Accelerating Drug & Clinical Trial Approvals in Asia REGULATOR ...
Accelerating Drug & Clinical Trial Approvals in Asia REGULATOR ...
Accelerating Drug & Clinical Trial Approvals in Asia REGULATOR ...
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Book before<br />
14 June 2013 and<br />
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27 – 30 August 2013 » Grand Copthorne Waterfront Hotel, S<strong>in</strong>gapore<br />
<strong>Accelerat<strong>in</strong>g</strong> <strong>Drug</strong> & <strong>Cl<strong>in</strong>ical</strong> <strong>Trial</strong> <strong>Approvals</strong> <strong>in</strong> <strong>Asia</strong><br />
Attend IBC’s Regulatory<br />
Affairs Summit for:<br />
Targeted Discussions on Practical<br />
Industry Issues Faced by Regulatory<br />
Professionals<br />
Latest Updates from <strong>Asia</strong>n Regulatory<br />
Authorities<br />
Interactive Discussions with Fellow<br />
Professionals across the Region<br />
Highlights <strong>in</strong> 2013<br />
<strong>Drug</strong> Registration Strategies <strong>in</strong><br />
South East <strong>Asia</strong> and North <strong>Asia</strong><br />
Regulatory Considerations for<br />
<strong>Cl<strong>in</strong>ical</strong> Development <strong>in</strong> North <strong>Asia</strong><br />
<strong>Cl<strong>in</strong>ical</strong> Data Shar<strong>in</strong>g & Bridg<strong>in</strong>g<br />
Strategies <strong>in</strong> Global <strong>Drug</strong><br />
Development<br />
Insightful<br />
Workshops On:<br />
A: Develop<strong>in</strong>g Successful Bridg<strong>in</strong>g<br />
Strategies for East <strong>Asia</strong> (Ch<strong>in</strong>a, Korea<br />
and Japan)<br />
B: Stability Test<strong>in</strong>g Requirements for<br />
<strong>Drug</strong> Approval <strong>in</strong> <strong>Asia</strong>/ASEAN<br />
Countries<br />
C: Overview and Guidel<strong>in</strong>es to<br />
Pharmaceutical/ Biopharmaceutical<br />
Regulations <strong>in</strong> India<br />
<strong>REGULATOR</strong> PANEL<br />
Dr. Kang Jaw-Jou<br />
Director General<br />
Taiwan Food and <strong>Drug</strong><br />
Adm<strong>in</strong>istration, Department<br />
of Health<br />
Pathom Sawanpanyalert<br />
Deputy Secretary General<br />
Food and <strong>Drug</strong><br />
Adm<strong>in</strong>istration of Thailand,<br />
M<strong>in</strong>istry of Public Health<br />
Prof. Andrea Laslop<br />
Head of Scientific Office, AGES<br />
PharmMed, Austria and<br />
Austrian member at CHMP<br />
(Committee for Human<br />
Medic<strong>in</strong>al Products) at<br />
EMA (European Medic<strong>in</strong>es<br />
Agency)<br />
INDUSTRY PANEL<br />
Kenneth Hartigan Go<br />
Director General<br />
Food and <strong>Drug</strong> Adm<strong>in</strong>istration,<br />
Philipp<strong>in</strong>es<br />
Melody Mart<strong>in</strong>ez Zamudio<br />
Food-<strong>Drug</strong> Regulation Officer IV, OIC –<br />
Licens<strong>in</strong>g and Registration Division<br />
Center for <strong>Drug</strong> Regulation and<br />
Research, Food and <strong>Drug</strong><br />
Adm<strong>in</strong>istration, Philipp<strong>in</strong>es<br />
Dr. Kim Ho Jeong, Ph.D<br />
Deputy Director, <strong>Drug</strong> Review<br />
Management Division, <strong>Drug</strong><br />
Evaluation Department, National<br />
Institute of Food and <strong>Drug</strong> Safety<br />
Evaluation, Korea<br />
• Dr. Victoria Elegant, Vice-President, Medical, <strong>Cl<strong>in</strong>ical</strong> & Regulatory Affairs, <strong>Asia</strong>-Pacific,<br />
Baxter Healthcare, Ch<strong>in</strong>a<br />
• Dr. Eva Kopecna, MSc, Head of Regulatory Affairs – Global OTC, Teva Pharmaceuticals<br />
Europe, UK<br />
• Lee So Jeong, Head of Regulatory, GlaxoSmithKl<strong>in</strong>e, Korea<br />
• Ari Fujishiro, Associate Director, Regulatory Affairs Group, <strong>Asia</strong> Development Department,<br />
Daiichi Sankyo, Japan<br />
• Akio Uemura, PhD, Senior Director, Head of Global <strong>Drug</strong> Development Japan and<br />
Regulatory Affairs Japan, Allergan, Japan<br />
• Ng Cheng Tiang, Director – Regulatory, Teva Pharmaceutical Industries, S<strong>in</strong>gapore<br />
• Woody Tan, Director, Regulatory Affairs (J-APAC), Genzyme-Sanofi, S<strong>in</strong>gapore<br />
• L<strong>in</strong> Hong, PhD, Associate Director, Regulatory Affairs, <strong>Asia</strong> Pacific Russia CIS (APAC)<br />
Established Pharmaceuticals, Abbott, USA<br />
• J<strong>in</strong> Shun, Associate Director, Regulatory Affairs, Takeda Development Center (<strong>Asia</strong>),<br />
S<strong>in</strong>gapore<br />
• Dr. Bobby George, Vice President and Head Regulatory Affairs, Reliance Life Sciences.,<br />
India<br />
Produced by:<br />
Supported by:<br />
www.pharmaregulatoryasia.com<br />
Media Partner:<br />
Life<br />
Sciences<br />
International Market<strong>in</strong>g<br />
REGISTER NOW! Customer Service Hotl<strong>in</strong>e: +65 6508 2401
DAY ONE 28 AUGUST 2013<br />
WEDNESDAY<br />
<strong>Accelerat<strong>in</strong>g</strong> <strong>Drug</strong> & <strong>Cl<strong>in</strong>ical</strong> <strong>Trial</strong> <strong>Approvals</strong> <strong>in</strong> <strong>Asia</strong><br />
0900 Chairperson’s Open<strong>in</strong>g Remarks<br />
L<strong>in</strong> Hong, PhD, Associate Director, Regulatory Affairs, <strong>Asia</strong> Pacific<br />
Russia CIS (APAC) Established Pharmaceuticals, Abbott, USA<br />
Country – Focused Keynotes and Q&A: Updates and Ga<strong>in</strong><strong>in</strong>g<br />
Clarity for Clear Interpretation of Regulations<br />
This session features latest updates and advice from key<br />
authorities/key op<strong>in</strong>ion leaders <strong>in</strong> <strong>Asia</strong>, help<strong>in</strong>g the <strong>in</strong>dustry to<br />
achieve consistent <strong>in</strong>terpretation of regulations and improve<br />
regulatory compliance for efficient approval. An essential session to<br />
help <strong>in</strong>dustry determ<strong>in</strong>e critical success factors and plan for the<br />
timely approval of future submissions.<br />
0910 Review and Updates of <strong>Drug</strong> Regulation Landscape <strong>in</strong><br />
Taiwan<br />
Dr. Kang Jaw-Jou, Director General, Taiwan Food and <strong>Drug</strong><br />
Adm<strong>in</strong>istration, Department of Health<br />
0950 Transformative <strong>Drug</strong> Regulatory Adm<strong>in</strong>istration: Us<strong>in</strong>g<br />
Regulations to Improve Health and Trade Outcomes<br />
Kenneth Hartigan-Go, Director General, Food and <strong>Drug</strong><br />
Adm<strong>in</strong>istration, Philipp<strong>in</strong>es<br />
1030 Morn<strong>in</strong>g Refreshments<br />
1100 Updates of Pharmaceutical Product Registration <strong>in</strong><br />
Thailand: Overview, GMPs, Biosimilars and Traditional<br />
Medic<strong>in</strong>es<br />
Pathom Sawanpanyalert, Deputy Secretary General, Food<br />
and <strong>Drug</strong> Adm<strong>in</strong>istration of Thailand, M<strong>in</strong>istry of Public<br />
Health<br />
1140 Recent Update of <strong>Drug</strong> Approval Process <strong>in</strong> Korea<br />
Dr. Kim Ho Jeong, Ph.D, Deputy Director, <strong>Drug</strong> Review<br />
Management Division, <strong>Drug</strong> Evaluation Department, National<br />
Institute of Food and <strong>Drug</strong> Safety Evaluation, Korea<br />
1220 Network<strong>in</strong>g Lunch<br />
1450 Potential of “<strong>Asia</strong>n Medic<strong>in</strong>es Agency”: Establish<strong>in</strong>g<br />
Cooperation and Harmonisation among <strong>Asia</strong>n Regulators<br />
Prof. Andrea Laslop, Head of Scientific Office, AGES<br />
PharmMed, Austria and Austrian member at CHMP<br />
(Committee for Human Medic<strong>in</strong>al Products) at EMA<br />
(European Medic<strong>in</strong>es Agency)<br />
Kenneth Hartigan-Go, Director General, Food and <strong>Drug</strong><br />
Adm<strong>in</strong>istration, Philipp<strong>in</strong>es<br />
Dr. Kang Jaw-Jou, Director General, Taiwan Food and <strong>Drug</strong><br />
Adm<strong>in</strong>istration, Department of Health<br />
Panel Discussion<br />
1530 Afternoon Refreshments<br />
1600 Japan Development Strategy <strong>in</strong> the Era of Global <strong>Drug</strong><br />
Development<br />
• Regulations for muiti-regional cl<strong>in</strong>ical trials<br />
• Development of Japan strategy by work<strong>in</strong>g with global<br />
team<br />
• Successful regulatory <strong>in</strong>teractions<br />
Akio Uemura, PhD, Senior Director, Head of Global <strong>Drug</strong><br />
Development Japan and Regulatory Affairs Japan, Allergan,<br />
Japan<br />
<strong>Accelerat<strong>in</strong>g</strong> Approval for <strong>Drug</strong> Registration<br />
1640 Regulatory Strategies for New Product Launch <strong>in</strong> Korea:<br />
Case Study Experience<br />
• Overview of the regulatory process and requirement<br />
• Opportunities for bridg<strong>in</strong>g study and bridg<strong>in</strong>g waiver<br />
• Development of regulatory strategy: Case study<br />
So-Jeong Lee, Head of Regulatory, GlaxoSmithKl<strong>in</strong>e, Korea<br />
1720 Craft<strong>in</strong>g Efficient <strong>Drug</strong> Registration Strategies <strong>in</strong> <strong>Asia</strong><br />
• Insights <strong>in</strong> liais<strong>in</strong>g with countries’ respective regulatory<br />
agencies and pathways to accelerated approval<br />
Ng Cheng Tiang, Director – Regulatory, Teva Pharmaceutical<br />
Industries, S<strong>in</strong>gapore<br />
1800 Chairperson’s Remarks and End of Day One<br />
1330 Reserved for speaker from Health Sciences Authority,<br />
S<strong>in</strong>gapore<br />
1410 Updates of European Regulatory Initiatives:<br />
• Interactions between the CHMP and the PRAC<br />
• New transparency <strong>in</strong> the EU<br />
• The future EU <strong>Cl<strong>in</strong>ical</strong> <strong>Trial</strong>s Regulation<br />
• Adaptive licens<strong>in</strong>g as the next authorisation step<br />
Prof. Andrea Laslop, Head of Scientific Office, AGES<br />
PharmMed, Austria and Austrian member at CHMP<br />
(Committee for Human Medic<strong>in</strong>al Products) at EMA<br />
(European Medic<strong>in</strong>es Agency)<br />
PROMOTIONAL OPPORTUNITIES<br />
Raise your corporate profile and demonstrate products and<br />
services to our targeted, multidiscipl<strong>in</strong>ary audience at 6th<br />
Pharma Regulatory Affairs <strong>Asia</strong> Summit. As our delegates<br />
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by jo<strong>in</strong><strong>in</strong>g us <strong>in</strong> sponsor<strong>in</strong>g or exhibit<strong>in</strong>g at this event you<br />
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We are able to tailor a sponsorship solution to your needs. To f<strong>in</strong>d out more please contact: Yvonne Leong<br />
Tel: +65 6508 2489 | Email: Yvonne.Leong@ibcasia.com.sg<br />
REGISTER TODAY! +65 6508 2401 register@ibcasia.com.sg www.pharmaregulatoryasia.com
DAY TWO 29 AUGUST 2013<br />
THURSDAY<br />
<strong>Accelerat<strong>in</strong>g</strong> <strong>Drug</strong> & <strong>Cl<strong>in</strong>ical</strong> <strong>Trial</strong> <strong>Approvals</strong> <strong>in</strong> <strong>Asia</strong><br />
0900 Chairperson’s Remarks<br />
Dr. Eva Kopecna, MSc, Head of Regulatory Affairs – Global OTC,<br />
Teva Pharmaceuticals Europe, UK<br />
Regulatory Requirements for <strong>Cl<strong>in</strong>ical</strong> Development &<br />
Data Shar<strong>in</strong>g <strong>in</strong> <strong>Asia</strong><br />
0910 CTA/ IND Strategies for Regulatory Approval <strong>in</strong> Ch<strong>in</strong>a and<br />
its Differences from EU/US<br />
• Timel<strong>in</strong>es, common mistakes made and how to avoid them<br />
Dr. Victoria Elegant, Vice-President, Medical, <strong>Cl<strong>in</strong>ical</strong> &<br />
Regulatory Affairs, <strong>Asia</strong>-Pacific, Baxter Healthcare, Ch<strong>in</strong>a<br />
0950 <strong>Cl<strong>in</strong>ical</strong> Data Shar<strong>in</strong>g & Optimization of Usage of <strong>Cl<strong>in</strong>ical</strong><br />
Data across Ch<strong>in</strong>a, Korea & Taiwan<br />
• Overview of the country-specific requirement of cl<strong>in</strong>ical<br />
data<br />
• Key aspects at extrapolation of cl<strong>in</strong>ical data to local cl<strong>in</strong>ical<br />
data package<br />
• Collaboration with local cl<strong>in</strong>ical and regulatory team and<br />
global team<br />
Ari Fujishiro, Associate Director, Regulatory Affairs Group, <strong>Asia</strong><br />
Development Department, Daiichi Sankyo, Japan<br />
1030 Morn<strong>in</strong>g Refreshments<br />
CMC Requirements<br />
1600 CMC Requirements & Manag<strong>in</strong>g Complications <strong>in</strong><br />
Module 3<br />
• Requirements and challenges <strong>in</strong> design and change <strong>in</strong><br />
manufactur<strong>in</strong>g process and product specifications<br />
• Stability studies<br />
• Similarities and differences with post approval changes <strong>in</strong><br />
Ch<strong>in</strong>a/US/EU<br />
L<strong>in</strong> Hong, PhD, Associate Director, Regulatory Affairs, <strong>Asia</strong> Pacific<br />
Russia CIS (APAC) Established Pharmaceuticals, Abbott, USA<br />
1640 Updates and Guidel<strong>in</strong>es on CMC and Stability Study<br />
Requirements <strong>in</strong> Philipp<strong>in</strong>es<br />
Melody Mart<strong>in</strong>ez Zamudio, Food-<strong>Drug</strong> Regulation Officer IV,<br />
OIC – Licens<strong>in</strong>g and Registration Division, Center for <strong>Drug</strong><br />
Regulation and Research, Food and <strong>Drug</strong> Adm<strong>in</strong>istration,<br />
Philipp<strong>in</strong>es<br />
1720 Chairperson’s Clos<strong>in</strong>g Remarks and End of Conference<br />
1100 Updates on <strong>Cl<strong>in</strong>ical</strong> <strong>Trial</strong> Regulations <strong>in</strong> India<br />
Dr. Bobby George, Vice President and Head Regulatory Affairs,<br />
Reliance Life Sciences., India<br />
Topic – Specific ‘Deep-Dive’ Sessions<br />
1140 Expansion of OTC <strong>in</strong> <strong>Asia</strong> – Challenges for Global<br />
Companies<br />
• Understand<strong>in</strong>g classification of OTC products <strong>in</strong> <strong>Asia</strong><br />
• Assess<strong>in</strong>g the regulatory strategy for OTC product<br />
registration <strong>in</strong> <strong>Asia</strong><br />
• Review<strong>in</strong>g the potential for Rx-to-OTC switches <strong>in</strong> <strong>Asia</strong><br />
• Overcom<strong>in</strong>g the key challenges when register<strong>in</strong>g an OTC<br />
product <strong>in</strong> <strong>Asia</strong><br />
Dr. Eva Kopecna, MSc, Head of Regulatory Affairs – Global OTC,<br />
Teva Pharmaceuticals Europe, UK<br />
1220 Network<strong>in</strong>g Lunch<br />
1330 Orphan <strong>Drug</strong> Regulation and Environment <strong>in</strong> <strong>Asia</strong>: How is<br />
it Different from Normal Regulatory Pathways<br />
• Overview of orphan drug designation <strong>in</strong> some <strong>Asia</strong>n<br />
countries<br />
• Current regulatory process <strong>in</strong> JAPAC region<br />
• Outl<strong>in</strong><strong>in</strong>g the challenges of the orphan drug market <strong>in</strong> <strong>Asia</strong><br />
Woody Tan, Director, Regulatory Affairs (J-APAC),<br />
Genzyme-Sanofi, S<strong>in</strong>gapore<br />
1410 <strong>Drug</strong> Registration Us<strong>in</strong>g Global <strong>Cl<strong>in</strong>ical</strong> <strong>Trial</strong> Data &<br />
Bridg<strong>in</strong>g Studies<br />
• Regulatory strategy consideration for bridg<strong>in</strong>g studies <strong>in</strong><br />
• AP region<br />
• Key regulatory consideration on study design<br />
• Regulatory timel<strong>in</strong>e plann<strong>in</strong>g<br />
J<strong>in</strong> Shun, Associate Director, Regulatory Affairs,<br />
Takeda Development Center (<strong>Asia</strong>), S<strong>in</strong>gapore<br />
1450 Afternoon Refreshments<br />
Testimonials for the Longest<br />
Runn<strong>in</strong>g Regulatory Affairs<br />
Event <strong>in</strong> <strong>Asia</strong><br />
“Comprehensive and relevant to today's regulatory<br />
affairs personnel”<br />
~ Bayer<br />
“An outstand<strong>in</strong>g excellent meet<strong>in</strong>g which <strong>in</strong>troduced<br />
to me the ASEAN regulatory environment”<br />
~ AGES<br />
“Got a good impression of regulatory status <strong>in</strong> <strong>Asia</strong><br />
region, theory as well as practice”<br />
~ Novartis<br />
“The variety of topics discussed was good. It provided<br />
<strong>in</strong>sight to relevant and important <strong>in</strong>formation<br />
perta<strong>in</strong><strong>in</strong>g to regulatory field<br />
~ MSD Pharmaceuticals<br />
REGISTER TODAY! +65 6508 2401 register@ibcasia.com.sg www.pharmaregulatoryasia.com
WORKSHOPS 27 & 30 AUGUST 2013<br />
TUESDAY & FRIDAY<br />
<strong>Accelerat<strong>in</strong>g</strong> <strong>Drug</strong> & <strong>Cl<strong>in</strong>ical</strong> <strong>Trial</strong> <strong>Approvals</strong> <strong>in</strong> <strong>Asia</strong><br />
PRE-CONFERENCE WORKSHOPS | 27 AUGUST 2013<br />
Registration beg<strong>in</strong>s 30 m<strong>in</strong>utes before workshop commences. Morn<strong>in</strong>g/afternoon refreshments are <strong>in</strong>cluded; lunch will be served for delegates who<br />
attend the full day i.e. morn<strong>in</strong>g and afternoon sessions.<br />
WORKSHOP A: (0900 – 1230)<br />
Develop<strong>in</strong>g Successful Bridg<strong>in</strong>g Strategies for East <strong>Asia</strong><br />
(Ch<strong>in</strong>a, Korea and Japan)<br />
East <strong>Asia</strong>n populations are very similar from various aspects. However,<br />
each country is <strong>in</strong>creas<strong>in</strong>gly requir<strong>in</strong>g cl<strong>in</strong>ical data generated <strong>in</strong> its<br />
own population.<br />
By attend<strong>in</strong>g this workshop, participants will f<strong>in</strong>d opportunities for<br />
scientific synergies <strong>in</strong> the East <strong>Asia</strong>n region and will learn possible<br />
regulatory pathways for the future.<br />
Conducted by<br />
So-Jeong Lee, Head of Regulatory, GlaxoSmithKl<strong>in</strong>e, Korea<br />
Workshop Outl<strong>in</strong>e:<br />
Collaborations <strong>in</strong> East <strong>Asia</strong><br />
Updates on Tripartite (Ch<strong>in</strong>a/Korea/Japan) collaboration<br />
<strong>Drug</strong> development strategies <strong>in</strong> East <strong>Asia</strong><br />
Opportunities for scientific synergies<br />
Possible regulatory pathways for the future<br />
WORKSHOP B:<br />
(1330 – 1700)<br />
Stability Test<strong>in</strong>g Requirements for <strong>Drug</strong> Approval <strong>in</strong> <strong>Asia</strong>/ASEAN Countries<br />
Stability test<strong>in</strong>g requirements are specific to a region and/or country,<br />
thus with the need of <strong>in</strong>ternational harmonization. A robust stability<br />
monitor<strong>in</strong>g program ensures a quality product. By attend<strong>in</strong>g this<br />
workshop, participants will learn specific requirements for <strong>Asia</strong>/ASEAN<br />
Countries and f<strong>in</strong>d opportunities from possible harmonization.<br />
Conducted by<br />
Nisha Desai, Chief Manager – Corporate Regulatory Affairs, Priamal<br />
Enterprises Limited, India<br />
Workshop Outl<strong>in</strong>e:<br />
Stability test<strong>in</strong>g requirements <strong>in</strong> <strong>Asia</strong>/ASEAN countries<br />
Country/region specific requirements<br />
Correlation with ICH requirements<br />
Opportunities for harmonization<br />
Challenges & possible solutions<br />
POST-CONFERENCE WORKSHOP | 30 AUGUST 2013<br />
WORKSHOP C: (0900 – 1230)<br />
Overview and Guidel<strong>in</strong>es to Pharmaceutical/Biopharmaceutical<br />
Regulations <strong>in</strong> India<br />
This workshop provides a comprehensive review of regulatory<br />
guidel<strong>in</strong>es and updates to successful product registration and cl<strong>in</strong>ical<br />
trial development <strong>in</strong> India. Recommended for professionals <strong>in</strong>volved<br />
<strong>in</strong> regulatory affairs, product registration and cl<strong>in</strong>ical development <strong>in</strong><br />
India.<br />
Workshop Outl<strong>in</strong>e:<br />
Overview of regulatory framework <strong>in</strong> India<br />
Registration of overseas manufacturers and their products <strong>in</strong> India<br />
Fil<strong>in</strong>gs for obta<strong>in</strong><strong>in</strong>g an approval for a biological product<br />
Changes <strong>in</strong> <strong>Cl<strong>in</strong>ical</strong> <strong>Trial</strong> related regulations<br />
Registration process for Ethics Committees<br />
About your Workshop Leader<br />
Dr. Bobby George, Vice President and Head Regulatory Affairs,<br />
Reliance Life Sciences., India<br />
Dr. George is currently responsible for provid<strong>in</strong>g regulatory guidance<br />
and strategic <strong>in</strong>puts for Reliance Life Sciences’ biopharmaceutical &<br />
pharmaceutical development programs to assure appropriate and<br />
timely regulatory fil<strong>in</strong>g and approvals, across different regions. He has<br />
over 14 years of <strong>in</strong>dustrial experience, of which the last 10 years have<br />
been with Reliance. Dur<strong>in</strong>g this period, he has been <strong>in</strong>strumental <strong>in</strong><br />
commercializ<strong>in</strong>g as many as 7 biosimilars already <strong>in</strong> India. Many of<br />
these are also under process of registration <strong>in</strong> the rest of the world<br />
markets.<br />
REGISTER TODAY! +65 6508 2401 register@ibcasia.com.sg www.pharmaregulatoryasia.com
6 PHARMACEUTICAL<br />
TH ANNUAL<br />
<strong>REGULATOR</strong>Y AFFAIRS ASIA<br />
27 – 30 August 2013 » Grand Copthorne Waterfront Hotel, S<strong>in</strong>gapore<br />
<strong>Accelerat<strong>in</strong>g</strong> <strong>Drug</strong> & <strong>Cl<strong>in</strong>ical</strong> <strong>Trial</strong> <strong>Approvals</strong> <strong>in</strong> <strong>Asia</strong><br />
Be<strong>in</strong>g up-to-date with current requirements and understand<strong>in</strong>g <strong>in</strong>dividual authority<br />
<strong>in</strong>terpretation of guidel<strong>in</strong>es is critical for successful product registration. The<br />
challenges <strong>in</strong> <strong>Asia</strong> are the frequency of chang<strong>in</strong>g regulations and <strong>in</strong>creas<strong>in</strong>g timelag<br />
for regulatory approval – factors which can significantly impact your time to<br />
market and bottom l<strong>in</strong>e.<br />
IBC’s Pharmaceutical Regulatory <strong>Asia</strong> Summit is the longest stand<strong>in</strong>g event of<br />
its k<strong>in</strong>d <strong>in</strong> the region. The 6th annual event will cont<strong>in</strong>ue its focus on:<br />
Real-life <strong>in</strong>dustry experience <strong>in</strong> deal<strong>in</strong>g with particular authorities around <strong>Asia</strong><br />
Pacific and beyond<br />
More opportunities to engage <strong>in</strong> Q&A discussions with regulatory authorities<br />
and <strong>in</strong>dustry experts<br />
The chance to ask questions that you want answered to expedite your own<br />
approval process<br />
Who Should Attend:<br />
Director, Associate, Manager, Vice President, Heads of Department, Executive, Specialist <strong>in</strong>:<br />
• Regulatory Affairs<br />
• Global Regulatory Affairs<br />
• International Regulatory Affairs<br />
• <strong>Asia</strong>-Pacific Regulatory Affairs<br />
• <strong>Drug</strong> Regulatory Affairs<br />
• Regulatory Affairs SE <strong>Asia</strong><br />
• Regulatory Strategy<br />
• Product Registration<br />
• Regulatory Submissions<br />
• Project Management<br />
• <strong>Cl<strong>in</strong>ical</strong> Development<br />
• Regulatory CMC<br />
• Compliance<br />
• <strong>Drug</strong> Safety<br />
• Pharmacovigilance<br />
• <strong>Cl<strong>in</strong>ical</strong> Regulatory Strategy<br />
• QA/QC<br />
• Medical and Regulatory Affairs<br />
• Regional Registration<br />
• Product Development<br />
BY INDUSTRY<br />
■ Pharma/generics/<br />
biopharm 70%<br />
■ Med Device 5%<br />
■ Regulatory Authority 5%<br />
■ CRO 10%<br />
■ Regulatory Consultant<br />
5%<br />
■ eSoftware 5%<br />
BY COUNTRY<br />
■ South East <strong>Asia</strong> 50%<br />
■ North <strong>Asia</strong> 30%<br />
■ Europe 5%<br />
■ Aust 3%<br />
■ India 5%<br />
■ USA/ROW 7%<br />
What is New <strong>in</strong> 2013<br />
MORE <strong>Asia</strong>n regulators – <strong>in</strong>dustry<br />
Q&A sessions and panels.<br />
MORE <strong>in</strong>teractive discussions on<br />
real-life issues and scenarios<br />
MORE <strong>Asia</strong>n and <strong>in</strong>ternational<br />
regulatory and <strong>in</strong>dustry experts to<br />
learn from, meet and network with<br />
Jo<strong>in</strong> Our<br />
World-Class Events <strong>in</strong> the<br />
Life Sciences Series<br />
5th Annual BioProcess<br />
International Ch<strong>in</strong>a<br />
20 – 21 August 2013<br />
Shanghai, Ch<strong>in</strong>a<br />
www.ibclifesciences.com/BPICh<strong>in</strong>a<br />
5th Annual Partnerships<br />
<strong>in</strong> <strong>Cl<strong>in</strong>ical</strong> <strong>Trial</strong>s<br />
4 – 6 September 2013<br />
Shanghai, Ch<strong>in</strong>a<br />
www.cl<strong>in</strong>icalpartnershipsasia.com<br />
8th Branded Generics <strong>Asia</strong><br />
11 – 14 November 2013<br />
S<strong>in</strong>gapore<br />
www.generics-asia.com<br />
Past Participat<strong>in</strong>g Organizations <strong>in</strong>clude:<br />
3M Innovation • Abbott • Actelion Pharmaceuticals • Allergan • Arch Pharmalabs • Australian Nuclear Science & Technology Organisation • Baker &<br />
McKenzie • Bayer Healthcare • Bayer Pharma • Beaufour-Ipsen (Tianj<strong>in</strong>) Pharmaceutical • Beij<strong>in</strong>g Novartis Pharmaceutical • Biocon • Biogen Idec • BioMar<strong>in</strong><br />
Pharmaceutical • Celltrion • Cephalon Inc Beij<strong>in</strong>g Rep Office • Corporate Law Group • Covance <strong>Cl<strong>in</strong>ical</strong> Development Services • Covidien Pte • CSL Limited<br />
• DNP <strong>Asia</strong> Pacific • HangZhou Tigermed Consult<strong>in</strong>g • Hospira • INC Research • Indena S.p.A • iNova Pharmaceuticals (Australia) • Institut Pasteur of<br />
Shanghai • Jadran Galenski Laboratory DDs • LFB Biotechnologies • Lionbridge Life Sciences • Lundbeck • Millennium: The Takeda Oncology Company<br />
• MSD International Gmbh (S<strong>in</strong>gapore Branch) • National Cancer Center • Novartis Institue for Tropical Diseases • Novartis Pharma • Novozymes (Ch<strong>in</strong>a)<br />
Investment • Octapharma Pharmazeutika Produktionsges • Oxo Pharma • Pierre Fabre Medicament • Procter & Gamble • Reckitt Benckiser • RPS Research<br />
• Sanofi (Ch<strong>in</strong>a) Investment • Santen Pharmaceutical • Shanghai Henlius Biotech • Shire S<strong>in</strong>gapore • Taiho Pharma • Takeda • Teva Pharmaceutical Industries<br />
• The Government Pharmaceutical Organization • The Hong Kong Association of the Pharmaceutical Industry • TTY Biopharm • Venturepharm Laboratories<br />
(And many more!)<br />
REGISTER TODAY! +65 6508 2401 register@ibcasia.com.sg www.pharmaregulatoryasia.com