Venue
ICC Sydney
ICC Sydney, 14 Darling Dr, Sydney NSW 2000, Australia

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Event Date Mon May 23 AEST - Wed May 25 AEST (almost 3 years ago)
In your timezone (EDT): Sun May 22 10:00am - Tue May 24 10:00am
Location ICC Sydney
14 Darling Dr, Sydney NSW 2000, Australia
Region EMEA
Details

Initially, we came together with a common goal, to survive and manage the pandemic. We implemented the changes through necessity and valued each other’s input. The next step is to continue this collaboration by understanding that working together with a common purpose benefits all of us.
These changes are the results of three key actions:
• A common purpose.
Ensuring all are ‘on the same page’, brings a clear focus on what we are trying to achieve. If there are roadblocks to having a common purpose, we need to address and ensuring our policies, standards and guidance’s are fit for our purpose. This common purpose underpins our ability of working together for success.
• Technology as an enabler.
Accelerating the adoption of digitalisation is enabling major shifts in clinical trial design and operations, regulatory strategies and therapeutic area asset and portfolio management, just to mention a few. The pandemic has fast tracked this implementation it is already having an enormous impact on the utilisation of information.
• Stakeholder inclusiveness.
Including the voices of all stakeholders is starting to revolutionised the way we look at innovation. Patients, investigators, sponsors, manufactures and governments have a role in the development of innovative therapies. These voices ensure that otherwise silent issues are brought to the fore, ensuring our deliverables meet the needs of all our customers.

Speakers

2022 Speakers

KEY SPEAKERS

Ajunct Professor John Skerritt
Heads of Health Products Regulation Group

Adam Roach
VP and Head of Asia Pacific, BieGene

Dr Mike Freelander MP
Paediatrician, Royal Alexandra Hospital

SPEAKERS

Blaise Agresta
Managing Director, MAOSS

Amalia Alexe
Clinical Pharmacist

Bernadette Aliprandi-Costa
Manager, Safety and Quality Improvement Systems and Intergovernmental Relations, Australian Commission on Safety and Quality in Health Care (the Commission)

Sarah Amos
Research Business Operations and Start-Up Manager, GenesisCare

Joanna Anderson
Senior Clinical Operations Manager

Anthony Anselmo
Pharmacovigilance and Medical Information Manager, Vifor Pharma

Nitin Bagul
Team Lead in HR Operations, Axis Bank

Michael Bainbridge

David Barda
Garvan Institute of Medical Research, Sydney Australia

Rebecca Bateson

Karen Battat
Pharmacovigilance Manager, AstraZeneca

Jasjit Baveja
Senior Manager, Regulatory Affairs and Procurement, Medical Technology Association of Australia (MTAA)

Julianne Bayliss
Associate Medical Director Vaccines

Jessica Bean
Chairperson, Patient Voice Initiative

Maree Beare
Founder, Clinials

Dorit Becher
Clinical Operations Manager, BeiGene

Kylie Becker

Jan Bekker

Jarrod Belcher
Director Researcher Exchange and Development within Industry, MTPConnect ·

Sharon Bennett
Assistant Director, Deputy Australian Recall Coordinator

Jean Boudaud
Director, Head of Medical Devices / IVD, AustraliaDirector, Head of Medical Devices / IVD, Australia, PharmaLex

Tiffany Boughtwood
Managing Director of Australian, Genomics

Janelle Bowden
Managing Director and Consultant, AccessCR Pty Ltd

Arthur Brandwood
Executive Chair, Ellen Medical Devices

Lance Brendon
Managing Director, DQS Certification AUSNZ Pty Ltd

Matthew Brittland
Medical Director, Amgen and President of APPA

Conor Brophy
Chair, UHREC, QUTChair, UHREC, QUT, Queensland University of Technology

Cath Brown
Acting Director of the Medicine Shortages Section, Pharmacovigilance Branch

Carl Bufe
Pharmacovigilance Manager, ProPharma Group ANZ

David Bunker
Executive Director ( CEO ) Executive Director ( CEO ) , Health Translation Queensland

Ian Burgess
CEO at Medical Technology Association of Australia (MTAA); Non Executive Director of Red Nose

Jennifer Burnett
Assistant Secretary of the Manufacturing Quality Branch

Kimberley Bury
Registered Nurse, James Cook University

Mark Buzza
Head of Research, VCCC Alliance

Jon Carrano
Managing Director, Pharmsite

Darryl Carrington
Senior Clinical Operations Manager, Beigene

Andrew Carter
Managing Director, Commercial Eyes

Romana Cecchele
Senior Pharmacist- Investigational Drugs Unit, RPA Hospital

Shruthi Challa
Regulatory Affairs Manager, Grifols

Uphar Chamoli
Senior Engineering Assessor, Devices Conformity Assessment Section

Dennis Chang
Director of NICM Health Research Institute, Western Sydney University

Nicholas Chapman
Business Lead - Personalised Healthcare and Precision Diagnostics, Roche

Lucy Cheetham

Yervant Chijian
Director, Team Lead Medical Devices / IVD, Australia, PharmaLex

Katrina Chisholm

Orin Chisholm
Academic Lead, Pharmaceutical and Medical Device Development programsAcademic Lead, University of Sydney

John Christodoulou
Chair of Genomic Medicine, Murdoch Childrens Research Institute

Jana Chromicka
Medical Manager in Specialty Care - Rare Diseases, Sanofi

Ian Chubb
Chief Scientist, Australian National University

Julie Cini
Chief Executive OfficerChief Executive Officer, Spinal Muscular Atrophy Australia Inc.

Eliza Colgrave

Laura Collie
Senior Medical Advisor, NSW Ministry of Health

Nicholette Conway
Commercialisation Director,
23Strands

Deborah Cooper
COO and Senior Consultant, Adjutor Healthcare Pty Ltd

Amanda Craig
Director of the Devices Post-Market Reforms and Reviews Section

Helen Critchley
Global Regulatory Affairs - Country Head Australia & New Zealand, Sanofi

Rosalie Cull
Chief Executive Officer,
Adjutor Healthcare Pty Ltd

Rima Darwiche
Chief Executive Officer, CPL Australia

Elizabeth de Somer
CEO, Medicines Australia

Jordan Debono
Scientific Advisor for the Products of National Significance (PNS), Seqirus

Angelo Di Sapia
Founder & Director, Legacy Health

David Dickison

Jacqueline Dixon
Program Manager, Alfred Health

Kerry Dranganoudis
Director, Compliance Connection

Tracey Duffy
First Assistant Secretary of the Medical Devices and Product Quality Division

Karen Duggan
Medical & Scientific Director, Vectus Biosystems

Shanny Dyer
Chief Executive Officer, ARCS Australia Ltd

Pippa Eaton
Project Manager, Clinical Research Engineers

Kristina Elvidge
Head Of Research, Childhood Dementia Initiative

Anne- Maree Englund
Head of Strategic Policy Implementation, Medicines Australia

Tamara Etto
Head of Medical Affairs for APAC and Senior Medical Director for ANZ,Antengene

Susan Evans
Associate Professor, University of Adelaide

Stephen Farrell
Director, GMP Clearance Manufacturing Quality Branch

Ali Fathi
Chief Technology Officer | Founder, Tetratherix

Stephen Firmer
Director, Asia Pacific Consultants

Megan Ford
Executive Director,
Ingham Institute for Applied Medical Research & SWSLHD

Nathan Fox
Health Economics and Market Access Consultant, Consultant

Mike Freelander MP

Rama Gitifar
Regulatory Affairs Manager, Bayer

Mark Glover
General Manager, Biointelect Pty Ltd

William Glover
Chief Operating Officer, Ab Initio Pharma

Craig Goldblatt
VP Partners & Alliances, Globalization Partners

Stephen Graves
Director, Australian Orthopaedic Association National Joint Replacement Registry

Mitchell Green
Associate Regulatory Affairs Manager, BeiGene

Sarah Griffin
Director, Medtechnique Consulting

Ashley Gryl
Senior Clinical Operations Manager, BeiGene Australia

Christine Guo
Chief Scientific Officer, ActiGraph

Melissa Hagan

Cate Halmagyi
Regulatory Affairs Manager, Sandoz

Sonia Harvey
Project Manager, CT:IQ

David Hau
TGA representative currently, IMDRF AIMD Working Group

Cheryl-Ann Hawkins
Chief Operating Officer, Emeritus Research

Guillaume Herry
Director, Biointelect Pty Ltd

Jennifer Herz
Managing Director, Biointelect Pty Ltd

Sian Hope
Senior Policy Officer, Advanced Therapeutics, NSW Health

Alison Horsnell
Director, Clinical Trial Quality & Compliance

Adele Hosseini
Member Board of Director, ARCS Australia

Kath Irish
Manager clinicaltrialsNSW, NSW Health

Kathryn Jajko
Research Lead Radiation Oncology, GenesisCare

Chris James
Group Manager Medsafe, Ministry of Health New Zealand

John Jamieson
Head of the Medical Devices, Authorisation Branch

Pradeep Kumar Jandhyala
Account Executive, ANZ/ASEAN R&D and Quality, Veeva Systems

Catherine Johnson
Hunter Medical Research Institute as the Clinical Trials Network Officer and Calvary Mater Newcastle as a Gastrointestinal Cancer Clinical Nurse Consultant

Lucy Johnson
Clinical Research Associate , AstraZeneca

Steven Kennedy
Vice President Global Regulatory Affairs, Cochlear

Rob Kent
Research Operations Manager, The Kinghorn Cancer Centre Board of Directors, ARCS Australia

Mohit Khera
Assistant Director in Prescription Medicines Authorisation Branch, TGA

Julia Kuszewski
Clinical Research Site Manager, Emeritus Research

Crissa Kyriazis
General ManagerGeneral Manager,
Biocelect Pty Ltd

Lucy Lang

Katrina Lapham
Director, Strategic Market Access and Policy, Biointelect Pty Ltd

Claire Larter
Director of the Adverse Event and Medicine , Defect Section

John Lawson
Paediatric neurologist, Sydney Children’s Hospital

Bronwyn Le Grice

CEO | Managing Director [Founder], ANDHealth

Amber Leah
Principal Investigator, Paratus Clinical Pty Ltd

Andrew Leaver
Medical Officer and Assistant Director , Clinical Evaluation Section B

Nicola Leavold
Commercial Director, AustralasiaBXTAccelyon Pty Ltd

Navinisha Lee
ARCS Volunteer Facilitator, ARCS Australia

Lillian Leigh
Member of the Advisory Council, Cancer Australia

Geraldine Lester
Assistant Director, Contained Dealing and Evaluation Section

David Lewis
EU QPPV Head QPPV Office at Novartis Pharma GmbH at Novartis

Jan Lewis
ssoc Medical Director, Australia and New Zealand at AbbVie

George Lillis
Head Of Regulatory Affairs, Novartis Pharmaceuticals Australia and New Zealand

Madelaine Lindao
Compliance & Operational Strategy/Process Manager, Scientia Clinical Research

Edwina Ling
Director, Elemente Consulting

Jia (Jenny) Liu
Visiting Scientist, Children's Medical Research Institute

Jamie Lopez
Senior Manager, Medical Lead Haematology, Multiple Myeloma, Bristol Myers Squibb

Ian Lucas
Director, SeerPharma Pty Ltd and Owner

Joey Lynch

Kevin Lync
Australian-trained physician

Madison Macdonald
Quality Manager - Clinical Trials, St Vincent’s Health Network Sydney

Neil MacGregor
Managing Director Australia & New Zealand, Bristol-Myers Squibb

Karla MacKenzie
Head of Site Management and Decentralized Clinical Trials Oceania, LEO Pharma

Maurice Makdessi
Team leader, Manufacturing Quality Branch (MQB)

Richard Makin
BMT Network and Quality Manager, NSW Agency for Clinical Innovation

Gillian Mason
Board Member, Australasian Institute of Digital Health

Gabrijela Matanović
Regulatory Affairs Manager, Medis - Generic Pharmaceuticals and Intellectual Property

James Matcham
Vice President, Strategic Consulting,Cytel

Rod Mathews
Business Masterclass and Business Breakthrough Training | Tailored Corporate Programs | Study Tours, Rod Matthews Pty Ltd

Sarah McDonald
Chief Visionary Officer and Founder, Baymatob

Eleanor McGregor
Senior Clinical Trial Monitor, Bristol Myers Squibb

Iain McGregor
Academic Director, University of Sydney

Rob McInnes
PrincipalPrincipal, Rob McInnes IP Advisory Pty Ltd

Gerry McKiernan
Director of Quality, Cell Therapies Pty Ltd

Andrew McLachlan
Head of School and Dean of Pharmacy, The University of Sydney

Maria McManus
Marketing, Digital and Commercial Operations Consulting & Projects, Maria Mcmanus Consulting

Narelle McPhee
Cancer Research Manager, Bendigo Health

Cheryl McRae
TGA Complementary and Over the Counter Medicines Branch

Sophie Mepham
Executive Manager Research Global, Icon Group

Lois Meyer
Honorary Associate Professor, UNSW Sydney

Chi Miles
Senior Clinical Operations Manager, Beigene

Rosa Miles
Director, Regulatory Affairs, Australia & NZ

Douglas Millar
Senior Manager Market Access and Pricing, Commercial Eyes Pty Ltd

Sharon Millman
CEO, Lymphoma Australia

Heidi Mitchell
Director of the Contained Dealings Evaluation Section, Office of the Gene Technology Regulator

Sara Moldovan
Quality Manager for Australia and New Zealand, IQVIA.

Sandra Montez
Regional controller, US Physical Therapy

Mia Mudge
Senior Partner, THEMA Consulting

Marion Mueller
Global Risk Management Plan Manager bei Novartis

Eman Nafea
Director, Victorian Clinical Trials Education Centre

Teresa Nicoletti
Partner, Mills Oakley

Ian Noble
Director, Value Access and Policy, Amgen

Mark O'Donnell
Partner, Madderns Patent & Trade Mark Attorneys

Catherine O'Mahony
Managing Director, On Q Recruitment

Anne O'Neill
Director, Enterprise and International Partnerships, Office for Health and Medical Research, NSW Health

Hui Xin Ong
Research Leader, Woolcock Institute of Medical Research

Rob Ormsby
Founder, Ormsby Coaching

Seamus Orr
Technical Services Manager, AstraZeneca

Bonny Parkinson
Associate Professor in Health Economics, Macquarie University

Kate Pascall

Luciano Peloche Moraes
Manager, TXM Consulting Operations

Antonio Penna
Executive Director, Office for Health and Medical Research, NSW Health

Marisa Petersen
Retired CEO, Global CRO

Marnie Peterson
Chief Executive Officer, GBMA

Franz Pichler

Independent Consultant, Franz Pichler Consulting

Sarah Piplica
Ethics and Regulatory Manager, University of the Sunshine Coast

Anna Pohl
Regulatory Affairs Consultant

Lachlan Porter
Clinical Project Manager, Mobius Medical Pty Ltd

Sally Rayner
Director of the Clinical Quality Registries Section, Commonwealth Department of Health

Stefanie Reyes
Senior Medical Manager, AbbVie

Bita Rezaallah
Medical Safety Lead Neuroscience, Novartis

Adam Roach
Vice President, Head of Asia Pacific, BeiGene

Alan Robertson
Managing Director, Canthera Discovery

Piety Rocha
Director Head of Regulatory Affairs, PharmaLex

Josephine Root
Policy Director, CHF

Linda Ross
Associate Director, LabCorp Drug Development

John Rule
Senior Research Manager, National Association of People with HIV Australia

Rania Salama
AcademicAcademic, Macquarie University

Joan Sally
Director of Quality - Takeda Oceania

Jolanta Samoc
Project manager, Therapeutic Goods Administration

Angela Scheppokat
Sponsor Operations Manager, Oxygen The National Centre of Excellence in Youth Mental Health

Brittany Schoeninger
Principal, IQVIA

Deon Schoombie
CEO, Consumer Healthcare Products Australia

Kylie Shackleton
Deputy Manager, Parkville Cancer Clinical Trial Unit, Peter MacCallum Cancer Centre

David Shannon
Senior Lawyer

Diane Sheehan
Director, Health Security Advisory Service

Corrin Shepherd
Cluster Safety Lead, Australia / South Asia, Pfizer

Euho Shin
Head of Asia Vault R&D Strategy, Veeva Systems

Kirby Siemering
Managing Director, Double Helix Investments

Amy Sillett
Senior Director, Astrazeneca

Simon Singer
Principal Medical Adviser, Medical Devices Authorisation Branch

Katrina Skellern
Research Fellow, University of Technology Sydney

John Skerritt
Heads, Health Products Regulation Group

Charlotte Smith
Medical Science Liaison, MSD Australia

Vicki Sproule
Clinical Research Manager, Genesis Care

Giles Stratton
Associate Principal in Real World Evidence

Robert Stringer
Principal Consultant, Brandwood CKC Pty Ltd

Jaymen Swift
Senior Medical Science Liaison, Lundbeck

Colman Taylor
Owner and Chief Vision Officer, HTANALYSTS

Sarah Thapa

Terrance (T.J.) Thiel
Senior Director, Principal Consultant, PharmaLex

Falko Thiele
Director Clinical and Regulatory Affairs, BIOTRONIK

Jessica Tidemann
Director of the Medicines Surveillance and Targeted Review team within the Pharmacovigilance Branch,Therapeutic Goods Administration

Panida Tienchantuk-Hunt

Dominic Tilden
Director, THEMA Consulting Pty Ltd

Bryan Tran
Senior Clinical Research Associate, MSD

Nhat Tu
Senior Product Safety Associate, Sanofi

Carolyn Tucek-Szabo
Senior Director, Regulatory Sciences, Australia/NZ, Moderna International

Craig Underhill
Director of Cancer Services, Albury-Wodonga Regional Cancer Centre

Luke Unicomb
Therapeutic Head Medical Affairs Neurodegenerative Diseases, Biogen

Michelle Van Wijk
Project manager, UDI implementation in Australia

Shanthi Vijayakumar
Regulatory Affairs Manager, Phebra Pty Ltd

George Vuckovic
Assistant Secretary, Scientific Evaluation Branch

Brigid Waite
Chapter Lead - Healthcare Ecosystems, Integrated Medicines/Customer Engagement Community, Roche

Bernadette Waller

Brad Walsh
CEO, Minomic International Ltd and GlyTherix Ltd

Robyn Ward
Executive Dean and Pro Vice-Chancellor. Faculty of Medicine and Health, University of Sydney

Julia Warning
Principal Policy Officer, Advanced Therapeutics, OHMR

Andrew Watson
Director, CBE Pty Ltd

Kerry Watts
Acting Deputy Director of Pharmacy, Wollongong Hospital

Joanna Waugh
Regulatory Affairs Manager, Roche

Steve Webb
Senior Staff Specialist, Intensive Care Unit at Royal Perth Hospital

Leanne Wells

Jerneen Williams
Early Phase Clinical Trial Manager , Bellberry Limited

Steve Williams
Director, CBE

Aaron Willis
Lead of Sensors & Wearables, THREAD

Andrew Wilson
Director and Professor, Menzies Centre for Health Policy and Economics

Andrew Wiltshire
Head of Healthcare Public Policy, Amazon Web Services APAC

Annrée Wogan
Founder and Principal Consultant - Medical Affairs, Advocacy, Strategy and Leadership Development, Garrolagh Consulting and Pharmaceutical Development

Anne Woollett
Director, Clinical Trials Hub, Alfred Health

Alina Yoffe
Master of Pharmaceutical Medicine degree, UNSW Faculty of Medicine

Oksana Zdanska
Early Phase Team Leader - medical oncology, The Kinghorn Cancer Centre

Nikolajs Zeps
Partner, Chrysalis Clinical

Sponsors & Partners

2022 Sponsors

MAJOR SPONSORS:
• BeiGene

SESSION STREAM SPONSORS:
• Prospection
• Biointelect
• AstraZeneca
• MTP Connect

EDUCATION SESSION SPONSORS:
• Biointelect
• Veeva
• Maoss Database