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Program

Day 1 – Thursday 15 September 2011

8:30 – 9:30 Registration, Welcome Coffee & Trade Exhibition
9:30 – 10:30 Opening of ARCS Congress – ANZTPA and other Therapeutic Goods Regulation developments (T1)
10:30 – 11:00 Morning Tea & Trade Exhibition
11:00 – 12:00 T1 continued
12:00 – 1:30 Lunch & Trade Exhibition
1:30 – 3:00 GMP/Quality GMP Audits in Asia, global trends, trials and tribulations  (T2)
Devices/Biologicals/OTCs Medicines, Medical Devices, IVDs – the evolving world of combination products (T3)
Prescriptions TGA Regulatory reforms (T4)
In Vitro Diagnostics IVD Regulation after 12 Months and what the future holds  (T5)
3:00 – 3:30 Afternoon Tea & Trade Exhibition
3:30 – 5:00 GMP/Quality PIC/S and Quality Risk Management (T6)
Prescriptions The Orphan Drug Program in Australia; experiences to date and where to next (T7)
Devices/Biologicals/OTCs Clinical Evidence and expectations for all risk classifications for Medical Devices and Procedure Packs (T8)
Prescriptions New changes to Medicines Regulations in New Zealand (T9)
5:00 – 7.00 Pre-Dinner Drinks & Trade Exhibition
7:00 – 10:30 Conference Gala Dinner (including entertainment)

Day 2 – Friday 16 September 2011

8:00 – 8:30 Registration, Welcome Coffee & Trade Exhibition
8:30 – 10:00 Day 2 Opening Plenary – The importance of PIC/S as a global coordinator in the development of regulatory guidelines  (F1)
10:00 – 10:30 Morning Tea & Trade Exhibition
10:30 – 12:00 GMP/Quality Information quality integrity and validation (F2)
Prescriptions TGA labelling and packaging regulatory framework (F3)
Pharmacovigilance Social Media (F4)
Prescriptions Bringing products to market with less panic and minimal ad hoc decisions (F5)
12:00 – 1:00 Lunch & Trade Exhibition
1:00 – 2:30 Prescriptions Requirements and responsibilities for industry, associated with release of the 17th edition of the Australian Regulatory Guidelines (F6)
Prescriptions Update on the Biologicals Framework (F7)
Prescriptions Publishing electronic submissions from an eCTD and Nees perspective – it’s not all magic (F8)
Prescriptions Biosimilars - Why are there special regulatory requirements? (F13)
2:30 – 3:00 Afternoon Tea & Trade Exhibition
3:00 – 4:30 GMP/Quality TGA on – site GMP audit of an overseas manufacturing site – what does it mean for an Australian regulatory affairs department (F9)
Prescriptions Quality Module 3 and beyond (F10)
Prescriptions The Regulatory Super Sleuth (F11)
Prescriptions RMP implications for Prescription Medicine Registrations (F12)

DISCLAIMER: Some speakers and topics will be changed as it is finalised. ARCS Australia reserves the right to change the program and contents as necessary.

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