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

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27 – 30 August 2013 » Grand Copthorne Waterfront Hotel, Singapore
Accelerating Drug & Clinical Trial Approvals in Asia
Attend IBC’s Regulatory
Affairs Summit for:
Targeted Discussions on Practical
Industry Issues Faced by Regulatory
Professionals
Latest Updates from Asian Regulatory
Authorities
Interactive Discussions with Fellow
Professionals across the Region
Highlights in 2013
Drug Registration Strategies in
South East Asia and North Asia
Regulatory Considerations for
Clinical Development in North Asia
Clinical Data Sharing & Bridging
Strategies in Global Drug
Development
Insightful
Workshops On:
A: Developing Successful Bridging
Strategies for East Asia (China, Korea
and Japan)
B: Stability Testing Requirements for
Drug Approval in Asia/ASEAN
Countries
C: Overview and Guidelines to
Pharmaceutical/ Biopharmaceutical
Regulations in India
REGULATOR PANEL
Dr. Kang Jaw-Jou
Director General
Taiwan Food and Drug
Administration, Department
of Health
Pathom Sawanpanyalert
Deputy Secretary General
Food and Drug
Administration of Thailand,
Ministry of Public Health
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)
INDUSTRY PANEL
Kenneth Hartigan Go
Director General
Food and Drug Administration,
Philippines
Melody Martinez Zamudio
Food-Drug Regulation Officer IV, OIC –
Licensing and Registration Division
Center for Drug Regulation and
Research, Food and Drug
Administration, Philippines
Dr. Kim Ho Jeong, Ph.D
Deputy Director, Drug Review
Management Division, Drug
Evaluation Department, National
Institute of Food and Drug Safety
Evaluation, Korea
• Dr. Victoria Elegant, Vice-President, Medical, Clinical & Regulatory Affairs, Asia-Pacific,
Baxter Healthcare, China
• Dr. Eva Kopecna, MSc, Head of Regulatory Affairs – Global OTC, Teva Pharmaceuticals
Europe, UK
• Lee So Jeong, Head of Regulatory, GlaxoSmithKline, Korea
• Ari Fujishiro, Associate Director, Regulatory Affairs Group, Asia Development Department,
Daiichi Sankyo, Japan
• Akio Uemura, PhD, Senior Director, Head of Global Drug Development Japan and
Regulatory Affairs Japan, Allergan, Japan
• Ng Cheng Tiang, Director – Regulatory, Teva Pharmaceutical Industries, Singapore
• Woody Tan, Director, Regulatory Affairs (J-APAC), Genzyme-Sanofi, Singapore
• Lin Hong, PhD, Associate Director, Regulatory Affairs, Asia Pacific Russia CIS (APAC)
Established Pharmaceuticals, Abbott, USA
• Jin Shun, Associate Director, Regulatory Affairs, Takeda Development Center (Asia),
Singapore
• Dr. Bobby George, Vice President and Head Regulatory Affairs, Reliance Life Sciences.,
India
Produced by:
Supported by:
www.pharmaregulatoryasia.com
Media Partner:
Life
Sciences
International Marketing
REGISTER NOW! Customer Service Hotline: +65 6508 2401

DAY ONE 28 AUGUST 2013
WEDNESDAY
Accelerating Drug & Clinical Trial Approvals in Asia
0900 Chairperson’s Opening Remarks
Lin Hong, PhD, Associate Director, Regulatory Affairs, Asia Pacific
Russia CIS (APAC) Established Pharmaceuticals, Abbott, USA
Country – Focused Keynotes and Q&A: Updates and Gaining
Clarity for Clear Interpretation of Regulations
This session features latest updates and advice from key
authorities/key opinion leaders in Asia, helping the industry to
achieve consistent interpretation of regulations and improve
regulatory compliance for efficient approval. An essential session to
help industry determine critical success factors and plan for the
timely approval of future submissions.
0910 Review and Updates of Drug Regulation Landscape in
Taiwan
Dr. Kang Jaw-Jou, Director General, Taiwan Food and Drug
Administration, Department of Health
0950 Transformative Drug Regulatory Administration: Using
Regulations to Improve Health and Trade Outcomes
Kenneth Hartigan-Go, Director General, Food and Drug
Administration, Philippines
1030 Morning Refreshments
1100 Updates of Pharmaceutical Product Registration in
Thailand: Overview, GMPs, Biosimilars and Traditional
Medicines
Pathom Sawanpanyalert, Deputy Secretary General, Food
and Drug Administration of Thailand, Ministry of Public
Health
1140 Recent Update of Drug Approval Process in Korea
Dr. Kim Ho Jeong, Ph.D, Deputy Director, Drug Review
Management Division, Drug Evaluation Department, National
Institute of Food and Drug Safety Evaluation, Korea
1220 Networking Lunch
1450 Potential of “Asian Medicines Agency”: Establishing
Cooperation and Harmonisation among Asian Regulators
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)
Kenneth Hartigan-Go, Director General, Food and Drug
Administration, Philippines
Dr. Kang Jaw-Jou, Director General, Taiwan Food and Drug
Administration, Department of Health
Panel Discussion
1530 Afternoon Refreshments
1600 Japan Development Strategy in the Era of Global Drug
Development
• Regulations for muiti-regional clinical trials
• Development of Japan strategy by working with global
team
• Successful regulatory interactions
Akio Uemura, PhD, Senior Director, Head of Global Drug
Development Japan and Regulatory Affairs Japan, Allergan,
Japan
Accelerating Approval for Drug Registration
1640 Regulatory Strategies for New Product Launch in Korea:
Case Study Experience
• Overview of the regulatory process and requirement
• Opportunities for bridging study and bridging waiver
• Development of regulatory strategy: Case study
So-Jeong Lee, Head of Regulatory, GlaxoSmithKline, Korea
1720 Crafting Efficient Drug Registration Strategies in Asia
• Insights in liaising with countries’ respective regulatory
agencies and pathways to accelerated approval
Ng Cheng Tiang, Director – Regulatory, Teva Pharmaceutical
Industries, Singapore
1800 Chairperson’s Remarks and End of Day One
1330 Reserved for speaker from Health Sciences Authority,
Singapore
1410 Updates of European Regulatory Initiatives:
• Interactions between the CHMP and the PRAC
• New transparency in the EU
• The future EU Clinical Trials Regulation
• Adaptive licensing as the next authorisation step
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)
PROMOTIONAL OPPORTUNITIES
Raise your corporate profile and demonstrate products and
services to our targeted, multidisciplinary audience at 6th
Pharma Regulatory Affairs Asia Summit. As our delegates
are seeking regulatory consultancy and software solutions,
by joining us in sponsoring or exhibiting at this event you
will be able to:
✔ Meet new clients with an exhibition stand in the main networking area
✔ Raise your profile and shape your corporate image with logo placement
✔ Launch new products/services and ensure market leadership with a
speaking slot
✔ Develop new client relationships and affirm existing ones with your
presence at this event
We are able to tailor a sponsorship solution to your needs. To find out more please contact: Yvonne Leong
Tel: +65 6508 2489 | Email: Yvonne.Leong@ibcasia.com.sg
REGISTER TODAY! +65 6508 2401 register@ibcasia.com.sg www.pharmaregulatoryasia.com

DAY TWO 29 AUGUST 2013
THURSDAY
Accelerating Drug & Clinical Trial Approvals in Asia
0900 Chairperson’s Remarks
Dr. Eva Kopecna, MSc, Head of Regulatory Affairs – Global OTC,
Teva Pharmaceuticals Europe, UK
Regulatory Requirements for Clinical Development &
Data Sharing in Asia
0910 CTA/ IND Strategies for Regulatory Approval in China and
its Differences from EU/US
• Timelines, common mistakes made and how to avoid them
Dr. Victoria Elegant, Vice-President, Medical, Clinical &
Regulatory Affairs, Asia-Pacific, Baxter Healthcare, China
0950 Clinical Data Sharing & Optimization of Usage of Clinical
Data across China, Korea & Taiwan
• Overview of the country-specific requirement of clinical
data
• Key aspects at extrapolation of clinical data to local clinical
data package
• Collaboration with local clinical and regulatory team and
global team
Ari Fujishiro, Associate Director, Regulatory Affairs Group, Asia
Development Department, Daiichi Sankyo, Japan
1030 Morning Refreshments
CMC Requirements
1600 CMC Requirements & Managing Complications in
Module 3
• Requirements and challenges in design and change in
manufacturing process and product specifications
• Stability studies
• Similarities and differences with post approval changes in
China/US/EU
Lin Hong, PhD, Associate Director, Regulatory Affairs, Asia Pacific
Russia CIS (APAC) Established Pharmaceuticals, Abbott, USA
1640 Updates and Guidelines on CMC and Stability Study
Requirements in Philippines
Melody Martinez Zamudio, Food-Drug Regulation Officer IV,
OIC – Licensing and Registration Division, Center for Drug
Regulation and Research, Food and Drug Administration,
Philippines
1720 Chairperson’s Closing Remarks and End of Conference
1100 Updates on Clinical Trial Regulations in India
Dr. Bobby George, Vice President and Head Regulatory Affairs,
Reliance Life Sciences., India
Topic – Specific ‘Deep-Dive’ Sessions
1140 Expansion of OTC in Asia – Challenges for Global
Companies
• Understanding classification of OTC products in Asia
• Assessing the regulatory strategy for OTC product
registration in Asia
• Reviewing the potential for Rx-to-OTC switches in Asia
• Overcoming the key challenges when registering an OTC
product in Asia
Dr. Eva Kopecna, MSc, Head of Regulatory Affairs – Global OTC,
Teva Pharmaceuticals Europe, UK
1220 Networking Lunch
1330 Orphan Drug Regulation and Environment in Asia: How is
it Different from Normal Regulatory Pathways
• Overview of orphan drug designation in some Asian
countries
• Current regulatory process in JAPAC region
• Outlining the challenges of the orphan drug market in Asia
Woody Tan, Director, Regulatory Affairs (J-APAC),
Genzyme-Sanofi, Singapore
1410 Drug Registration Using Global Clinical Trial Data &
Bridging Studies
• Regulatory strategy consideration for bridging studies in
• AP region
• Key regulatory consideration on study design
• Regulatory timeline planning
Jin Shun, Associate Director, Regulatory Affairs,
Takeda Development Center (Asia), Singapore
1450 Afternoon Refreshments
Testimonials for the Longest
Running Regulatory Affairs
Event in Asia
“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
REGISTER TODAY! +65 6508 2401 register@ibcasia.com.sg www.pharmaregulatoryasia.com

WORKSHOPS 27 & 30 AUGUST 2013
TUESDAY & FRIDAY
Accelerating Drug & Clinical Trial Approvals in Asia
PRE-CONFERENCE WORKSHOPS | 27 AUGUST 2013
Registration begins 30 minutes before workshop commences. Morning/afternoon refreshments are included; lunch will be served for delegates who
attend the full day i.e. morning and afternoon sessions.
WORKSHOP A: (0900 – 1230)
Developing Successful Bridging Strategies for East Asia
(China, Korea and Japan)
East Asian populations are very similar from various aspects. However,
each country is increasingly requiring clinical data generated in its
own population.
By attending this workshop, participants will find opportunities for
scientific synergies in the East Asian region and will learn possible
regulatory pathways for the future.
Conducted by
So-Jeong Lee, Head of Regulatory, GlaxoSmithKline, Korea
Workshop Outline:
Collaborations in East Asia
Updates on Tripartite (China/Korea/Japan) collaboration
Drug development strategies in East Asia
Opportunities for scientific synergies
Possible regulatory pathways for the future
WORKSHOP B:
(1330 – 1700)
Stability Testing Requirements for Drug Approval in Asia/ASEAN Countries
Stability testing requirements are specific to a region and/or country,
thus with the need of international harmonization. A robust stability
monitoring program ensures a quality product. By attending this
workshop, participants will learn specific requirements for Asia/ASEAN
Countries and find opportunities from possible harmonization.
Conducted by
Nisha Desai, Chief Manager – Corporate Regulatory Affairs, Priamal
Enterprises Limited, India
Workshop Outline:
Stability testing requirements in Asia/ASEAN countries
Country/region specific requirements
Correlation with ICH requirements
Opportunities for harmonization
Challenges & possible solutions
POST-CONFERENCE WORKSHOP | 30 AUGUST 2013
WORKSHOP C: (0900 – 1230)
Overview and Guidelines to Pharmaceutical/Biopharmaceutical
Regulations in India
This workshop provides a comprehensive review of regulatory
guidelines and updates to successful product registration and clinical
trial development in India. Recommended for professionals involved
in regulatory affairs, product registration and clinical development in
India.
Workshop Outline:
Overview of regulatory framework in India
Registration of overseas manufacturers and their products in India
Filings for obtaining an approval for a biological product
Changes in Clinical Trial related regulations
Registration process for Ethics Committees
About your Workshop Leader
Dr. Bobby George, Vice President and Head Regulatory Affairs,
Reliance Life Sciences., India
Dr. George is currently responsible for providing regulatory guidance
and strategic inputs for Reliance Life Sciences’ biopharmaceutical &
pharmaceutical development programs to assure appropriate and
timely regulatory filing and approvals, across different regions. He has
over 14 years of industrial experience, of which the last 10 years have
been with Reliance. During this period, he has been instrumental in
commercializing as many as 7 biosimilars already in India. Many of
these are also under process of registration in the rest of the world
markets.
REGISTER TODAY! +65 6508 2401 register@ibcasia.com.sg www.pharmaregulatoryasia.com

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