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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 |
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.
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
2022 Sponsors
MAJOR SPONSORS:
• BeiGene
SESSION STREAM SPONSORS:
• Prospection
• Biointelect
• AstraZeneca
• MTP Connect
EDUCATION SESSION SPONSORS:
• Biointelect
• Veeva
• Maoss Database