Day 1
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
Gaining Clarity on Drug Regulations in Korea
Korean Food & Drug Administration
1220
Networking Lunch
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)
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
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, Director and Head, Regulatory Affairs, 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
Day 2
0900
Chairperson’s Remarks
| 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 Japan, 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
1100
Crafting Sustainable Internal and External Regulatory Strategies for Clinical Development & MRCT in China
Shell Li, Head of Clinical Research, Boehringer Ingelheim, China
1140
Updates on Clinical Trial Regulations in India
Dr. Bobby George, Assistant Vice President and Head Regulatory Affairs, Reliance Life Sciences., India
1220
Networking Lunch
| Topic – Specific ‘Deep-Dive’ Topic – Specific ‘Deep-Dive’ Breakout Sessions |
Delegates will break into 2 groups by choosing the topic most relevant to their area of work. The facilitator will share their insights and present key issues, along with interactive Q&A among the participants.
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
1520
Data Exclusivity & IP Protection
- Patent term extensions and how to successfully manage cross border litigation in Asia Pac
If you would like to feature your services and expertise to Asia’s regulatory audience by leading this session, please contact Yvonne Leong at Tel: +65 6508 2489 or Email: Yvonne.leong@ibcasia.com.sg |
 |
1330
Product registration in Malaysia: An Overview, Challenges and Updates
- Current status of product registration in Malaysia
- Getting through the changes and challenges, what do we do?
- Experiences in reference to biologic, new molecular entity and/or generic registration.
Reserved for Chan Jeh Huei, Regulatory Affairs Manager, Medical and Regulatory Affairs, Roche, Malaysia
1410
Implementation of Risk Management Plan for NewDrug Registration
- Highlights of new RMP requirements (differences andimpact)
- Experiences of the implementation of RMP for new drug registration (by all)
- What could we do as pharmaceutical companies to face the challenges?
Jacqueline Mao Yun, M.D., MBA., Director SSRM (Safety Surveillance and Risk Management), Pfizer, China
1450
Afternoon Refreshments
1520
Navigating Regulatory Landscape of Medical Device & Diagnostics in China
Dr. Yin Qiman, Regulatory Affairs Director – China, Medtronic, China |
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
Pre-Conference Workshop
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
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.
Workshop Outline:
- Stability testing requirements in Asia/ASEAN countries
- Country/region specific requirements
- Correlation with ICH requirements
- Opportunities for harmonization
- Challenges & possible solutions
About your Workshop Leader
Dr. Milind Joshi
President – Global Regulatory Management
J.B.Chemicals & Pharmaceuticals, India
Currently responsible for providing professional & scientific leadership in J. B. Chemicals & Pharmaceutical, Dr. Joshi also develops & expands cooperative working relations with appropriate government agencies, industry, scientific & international organizations including pharmacopoeias. He has published more than 25 scientific articles in the fields of analytical chemistry, biopharmaceutics, bioanalytics & pharmaceutical sciences. He is also a co-inventor for various Indian & International patents for pharmaceutical specialties including controlled release formulations, herbal formulations & synthesis of bulk drugs.
Post Conference Workshop
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
Assistant 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.
