryMedical BenefitsPeter Chesworth, Pharmaceuticals IndustryStrategy and Environment Section, DIISRTE(invited)Prof Andrew McLachlan, NationalMedicines Policy

Anne Mackenzie, Consumer Advocate,UWARebecca Doolan, TGA Elizabeth de Somer, Medicines Australia

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

Rico Schoeler, PHARMAC Dr Richard Milne, Health OutcomesAssociates

Shane Porter, Assistant Secretary, MedicareFinancing and Listing Branch, DOHA Carol Bryant, Macquarie University HospitalPhil Smith, Device Technologies Australia

Brad Roberts, SeerpharmaAshley Isbel, PharmOut

Dr Jane Cook, Office Head, Office ofProduct Review, TGA Industry speaker (invited)

Time Session Information Speaker Information

T8 The challenges of prescription medicines derived from natureNaturally-derived prescription medicines can have their own unique regulatory challenges compared totheir synthetic counterparts. This session is intended to show that the fate of naturally-derivedproducts depends on identifying, early on, not only commercial feasibility, but also the regulatoryhurdles associated with the desired claims and indications. We aim to explore this topic from theperspective of the innovator and the regulator, considering local and global approaches.Session chair: Mary Nteris INC Research Australia Session Information Speaker Inf

Time T9 Educational topics in medicines reimbursement – Session 1The objective of this session is to propose a taxonomy of uncertainties for PBAC decision making tohelp the industry and decision makers evaluate uncertainty consistently, to understand possiblemechanisms for reducing uncertainties and who should or could be responsible for establishing thosemechanisms. The increased prominence of DUSC in reviewing actual utilisation, post marketing andthe utilisation of AMT and the impact that this will have upon industry will also be discussed.Session chair: Dominic Tilden THEMA Consulting

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

T11 Managing compliance concerns and behavioural GMPHave you ever considered how human behaviours impact on GMP compliance? Does your companyhave an effective organisational change management strategy and methodology that is designed tomodel and change behaviours to execute the company strategy in a holistic manner? Can therelationship between company strategy and GMP behaviours be managed in a similar manner to Salesand Marketing and commercial targets? These questions and more will be addressed in thisenlightening session which will provide the attendee with an understanding of behavioural GMP as away of life, versus something different to the norm.Session chair: Lucy Dias Elanco 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 20128:00 – 8:30 Registration, Welcome Coffee & Trade Exhibition

8:30 – 10:00am Day 2 Sub Plenaries

F1 Building on the TGA business reform – optimising the Streamlined Submission Process Using industry case studies and making comparisons with other international agency processes, thesession will investigate the effectiveness and robustness of the new Streamlined Submission Processto date and explore opportunities to build on and improve this process.Session chair: Mandy Cooke GlaxoSmithKline Australia

F2 Global device IMDRF regulatory updateThe IMDRF meeting comes to Australia in the preceding few days, so we kindly welcome Dr LarryKelly, chair of the IMDRF and European IMDRF representatives to speak on the very latest oninternational device regulation. Dr Minor will speak on the proposed reforms to the EuropeanMedical Devices Directive and Laurent Sellés will discuss the international approach to UniqueDevice Identifiers (UDI). Michael Gropp will discuss the international changes impacting upon themedical devices industry and the perspective of the GMTA, a global alliance of industry associations.

Session chair: Dr Larry Kelly Chair, IMDRF and TGA

F3 Co-dependency and reimbursement Increasingly bringing a medicine and IVD to market concurrently is critical for patients, healthprofessionals and industry. We welcome Dr Robyn Ward, chair of MSAC, Dr Sue Hill, chair ofPBAC, Dr George Koumantakis of Roche Diagnostics and Susan Phillips of GSK who will discuss theprocess of putting together a HE submission for co-dependents, the challenges to the decisionanalytic protocol (DAP) and the progress and learnings from the pilot through PBAC and MSACduring the course of 2012.Session chair: Carlene Todd Roche Products

10:00 – 10:30 Morning Tea & Trade Exhibition

Dr Dianne Jackson-Matthews, ERAConsulting Dr James Aylward, Oncolin TGA speaker (invited)

Dominic Tilden, THEMA Consulting PBD Speaker, Department of Health(invited)NEHTA Speaker (invited)

Professor Simon Foote, Australian Schoolof Advanced Medicine, Macquarie UniversityProfessor Ian Caterson, Boden Institute ofObesity, Nutrition, Exercise & EatingDisorders, Sydney Medical School, theUniversity of Sydney Associate Professor Sue O’Malley,Macquarie University and Medical Intelligence

Brad Roberts, SeerpharmaJohn Montalto, PharmOutRai Karklins, Independent consultant

Dr Felicity Jameson, TGA Damien Gallagher, Ascent Pharmaceuticals Dr Stewart Jessamine, MedsafeTony Whittaker, Commercial Eyes

Dr Larry Kelly, Chair, IMDRF and TGA Jacqueline Minor, Director of ConsumerAffairs DG SANCO, European Commission Laurent Sellés, Deputy Head of Unit,Cosmetics and Medical Devices, EuropeanCommission Michael Gropp, Vice President GlobalRegulatory Strategy, Medtronic and Co-chairof the Global Medical Technology Alliance(GMTA)Mike Flood, Locus Consulting

Professor Robyn Ward, Faculty ofMedicine, UNSW, Chair of MSAC andmember of PBACDr Sue Hill, Chair PBAC Dr George Koumantakis, RocheDiagnosticsSusan Phillips, GSK

PRELIMINARY PROGRAMME

Time Session Information Speaker Information

10:30 – 12:00pm F4 Electronic Consumer Medicines Information (CMI) and the patient/pharmacist perspectiveDon’t miss this chance to enhance your skills to produce high quality CMIs which will benefit patientsand pharmacists and contribute to the Quality Use of Medicines. This session aims to stimulate thosethat 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 enormouschange. In this critical update for everyone associated with non-prescription medicines you will hearthe industry, regulator and consumer perspectives on the new packaging and labelling requirementsfor non-prescription medicines. The session will go on to look at the evidence required to supportindications for listed medicines.Session chair: Andrea Olsen Reckitt Benckinser

F6 HTA: a local and global perspective In 1993, Australia became the first country in the world to adopt a system of mandatory healtheconomic evaluation for new medicinal products seeking listing on the Pharmaceutical BenefitsScheme (PBS). Nineteen years later the trend towards economically rational reimbursement is welland truly entrenched. This session will provide a comparative overview of the drug reimbursementand pricing systems in a range of international markets, including those of countries in the Asia-Pacificregion. This session will also discuss issues that pharmaceutical manufacturers of new health caretechnologies 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 clinicalpractice in Australia and other countries. Session chair: Giao Tran Roche Products

F7 Global device IMDRF regulatory update (continued)See F2 for details

F8 Pharmaceuticals in the environmentEcotoxicologists and health experts alike are calling for a concerted effort to better understand howpharmaceuticals behave in the natural environment and controls to limit exposure. This session willinclude discussion of the background concerns and issues, methods for risk assessment, potentialmitigation strategies, and current regulations in Australia. It will also look at the impact of theEuropean Guideline on the Environmental Risk Assessment of Medicinal Products for Human Usewhich requires an environmental risk assessment to be included in all new applications for marketingauthorisation.Session chair: Judy Bingham Easington

12:00 - 1:00pm Lunch & Trade Exhibition

1:00 – 2:30pm F9 Medicines shortages and supply chain managementAre medicines shortages avoidable? Why do they occur and what can the industry and/or thegovernment do to mitigate the impact of these issues. What can be and needs to be done to assist insecuring the supply chain in multiple situations such as: single source suppliers, natural disasters thatinterrupt 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 applicationsWith the BPR for OTC medicines fast approaching, it will become increasingly important to ensureapplications are ‘right first time’. This session will begin with an update on the status of the BPR forOTC medicines. This will be followed with the evaluators’ perspective looking at the commondeficiencies observed in non-prescription regulatory applications. Session chair: Sarina Caruso Probiotec

F11 Educational topics in medicines reimbursement - Session 2How does the reimbursement of orphan drugs compare with non-orphan drugs inAustralia? An analysis of PBAC outcomes from 1999–2011Research will be presented examining submissions for orphan drugs considered by the PBAC fromDec 1999 to Nov 2011 for listing on the PBS and LSDP. Was the recommendation rate forsubmissions for orphan drugs (which included orphan indications of non-orphan drugs) any greater orless than that for submissions involving non-orphan drugs/indications and is the average time fromPBAC recommendation to PBS listing for orphan drugs any different to a representative sample ofnon-orphan drugs . “ICERs thresholds in a galaxy far, far away…. ” This session will also examine ICER thresholds compared with those published internationally. Theresearch aim being to examine the indicators of success in reimbursement application in Australiamade by the PBAC, and the underlying rationale, clarifying the basis of decision making and theimpact of economic evaluations.Session chair: Delia Schaffer Nycomed

Dr Jacky Arkell, Roche ProductsDiana Aspinall, PatientPatrick Reid, Pharmacy Guild of Australia

Dr Deon Schoombie, ASMIJudy Develin, TGAJanne Graham, AM, Health care advocate

Andrew Manton, Commercial Eyes Eugene Salole, PfizerMichael Wonder, Wonder Consulting Professor Robyn Ward, Faculty ofMedicine, UNSW, Chair of MSAC andmember of PBAC

John Frangos, Golders & Associates Dr Mike Williams, CSIROJudy Bingham, Easington

Dr Simon Quilty, John Hunter HospitalElizabeth de Somer, Medicines Australia, Dr Tony Gill, Market Authorisation Group,Acting Principal Medical Adviser, TGA

TGA speaker, BPR OTC (invited)TGA speaker, Application screening(invited)Dr Susan James, Regulatory AffairsConsultant

Geoffrey Chin, Novartis PharmaceuticalsMichael Wonder, Wonder Consulting Kelly Makarounas-Kirchmann, MonashUniversity and KMC Health Care

Time Session Information Speaker Information

F12 Hot topics in medical device regulation - Part 1This 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 thetrend toward greater regulatory scrutiny for medical devices and perceptions and inconsistencies ininternational regulatory review of devices. Also an outline of the concepts of clinical evidence contained in the GHTF guidance on clinicalevidence for IVDs and an update on the implementation of the GHTF model globally will bepresented. Session chair: Alex MacTavish Biogen Idec

F13 Pharmacogenomics and personalised medicineGenetic 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. Personalisedmedicine aims to tailor drug treatment for a particular patient (e.g. choice of drug and doseprescribed) in order to ensure a therapeutic response is achieved and adverse drug reactions areavoided. This session will provide a general background on pharmacogenomics and personalisedmedicine, including an overview of general concepts and examples of therapeutic relevance. Thecurrent application of these principles to clinical practice in Australia will be described and futureperspectives considered. The role of pharmacogenomics in the safety of medicines will be discussedin detail with a focus on current examples of clinical relevance such as abacavir and antipepilepticdrugs. This session will also discuss the economic and regulatory challenges posed by recentdevelopments in pharmacogenomics and personalised medicine.Session chair: Annette Gross GlaxoSmithKline R&D

2:30pm - 3:00pm Afternoon Tea & Trade Exhibition

3:00 - 4.30pm F14 Recalls – all you ever wanted to knowManaging 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 yourcritical role within it? Is your company continually improving its processes to align with latestdevelopments? 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 toimprove 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 challengesIncreasingly, organisations in Australia are now working or expanding their coverage into Asia. Thereare 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 underthe Australian regulatory environment. The aim of this session is to provide insight into the currentand 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 PEBBack by popular demand! Key staff from the Department of Health will present information about themost recent developments at the department as they relate to PBAC submissions and post- PBACprocesses including: Expanded Accelerated Price Disclosure; Progress on Parallel Processing; Statinand Oral Anticoagulant Reviews; Introduction of Australian Medicine Terminology and its impact oncompanies; PBAC Guidelines; Restructure of the PBD and Flow-on EffectsThere 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 2Class I to III Device conformity assessment explained: Confused about Medical Deviceconformity assessment? You are not alone! This session will explain key concepts, the reason behindthem, the meaning of the different Parts or Annexes and how they are applied to choose the correctpath for successful certification of registration medical devices. The session will also include thecommon pitfalls that cause rejection as well the general submission requirements for class III medicaldevices required to undergo TGA conformity assessment.Session chair: Julia Guinan Link Pharmaveutical Group

F18 Mechanisms, clinical trials and regulatory evaluation of drug-induced QT/QTc prolongationDon’t miss this unique opportunity to hear from local and global experts. This session will provide anoverview of the mechanisms leading to drug-induced QT/QTc prolongation and the design of clinicaltrials in which ECG safety, particularly QT/QTc prolongation liability, is assessed. It will enableregulatory professionals to contribute to clinical research strategies for ECG assessment and analysisto meet regulatory expectations. Dr Borje Darpo was deputy topic leader representingpharmaceutical industry in Europe (EFPIA) on the Implementation Working Group for the ICH E14document. Session chair: Professor John McNeil Monash University

4.30pm Congress close

Lora Allemeier, Head Regulatory Affairs,Cochlear Shelley Tang, Stellar Consulting Professor John McNeil, Head ofDepartment of Epidemiology & PreventiveMedicine, Head of School of Public Health &Preventive Medicine, Monash University

Professor Andrew Somogyi, University ofAdelaideProfessor Elizabeth Phillips, MurdochUniversityProfessor Ross McKinnon, FlindersUniversity

Lisa Steinberg, CSL Biotherapies, Tania Snioch, GS1 Australia, Jan Murton, Johnson & Johnson Medical

Allen Chu, Eli Lilly AustraliaRodney Turner, iNova Pharmaceuticals Dr Arthur Brandwood, BrandwoodBiomedical

David Brown PEB (invited)Adriana Platona PEB (invited)Paul Storey PEB (invited)Andrew Mitchell PEB (invited)Felicity McNeill, PBD, PEB (invited)

Garry Burgess, Director, DevicesConformity Assessment Section, ODA, TGA Mike Flood, Locus Consulting

Professor Terry Campbell, UNSW Professor Borje Darpo, KarolinskaInstitute, Sweden (by video link) Dr Roger Feltham, TGA