Join us as we DISCOVER, ANALYZE and LEARN the current state of the global biomanufacturing industry and the future growth potential and recent developments in Asia.
Some of the Key Highlights You Won’t Want to Miss Include
USA
Smart & Flexible Manufacturing Solutions in Multi-Product Facilities
Franz Walz, Executive Director Global Manufacturing, Science and Technology & Network Coordination, BOEHRINGER INGELHEIM
EUROPE
MAb Manufacturing Facilities for China & Automated Single-Use Processing to Bring Control & Flexibility to Manufacturing
Pauline Nicholson, Global Product Manager, Allegro Single-Use Systems, PALL
Niels Guldager, Senior Technology Partner, NNE PHRAMAPLAN
KOREA:
How to Bring Global Biopharmaceutical Capability through its Fully-Integrated Production Facilities?
Jeremy Caudill, Global VP Business Development, SAMSUNG BIOLOGICS
SINGAPORE
What do Investors Look for When Investing in Biologics Manufacturing?
Steven Lee, Global Head of Biologics Tech Operations & Managing Director, DR. REDDY'S LABORATORIES
INDIA
Developing a Multiproduct Facility for Biosimilars & Engineering & Biomanufacturing of Enzymes for Different Applications
Arvind Mishra, Global Head of Quality & Regulatory & Head of Strategic Business Unit, Biologicals,
CADILLA PHARMACEUTICALS
Ravindra Wagh, Vice President, ZYDUS BIOLOGICS
Rajeev Soni, Senior Manager, R&D, NOVOZYMES
HONGKONG
What are the Experiences & What is the Future for the Investors in the Biomanufacturing Space?
Ramesh Rajentheran, Head of Asian Healthcare Investment Banking, BARCLAYS
Jason Mann, Managing Director, FENEX CAPITAL MANAGEMENT
INDONESIA
Improving Quality Control & Maintenance of Global Biological Product Distribution
Galatia Chandra, Head of Sales & System, Global Operation, KALBE INTERNATIONAL PTE LTD
http://www.biomanufacturing-asia.com
Cell Line Development and Engineering 2015 Rita Barry
The 4th Annual Cell Line Development & Engineering Asia conference is a must attend event for you to get the latest updates and best practices in Cell Line Generation, Bioprocessing and Antibodies Development!
This exclusive forum is where industry experts will share lessons learned through case studies, strategic discussion groups and interactive roundtables to collectively collaborate and provide solutions to your most pressing challenges. Bring back new ideas to do better business!
4 Reasons Why You Must Attend this 2015
1. Update yourself with latest technologies to accelerate every stage of cell line development with maximum efficiency, quality and reduced cost
2. Enhance cell line generation in the early stages with best practices in transfection, optimizing cell culture media, and implement advancements in clone screening and selection techniques
3. Gain effective bioprocess control & optimization strategies, for efficient, safe and cost effective scale-up
4. Latest cutting edge updates on antibody development- novel screening strategies for target discovery, challenges in ADCs, engineering bispecifics and boosting efficacy in antibody therapeutics
http://www.celllineasia.com
“A key source of growth in biologics over the next several years will be Biomanufacturing” Ge Li, Chairman and CEO, Wuxi” <outsourcing-pharma.com,>
“Other issues with single-use include standardization of systems, the dependability to vendors, and the supply chain and waste management but if we can overcome extractables and leachables, we will eventually be able to scale up to many thousands of liters.” Jason Li, Senior Director, Downstream Processing, Genor Biopharma <biopharma-reporter.com,>
Industry experts will discuss these and more at the 5th Annual Biomanufacturing Conference in Grand Hyatt Shanghai, China on 19 – 22 May 2015 during IBC’s Biopharma Development & Production (BDP) Week.
ISPE Singapore Conference and Exhibition 2014Rita Barry
International and regional speakers drawn from the regulatory, manufacturing and services spheres will share their views and insights on current issues and challenges.
Key Themes will Include:
Asia’s Growing Demand for Biopharmaceuticals
Improving Product Quality and Productivity
Compliance, Safety and Reliability
Balancing Cost & Efficiency
Future Proofing Pharma Manufacturing
Why Attend in 2014?
Up to the minute conference programme, developed BY the industry FOR the industry
Plenary session featuring Keynote Regulatory and Industry speakers and experts
Educational workshops led by your peers and industry leaders
Learn from experts in pharmaceutical manufacturing
Gather the latest updates on technology developments
Gain insights on new opportunities for manufacturers in Asia
Hear case studies from biopharma, CMOs and biotechs to optimize pharma manufacturing
Now held alongside ISPE Singapore’s dedicated Exhibition to maximize networking
http://www.ispesingapore.org/
5th Annual Pre-Filled Syringes East CoastTeri Arri
Building on the success of previous sell-out shows, SMi Group is delighted to announce the return of the 5th annual conference and exhibition: Pre-Filled Syringes - East Coast, taking place on April 11th – 12th 2018 in Boston, Massachusetts, USA.
A rise in chronic diseases, improvements in technology and a growing demand for easy to use drug administration products has in recent years, created a booming Pre-Filled Syringes industry.
Some notable areas of increased attention have been the broader trends for combination products and biologics, as well as the move towards digital health and improving patient adherence due to increased self-administration figures. As well as these areas of lucrative opportunity, there are still several ongoing challenges that the key-thought leaders are battling to overcome such as chemical compatibility, user safety, high-volume and highly viscous formulation, and non-compliance.
Pre-Filled Syringes East Coast will once again play host to an international audience of drug delivery, medical device and PFS experts to discuss emerging trends and offer innovative solutions to the challenges facing the prefilled industry, helping attendees to secure global success for their PFS device.
Concept to commercialization document gives an insight into the basic prerequisites of the technical & commercial process being followed at Stabicon. Its key input includes various segments of unmet needs in the Quality Management and address development, Analytical and services and innovation technology. Also a simplified business model along with our concept to completion laboratory design gives Stabicon additional efficiency & viability to our clients.
Cell Line Development and Engineering 2015 Rita Barry
The 4th Annual Cell Line Development & Engineering Asia conference is a must attend event for you to get the latest updates and best practices in Cell Line Generation, Bioprocessing and Antibodies Development!
This exclusive forum is where industry experts will share lessons learned through case studies, strategic discussion groups and interactive roundtables to collectively collaborate and provide solutions to your most pressing challenges. Bring back new ideas to do better business!
4 Reasons Why You Must Attend this 2015
1. Update yourself with latest technologies to accelerate every stage of cell line development with maximum efficiency, quality and reduced cost
2. Enhance cell line generation in the early stages with best practices in transfection, optimizing cell culture media, and implement advancements in clone screening and selection techniques
3. Gain effective bioprocess control & optimization strategies, for efficient, safe and cost effective scale-up
4. Latest cutting edge updates on antibody development- novel screening strategies for target discovery, challenges in ADCs, engineering bispecifics and boosting efficacy in antibody therapeutics
http://www.celllineasia.com
“A key source of growth in biologics over the next several years will be Biomanufacturing” Ge Li, Chairman and CEO, Wuxi” <outsourcing-pharma.com,>
“Other issues with single-use include standardization of systems, the dependability to vendors, and the supply chain and waste management but if we can overcome extractables and leachables, we will eventually be able to scale up to many thousands of liters.” Jason Li, Senior Director, Downstream Processing, Genor Biopharma <biopharma-reporter.com,>
Industry experts will discuss these and more at the 5th Annual Biomanufacturing Conference in Grand Hyatt Shanghai, China on 19 – 22 May 2015 during IBC’s Biopharma Development & Production (BDP) Week.
ISPE Singapore Conference and Exhibition 2014Rita Barry
International and regional speakers drawn from the regulatory, manufacturing and services spheres will share their views and insights on current issues and challenges.
Key Themes will Include:
Asia’s Growing Demand for Biopharmaceuticals
Improving Product Quality and Productivity
Compliance, Safety and Reliability
Balancing Cost & Efficiency
Future Proofing Pharma Manufacturing
Why Attend in 2014?
Up to the minute conference programme, developed BY the industry FOR the industry
Plenary session featuring Keynote Regulatory and Industry speakers and experts
Educational workshops led by your peers and industry leaders
Learn from experts in pharmaceutical manufacturing
Gather the latest updates on technology developments
Gain insights on new opportunities for manufacturers in Asia
Hear case studies from biopharma, CMOs and biotechs to optimize pharma manufacturing
Now held alongside ISPE Singapore’s dedicated Exhibition to maximize networking
http://www.ispesingapore.org/
5th Annual Pre-Filled Syringes East CoastTeri Arri
Building on the success of previous sell-out shows, SMi Group is delighted to announce the return of the 5th annual conference and exhibition: Pre-Filled Syringes - East Coast, taking place on April 11th – 12th 2018 in Boston, Massachusetts, USA.
A rise in chronic diseases, improvements in technology and a growing demand for easy to use drug administration products has in recent years, created a booming Pre-Filled Syringes industry.
Some notable areas of increased attention have been the broader trends for combination products and biologics, as well as the move towards digital health and improving patient adherence due to increased self-administration figures. As well as these areas of lucrative opportunity, there are still several ongoing challenges that the key-thought leaders are battling to overcome such as chemical compatibility, user safety, high-volume and highly viscous formulation, and non-compliance.
Pre-Filled Syringes East Coast will once again play host to an international audience of drug delivery, medical device and PFS experts to discuss emerging trends and offer innovative solutions to the challenges facing the prefilled industry, helping attendees to secure global success for their PFS device.
Concept to commercialization document gives an insight into the basic prerequisites of the technical & commercial process being followed at Stabicon. Its key input includes various segments of unmet needs in the Quality Management and address development, Analytical and services and innovation technology. Also a simplified business model along with our concept to completion laboratory design gives Stabicon additional efficiency & viability to our clients.
This presentation will enable you to understand the requirements needed to make any forensic or analytical laboratory accredited and at par with other accredited laboratories worldwide. QMS is a mandatory and integral part of any organization to assure good quality to customers or consumers.
Hear from a selection of carefully handpicked keynote addresses and case studies presented by big pharma such as Genentech, Allergan, Medimmune and Roche as well leading industry KOL's including Nemera, Nipro PharmaPackaging, Terumo, Worrell, Zeon + more!
I am seeking to obtain a position with a progressive, large international company or organization offering responsibility, advancement& individual growth.
•To find a career opportunity that would utilized abroad range of my experience
•To work in a dynamic & corporate environment, which will enable me to apply my expertise and problem solving skills, gained through advanced tertiary qualifications, work experience & international accreditations, to the best benefit of organization thereby achieving symbiotic growth
Effectiveness of ISO 15189 2012: a requirement for medical laboratories with ...iosrjce
IOSR Journal of Business and Management (IOSR-JBM) is a double blind peer reviewed International Journal that provides rapid publication (within a month) of articles in all areas of business and managemant and its applications. The journal welcomes publications of high quality papers on theoretical developments and practical applications inbusiness and management. Original research papers, state-of-the-art reviews, and high quality technical notes are invited for publications.
I am seeking to obtain a position with a progressive, large international company or organization offering responsibility, advancement& individual growth.
•To find a career opportunity that would utilized abroad range of my experience
•To work in a dynamic & corporate environment, which will enable me to apply my expertise and problem solving skills, gained through advanced tertiary qualifications, work experience & international accreditations, to the best benefit of organization thereby achieving symbiotic growth.
Why you should attend:
1. Learn from in-depth case studies on strategic partnering and effective collaboration
2. Explore new business opportunities and strategies to reach the biosimilars market in the region
3. Gain insights into the regulatory landscape for biosimilars in China, India, Korea, Taiwan and more
4. Gather the latest market intelligence and analysis and identify new trends and opportunities in Biosimilars R&D, contract manufacturing and commercialization in Asia
报名参加的五大理由
1. 深入学习有关与亚洲公司建立战略合作和有效协作的案例研究
2. 探索新的商机和战略,以便进入当地的生物仿制药市场
3. 深入了解中国、印度、韩国、台湾以及更多国家或地区的生物仿制药监管形势
4. 收集最新的市场情报和分析,确定生物仿制药研发、合同制造和商业化在亚洲的新趋势和机会
Hear about:
Biopharma Regulatory Updates and Development
Victoria Elegant, VP Medical & Regulatory Affairs, Baxter, China
Andrea Laslop, Head of Scientific Office, Austrian Agency for Food and Health Safety, Austrian Member, European Medicines Agency
Arvind Mishra, Global Head of Quality & Regulatory & Head of Strategic Business Unit, Biologicals, Cadilla Pharmaceutical, India
Advances in Biosimilars R&D
Jeffrey Su, CSO, Cytovance Biologics, USA
Wenzhi Tian, CEO, Huabo Biopharma, China
Ming Wang, President and COO, Gan & Lee Pharmaceuticals, China
Feng Li, CEO, Beijing Mabworks, China
Shaligram Rane, Vice President for Quality, Intas Pharmaceuticals, India
Understanding Obstacles and Hurdles for Entering the Biosimilars Market
Khai Meng Ang, Vice President Asia, Hospira, China
Jason Li, Senior Director, Genor Biopharma, China
Sachidananda Moorthy, Vice President - Clinical Research, Medical and Regulatory Affairs, Avesthagen, India
Sameer Agarwal, Senior Vice President, Business Center Strategic Marketing, Business Unit Generic Drugs & Standard Solutions, Fresenius Kabi, Germany
What can Asia Learn from Global Biosimilars Development and Litigation?
Li Cai, Regional R&D Counsel, Pfizer, China
Vivek Mittal, Head – Legal, Lupin, India
Viren Mahurkar, Managing Director, HitechnRock Advisors, Singapore
http://www.biosimilarsasia.com
Pre-Conference Special Focus Day, 20 May 2014
Clinical Development for Biosimilars
Post-Conference Workshops, 23 May 2014
A: Challenges in Demonstrating Biosimilarity and Interchangeability of Biosimilar Products
B: Successfully Bringing Biosimilars to Market
会前特别关注日,2014 年 5 月 20 日
生物仿制药的临床开发
会后研讨会,2014 年 5 月 23 日
A:在展示生物仿制药产品的生物相似性和可互换性方面所面临的挑战
B:成功地将生物仿制药推向市场
The 4th Annual Biomanufacturing Conference is taking place on the 20 - 23 May 2014 at Grand Hyatt, Shanghai. A must go event for you to get the latest updates from the industry, to learn more of the latest developments and best practices in increasing production, enhancing quality and optimizing operations in the biomanufacturing industry.
Key Conference Topics
GMP & Standards
Successful Partnerships, Investment & Financing
Effective Planning, Facility Design & Development
Improving Operations & Supply Chain Management
Cost Effective Single-Use Systems & Technology Transfer
This presentation will enable you to understand the requirements needed to make any forensic or analytical laboratory accredited and at par with other accredited laboratories worldwide. QMS is a mandatory and integral part of any organization to assure good quality to customers or consumers.
Hear from a selection of carefully handpicked keynote addresses and case studies presented by big pharma such as Genentech, Allergan, Medimmune and Roche as well leading industry KOL's including Nemera, Nipro PharmaPackaging, Terumo, Worrell, Zeon + more!
I am seeking to obtain a position with a progressive, large international company or organization offering responsibility, advancement& individual growth.
•To find a career opportunity that would utilized abroad range of my experience
•To work in a dynamic & corporate environment, which will enable me to apply my expertise and problem solving skills, gained through advanced tertiary qualifications, work experience & international accreditations, to the best benefit of organization thereby achieving symbiotic growth
Effectiveness of ISO 15189 2012: a requirement for medical laboratories with ...iosrjce
IOSR Journal of Business and Management (IOSR-JBM) is a double blind peer reviewed International Journal that provides rapid publication (within a month) of articles in all areas of business and managemant and its applications. The journal welcomes publications of high quality papers on theoretical developments and practical applications inbusiness and management. Original research papers, state-of-the-art reviews, and high quality technical notes are invited for publications.
I am seeking to obtain a position with a progressive, large international company or organization offering responsibility, advancement& individual growth.
•To find a career opportunity that would utilized abroad range of my experience
•To work in a dynamic & corporate environment, which will enable me to apply my expertise and problem solving skills, gained through advanced tertiary qualifications, work experience & international accreditations, to the best benefit of organization thereby achieving symbiotic growth.
Why you should attend:
1. Learn from in-depth case studies on strategic partnering and effective collaboration
2. Explore new business opportunities and strategies to reach the biosimilars market in the region
3. Gain insights into the regulatory landscape for biosimilars in China, India, Korea, Taiwan and more
4. Gather the latest market intelligence and analysis and identify new trends and opportunities in Biosimilars R&D, contract manufacturing and commercialization in Asia
报名参加的五大理由
1. 深入学习有关与亚洲公司建立战略合作和有效协作的案例研究
2. 探索新的商机和战略,以便进入当地的生物仿制药市场
3. 深入了解中国、印度、韩国、台湾以及更多国家或地区的生物仿制药监管形势
4. 收集最新的市场情报和分析,确定生物仿制药研发、合同制造和商业化在亚洲的新趋势和机会
Hear about:
Biopharma Regulatory Updates and Development
Victoria Elegant, VP Medical & Regulatory Affairs, Baxter, China
Andrea Laslop, Head of Scientific Office, Austrian Agency for Food and Health Safety, Austrian Member, European Medicines Agency
Arvind Mishra, Global Head of Quality & Regulatory & Head of Strategic Business Unit, Biologicals, Cadilla Pharmaceutical, India
Advances in Biosimilars R&D
Jeffrey Su, CSO, Cytovance Biologics, USA
Wenzhi Tian, CEO, Huabo Biopharma, China
Ming Wang, President and COO, Gan & Lee Pharmaceuticals, China
Feng Li, CEO, Beijing Mabworks, China
Shaligram Rane, Vice President for Quality, Intas Pharmaceuticals, India
Understanding Obstacles and Hurdles for Entering the Biosimilars Market
Khai Meng Ang, Vice President Asia, Hospira, China
Jason Li, Senior Director, Genor Biopharma, China
Sachidananda Moorthy, Vice President - Clinical Research, Medical and Regulatory Affairs, Avesthagen, India
Sameer Agarwal, Senior Vice President, Business Center Strategic Marketing, Business Unit Generic Drugs & Standard Solutions, Fresenius Kabi, Germany
What can Asia Learn from Global Biosimilars Development and Litigation?
Li Cai, Regional R&D Counsel, Pfizer, China
Vivek Mittal, Head – Legal, Lupin, India
Viren Mahurkar, Managing Director, HitechnRock Advisors, Singapore
http://www.biosimilarsasia.com
Pre-Conference Special Focus Day, 20 May 2014
Clinical Development for Biosimilars
Post-Conference Workshops, 23 May 2014
A: Challenges in Demonstrating Biosimilarity and Interchangeability of Biosimilar Products
B: Successfully Bringing Biosimilars to Market
会前特别关注日,2014 年 5 月 20 日
生物仿制药的临床开发
会后研讨会,2014 年 5 月 23 日
A:在展示生物仿制药产品的生物相似性和可互换性方面所面临的挑战
B:成功地将生物仿制药推向市场
The 4th Annual Biomanufacturing Conference is taking place on the 20 - 23 May 2014 at Grand Hyatt, Shanghai. A must go event for you to get the latest updates from the industry, to learn more of the latest developments and best practices in increasing production, enhancing quality and optimizing operations in the biomanufacturing industry.
Key Conference Topics
GMP & Standards
Successful Partnerships, Investment & Financing
Effective Planning, Facility Design & Development
Improving Operations & Supply Chain Management
Cost Effective Single-Use Systems & Technology Transfer
What’s NEW in 2015’s program?
• More case studies on successful commercialization
• Insights on developing biosimilars under new CFDA guideline
• Emerging business models in regulated and developing markets
• New and timely topics on:
o Valuating biosimilars investments
o Successful technology transfer
o Key criteria in gaining approval
Also, NEW Expert Faculty includes:
Dr Shin Jae Chang, Vice President, Celltrion, Korea
Ira Jacobs, Global Oncology Lead, Biosimilars, Pfizer, US
Paul Thomas, Business Unit Head – Biosimilars, Biocon, India
Dr. Martina A. Sersch, Global Clinical Lead, Oncology Global Development, APAC Biotherapeutics Lead, Genentech, Inc. / F. Hoffmann-La Roche Ltd.
Raj Kannan, Vice President, Commercial Head, Biosimilars, Merck, Switzerland
Huiguo (Forrest) Hu, General Manager of International Business, Shanghai CP Guojian Pharmaceutical Co., Ltd, China
Ko Chung Lin, Chief Executive Officer, PharmaEssentia Corporation, Taiwan
Wen Yong, Vice Director, Drug Research Institutes, Biopharmaceutical Institute, Jiangsu AoSaiKang Pharmaceutical Co Ltd, China
http://www.biosimilarsasia.com
With cancer being the fastest growing healthcare priority in the pharmaceutical industry, IBC Asia announces the region's first ever strategic oncology conference focusing on clinical development and market access.
Download the brochure <link> now to identify new trends and opportunities in development and commercialization in the region.
ONCOLOGY ASIA focuses on the clinical development and effective market access for cancer drugs in Asia. It will cover strategies for developing oncology products and businesses from innovative pipelines, commercializing products, sales and marketing strategies to capture opportunities in Asia’s markets.
Featured sessions from top industry thought leaders:
Market Trends and Drivers in the Region
• James Garner, Head Unit Development Operations, Asia R&D, Sanofi, Singapore
What You Need to Know When Marketing Oncology Drugs
• Dr Paul Cornes, Clinical Oncologist, Bristol Oncology Centre, UK
Successful Market Access Strategies for Oncology Drugs
• Sameer Agarwal, Senior Vice President, Business Center Strategic
Marketing, Fresenius Kabi Deutschland GmbH, Germany
Clinical Engagement for Successful Oncology Products
• Dr Anish Desai, Director Medical & Clinical Affairs, Johnson & Johnson, India
http://www.oncologyasia.com
Medical Device Asia Conference, 28-31 Oct 2014, SingaporeLei Ching Y.
MED DEVICE ASIA is the only high level platform in Asia to showcase innovative ideas, trends in partnerships with public sector and clinicians and to network with experts and industry leaders to find out about regulatory updates, investment opportunities, product development and market access.
Highly Potent Active Pharmaceutical Ingredients 2017Fateja Begum
The Highly Potent Active Pharmaceutical Ingredients conference features key speakers of the industry presenting challenges, issues, innovation and new developments in various areas of HPAPI production, development and manufacturing.
Biologics World Taiwan 2016 (email me at justin.dejesus@imapac.com) Justin Barin de Jesus
The ONLY biopharmaceutical
gathering in Taiwan
Emphasizes on new business collaborations, demonstrate state-of-the-art developments and to propel Taiwan's biotech firms onto the world stage.
We’re pleased to announce that the Conference and Workshop programme for ISPE Singapore is ready to view on www.ispesingapore.org
FINAL BROCHURE NOW AVAILABLE FOR DOWNLOAD HERE!
This year, you’ll find:
• 90% NEW & 50% MORE Speakers than in 2013
• Over 34 presenters sharing their case studies and experience
• Choose from 36 hours of Learning, 6 hours of Networking Across the Plenary Conference & 9 practical workshops
• The latest solutions at the ISPE Singapore Exhibition on 23-24 June
• And don’t forget to sign up for the Site Visit to MSD Singapore Plant Extension!
Build your own agenda from 3 concurrent sessions:
Sunday 22 June (1.30-5.30pm):
A: Quality / Validation
B: Operational Excellence
C: Bio / Sterile / Clean Utilities
Monday 23 June (2.00-5.45pm):
D: Tech Transfer / Process Validation
E: QBD / PAT
F: Sterile Operations
Tuesday 23 June (9.00-3.30pm):
G: Quality / Audit / Regulatory
H: Operational Excellence / Lean Manufacturing
J: Biologics
P 141 pre-filled syringes america revisedAlia Malick
The global prefilled syringe market is estimated to reach $6.9bn by 2018. This figure is reflective of manufacturers striving to improve their technologies to meet the increasing number of biologic drugs reaching the market. The rising demand for prefilled syringes is driving the manufacturers to introduce improvements in technology and with the focus still on the safety for the user, innovation improvements for device development and ease of use for the patient are key areas to be addressed.
SMi’s leading prefilled syringes conference will focus on a number of hot talking points that will no doubt cause controversy and debate and on reflection open the floor to discussion in our breakout sessions. In addition, with a new competitive market just around the corner for biosimilars we look at this new session for 2015 in addition to the vision and benefit of lyophilisation in a prefilled syringe.
Biopharma Production and Development China 2015 Rita Barry
As the BioPharma industry grows in China and the Asian region, we invite you to be a part of this tremendous growth & development opportunities!
IBC’s Biopharma Development & Production Week in China is THE meeting place for biopharma industry professionals and scientists to get the highest quality and practical information that will enable them to develop competitive advantages and advance their capabilities in developing and manufacturing cell lines, biosimilars, biobetters, vaccines or novel biologics.
Top Reasons Why You Should Participate:
- Establish Business Partnerships with Chinese/Asian drug developers and contract
manufacturers
- Learn technical & practical know how from experiences on the ground in Asia
- Showcase your cutting edge solutions in front of key China/Asian Biopharma
decision makers
http://www.biopharmaproduction.com
Animal Health Conference China - featuring senior executives from animal heal...Lei Ching Y.
IBC’s Animal Health Conference focuses on the investments, projects, research and partnerships going into the Asian Animal Health Business.
Key Conference Themes:
• Regulation, Trends & Market Opportunities in Asia Pacific
• Animal Health Business Models & Collaboration
• Prevention & Control of Animal Diseases
• Zoonoses, Human-Animal Interaction & Risk Mitigation
• Product Development & Marketing
• Animal Health Vaccines
For more information, visit www.animalhealthconference.com
Factors to keep in mind when you’re considering cloud storage services.Rita Barry
Cloud storage is a broad term. It can encompass anything from on premise solutions, to le storage, disaster recovery and off premise options. To narrow the scope, I’ve dedicated the focus of today’s discussion to the more popular cloud storage services—such as Dropbox, Box, OneDrive—which are also known as hosted, off premise solutions.
Unlike more tangible technologies where a failed implementation causes a down network, SIEM (security information and event management) requires a more qualitative approach to determining success or failure. The surprising reality is that most SIEM projects completely fail to deliver any discernable bene ts to the organization and are abandoned in frustration
www.rkon.com
Carve-outs and Mergers and Acquisitions place unique demands on IT. How can y...Rita Barry
Mergers are complex and Carve-outs only add to the dif culty and the level of complexity that the delivery team must manage. The creation of a stand-alone entity in a matter of weeks is daunting; moreover, the lack of cooperation from the legacy organization or the attrition of employees creates a chaotic environment that must be overcome. RKON helps clients to determine the most favorable level of IT sourcing and to implement the most appropriate technology for the new business unit — all to ensure a successful “day one.”
Tertiary Hospital Services Asia 2015, part of the Asia Healthcare Summit, will examine successful case studies on achieving top financially performing healthcare organizations whilst delivering quality tertiary healthcare services.
Top Industry Issues to Be Discussed Include:
Benchmarks and lessons from World Class Tertiary Hospitals
Insights on clinical and operational excellence
Investment in Tertiary Hospital Services and achieving financial success
Streamlining outpatient services
Advanced consultative care & remote monitoring of patient health
Latest technology transforming patient accessibility, care and experiences
Keynote representatives and decision makers from more than 15 public and private hospitals across the Asia Pacific region will convene and share their perspectives in developing world class tertiary hospital services, including:
Chan Choo Lin, Director of Operations, Johns Hopkins, Singapore
Dr. Alejandro C. Dizon, Chief Quality Officer, St. Luke's Medical Center, Philippines
Alastair Mah, Chief Medical Officer, University Hospital Geelong & Barwon Health, Australia
Haji Abdul Aziz Abdul Rahman, CEO, KPJ Penang Specialist Hospital, Malaysia
Seemant Jauhari, CEO, Research & Innovations, Apollo Hospitals, India
Nguyen Thi Le Thu, Marketing & Business Development Director, FV Hospital, Vietnam
Grace Siew Wah Lim, Chief Financial Officer, KK Woman’s and Children’s Hospital, Singapore
Andres M.Licaros, Jr., President & Chief Executive Officer, Asian Hospital and Medical Center, Philippines
Michael Wong, CEO, Pantai Hospitals (Ayer Keroh), Malaysia
David Sun, Consultant of Neurosurgery, Prince of Wales Hospital, Hong Kong
Joe Hau, Director Corporate Services, Tan Tock Seng Hospital, Singapore
Alan Young, Head of IT, Canossa Hospital (Caritas), Hong Kong
Prof Kazuhiro Hara, President, Japanese Telemedicine and Telecare Association, Specially-appointed professor of Seto Inland Sea Regional Research Center, Kagawa University, Japan
Chan Woo Kuk, Center for Future Innovation, Advisory Specialist, Samsung Medical Center, Korea
http://www.tertiaryhospitalservices.com
Biopharma Production & Development Week 2015 Rita Barry
What’s New for 2015
- C-Level Panel: Cutting Edge Insights on China’s Growing Biotech Market
- China FDA Special Address
- 80+ Key Expert Speakers from Asia’s leading Pharma & Biotech
- 1 Joint Exhibition & Networking Area
- 4 Days of Expert Knowledge Sharing
- Revamped Program with New Special Focused Tracks & Sessions
As you know, pharma compliance is a critical issue, particularly in China. The Chinese government’s recent crackdowns on the business practices of various pharmaceutical companies have sent shockwaves throughout the industry and the price to pay for non-compliance is exceedingly high, with massive revenue losses and irreclaimable reputational damages
To address this pertinent issue, IBC Asia is convening the forthcoming Pharma Compliance Summit
(Mar 2015) in Shanghai, China. Set to be an informative and insightful event, this conference will prepare participants in dealing with the latest legal compliance landmines and equip them with an in-depth understanding of how to mitigate non- compliance risks at every part of the pharma value chain.
Top companies will share best practices of internal compliance programs and third party due diligence strategies; Gain these exclusive insights and incorporate them into their own company, reaping maximum benefits.
Your expert speaker faculty includes:
• Leon Wang, Vice President, AstraZeneca China
• Heike Deters, Head of Compliance, Bayer Healthcare China
• Dr Wang Xianlin, Member, Expert Advisory Group of Anti-Monopoly Commission, State Council People’s Republic of China
• Maija Burtmanis, Regional Legal & Compliance Director JAPAC, AbbVie
• Gareth Lee, General Counsel & Head of Compliance APAC, Allergan
• Cristopher Landrito, Regional Compliance Manager APAC, Merck
• David Shen, General Counsel & VP Legal, AstraZeneca China
• Dr Wu Ke, President, Shanghai BravoBio
• Alejandro Castro, Regional Audit Manager Asia Pacific, Novartis
• Linda Ling, Senior Healthcare Compliance Manager, OTC China, Johnson & Johnson
http://www.pharmacompliance-china.com
IBC’s OTC Pharma Asia conference is returning 2-5 March 2015 at Grand Copthorne Waterfront Hotel, Singapore to prepare you for future growth in the OTC and Consumer Health market in Asia. You will witness how the OTC landscape varies by country as well as the latest product trends, consumer insights and innovative offerings in OTC – a crucial element to achieve global success.
http://www.otcpharmaasia.com
The inaugural Philippines Healthcare will focus on investment opportunities in the Philippines healthcare sector as well as examine the developments in healthcare plans and policies by government, market access opportunities for pharma and technology, new healthcare facility projects, upgrades and expansions and increasing efficiencies of existing facilities.
Philippines is currently focused on speeding up health facilities and upgrades, meeting the needs and growing demand for health specialists, training to ensure competency and quality of healthcare services and ensuring the availability of drugs throughout the country.
The conference will have discussions on policy and regulation updates, investment opportunities, projects and developments to strengthen Philippines healthcare infrastructure and delivery.
It will be held in Manila and will have representations from government, hospitals, insurance companies, pharma companies, health technology and medical device providers and other related stakeholders.
For 2015, we are going to hear NEW panel speakers from Indonesia Stock Exchange, Australia Stock Exchange, Philippine Stock Exchange, Tokyo Stock Exchange, Osaka Stock Exchange and Colombo Stock Exchange. Each of the exchanges will present a 10 minute update about their country on what are the new initiatives that have rolled out, how they address the needs of the private side, which infrastructure support the local regulatory body address in the short term vs. long term and the ASEAN trading link to ease cross border trading.
Not only that, we will answer key questions of the post trade industry including:
• Have Asian market participants been preparing for operational readiness as Dodd Frank, Emir and Basel 3 are being unrolled in Asia?
• Will T2S lead to a migration of all financial players to ISO 20022 in Europe?
• What are the impacts of Hong Kong Shanghai Stock Connect on Asia’s economy and the global financial markets?
• What is the impact on transaction funding and foreign exchange operations of moving from T+3 to T+2?
• Are CCPs all equal? Can we quantify the benefits of moving to a CCP?
• How is the buyside firm in Asia dealing with a collateral solution? Do the costs outweigh the benefits?
The offshore RMB market has evolved rapidly since 2010 and there have been periods of significant pricing dislocation between onshore and offshore forex and interest rate markets. Over the medium to long term, as the RMB exchange rate becomes more flexible, more products are traded in the offshore RMB market with growing liquidity, and capital account is gradually liberalized, the convergence trend in the pricing of onshore and offshore RMB asset markets is inevitable. <China Money Network, 28 July 2014)
The Value of RMB Currency in the Market, Liquidity & Risk will be discussed at IBC’s Offshore RMB Seminar (Parkroyal on Beach Road, Singapore * 27 November 2014) by these industry leaders:
Joe Ng, Head of Renminbi Payments Product Management - Asia Pacific, Global Transaction Banking, Deutsche Bank, Hong Kong
Update Speaker from Gladys, ICBC, Singapore
Motasim Iqbal, Head of Transaction Banking, Standard Chartered Bank, Singapore
Noritaka Akamatsu, Deputy Head, Office of Regional Economic Integration, Chair, Financial Sector Community of Practice, Asian Development Bank, Philippines
Other Key Topics Addressed Include:
• RMB Policy Liberalization
• Investing in RMB Capital Markets
• RMB Cross-Border Settlements
• Developing of Offshore RMB Operations
View more at http://www.offshorermbseminar.com
A successful generic product starts with understanding consumer needs and brand value. On November 4-7 in Singapore, IBC will host the 9th Annual Generics Asia 2014, Asia’s longest running Generics conference, to help you and your organization understand how to incorporate marketing and partnership into your business strategy.
The key topics to be covered at the event include:
Regulatory Update and Accelerating Access to New market
o A panel of experts from Philippines Chamber of Pharmaceutical Industry, Actavis, Hovid and Pfizer
Building Brand Awareness and Delivering New Products with a Cost Effective Strategy
o Allan Marx Ancheta, Director Business Development and Strategy, Commercial Innovation and Alliance, Merck
Managing Sale Force Effectiveness and Innovative Channels for Generics Products
o Marvin Biliwang, Commercial Effectiveness Director, Takeda Pharmaceuticals
Establishing Partnerships to Add Value and Build Market Share
o Philip Cox, President Director, PT Takeda Indonesia
Innovative Models and Super Generics for Prolonging Product Life Cycles
o Dr. Shirish Kulkarni, Senior Vice President, Formulation Development, Sun Pharmaceutical
IBC’s Indonesia Healthcare conference brings together healthcare leaders to discuss evolving policies, opportunities for private healthcare investment, partnerships, projects and initiatives.
Key Conference Themes:
Updates on Regulation and the Road Towards Universal Healthcare Coverage
Hospital Management & Cutting Edge Healthcare Delivery Standards
Digital Marketing and Telehealth Solutions
Healthcare Infrastructure Projects, Investments & Development
Generics & Access to Medicine
Public-Private Partnerships & Collaboration
Why You Must Attend This Year’s Event
Understand the proactive steps to take by hospitals, pharmaceutical and insurance companies for the new Universal Healthcare Coverage policy
Discover partnerships and investment opportunities in Indonesia
Hear different case studies from major hospitals, insurance and pharmaceutical companies
Meet and exchange business cards with your peers during the networking sessions
Learn how to deliver safe and quality healthcare from other Asian countries
Medical Affairs teams in Asia’s diverse markets need to collaborate with R&D and understand the science, the business and the regulations. They need to constantly think strategically and communicate effectively.
• How can Medical Affairs teams be even more impactful in enhancing your company’s scientific reputation?
• How can you better communicate the value of your products to KOLs and Healthcare professionals?
• What makes a successful Medical Affairs team in Asia?
Get the answers and more at the 3rd MEDICAL AFFAIRS FORUM ASIA {link} - the region’s longest running strategy forum where leading medical affairs professionals share best practices, discuss common issues and learn from industry experts to enhance scientific reputation and better communicate the value of products to KOLs.
http://www.pharmaconasia.com/medical-affairs-forum-asia
PharmaCon - Pharmaceutical Congress Asia 2014 Rita Barry
The Leading Event Bringing 4 Successful Events Under 1 Roof!
The Pharmaceutical Congress Asia recognizes the importance of strong partnerships to drive innovation, development and winning products and services in Asia’s growing pharmaceutical industry. Packed with case studies from market leaders, four agendas will unite to create a hub of research, innovation, improved regulatory frameworks, best practice business, marketing and distribution models that will define Asia’s pharmaceutical future.
http://www.pharmaconasia.com
The Most Comprehensive Coverage of China’s Evolving Biologics Market
________________________________________
20 Case Studies ● Keynote from China SFDA Official
17 New Data Presentations ● Panel Discussions on Biosimilar and Analytical Methods
• Harness novel cell line technologies and approaches for improved developability and upstream processing
• Enhance analytical capabilities with new characterization and specification methods
• Benchmark your biosimilar program with case studies and new data on development and production
• Meet complex drug product and manufacturing challenges with new facility technologies and designs
http://www.ibclifesciences.com/bpichina
‘’Healthcare providers are aware of the long-term cost benefits of cloud solutions; what they are looking for now are reliable technology partners who can address their concerns over data privacy and security. ‘’ –Pharmatimes, October 2013
Select your dream technology partner this 4th Electronic Health records!
With our Open Sharing session on EHR technology, YOU get the chance to voice your thoughts out or hear from our speakers and attendees their experiences with various vendors and learn from their challenges faced and select the RIGHT EHR technology which suits your needs!
In addition, don’t miss our brand new sessions on EHR’s data privacy & security & its data protection laws!
Introducing our panel of expert speakers!
Jovita Aragona, Information Technology Officer III, Department of Health, Philippines
Johan A. Hutauruk, IT Director, Jakarta Eye Centre, Indonesia
Md. Khadzir b Sheikh Haji Ahmad, Deputy Director, Health Informatic Centre, Ministry of Health, Malaysia
Suresh Poonudurai, CEO, Malaysian Healthcare, Malaysia
Stephen Chu, Chief Clinical Informatician & Terminologist, NEHTA, Australia
Robert P. Jalleh, Chairman, Alpha Specialist Centre, Malaysia
Marc Hsu, Director, Medical Informatics Centre, Ministry of Health and Welfare, Taiwan
Bryan Tan, Partner, Pinsent Mason Mpillay, Singapore
www.electronichealthasia.com
International and regional experts coming together
to discuss strategies and opportunities in the Medical
Affairs function
• Unique insights and case studies on experiences in
the Asia market, successful programmes and best
practices
• Detailed and practical workshop to complement
your learning and networking experience
Flu Vaccine Alert in Bangalore Karnatakaaddon Scans
As flu season approaches, health officials in Bangalore, Karnataka, are urging residents to get their flu vaccinations. The seasonal flu, while common, can lead to severe health complications, particularly for vulnerable populations such as young children, the elderly, and those with underlying health conditions.
Dr. Vidisha Kumari, a leading epidemiologist in Bangalore, emphasizes the importance of getting vaccinated. "The flu vaccine is our best defense against the influenza virus. It not only protects individuals but also helps prevent the spread of the virus in our communities," he says.
This year, the flu season is expected to coincide with a potential increase in other respiratory illnesses. The Karnataka Health Department has launched an awareness campaign highlighting the significance of flu vaccinations. They have set up multiple vaccination centers across Bangalore, making it convenient for residents to receive their shots.
To encourage widespread vaccination, the government is also collaborating with local schools, workplaces, and community centers to facilitate vaccination drives. Special attention is being given to ensuring that the vaccine is accessible to all, including marginalized communities who may have limited access to healthcare.
Residents are reminded that the flu vaccine is safe and effective. Common side effects are mild and may include soreness at the injection site, mild fever, or muscle aches. These side effects are generally short-lived and far less severe than the flu itself.
Healthcare providers are also stressing the importance of continuing COVID-19 precautions. Wearing masks, practicing good hand hygiene, and maintaining social distancing are still crucial, especially in crowded places.
Protect yourself and your loved ones by getting vaccinated. Together, we can help keep Bangalore healthy and safe this flu season. For more information on vaccination centers and schedules, residents can visit the Karnataka Health Department’s official website or follow their social media pages.
Stay informed, stay safe, and get your flu shot today!
ARTIFICIAL INTELLIGENCE IN HEALTHCARE.pdfAnujkumaranit
Artificial intelligence (AI) refers to the simulation of human intelligence processes by machines, especially computer systems. It encompasses tasks such as learning, reasoning, problem-solving, perception, and language understanding. AI technologies are revolutionizing various fields, from healthcare to finance, by enabling machines to perform tasks that typically require human intelligence.
Report Back from SGO 2024: What’s the Latest in Cervical Cancer?bkling
Are you curious about what’s new in cervical cancer research or unsure what the findings mean? Join Dr. Emily Ko, a gynecologic oncologist at Penn Medicine, to learn about the latest updates from the Society of Gynecologic Oncology (SGO) 2024 Annual Meeting on Women’s Cancer. Dr. Ko will discuss what the research presented at the conference means for you and answer your questions about the new developments.
Explore natural remedies for syphilis treatment in Singapore. Discover alternative therapies, herbal remedies, and lifestyle changes that may complement conventional treatments. Learn about holistic approaches to managing syphilis symptoms and supporting overall health.
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Ve...kevinkariuki227
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
Factory Supply Best Quality Pmk Oil CAS 28578–16–7 PMK Powder in Stockrebeccabio
Factory Supply Best Quality Pmk Oil CAS 28578–16–7 PMK Powder in Stock
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Hot Selling Organic intermediates
Title: Sense of Smell
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the primary categories of smells and the concept of odor blindness.
Explain the structure and location of the olfactory membrane and mucosa, including the types and roles of cells involved in olfaction.
Describe the pathway and mechanisms of olfactory signal transmission from the olfactory receptors to the brain.
Illustrate the biochemical cascade triggered by odorant binding to olfactory receptors, including the role of G-proteins and second messengers in generating an action potential.
Identify different types of olfactory disorders such as anosmia, hyposmia, hyperosmia, and dysosmia, including their potential causes.
Key Topics:
Olfactory Genes:
3% of the human genome accounts for olfactory genes.
400 genes for odorant receptors.
Olfactory Membrane:
Located in the superior part of the nasal cavity.
Medially: Folds downward along the superior septum.
Laterally: Folds over the superior turbinate and upper surface of the middle turbinate.
Total surface area: 5-10 square centimeters.
Olfactory Mucosa:
Olfactory Cells: Bipolar nerve cells derived from the CNS (100 million), with 4-25 olfactory cilia per cell.
Sustentacular Cells: Produce mucus and maintain ionic and molecular environment.
Basal Cells: Replace worn-out olfactory cells with an average lifespan of 1-2 months.
Bowman’s Gland: Secretes mucus.
Stimulation of Olfactory Cells:
Odorant dissolves in mucus and attaches to receptors on olfactory cilia.
Involves a cascade effect through G-proteins and second messengers, leading to depolarization and action potential generation in the olfactory nerve.
Quality of a Good Odorant:
Small (3-20 Carbon atoms), volatile, water-soluble, and lipid-soluble.
Facilitated by odorant-binding proteins in mucus.
Membrane Potential and Action Potential:
Resting membrane potential: -55mV.
Action potential frequency in the olfactory nerve increases with odorant strength.
Adaptation Towards the Sense of Smell:
Rapid adaptation within the first second, with further slow adaptation.
Psychological adaptation greater than receptor adaptation, involving feedback inhibition from the central nervous system.
Primary Sensations of Smell:
Camphoraceous, Musky, Floral, Pepperminty, Ethereal, Pungent, Putrid.
Odor Detection Threshold:
Examples: Hydrogen sulfide (0.0005 ppm), Methyl-mercaptan (0.002 ppm).
Some toxic substances are odorless at lethal concentrations.
Characteristics of Smell:
Odor blindness for single substances due to lack of appropriate receptor protein.
Behavioral and emotional influences of smell.
Transmission of Olfactory Signals:
From olfactory cells to glomeruli in the olfactory bulb, involving lateral inhibition.
Primitive, less old, and new olfactory systems with different path
Title: Sense of Taste
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the structure and function of taste buds.
Describe the relationship between the taste threshold and taste index of common substances.
Explain the chemical basis and signal transduction of taste perception for each type of primary taste sensation.
Recognize different abnormalities of taste perception and their causes.
Key Topics:
Significance of Taste Sensation:
Differentiation between pleasant and harmful food
Influence on behavior
Selection of food based on metabolic needs
Receptors of Taste:
Taste buds on the tongue
Influence of sense of smell, texture of food, and pain stimulation (e.g., by pepper)
Primary and Secondary Taste Sensations:
Primary taste sensations: Sweet, Sour, Salty, Bitter, Umami
Chemical basis and signal transduction mechanisms for each taste
Taste Threshold and Index:
Taste threshold values for Sweet (sucrose), Salty (NaCl), Sour (HCl), and Bitter (Quinine)
Taste index relationship: Inversely proportional to taste threshold
Taste Blindness:
Inability to taste certain substances, particularly thiourea compounds
Example: Phenylthiocarbamide
Structure and Function of Taste Buds:
Composition: Epithelial cells, Sustentacular/Supporting cells, Taste cells, Basal cells
Features: Taste pores, Taste hairs/microvilli, and Taste nerve fibers
Location of Taste Buds:
Found in papillae of the tongue (Fungiform, Circumvallate, Foliate)
Also present on the palate, tonsillar pillars, epiglottis, and proximal esophagus
Mechanism of Taste Stimulation:
Interaction of taste substances with receptors on microvilli
Signal transduction pathways for Umami, Sweet, Bitter, Sour, and Salty tastes
Taste Sensitivity and Adaptation:
Decrease in sensitivity with age
Rapid adaptation of taste sensation
Role of Saliva in Taste:
Dissolution of tastants to reach receptors
Washing away the stimulus
Taste Preferences and Aversions:
Mechanisms behind taste preference and aversion
Influence of receptors and neural pathways
Impact of Sensory Nerve Damage:
Degeneration of taste buds if the sensory nerve fiber is cut
Abnormalities of Taste Detection:
Conditions: Ageusia, Hypogeusia, Dysgeusia (parageusia)
Causes: Nerve damage, neurological disorders, infections, poor oral hygiene, adverse drug effects, deficiencies, aging, tobacco use, altered neurotransmitter levels
Neurotransmitters and Taste Threshold:
Effects of serotonin (5-HT) and norepinephrine (NE) on taste sensitivity
Supertasters:
25% of the population with heightened sensitivity to taste, especially bitterness
Increased number of fungiform papillae
Ozempic: Preoperative Management of Patients on GLP-1 Receptor Agonists Saeid Safari
Preoperative Management of Patients on GLP-1 Receptor Agonists like Ozempic and Semiglutide
ASA GUIDELINE
NYSORA Guideline
2 Case Reports of Gastric Ultrasound
Anti ulcer drugs and their Advance pharmacology ||
Anti-ulcer drugs are medications used to prevent and treat ulcers in the stomach and upper part of the small intestine (duodenal ulcers). These ulcers are often caused by an imbalance between stomach acid and the mucosal lining, which protects the stomach lining.
||Scope: Overview of various classes of anti-ulcer drugs, their mechanisms of action, indications, side effects, and clinical considerations.
Couples presenting to the infertility clinic- Do they really have infertility...Sujoy Dasgupta
Dr Sujoy Dasgupta presented the study on "Couples presenting to the infertility clinic- Do they really have infertility? – The unexplored stories of non-consummation" in the 13th Congress of the Asia Pacific Initiative on Reproduction (ASPIRE 2024) at Manila on 24 May, 2024.
MANAGEMENT OF ATRIOVENTRICULAR CONDUCTION BLOCK.pdfJim Jacob Roy
Cardiac conduction defects can occur due to various causes.
Atrioventricular conduction blocks ( AV blocks ) are classified into 3 types.
This document describes the acute management of AV block.
Pulmonary Thromboembolism - etilogy, types, medical- Surgical and nursing man...VarunMahajani
Disruption of blood supply to lung alveoli due to blockage of one or more pulmonary blood vessels is called as Pulmonary thromboembolism. In this presentation we will discuss its causes, types and its management in depth.
Biomanufacturing in China: Technologies and Facility Design
1. Produced by: Associations:
International Marketing
Partner:
www.biomanufacturing-asia.com
Increasing Production, Enhancing Quality & Optimizing Operations
Part of
PRODUCTION
BIOPHARMA
DEVELOPMENT &
WEEK
20 — 23 May 2014
Grand Hyatt Shanghai, China
IBC LIFE
SCIENCES
PLUS:
• WUXI APPTEC • SANOFI • NOVARTIS
• TAKEDA PHARMACEUTICAL • BAXTER
& many more!
BIOBIO
4TH ANNUAL
Jingrong Li
Executive Director, Biologics,
SIMCERE PHARMACEUTICALS, CHINA
Key Conference Themes:
• Regulations, GMP & Standards
• Successful Partnerships, Investment
& Financing
• Effective Planning, Facility Design &
Development
• Improving Operations & Supply Chain
Management
• Cost Effective Single-Use Systems &
Technology Transfer
Steven Lee
Global Head of Biologics Tech Operations &
Managing Director,
DR. REDDY’S LABORATORIES, SINGAPORE
THE 2014 NEW EXPERT FACULTY INCLUDES:
Ting Xu
Founder & CEO,
ALPHAMAB, CHINA Racho Jordanov
President & CEO,
JHL BIOTECH, TAIWAN
PRE-CONFERENCE WORKSHOP: 20 MAY 2014
Biomanufacturing Technologies & Facility Design
POST-CONFERENCE WORKSHOP: 23 MAY 2014
Meeting International Quality & Regulatory
Requirements in Biomanufacturing
Media Partners:
Jeremy Caudill
Global VP Business Development,
SAMSUNG BIOLOGICS, KOREA
Darren Ji
Global Head, Asia Emerging Markets Partnering,
F. HOFFMANN-LA ROCHE, CHINA
Life
Sciences
2. REGISTERTODAY! +65 6508 2401 / +86 21 2326 3680 register@ibcasia.com.sg www.biomanufacturing-asia.com
12.50 Networking Lunch & VIP Tables
VIP Table 1: Jian Dong, DeputyGeneralManager, SHANGHAI UNITED
CELL BIOTECHNOLOGY, CHINA
VIP Table 2: Jeremy Caudill, Global VP Business Development,
SAMSUNG BIOLOGICS, KOREA
If you would like to be seated on a table with the above guests in an
exclusive lunch setting, please register your interest with
gladys.landicho@ibcasia.com.sg. Limited seats are available!
2.30 Examining the Impact of the US H.R. 3204 Drug Quality & Security
Act in the Biomanufacturing Industry
• What are the substandard or counterfeit medicines & where are
counterfeit medicines found?
• To what extent could substandard medicine be considered as
counterfeit & what should be done to ensure the safety, efficacy &
quality of medicines?
• Dealing with corruption & conflict of interest & what consumers
should do?
• How to boost security in the biopharmaceutical supply chain?
• Understanding the effects of traceability requirement in the supply
chain partners & pharmacies
Masih Sabet, Associate Director, Quality Assurance, UCB, CHINA
PARTNERSHIPS, INVESTMENT & FINANCING
3.00 Critical Success Factors for Choosing the Right Biomanufacturing
Outsourcing Partner
• What are the essential partner attributes to look for when selecting
a partner?
• Identifying the best technology capacity
• Determining the partner’s expression platform
• Maximizing the outsourcing opportunities in Asia
Kang Li, Head of Biologics, BEIGENE, CHINA
3.30 Afternoon Networking & Refreshment Break
4.00 What do Investors Look for When Investing in Biologics
Manufacturing?
• Examining business models & growth strategies
• Attracting foreign investors
• Ensuring financial security in the biomanufacturing business
• Selecting & managing partners
~ Prototyping
~ Negotiating
StevenLee, GlobalHeadofBiologicsTechOperations&ManagingDirector,
DR. REDDY’S LABORATORIES, SINGAPORE
4.30 Venture Capital & Private Equity in the Biomanufacturing Space –
What are the Experiences & What is the Future for Investors?
• Understanding the growing pipeline of biologics portfolio
• What are the current trends in the biomanufacturing industry in
Asia?
• What are the investment opportunities for entering the
biomanufacturing market in China as compared to other countries
in Asia?
• What are the risks involved in investing in the biomanufacturing
industry?
Panelists:
Ramesh Rajentheran, Head of Asian Healthcare Investment Banking,
BARCLAYS, HONG KONG
Nisa Leung, Managing Partner, QIMING VENTURE PARTNERS, CHINA
Jason Mann, Managing Director, FENEX CAPITAL MANAGEMENT,
HONG KONG
5:30 Chairperson’s Summary of Day One
6.00 Speed Networking & Networking Cocktail
VIP 1: Atul Deshpande, Associate Director, Unit Strategy Officer,
Asia Pacific, SANOFI, CHINA
VIP 2: Sune Duus Svenningsen, Head of Operations, Asia Pacific,
NOVARTIS, CHINA
Exclusive to Registered Participants Only: Limited Spots Available!
Participants have the chance to spend two minutes getting to know
the below key experts in the Biopharma Industry! Secure your place
today with gladys.landicho@ibcasia.com.sg
7.00 End of Conference Day One
DAY ONE 21 May 2014 | Wednesday
08:00 Registration Opens & Morning Coffee
08:50 Welcome Address from IBC Asia & Ice Breaker
Exchange Business Cards & Get To Know Industry Peers
09:00 Chairperson’s Opening Remarks
BIOPHARMA VISIONARY KEYNOTE SESSIONS
09:05 Global Biopharma Outlook
• Trends in the global biopharma industry
• Priorities of investment in China & opportunities for growth
• Challenges & opportunities in the Asian region
• The role of Biosimilars in the region’s biopharma industry
• Key criteria to further the development of the sector in China and
Asia
Moderator:
Scott Liu, CEO, HENLIUS PHARMACUETICALS, CHINA
Panelists:
Youling Wu, CEO, ZHEJIANG TERUISI, CHINA
Jianguo Yang, Principal Scientist, SANOFI GENZYME, USA
Jeremy Caudill, Global VP Business Development, SAMSUNG
BIOLOGICS, KOREA
Abdullah Baaj, CEO, BOSTON ONCOLOGY, USA
Sameer Agarwal, Senior Vice President, Business Center Strategic
Marketing, Business Unit Generic Drugs & Standard Solutions, FRESENIUS
KABI DEUTSCHLAND GMBH, GERMANY
09:50 Biopharma Regulatory Updates & Development
• Clinical approvals for biopharmaceuticals
• Regulatory differences between the FDA/EMA/ICH & local agencies
in China & other emerging markets such as India & SEA
• How to demonstrate process consistency & what is required?
• Accelerating IND applications
• Updates on Biosimilars guidelines in key Asian markets
Panelists:
Victoria Elegant, Vice President, Medical & Regulatory Affairs, BAXTER,
CHINA
Andrea Laslop, Head of Scientific Office, AUSTRIAN AGENCY FOR
HEALTH AND FOOD SAFETY (AGES) PHARMMED, AUSTRIA & Austrian
Member, Committee for Human Medicinal Products (CHMP), EUROPEAN
MEDICINES AGENCY (EMA), AUSTRIA
Dr.ArvindMishra,GlobalHeadofQuality&Regulatory&HeadofStrategic
Business Unit, Biologicals, CADILLA PHARMACEUTICALS, INDIA
BIOPHARMA TECHNOLOGY SHOWCASE
10:30 Cutting Edge Solutions & Innovation in Biopharma
If you have leading edge technology & solutions & would like to
showcase your innovation in front of biopharma industry stakeholders,
please contact Yvonne Leong: Yvonne.leong@ibcasia.com.sg
11:00 Morning Networking & Refreshment Break
11.45 Chairperson’s Opening Remarks
Jeremy Caudill, Global VP Business Development, SAMSUNG
BIOLOGICS, KOREA
QUALITY & GMP STANDARDS
11.50 Bridging the Quality Differences of China GMP Standards vs. Europe
& the US
• Examining the quality assurance procedures
• Analyzing the facility requirements
• Assessing differences in standards
• Determining the effects vs. quality of products outsourced from
China
JingrongLi, ExecutiveDirector,Biologics, SIMCEREPHARMACEUTICALS,
CHINA
12.10 Developing a Multiproduct Facility for Biosimilars According to
GMP Standards
• Risk management techniques during design
• Does the multiproduct facility affect the product?
• Cleaning validation study for multi-product equipment
• Identifying the best multiproduct facility management strategies
Shaligram Rane, Vice President, Quality, INTAS PHARMACEUTICALS
LTD, INDIA
12.30 The US FDA Quality Inspection Standards for Biological Products
Manufactured in China
• Examining the facility, management & control system
• Ensuring the quality of the biological products manufactured in
China are up to US FDA standards
• Comparing how the US FDA & CFDA define a state of control for:
~ Plant layout
~ Smooth work flows
~ Efficient documentation systems
~ Well controlled processes
• What are the strategies on how to prepare for an inspection?
• How to deal with the inspector? What to communicate & how to
communicate effectively with an inspector?
Shaoyu Chen, Managing Director, China Food & Drug Practice,
COVINGTON & BURLING LLP, CHINA & Former, Assistant Chief Counsel,
FOOD AND DRUG ADMINISTRATION, USA
REGULATORY
LEADERSPANEL
PANELDISCUSSION
3. PANELDISCUSSION
12.00 Networking Luncheon & VIP Lunch Tables
VIP Table 1: Sune Duus Svenningsen, Head of Operations,
Asia Pacific, NOVARTIS, CHINA
VIP Table 2: Darren Ji, Global Head, Asia & Emerging Markets
Partnering, F. HOFFMANN-LA ROCHE, CHINA
If you would like to be seated on a table with the above guests in an
exclusive lunch setting, please register your interest with
gladys.landicho@ibcasia.com.sg. Limited seats are available!
BIOMANUFACTURING TECHNOLOGIES & TECHNOLOGY TRANSFER
2.00 Developing a Robust Commercial Process for Technology Transfer:
Ensuring Product Comparability to Avoid Rejection
• Comparative protocols to demonstrate the same quality of products
produced
• What could be the impact of technology transfer?
~ Manpower
~ Cost
~ Quality
• To what extent can the R&D process be copied?
Rajeev Soni, Associate Vice President, Research & Development, BIOCON,
INDIA
3.00 Afternoon Networking & Refreshment Break
3.30 To What Extent Could Disposable Technologies Be a Commercial
Manufacturing Technology in China?
• What are the requirements from the government?
• Examining the validation of lethable and extractable. Is it safe to
do?
• Examining the growth potential & opportunity for disposable
technologies
Panelists:
Lei Sun, Vice President, Technology & Manufacture, AUTEKBIO, CHINA
Jason Li, Senior Director, Downstream Processing, GENOR BIOPHARMA,
CHINA
Racho Jordanov, President & CEO, JHL BIOTECH, TAIWAN
Jimmy Li, Executive Director of Biologics & Bioprocesses, WUXI APPTEC,
CHINA
ROUND TABLE DISCUSSIONS
4:30 Round Table Discussions
Financing & Investment Opportunities in the Biomanufacturing
Industry
Jason Mann, Managing Director, FENEX CAPITAL MANAGEMENT,
HONGKONG
Examining Disposable Solutions
Jason Li, Senior Director, Downstream Processing, GENOR BIOPHARMA,
CHINA
Optimizing Operations in Biomanufacturing
Sune Duus Svenningsen, Head of Operations, Asia Pacific, NOVARTIS,
CHINA
Limited Seats Are Available! Secure your place with
gladys.landicho@ibcasia.com.sg
5:30 Chairperson’s Summary of the Day & End of Conference
REGISTERTODAY! +65 6508 2401 / +86 21 2326 3680 register@ibcasia.com.sg www.biomanufacturing-asia.com
DAY TWO 22 May 2014 | Thursday
08.55 Chairperson’s Opening Remarks
JeremyCaudill, GlobalVPBusinessDevelopment, SAMSUNGBIOLOGICS,
KOREA
BIOMANUFACTURING PLANNING, FACILITY DESIGN & DEVELOPMENT
09.00 Setting up A Vaccine Manufacturing Facility in China: What to Do
& What to Expect?
• Overview of the China vaccine market
• Identifying the key success factors to set up a vaccine business in
China
• Understanding the business penetration model in China
• What are the innovative approaches & best practices in vaccine
manufacturing?
Homer He, Vice President, SHANGHAI LEIYUNSHANG WEST
PHARMACEUTICAL & General Manager, SHANGHAI JINGAN
PHARMACEUTICAL, CHINA
9.20 Biomanufactuing Production Capacity Planning, Scale Up &
Development
• Production capacity planning & considerations
• Successful comparability study design between pilot scale &
commercial scale
• Determining the proper commercial scale in biologics
~ Designing & planning procedures
• Reducing animal source materials in biomanufacturing
Yong Ho Ahn, Vice President & Head of Biosimilar & Process Development,
HANHWA BIOLOGICS, KOREA
9.40 Opportunities & Development for Follow-on Complex Biologics
Production
• In depth understanding of complex biologics, Abetacept
• Understanding the development of Abetacept biosimilar
• Analysing the QbD approach during Abatacept development
Ting Xu, CEO & President, ALPHAMAB, CHINA
10:00 Morning Networking & Refreshment Break
OPTIMIZING OPERATIONS & SUPPLY CHAIN MANAGEMENT
10.30 Improving Quality Control & Maintenance of Global Biological
Product Distribution
• Engaging the different distribution channels
• Warehousing & distribution procedures
• Appropriate storage condition
• Engaging third party suppliers
Galatia Chandra, Head of Sales & System, Global Operation,
KALBE INTERNATIONAL PTE LTD, INDONESIA
11.00 Best Practices in Cold Chain Temperature Mapping for
Biopharmaceutical and Pharmaceutical Products
• Analyzing the importance of cold chain temperature mapping in
biomanufacturing
• Understanding complexities of the supply chain
• Is there an overlap between GDP & GMP?
• What are the bulk pharmaceutical shipment systems between
upstream & downstream processing facilities?
Omar Tabanjeh, Associate Director, Head of Quality Assurance, Middle
East, Turkey & Africa, TAKEDA PHARMACEUTICALS, UAE
11.30 Analyzing the Biomanufacturing Supply Chain Challenges &
Potential Solutions
• How regulatory challenges affect launching new products in terms
of patency & GMP issues?
• What are the financial risky challenges that shape the supply chain
strategy in case of unexpected currency change rates?
• How politics influence the Supply Chain Manager’s decisions?
• Contracting & importing biopharmaceuticals
Mina Ghaly, Head of Procurement Office, EVA PHARMA, CHINA
4. Biomanufacturing Technologies & Facility
Design
The purpose of this workshop is to acquaint the participant with
current technology trends in biomanufacturing and key facility design
concepts.
8.30 Registration
8.50 Introduction
9.00 Session 1: Biomanufacturing Landscape in China
• Existing biomanufacturing facilities in China
• Recent additions and on-going plans for new facilities
10.00 Session 2: Facility Size & Scales
• Factors to consider in deciding manufacturing scales
• Large vessel vs multiple smaller vessels?
10.45 Coffee Break
11.15 Session 3: Manufacturing Technologies: Disposable vs.
Stainless Steel
• Pros & cons of disposable & stainless steel facilities
• How should the decision be made – factors to consider?
12.00 Networking Lunch Break
13.30 Session 4: Facility Design – Basic Concepts
• Key concepts for facility design
• Facility design steps & timelines
14.30 Session 5: Facility Design – Process Design Concepts
• How should process design integrate with facility design?
• Process design principles
15.00 Coffee Break
15.30 Session 6: Design of Drug Product (Fill Finish) Facility
• Challenges in drug product facility design
• Examples of a drug product facility
16.15 Session 7: Facility Start-Up & Commissioning
• Key activities/milestones in facility start-up
• Case study: 1st cGMP biologics facility start-up & commissioning
17.15 Closing Remarks & End of Workshop
Meeting International Quality & Regulatory
Requirements in Biomanufacturing
The purpose of this workshop is to acquaint the participant with a
strong understanding of how to improve their regulatory submissions
& quality systems, & how to successfully pass a foreign inspection.
8.30 Registration
8.50 Introduction
9.00 Session 1: Preparation of Clinical Trial Applications (CTA)
• CTA & Investigational New Drug (IND) applications for Europe &
the US
• Guide to the preparation of documents
• Key issues and common pitfalls
10.00 Session 2: Good Record Keeping in Support of Regulatory
Applications
• Understanding the value of development reports
• Key writing skills for clear communication
10.30 Coffee Break
11.00 Session 3: Drug Master Files & Facility Registration
• Types of drug master files in Europe and US
• How to prepare & submit a master file?
• How to register your facility?
12.00 Networking Lunch Break
13.30 Session 4: Quality Systems
• Key Quality Systems for international cGMP
• How to establish & organize your quality program?
14.30 Session 5: Current Quality Issues
• Current topics in Quality Assurance
• Examples & case studies of real problems
15.00 Coffee Break
15.30 Session 6: Preparing for Inspections & Audits
• How to prepare your company for foreign inspections and audits?
• How to work with inspectors & auditors?
• How to reply to observations?
16.30 Session 7: cGMP Facility Design
• Variations in requirements between different regulatory agencies
• Basic principles for facility
• Review of facility examples
17.30 Closing Remarks & End of Workshop
REGISTERTODAY! +65 6508 2401 / +86 21 2326 3680 register@ibcasia.com.sg www.biomanufacturing-asia.com
WORKSHOPS
PRE-CONFERENCE WORKSHOP: 20 MAY 2014 • Tuesday POST-CONFERENCE WORKSHOP: 23 MAY 2014 • FRIDAY
Jincai (Jimmy) Li
Executive Director of Biologics & Bioprocesses,
WUXI APPTEC, CHINA
Scott M. Wheelwright
Co-Founder & Principal Consultant,
COMPLY ASIA CO. LTD, CHINA
About Your Workshop Leader About Your Workshop Leader
Dr. Jincai (Jimmy) Li is responsible for cell culture process development as well
as operation of the non-GMP pilot plant. He has extended experience in both
mammalian cell culture and microbial fermentation. His expertise includes
recombinant protein, especially monoclonal antibody expression and process
development, scale-up, technology transfer, process characterization and
validation, as well as post-marketing process improvement. Before joining
Wuxi, Dr. Li was Sr. Engineer and Group Leader at Genentech Inc., where he
led a group responsible for cell culture process development. He participated
in multiple monoclonal antibody therapeutic projectsí cell culture process
development, clinical material production, IND submission and also in several
Phase III as well as post-marketing products’ tech transfer and process
characterization/validation work. In addition, Dr. Li was also a core member
of the team that developed Genentech’s next-generation chemically-defined
cell culture medium and process platform, and his team developed the record
9+ g/L cell culture process at Genentech. Before Genentech, Dr. Li also worked
atTanox, Inc., where he led the manufacturing sciences group supporting PhIII
production of a mAb product, and at Diversa Corporation (now Verenium), in
charge of process development for multiple recombinant enzyme projects.
Dr. Li is the author of over a dozen peer-reviewed publications and patents.
Dr.Wheelwright has 30 years of hands on expertise quality assurance, regulatory,
manufacturing and process development. He has directly participated in
developing oncology, infectious disease, cardiovascular, wound healing,
angiogenesis, vaccine and diagnostic products. Dr. Wheelwright has been an
executive officer in several biotech startups, and has supervised the areas of
manufacturing, process development, compliance, quality assurance, quality
control, validation, engineering and facilities. He has led the development of
several products that are now on the market and has led the construction of
multiple manufacturing facilities that meet cGMP requirements. His corporate
experience includes Abbott, Chiron (now Novartis) and Scios (now J&J). Dr.
Wheelwright served as the founding COO for Innovent, a biopharmaceutical
company in China, and is founder and president of Strategic Manufacturing
Worldwide, Inc., a consulting firm that provides business and technical expertise
to biotech and related industries. Dr. Wheelwright obtained his PhD degree
in chemical engineering from the University of California at Berkeley and
performed post-doctoral studies in biophysics at the Max Planck Institute in
Germany. He is the author of a book on protein purification and has published
many papers on process design, manufacturing, and compliance for
pharmaceuticals and biologics.
PRE-CONFERENCE WORKSHOP: 20 MAY 2014
POST-CONFERENCE WORKSHOP: 23 MAY 2014
5. REGISTERTODAY! +65 6508 2401 / +86 21 2326 3680 register@ibcasia.com.sg www.biomanufacturing-asia.com
About the BDP Week
The Biopharma Development & Production Week is
the leading industry platform for pharma, biotech,
CMOs, CROs, research institutes, investors and industry
stakeholders to meet, network and discuss current
industry trends, establish business partnerships
and be updated on investment opportunities in
China and surrounding Asia.
Visit www.biopharmaproduction.com for more
information.
Co-Located with:
30+ Top Level Speakers
New Pre & Post Interactive Workshops
4 Interactive Panel Discussions
Hot Topic Round Table Discussions
Meet the Experts Via Specially Hosted VIP Lunch Tables
Speed Networking Sessions
Morning Ice Breaker & Get to Know your Peers
Conference Cocktail
Acceleron Pharma • AlphaMab • Amgen • Autekbio • Bayer HealthCare • Berna Biotech Korea • Biopharm Services • BioPharmaNeer Alliance • Bioprocessing
Technology Institute • Boehringer Ingelheim • Bristol-Myers Squibb • Celltrion Healthcare • Chugai Pharmaceutical • CMC Biologics • CMC Biologics •
Compliance Concepts International • Daewoong Pharmaceutical • DMS Biotechnology • Dow Corning • ExcellGene • Genor Biopharma • Genzyme/Sanofi •
Indian Immunologicals • Innobiologics • Innovent Biologics • Mass Biologics • Novasep • Pfizer Biotherapeutics • Sartorius Stedim Biotech • Saint Gobain •
SFDA Training Center • Shanghai Henlius Biotech • Swiss Federal Institute of Technology • Wuxi Apptec • Yooyoung Pharmaceutical & many more
20 — 23 May 2014
Grand Hyatt Shanghai, China
Part of
PRODUCTION
BIOPHARMA
DEVELOPMENT &
WEEK
Asian countries such as India, Singapore, South Korea
& China are fast becoming biomanufacturing hubs.
Biologics manufacturing is a huge investment & can
amount to US10 million or more to construct, equip, &
launch a successful certified GMP plant facility
(Biospectrum Asia, 2013). With the intensifying growth
& demand of biologics production, IBC’s 4th Annual
Biomanufacturing Conference provides a timely
platform to explore the opportunities & challenges
faced in this sector including:
The investment opportunities for entering the
biomanufacturing market in China & the surrounding
Asian region
Bridging the quality differences of China GMP
Standards vs. Europe & the US
What is the growth potential & opportunity for
disposable technologies in biomanufacturing in
China?
Identifying the critical factors in choosing the right
outsourcing partner
Developing a robust commercial process for
technology transfer
Examining the impact of the US H.R. 3204 Drug Quality
& Security Act in the biomanufacturing industry
For sponsorship opportunities, contact Yvonne Leong at
Tel: +65 6508 2489
Email: Yvonne.leong@ibcasia.com.sg
BY INDUSTRY
■ Biopharmaceutical / Pharmaceutical /
Biotechnology 45%
■ Technology and Solution Service Providers 20%
■ CMO 15%
■ Research Institutes 10%
■ Government 10%
www.biosimilarasia.com
www.celllineasia.com
LIMITED SPONSORSHIP & EXHIBITION OPPORTUNITIES AVAILABLE
Do you provide innovative technology to support the biomanufacturing Industry in Asia?
• Showcase the latest technology
• Meet & network with senior decision makers in Asia
• Position your brand as the market leader to stand out amidst
competition
• Generate new business contacts & strengthen existing accounts
Who Should Attend
SNAPSHOT OF PAST ATTENDING COMPANIES INCLUDE:
Abundant Networking Opportunities &
Interactive Formats!
AnInternationalEvent
China, Taiwan, Hong Kong 55%
Europe 10%
USA 5%
Australia 5%Southeast Asia 10%
Japan,
Korea 10%
India 5%
6. GROUP BONUS: REGISTER 3 DELEGATES FROM THE SAME COMPANY AND THE 4TH ATTENDS FOR FREE!
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