5th Annual Pharmaceutical Regulatory Affairs Asia 2012

Venue: Sheraton Towers Singapore

Location: singapore, Singapore

Event Date/Time: Aug 21, 2012 End Date/Time: Aug 24, 2012
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Being up-to-date with current requirements and understanding individual authority interpretation of guidelines is critical for successful product registration. The challenge in Asia is the frequency of changing regulations and increasing time-lag for regulatory approval – factors which can significantly impact on your time to market and bottom line.

IBC’s Pharmaceutical Regulatory Asia Summit is the longest standing event of its kind in the region. In our 5 th year, we are emphasizing collaborations between industry and authority to expedite the approval of safe and effective drugs.

In this event you will not be presented with a series of regulatory checklists that you can find online. What you will gain is:

â– Real-life industry experience in dealing with particular authorities
â– More opportunity to engage in Q&A discussions with regulatory authorities and industry experts
â– The chance to ask questions that you want answered to expedite your own approval process

Conference Highlights

â– Reduce approval timelags by understanding regulatory interpretation of guidelines and latest updates at BPOM (Indonesia), KFDA (Korea), TFDA (Taiwan)

â– Unique opportunity to engage in open discussion with the regulators in our Meet the Regulators Q&A

â– Understand the preparedness of ASEAN countries to the 2015 ASEAN Economic Community and impact on industry

■Optimise your China regulatory knowledge – this new-format round-table session provides an overview of the regulatory topicspertinent to SFDA approval followed participation in-depth discussion in the topic of your choice

■Maximise your commercial value in Asia – understand the components for successful regulatory strategy in key growth markets of India, Indonesia and Korea

â– Get up-to-speed with latest developments in regulated markets including EU, USA, Australia, impact of these changes in Asia and what it means for your regulatory strategy

■First-time case study on Pfizer’s experience in delivering global submissions – take-away best practice for your own regulatory processes