ARCS Conferences

Opening Plenary: ANZTPA and other therapeutic goods regulation developments (T1)

Synopsis

The pace of reform has accelerated in the last 12 months. To this end Megan Morris has been appointed Deputy Secretary in charge of trans-Tasman harmonization and will provide an introduction and overview with the reinvigoration of this initiative. Dr Stewart Jessamine will give us a perspective from across the Tasman on behalf of Medsafe and will also discuss interim reforms and changes within NZ. Lastly on this section, Steve McCutcheon, FSANZ will give us a perspective of the experiences, bestpractice  and salient learnings for an agency and industry that came with the food standards trans-Tasman harmonization.
After morning tea, Professor Dennis Pearce will discuss the consultation process that led to the 21 recommendations of the TGA Transparency Review, which he chaired. Dr Rohan Hammett will bring these initiatives together and discuss how reforms and transparency review fit before a conclusion from Adrian Bootes – on ARCS member feedback on important issues with new processes, harmonisation and transparency reform from the medicines and devices sectors.

• Next: GMP audits in Asia, global trends, trials and tribulations (T2)