4.0 HEALTHCARE 4.0. The Data Imperative August 2018 Royal Randwick Turf Club, Sydney ANNUAL CONFERENCE MAJOR SPONSOR

Transcription

1 HEALTHCARE 4.0 The Data Imperative August 201 Royal Randwick Turf Club, Sydney 4.0 MAJOR SPONSOR Professional Development in Therapeutics

2 4.0 Join us at this year s ARCS Annual Conference Healthcare 4.0 the data imperative on August 201 at Royal Randwick Racecourse, Sydney (NSW). The ARCS Annual Conference is a must attend event for industry personnel from the medtech, biotech and pharmaceutical sectors at all stages of their careers. The event provides an excellent opportunity to network and engage with everyone from senior industry executives to new starters. Last year s conference attracted over 1,500 day visitors. Running over three days, this year s program consists of over 0 individual sessions grouped in up to eight parallel streams, scene setting plenaries with international and Australian keynote speakers, poster presentations covering regulatory, clinical research, medical affairs and digital health topics. The conference exhibition provides the opportunity to engage with businesses and organisations providing services to the sector, and allow for a more in-depth discussion. Over 50 exhibition stands, two networking areas and coffee stations will provide the backdrop for ample networking opportunities and informal discussions. There are flexible conference registration options available ranging from full conference to single day passes or social program only options in a variety of pricing categories. Register before 20 July to take advantage of the early bird pricing options. For more information and to register: Keynote Speakers Adjunct Professor John Skerritt Deputy Secretary, Health Products Regulation Group, Department of Health Tomas Salmonson Chair, Committee for Medicinal Products for Human Use (CHMP), European Medicines Agency (EMA) Erica Kneipp Assistant Secretary, Office of Health and Medical Research, Health Economics and Research Division, Department of Health Dr Jason Fox Author and leadership adviser Registration is open at Early bird until 20 July. Registration closes 14 August.

3 DAY 1 TUESDAY 21 AUGUST Royal Randwick Turf Club August 201 :00 Registration opens 4.0 9:00-10:30 A01 Regulatory affairs keynote the Australian and international landscape Regulatory A02 Public policy and its role in the timely access to emerging medicines and medical technologies Health Economics 10:30-11:15 Morning tea 11:15-12:15 A03 Hints and tips for acceptance of your prescription medicines application Regulatory (Prescription Medicines) A04 Prescription medicines sector update Regulatory (Prescription Medicines) A05 Update from the Complementary and OTC Medicines branch Regulatory (Non-prescription) A06 Design thinking in medical device development Regulatory (MedTech) A07 What Australian-based life science companies need to know about commercialisation Local Innovation (part 1) A0 Health savings with clinical success Health Economics (MedTech) A09 Progress to date in streamlining PBS medicines listings Health Economics (Medicines) 12:15-13:30 Lunch 13:30-14:30 A10 How can technology improve the communication of medicines information to Regulatory (Prescription Medicines) patients? A11 Update from the TGA Industry Working Group on Good Manufacturing Practice Regulatory (Prescription Medicines) (TIWGG) for regulatory affairs professionals A12 Update on Therapeutic goods advertising reforms Regulatory (Non-prescription) A13 Roundtable discussion on clinical evaluation reports for medical devices in Australia, Regulatory (MedTech) China and Europe A14 What Australian-based life science companies need to know about commercialisation Local Innovation (part 2) A15 Future of prostheses reimbursement and pricing Health Economics (MedTech) A16 Evaluation group perspective on PBAC submissions Health Economics (Medicines) E01 Regulatory affairs executive round table Executive 14:30-14:45 ROOM CHANGEOVER 14:45-15:45 A17 Temperature excursion symposium Regulatory (Prescription Medicines) A1 Putting together an effective GMP strategy Regulatory (Prescription Medicines) A19 Overcoming the stress of non-prescription medicine application screening Regulatory (Non-prescription) A20 Device vigilance: Local challenges and global trends Regulatory (MedTech) A21 What Australian-based life science companies need to know about commercialisation Local Innovation (part 3) A22 Future of prostheses reimbursement and pricing (continued) Health Economics (MedTech) A23 The emerging role of DUSC Health Economics (Medicines) E02 Peak body round table Executive 15:45-16:15 AFTERNOON TEA 16:15-17:15 A24 Electronic submissions: New specifications experiences and challenges Regulatory (Prescription Medicines) A25 Building confidence: Tracking biologic medicines and biosimilars in a multibrand Regulatory (Prescription Medicines) environment A26 Non-prescription medicines sector update Regulatory (Non-prescription) A27 Medical technology sector update Regulatory (MedTech) A2 Improving outcomes with high risk implantable devices - registries and regulators Regulatory (MedTech) A29 Evaluation group perspective on MSAC submissions Health Economics (MedTech) A30 Rare diseases: Challenges and opportunities from registration, reimbursement and industry perspectives Health Economics (Medicines) 17:30-1:30 WELCOME RECEPTION We reserve the right to make changes to the programme and/or speakers without prior notice.

4 4.0 DAY 2 WEDNESDAY 22 AUGUST Royal Randwick Turf Club August 201 :00 Registration opens 9:00-10:30 B01 Keynote: Healthcare Pharmaceuticals as a service 10:30-11:15 Morning Tea 11:15-12:45 B Good Manufacturing Practice regulatory updates Quality/GMP B04 Update from the Prescription Medicine Authorisation Branch Regulatory (Prescription Medicines) B05 Apps and software as a device (their regulation and evaluation) Regulatory (MedTech) B06 Australian clinical research sector update (part 1) Clinical (General) B07 Participatory health: Digital patients ehealth B0 Precision medicines Precision Medicines B09 Adopting a leadership mindset: How to be a limited edition leader Leadership 12:45-14:00 Lunch E03 Clinical research policy round table (lunch) Executive 14:00-15:30 B10 Quality risk management: Updates, opportunities and threats Quality/GMP B11 News from across the Tasman: NZ regulatory update Regulatory (Prescription Medicines) B12 3D printing and the changes to custom made device regulations Regulatory (MedTech) B13 Australian clinical research sector update (part 2) Clinical (General) B14 ehealth session to be announced ehealth B15 Precision medicines (continued) Precision Medicines B16 Thinking Differently in Project Management and Leadership Leadership E04 Digital health implementation: Hurdles, issues and strategies moving forward Executive 15:30-16:00 Afternoon Tea 16:00-17:30 B17 Qualification and validation (Annex 15 updates) What are the changes, pitfalls and requirements? Quality/GMP B1 Update on generics reforms and risk-based approach to variations to registered medicines Regulatory (MedTech) B19 Update from the Medical Devices Branch Regulatory (MedTech) B20 Australian clinical research sector update (part 3) Clinical (General) B21 Reducing hurdles to real world data access for clinical trials ehealth B22 Clinical trials in a dish: Novel scientific technologies in pre-clinical drug development Clinical B23 Virtual workforce: The future? Leadership 17:30-1:30 Pre-Dinner Drinks/Networking 1:45-22:00 Conference Dinner We reserve the right to make changes to the programme and/or speakers without prior notice.

5 DAY 3 THURSDAY 23 AUGUST Royal Randwick Turf Club August 201 :00 Registration opens 4.0 :30-11:00 E05 Precision medicine round table Executive 9:00-10:30 C01 Challenges and opportunities for Australian co-ordinating centres and clinical trials Clinical networks in improving healthcare C02 Practical solutions to increase patient engagement in clinical trials Clinical C03 The tech savvy device trial Clinical C04 Launch Excellence: unlocking the strategic value of medical affairs Medical Affairs C05 Dialogue to cooperation to collaboration to partnership Clinical C06 Pharmacovigilance system in a global pharmaceutical company: A worldwide system PV ensuring national compliance and individual patient safety C07 Local Innovation/Australian-based Medical Technology to be announced Local Innovation 10:30-11:15 Morning Tea 11:15-12:15 C0 Investigator Initiated Studies (IIS) & the role of the investigator/institution as sponsor Clinical (challenges and strategies) C09 Challenges and opportunities for developing, sustaining and growing a clinical research Clinical business C10 Clinical Monitoring topic to be announced Clinical C11 The Medical Science Liaison: driving MSL excellence Medical Affairs C12 Early Phase Trials in AsiaPac Clinical C13 Pharmacovigilance hot topics PV C14 Local Innovation/Australian-based Medical Technology to be announced Local Innovation E06 Clinical research CRO Forum executive round table Executive 12:15-13:30 Lunch 13:30-14:30 C15 Investigator Initiated studies session to be announced Clinical C16 Implementing an esource Data Capture (EDC) system Clinical C17 Clinical research (Monitoring/CRO) to be announced Clinical C1 Beyond the MSL role: Where can medical affairs take you? Medical Affairs C19 Update from TransCelerate (cqms & elabel) Clinical C20 Pharmacovigilance topic to be announced PV C21 Home grown innovation: The need for evidence based digital health tech Local Innovation E07 Clinical research pharma & medtech executive round table Executive 14:30-14:45 Room Changeover 14:45-15:45 C22 Research in academic, clinical and industry: Points of difference/the National Mutual Clinical Acceptance as a change agent C23 Clinical research (coordination) session to be announced Clinical C24 Clinical trials in biologicals from the safety and regulatory perspective Clinical C25 Enabling your best as a medical affairs leader: Mind, body and medicine Medical Affairs C26 The adoption of the NHMRC safety monitoring and reporting in clinical trials involving Clinical therapeutic goods. C27 Update from the Pharmacoviglance and Special Access Branch PV C2 Home grown innovation: Developing the digital health technologies of today Local Innovation 15:45-16:15 Afternoon Tea 16:15-17:15 C33 Leadership in an era of change 17:15-1:15 Closing Reception

6 4.0 Royal Randwick Turf Club August 201 Key dates Early bird registration closes on 20 July 201 Conference registration closes on 14 August 201 Registration Fees The table below shows all available registration options. Day registration includes the social program for that day, and the pre-dinner drinks and awards dinner on 22 August regardless of day chosen. There is a separate Social Pass category, which includes all social functions (Welcome Reception, Conference Dinner including Pre-Dinner Drinks and Closing Reception) but not the conference sessions. All registration fees quoted are in Australian Dollars and include GST. Registration Type Early Bird (until 20 Standard (from 21 Day Ticket Member $35.00 $1, Non-Member $1, $1, Student/Retired $ $35.00 Government/Academia $ $35.00 Executive (Member) $1, $1, Executive (Non-Member) $1, $2, Day Ticket Member $1,10.00 $1, Non-Member $1, $2, Student/Retired $ $1,10.00 Government/Academia $ $1,10.00 Executive (Member) $1, $1, Executive (Non-Member) $2,20.00 $2, Day Ticket Member $1,35.00 $1, Non-Member $2,00.00 $2, Student/Retired $1, $1,35.00 Government/Academia $1, $1,35.00 Executive (Member) $1,75.00 $2, Executive (Non-Member) $2,60.00 $3, Social Program Members $ $20.00 Non-Members $ $ Group discounts are available for group of four and more. More information is available from the ARCS website: Professional Development in Therapeutics Join the conversation at #ARCSAus