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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. The 6th annual event will continue its focus on:
- Real-life industry experience in dealing with particular authorities around Asia Pacific and beyond
- More opportunity 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
- More Asia regulators – industry Q&A sessions and panels.
- More case-study driven content discussing real-life issues and scenarios
- More Asian and international regulatory and industry experts to learn from, meet and network with
- New pre/post sessions on medical device regulations and pharmacovigilance
Comprehensive and relevant to today's regulatory affairs personnel – Bayer
An outstanding excellent meeting which introduced to me the ASEAN regulatory environment - AGES
Got a good impression of regulatory status in Asia region, theory as well as practice – Novartis
The variety of topics discussed was good. It provided insight to relevant and important information pertaining to regulatory field – MSD Pharmaceuticals
- Gain clarity on interpretation of regulations across South East Asia and North Asia.
- Keep-up-to-date with impending changes and future expectations of Asia and the global regulatory landscape.
- Close interactions and Q&A sessions with health authorities.
- Real – life experiences from industry on achieving successful and timely drug approval in Asia.
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Dr. Kang Jaw-Jou
Director General
Taiwan Food and Drug Administration, Department of Health |
Kenneth Hartigan Go
Director General
Food and Drug Administration, Philippines |
Pathom Sawanpanyalert
Deputy Secretary General
Food and Drug Administration of Thailand, Ministry of Public Health |
Melody Martinez Zamudio
Food-Drug Regulation Officer IV, OIC – Licensing and Registration Division
Center for Drug Regulation and Research, Food and Drug Administration, Philippines |
Prof. Andrea Laslop
Head of Scientific Office,
AGES PharmMed, Austria and Austrian member at CHMP (Committee for Human Medicinal Products) at EMA (European Medicines Agency) |
Korean Food & Drug Administration |
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Dr. Victoria Elegant, Vice-President, Medical, Clinical & Regulatory Affairs, Asia-Pacific, Baxter Healthcare, China
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Lee So Jeong, Head of Regulatory, GlaxoSmithKline, Korea
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Ari Fujishiro, Associate Director, Regulatory Affairs Group, Asia Development Department, Daiichi Sankyo, Japan
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Akio Uemura, PhD, Director and Head, Regulatory Affairs, Allergan, Japan
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Ng Cheng Tiang, Director – Regulatory, Teva Pharmaceutical Industries, Singapore
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Woody Tan, Director, Regulatory Affairs (J-APAC), Genzyme-Sanofi, Singapore
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Shell Li, Head of Clinical Research, Boehringer Ingelheim, China
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Jacqueline Mao Yun, M.D., MBA., Director – SSRM (Safety Surveillance and Risk Management), Pfizer, China
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Lin Hong, PhD, Associate Director, Regulatory Affairs, Asia Pacific Russia CIS (APAC)
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Established Pharmaceuticals, Abbott, USA
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Jin Shun, Associate Director, Regulatory Affairs, Takeda Development Center (Asia), Singapore
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Dr. Bobby George, Assistant Vice President and Head Regulatory Affairs, Reliance Life Sciences., India
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Dr. Yin Qiman, Regulatory Affairs Director – China, Medtronic, China
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