Accelerating Drug & Clinical Trial Approvals in Asia REGULATOR ...

6 PHARMACEUTICAL
TH ANNUAL
REGULATORY AFFAIRS ASIA
27 – 30 August 2013 » Grand Copthorne Waterfront Hotel, Singapore
Accelerating Drug & Clinical Trial Approvals in Asia
Being up-to-date with current requirements and understanding individual authority
interpretation of guidelines is critical for successful product registration. The
challenges in Asia are the frequency of changing regulations and increasing timelag
for regulatory approval – factors which can significantly impact your time to
market and bottom line.
IBC’s Pharmaceutical Regulatory Asia Summit is the longest standing event of
its kind in the region. The 6th annual event will continue its focus on:
Real-life industry experience in dealing with particular authorities around Asia
Pacific and beyond
More opportunities to engage in Q&A discussions with regulatory authorities
and industry experts
The chance to ask questions that you want answered to expedite your own
approval process
Who Should Attend:
Director, Associate, Manager, Vice President, Heads of Department, Executive, Specialist in:
• Regulatory Affairs
• Global Regulatory Affairs
• International Regulatory Affairs
• Asia-Pacific Regulatory Affairs
• Drug Regulatory Affairs
• Regulatory Affairs SE Asia
• Regulatory Strategy
• Product Registration
• Regulatory Submissions
• Project Management
• Clinical Development
• Regulatory CMC
• Compliance
• Drug Safety
• Pharmacovigilance
• Clinical Regulatory Strategy
• QA/QC
• Medical and Regulatory Affairs
• Regional Registration
• Product Development
BY INDUSTRY
■ Pharma/generics/
biopharm 70%
■ Med Device 5%
■ Regulatory Authority 5%
■ CRO 10%
■ Regulatory Consultant
5%
■ eSoftware 5%
BY COUNTRY
■ South East Asia 50%
■ North Asia 30%
■ Europe 5%
■ Aust 3%
■ India 5%
■ USA/ROW 7%
What is New in 2013
MORE Asian regulators – industry
Q&A sessions and panels.
MORE interactive discussions on
real-life issues and scenarios
MORE Asian and international
regulatory and industry experts to
learn from, meet and network with
Join Our
World-Class Events in the
Life Sciences Series
5th Annual BioProcess
International China
20 – 21 August 2013
Shanghai, China
www.ibclifesciences.com/BPIChina
5th Annual Partnerships
in Clinical Trials
4 – 6 September 2013
Shanghai, China
www.clinicalpartnershipsasia.com
8th Branded Generics Asia
11 – 14 November 2013
Singapore
www.generics-asia.com
Past Participating Organizations include:
3M Innovation • Abbott • Actelion Pharmaceuticals • Allergan • Arch Pharmalabs • Australian Nuclear Science & Technology Organisation • Baker &
McKenzie • Bayer Healthcare • Bayer Pharma • Beaufour-Ipsen (Tianjin) Pharmaceutical • Beijing Novartis Pharmaceutical • Biocon • Biogen Idec • BioMarin
Pharmaceutical • Celltrion • Cephalon Inc Beijing Rep Office • Corporate Law Group • Covance Clinical Development Services • Covidien Pte • CSL Limited
• DNP Asia Pacific • HangZhou Tigermed Consulting • Hospira • INC Research • Indena S.p.A • iNova Pharmaceuticals (Australia) • Institut Pasteur of
Shanghai • Jadran Galenski Laboratory DDs • LFB Biotechnologies • Lionbridge Life Sciences • Lundbeck • Millennium: The Takeda Oncology Company
• MSD International Gmbh (Singapore Branch) • National Cancer Center • Novartis Institue for Tropical Diseases • Novartis Pharma • Novozymes (China)
Investment • Octapharma Pharmazeutika Produktionsges • Oxo Pharma • Pierre Fabre Medicament • Procter & Gamble • Reckitt Benckiser • RPS Research
• Sanofi (China) Investment • Santen Pharmaceutical • Shanghai Henlius Biotech • Shire Singapore • Taiho Pharma • Takeda • Teva Pharmaceutical Industries
• The Government Pharmaceutical Organization • The Hong Kong Association of the Pharmaceutical Industry • TTY Biopharm • Venturepharm Laboratories
(And many more!)
REGISTER TODAY! +65 6508 2401 register@ibcasia.com.sg www.pharmaregulatoryasia.com