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

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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
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