This document provides information about the "Pharmaceutical and Clinical Trial Logistics Asia Pacific" conference to be held on July 18-19, 2011 in Singapore, including an optional workshop on July 20. It outlines the conference agenda, key speakers, topics to be discussed, benefits of attending, and registration information. The conference will explore effective management of clinical trial logistics and supply chains in Asia Pacific, with sessions on regulations, cold chain solutions, lean supply chain practices, and more.
The document discusses plans by the Portiuncula Hospital Ballinasloe and Roscommon County Hospital group to improve quality of care, efficiency, and accountability. Key points include establishing clinical directorates and governance structures, implementing national clinical programs, improving access through initiatives to reduce waiting times, developing performance management frameworks, establishing financial control through cost containment plans, and addressing challenges around capacity, patient flow, and meeting access targets. The group aims to deliver on its promises by 2023 through efficiency gains, empowering staff, and adopting best practices.
Learning how to achieve a seven day turnaround in histopathologyNHS Improvement
Reducing the intervals between specimens being taken and results being made available will reduce the period of uncertainty for patients and will help to ensure that treatment can be started as soon as clinically appropriate. For inpatients reduced histopathology turnaround times can lead to reductions in lengths of stay.(Nov 2010).
In today’s drug development climate, clinical supply professionals face a unique set of challenges. These include adhering & complying with stringent regulations, using specialized temperature packaging and monitoring devices, evaluating cost-effective & validated distribution processes, shipping to and from research labs or hospitals and many more. The Clinical Logistics Supply conference will provide a unique opportunity to optimize logistics, overcome inefficiencies, develop safe vendor relationships and comply with US and international standards for your clinical supply chain.
CoreRx is a dosage form development company specializing in formulation development, analytical development, and clinical manufacturing. They focus on client satisfaction, quality science, strong communication, timeline management, and client goals. CoreRx offers preformulation, formulation development, analytical services, manufacturing, packaging, labeling, and stability services. They have experienced scientific staff and capabilities including specialized dosage forms. CoreRx aims to get clients' products to market quickly while maintaining compliance.
Prof. Greta Nasi. Associate Professor Bocconi University, Head of Ehealth Research Unit at Center for Health and Social Care Management, Bocconi University.
VIBpharma’s Clinical Trial Supply conference brings together senior representatives from pharma and biotech manufacturers to discuss key issues through a series of high caliber presentations and interactive roundtable discussions led by industry experts. The topics being addressed will also include innovative drug mobility and labelling strategies, getting the most out of your IVRS, ensuring compliance across Europe, best practice approaches for temperature controlled transportation.
Join us in London in February to discover practical approaches for ensuring a cost-efficient clinical supply chain.
Drug Information Agency (dia) 7th annual conference: Kapil Khandelwal, www.ka...Kapil Khandelwal (KK)
The 7th Annual Conference on Discovery through Commercialization: Innovative Strategies for Individualized Health Care will take place from November 1-4, 2012 in Hyderabad, India. Over multiple tracks, the conference will address strategy for drug discovery, clinical development, manufacturing, and commercialization in the era of personalized health care. It will also cover regulatory, ethical, social and legal issues; technology and data standards; and lean strategies for areas like pharmacovigilance and clinical operations. Keynote speakers, concurrent sessions, posters, exhibits and networking opportunities will be provided over the 4 day event.
Biomanufacturing in China: Technologies and Facility DesignRita Barry
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
The document discusses plans by the Portiuncula Hospital Ballinasloe and Roscommon County Hospital group to improve quality of care, efficiency, and accountability. Key points include establishing clinical directorates and governance structures, implementing national clinical programs, improving access through initiatives to reduce waiting times, developing performance management frameworks, establishing financial control through cost containment plans, and addressing challenges around capacity, patient flow, and meeting access targets. The group aims to deliver on its promises by 2023 through efficiency gains, empowering staff, and adopting best practices.
Learning how to achieve a seven day turnaround in histopathologyNHS Improvement
Reducing the intervals between specimens being taken and results being made available will reduce the period of uncertainty for patients and will help to ensure that treatment can be started as soon as clinically appropriate. For inpatients reduced histopathology turnaround times can lead to reductions in lengths of stay.(Nov 2010).
In today’s drug development climate, clinical supply professionals face a unique set of challenges. These include adhering & complying with stringent regulations, using specialized temperature packaging and monitoring devices, evaluating cost-effective & validated distribution processes, shipping to and from research labs or hospitals and many more. The Clinical Logistics Supply conference will provide a unique opportunity to optimize logistics, overcome inefficiencies, develop safe vendor relationships and comply with US and international standards for your clinical supply chain.
CoreRx is a dosage form development company specializing in formulation development, analytical development, and clinical manufacturing. They focus on client satisfaction, quality science, strong communication, timeline management, and client goals. CoreRx offers preformulation, formulation development, analytical services, manufacturing, packaging, labeling, and stability services. They have experienced scientific staff and capabilities including specialized dosage forms. CoreRx aims to get clients' products to market quickly while maintaining compliance.
Prof. Greta Nasi. Associate Professor Bocconi University, Head of Ehealth Research Unit at Center for Health and Social Care Management, Bocconi University.
VIBpharma’s Clinical Trial Supply conference brings together senior representatives from pharma and biotech manufacturers to discuss key issues through a series of high caliber presentations and interactive roundtable discussions led by industry experts. The topics being addressed will also include innovative drug mobility and labelling strategies, getting the most out of your IVRS, ensuring compliance across Europe, best practice approaches for temperature controlled transportation.
Join us in London in February to discover practical approaches for ensuring a cost-efficient clinical supply chain.
Drug Information Agency (dia) 7th annual conference: Kapil Khandelwal, www.ka...Kapil Khandelwal (KK)
The 7th Annual Conference on Discovery through Commercialization: Innovative Strategies for Individualized Health Care will take place from November 1-4, 2012 in Hyderabad, India. Over multiple tracks, the conference will address strategy for drug discovery, clinical development, manufacturing, and commercialization in the era of personalized health care. It will also cover regulatory, ethical, social and legal issues; technology and data standards; and lean strategies for areas like pharmacovigilance and clinical operations. Keynote speakers, concurrent sessions, posters, exhibits and networking opportunities will be provided over the 4 day event.
Biomanufacturing in China: Technologies and Facility DesignRita Barry
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
Program - 5th Annual Biomanufacturing Summit 2013, San DiegoMark Blendheim
This document provides an agenda for the Biomanufacturing Summit 2013 conference taking place in San Diego, California. The two-day conference will include presentations, panel discussions, and workshops on topics related to biomanufacturing quality, operations, and supply chain management. Speakers will discuss strategies for developing world-class quality systems, improving biomanufacturing processes, managing supply chains in emerging markets, and other challenges in the industry. Attendees will have opportunities to network and participate in one-on-one business meetings. The agenda provides timing, speaker names and affiliations, and brief descriptions of presentation topics each session.
SMi's 8th conference on Controlled Release builds upon the successes of the previous years in bringing together leading industry figures and tackling some of the most current and pressing issues faced by this important branch of drug development.
This white paper discusses how biopharmaceutical manufacturers can partner with knowledgeable suppliers to overcome challenges in operational excellence, safety, and risk mitigation. It describes how SAFC Biosciences provides integrated supply chain solutions through involvement in early process development. This allows suppliers to help optimize production processes and maximize revenue while reducing costs and ensuring reproducibility. Examples are given of how SAFC has worked with manufacturers to enhance efficiency, security, and safety through integrated approaches like developing flexible media transfer systems.
The document discusses the challenges that biopharmaceutical manufacturers face in ensuring operational excellence, safety, and risk mitigation given the complexity of biological production processes. It argues that these challenges can be overcome through early supplier integration, where suppliers partner with manufacturers during process development to help optimize costs, reproducibility, and safety. The document provides an example of the complexity of mammalian cell culture production processes and argues that creative supply chain solutions achieved through early supplier involvement are needed to remove constraints and find opportunities for improvements.
VIBpharma’s Clinical Trials in Emerging Markets conference will bring together pharma and biotech companies to share solutions to strategic and operational challenges in setting up and conducting studies in new territories. Attendees will hear from experienced professionals who will share their knowledge on making the most of the opportunities and benefits of conducting trials in emerging markets. Attend this practical, insightful and solution led event to generate new cost and time saving ideas for your clinical trials.
SMi's Pre-Filled Syringes Asia Pacific conference provides a fundamental analysis of the key growth drivers in the Asia-Pacific pre-filled syringes market. The conference brings together industry leaders to focus on opportunities and barriers to creating successful strategies in this emerging market. Register by March 31st to receive a $300 discount, or by April 28th to receive a $100 discount. The conference will take place on July 20-21, 2011 in Singapore and will include presentations and discussions on topics such as commercial opportunities, manufacturing, packaging, quality control, and regulatory trends related to pre-filled syringes in Asia-Pacific.
The presentation discusses the current state of quality management in the pharmaceutical industry and a proposed future "desired state" based on a risk-based, science-driven approach. It highlights guidelines from the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) including ICH Q6A on specifications and ICH Q8 on pharmaceutical development. The desired state focuses on process understanding, continuous monitoring and improvement rather than just documentation and testing to ensure consistent product quality.
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A reflection on progress made, and challenges to be addressed, in realizing the desired state articulated by the the FDA Initiative on Pharmaceutical Quality for the 21st Century.
IGPA Building a Culture of Quality Ajaz Hussain_5 Sept 2015_Rferences minAjaz Hussain
Improving Confidence in Quality of Medicines . We make two products – medicine and evidence (documents) but many forget this and do not pay attention to documentation.
Level of attention to documentation is a “canary in a coal mine”
Breaches are irrational –”System 1 thinking” and cognitive biases.
Culture of Quality is familiar to all of us – a framework proposed
Quality Metrics – great idea – very much needed; but we are not yet ready for an FDA Guidance.
We must first address our collective blind spots; be confident that process validation truly ensures complexity is sufficiently reduced and that outcomes are predictable.
Anthony Presentation DIA Florida Ctd Nov2007AKTaylor
Creating a business process that is accurate, predictable, and capable of
meeting the changing needs for disclosing information about clinical trials
in multiple study registries and results databases is difficult. Companies
need to leverage their current clinical trial process, determine if the disclosure
steps will be centralized or decentralized, determine how much to
leverage technology, and decide whether, and how, to use outside
resources. During this session, we will hear how a large pharma, a small
biopharmaceutical company, and a device company developed their clinical
trial disclosure business process.
Innovation in Phase 1 Clinical DevelopmentElisa_Ramella
Practical app roaches to
phase I trial develop ment
to enable faster go / no -go
decision s, reduce co st and
speed time to market
www.phase1clinicaldevelopment.com
SMi Group's Pharmaceutical Microbiology East Coast 2019 Dale Butler
This document provides information on the Pharmaceutical Microbiology East Coast conference taking place from April 10-11, 2019 in Boston, USA. It includes details on registration, chairpersons, key speakers and their topics. The conference will discuss challenges in pharmaceutical microbiology such as regulatory changes, environmental monitoring, rapid methods and sterility assurance. There will also be workshops on April 12th on mold contamination challenges and microbiological control using vapor phase hydrogen peroxide bio-decontamination. The event is aimed at professionals working in pharmaceutical microbiology.
The document summarizes the agenda and topics for the Pharmaceutical & Bio Cold Chain Conference 2011, which will cover best practices in cold chain management for pharmaceutical and biopharmaceutical products. Over two days, the conference will explore strategies to balance international cold chain requirements with local practices in India. Speakers will address topics such as setting up efficient cold chain logistics, managing transportation and ensuring compliance with regulations. The conference aims to identify practices to strengthen relationships across the supply chain and assess new technologies for optimal cold chain management.
Quality by design in pharmaceutical developmentManish Rajput
This document discusses the concept of Quality by Design (QbD) in pharmaceutical development. It provides background on QbD and outlines its key aspects, including defining target product profiles, critical quality attributes, risk assessment, design space, control strategy, and life cycle management. The benefits of QbD for industry and regulators are described. Traditional and QbD approaches to pharmaceutical development are compared. Tools used in QbD such as design of experiments, risk assessment methodologies, and process analytical technology are also summarized. Finally, an example application of QbD principles to influenza vaccine development is presented.
This document provides an overview of clinical research and career opportunities in the field. It defines clinical research as organized studies conducted on humans to evaluate the safety and efficacy of drugs, medical devices, and other therapies. Various types of clinical research are described. The document outlines the clinical research process and regulations, and notes the growth of the industry in India. Career opportunities are discussed for various roles in clinical research organizations, pharmaceutical companies, and other settings. Requirements and top cities for clinical research in India are also summarized.
The document discusses the concept of Pharmaceutical Quality by Design (QbD), which is a systematic approach to pharmaceutical development that emphasizes product and process understanding based on sound science and quality risk management. QbD aims to design quality products and manufacturing processes that consistently deliver intended performance, following ICH guidelines Q8 on pharmaceutical development, Q9 on quality risk management, and Q10 on pharmaceutical quality systems. Implementing QbD provides benefits like eliminating batch failures, minimizing deviations, and ensuring consistent product quality.
Mohd Tariq is a food technologist seeking a challenging career where he can apply his technical and managerial skills. He has over 9 years of experience in food production and operations management. Currently he is a Senior Executive at General Mills India Pvt. Ltd. where he oversees production tasks and ensures food safety and quality standards are met. Previously he worked as a Production Executive at ChefCraft Foods Pvt. Ltd. where he managed production processes and implemented HACCP. He holds a Bachelor's degree in Food Technology and has received several awards and certifications for his work in food safety and operations.
Process Automation in Pharmaceutical Industry.pptxShalakaDhikale
The document is a presentation on process automation in the pharmaceutical industry submitted for a Master's program. It discusses how automation technologies help enhance productivity in pharmaceutical development and manufacturing. The presentation covers various pharmaceutical manufacturing processes like mixing, milling, granulation and hot melt extrusion. It also describes common equipment used like fluid bed dryers and tablet compression machines. Benefits of automation include improved productivity and safety. A case study on automating a generic injectable drug manufacturing process is also summarized.
1. Process analytical technology (PAT) aims to shift pharmaceutical development and manufacturing from testing quality through sampling to building quality into products using continuous monitoring and control strategies.
2. PAT involves establishing quantitative relationships between raw materials, process parameters, and product quality attributes to decrease variability, contamination, and costs while improving quality.
3. The goals of PAT include encouraging innovation through a risk-based regulatory framework that facilitates new manufacturing technologies and ensures consistent application of regulations.
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Program - 5th Annual Biomanufacturing Summit 2013, San DiegoMark Blendheim
This document provides an agenda for the Biomanufacturing Summit 2013 conference taking place in San Diego, California. The two-day conference will include presentations, panel discussions, and workshops on topics related to biomanufacturing quality, operations, and supply chain management. Speakers will discuss strategies for developing world-class quality systems, improving biomanufacturing processes, managing supply chains in emerging markets, and other challenges in the industry. Attendees will have opportunities to network and participate in one-on-one business meetings. The agenda provides timing, speaker names and affiliations, and brief descriptions of presentation topics each session.
SMi's 8th conference on Controlled Release builds upon the successes of the previous years in bringing together leading industry figures and tackling some of the most current and pressing issues faced by this important branch of drug development.
This white paper discusses how biopharmaceutical manufacturers can partner with knowledgeable suppliers to overcome challenges in operational excellence, safety, and risk mitigation. It describes how SAFC Biosciences provides integrated supply chain solutions through involvement in early process development. This allows suppliers to help optimize production processes and maximize revenue while reducing costs and ensuring reproducibility. Examples are given of how SAFC has worked with manufacturers to enhance efficiency, security, and safety through integrated approaches like developing flexible media transfer systems.
The document discusses the challenges that biopharmaceutical manufacturers face in ensuring operational excellence, safety, and risk mitigation given the complexity of biological production processes. It argues that these challenges can be overcome through early supplier integration, where suppliers partner with manufacturers during process development to help optimize costs, reproducibility, and safety. The document provides an example of the complexity of mammalian cell culture production processes and argues that creative supply chain solutions achieved through early supplier involvement are needed to remove constraints and find opportunities for improvements.
VIBpharma’s Clinical Trials in Emerging Markets conference will bring together pharma and biotech companies to share solutions to strategic and operational challenges in setting up and conducting studies in new territories. Attendees will hear from experienced professionals who will share their knowledge on making the most of the opportunities and benefits of conducting trials in emerging markets. Attend this practical, insightful and solution led event to generate new cost and time saving ideas for your clinical trials.
SMi's Pre-Filled Syringes Asia Pacific conference provides a fundamental analysis of the key growth drivers in the Asia-Pacific pre-filled syringes market. The conference brings together industry leaders to focus on opportunities and barriers to creating successful strategies in this emerging market. Register by March 31st to receive a $300 discount, or by April 28th to receive a $100 discount. The conference will take place on July 20-21, 2011 in Singapore and will include presentations and discussions on topics such as commercial opportunities, manufacturing, packaging, quality control, and regulatory trends related to pre-filled syringes in Asia-Pacific.
The presentation discusses the current state of quality management in the pharmaceutical industry and a proposed future "desired state" based on a risk-based, science-driven approach. It highlights guidelines from the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) including ICH Q6A on specifications and ICH Q8 on pharmaceutical development. The desired state focuses on process understanding, continuous monitoring and improvement rather than just documentation and testing to ensure consistent product quality.
Pharmaceutical Product & Process Design & QualityAjaz Hussain
A reflection on progress made, and challenges to be addressed, in realizing the desired state articulated by the the FDA Initiative on Pharmaceutical Quality for the 21st Century.
IGPA Building a Culture of Quality Ajaz Hussain_5 Sept 2015_Rferences minAjaz Hussain
Improving Confidence in Quality of Medicines . We make two products – medicine and evidence (documents) but many forget this and do not pay attention to documentation.
Level of attention to documentation is a “canary in a coal mine”
Breaches are irrational –”System 1 thinking” and cognitive biases.
Culture of Quality is familiar to all of us – a framework proposed
Quality Metrics – great idea – very much needed; but we are not yet ready for an FDA Guidance.
We must first address our collective blind spots; be confident that process validation truly ensures complexity is sufficiently reduced and that outcomes are predictable.
Anthony Presentation DIA Florida Ctd Nov2007AKTaylor
Creating a business process that is accurate, predictable, and capable of
meeting the changing needs for disclosing information about clinical trials
in multiple study registries and results databases is difficult. Companies
need to leverage their current clinical trial process, determine if the disclosure
steps will be centralized or decentralized, determine how much to
leverage technology, and decide whether, and how, to use outside
resources. During this session, we will hear how a large pharma, a small
biopharmaceutical company, and a device company developed their clinical
trial disclosure business process.
Innovation in Phase 1 Clinical DevelopmentElisa_Ramella
Practical app roaches to
phase I trial develop ment
to enable faster go / no -go
decision s, reduce co st and
speed time to market
www.phase1clinicaldevelopment.com
SMi Group's Pharmaceutical Microbiology East Coast 2019 Dale Butler
This document provides information on the Pharmaceutical Microbiology East Coast conference taking place from April 10-11, 2019 in Boston, USA. It includes details on registration, chairpersons, key speakers and their topics. The conference will discuss challenges in pharmaceutical microbiology such as regulatory changes, environmental monitoring, rapid methods and sterility assurance. There will also be workshops on April 12th on mold contamination challenges and microbiological control using vapor phase hydrogen peroxide bio-decontamination. The event is aimed at professionals working in pharmaceutical microbiology.
The document summarizes the agenda and topics for the Pharmaceutical & Bio Cold Chain Conference 2011, which will cover best practices in cold chain management for pharmaceutical and biopharmaceutical products. Over two days, the conference will explore strategies to balance international cold chain requirements with local practices in India. Speakers will address topics such as setting up efficient cold chain logistics, managing transportation and ensuring compliance with regulations. The conference aims to identify practices to strengthen relationships across the supply chain and assess new technologies for optimal cold chain management.
Quality by design in pharmaceutical developmentManish Rajput
This document discusses the concept of Quality by Design (QbD) in pharmaceutical development. It provides background on QbD and outlines its key aspects, including defining target product profiles, critical quality attributes, risk assessment, design space, control strategy, and life cycle management. The benefits of QbD for industry and regulators are described. Traditional and QbD approaches to pharmaceutical development are compared. Tools used in QbD such as design of experiments, risk assessment methodologies, and process analytical technology are also summarized. Finally, an example application of QbD principles to influenza vaccine development is presented.
This document provides an overview of clinical research and career opportunities in the field. It defines clinical research as organized studies conducted on humans to evaluate the safety and efficacy of drugs, medical devices, and other therapies. Various types of clinical research are described. The document outlines the clinical research process and regulations, and notes the growth of the industry in India. Career opportunities are discussed for various roles in clinical research organizations, pharmaceutical companies, and other settings. Requirements and top cities for clinical research in India are also summarized.
The document discusses the concept of Pharmaceutical Quality by Design (QbD), which is a systematic approach to pharmaceutical development that emphasizes product and process understanding based on sound science and quality risk management. QbD aims to design quality products and manufacturing processes that consistently deliver intended performance, following ICH guidelines Q8 on pharmaceutical development, Q9 on quality risk management, and Q10 on pharmaceutical quality systems. Implementing QbD provides benefits like eliminating batch failures, minimizing deviations, and ensuring consistent product quality.
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The document is a presentation on process automation in the pharmaceutical industry submitted for a Master's program. It discusses how automation technologies help enhance productivity in pharmaceutical development and manufacturing. The presentation covers various pharmaceutical manufacturing processes like mixing, milling, granulation and hot melt extrusion. It also describes common equipment used like fluid bed dryers and tablet compression machines. Benefits of automation include improved productivity and safety. A case study on automating a generic injectable drug manufacturing process is also summarized.
1. Process analytical technology (PAT) aims to shift pharmaceutical development and manufacturing from testing quality through sampling to building quality into products using continuous monitoring and control strategies.
2. PAT involves establishing quantitative relationships between raw materials, process parameters, and product quality attributes to decrease variability, contamination, and costs while improving quality.
3. The goals of PAT include encouraging innovation through a risk-based regulatory framework that facilitates new manufacturing technologies and ensures consistent application of regulations.
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Process analytical technology innovative pharmaceutical development
Pharmaceutical & Clinical Trial Logistics Asia Pacific
1. "Very good. Well organised"
Senior Representative, Antisoma Research,
Clinical Trial Logistics Europe Conference 2010
SMi present their annual Conference…
Pharmaceutical and
Clinical Trial Logistics Asia Pacific
Monday 18th July and Tuesday 19th July 2011
Grand Copthorne Waterfront Hotel, Singapore
KEY SPEAKERS INCLUDE:
N. H. Kalyanakrishnan
Vice President Central SCM & Special Projects, DR REDDY'S
Gagan Bharadwaj
General Manager-Procurement & Supply Management, ZYDUS CADILA
Mubashir Hussain
Director Supply Chain, GETZ PHARMA PAKISTAN
Nitin Gokarn
Head- Logistics, Supply Chain Technical Operations, MERCK INDIA
Rodney Wee
Chief Executive Officer, ASIA COLD CHAIN CENTER
Sushant Sharma
Senior Manager Planning (Supply Chain), WOCKHARDT PHARMACEUTICALS INDIA
Shailendra Bajpai
Director - Medical and Regulatory Affairs, UCB
Sundar Narasimhan
General Manager - Supply Chain Management, NEULAND LABORATORIES
Ashwani Singh
General Manager - Supply Chain and Procurement, WATSON PHARMACEUTICALS
Shrikant Gade
Executive Vice President, Supply Chain & Business Development, MICROLABS
KEY BENEFITS OF ATTENDING
• Explore the best ways to effectively manage the logistics of clinical
trials with limited drug supplies
• Study logistical plans and strategies for various types or trials,
including for biologics
• Learn about maintaining regulatory compliance
• Network with senior thought leaders in this field
ATTEND AN INTERACTIVE POST CONFERENCE WORKSHOP ON:
Wednesday 20th July 2011
World Class Pharmaceuticals Distribution in India
In association with: ThinkLink SCS 8.30am – 12.30pm
Sponsored by
www.clinical-trial-logistics.com/asia
Register online and receive full information on all of SMi’s conferences
Alternatively fax your registration to +44 (0) 870 9090 712 or call +44 (0) 870 9090 711
2. Pharmaceutical and Clinica
Day One | 18th July 2011 www.clinical-trial-
8.30 Registration & Coffee 2.10 Integrated Cold Chain Solution: What to consider for a model to
manage end-to-end (E2E) temperature controlled transportation to
9.00 Chairman's Opening Remarks prevent disturbance of clinical trials
Rodney Wee, Chief Executive Officer, ASIA COLD CHAIN CENTER • Logistics and process management integrated with geographic,
climatic, packaging and supplier data
9.10 OPENING ADDRESS / KEYNOTE ADDRESS • Criticality of standardisation and proactive intervention in a process
Overview of Bio-Pharmaceutical Logistics in Asia • Quality agreement, control and assurance
• The Bio-Pharmaceutical Industry in Asia's growth dynamics • Peace of mind in global cold supply chain
• Supply Chain issues facing the Bio-Pharmaceutical Industry in Asia Shrikant Gade, Executive Vice President, Supply Chain & Business
• Meeting the dynamically changing challenges of tomorrow. Development, MICROLABS
Rodney Wee, Chief Executive Officer, ASIA COLD CHAIN CENTER
2.50 Session Reserved for OCASA
10.30 Morning Coffee Sponsored by
3.30 Afternoon Tea Sponsored by
10.50 Closing the loop- Regulatory issues in Supply chain management in Asia
• Diversity in the regulatory environment in Asia 3.50 Achieving effective resource utilizations, optimum inventories, and
• Logistical challenges – regulatory bottlenecks reduced make-times through advanced planning and scheduling
• Stakeholder expectation management techniques
Shailendra Bajpai, Director - Medical and Regulatory Affairs, UCB • Innovative decision support tools for faster and resilient decision
making
11.30 Solving the Clinical Trial Logistics Puzzle • Improving bottom-line by optimized inventories and deliveries
• Practical experience in temperature controlled packaging and • Increasing resource utilizations through comprehensive planning
systems Professor Iftekhar Karimi, Department of Chemical & Biomolecular
• How to achieve optimal results – no excursions Engineering, NATIONAL UNIVERSITY OF SINGAPORE
• Keys factors for successful temperature controlled shipments
• Challenges and case studies 4.30 Lean manufacturing and effective supply chain management to
Yin Lin Seow, Director, Global CTS Business Development, MARKEN expedite your processes
• Using a clinical supplies team to manage manufacturing and
12.10 Networking Lunch packaging vendors
• Effective planning and forecasting
1.30 Automation for a Speedier and Leaner Supply Chain • Regulatory hurdles
• Operational Excellence and business improvement • Benefits to the industry
• How lean supply chain adds value to the business Sushant Sharma, Senior Manager Planning (Supply Chain),
• Choosing the right partner WOCKHARDT PHARMACEUTICALS INDIA
Gagan Bharadwaj, General Manager-Procurement & Supply
Management, ZYDUS CADILA 5.10 Chairman’s Closing Remarks and Close of Day One
Register online at www.clinical-trial-logistics.com/asia • Alternative
Sponsored by
Founded in 1980, Marken is focused on supporting the premium logistics of Pharmaceutical, Biotechnology and clinical service
companies. Through our strategically placed offices we manage the collection, transport of specimens, and distribution of
temperature sensitive clinical trial supplies. Additionally through our depot network we support the storage and distribution of Life
Science assets such as critical medications and diagnostic equipment. Our team members and network of facilities bridge the
distance between patients and the essential resources of Life Science companies.
Marken understands the specialised and dynamic needs of our industry; we retain our global agility by continuously investing in our
people, technologies and global installations to better support our clients. www.marken.com
Coffee Break Sponsor
With more than 25 years of experience in developing Critical Logistics Solutions, OCASA relies on a worldwide network of affiliates and
branches strategically located around the globe in (North America, Latin America, Europe, Africa, and South East Asia), making OCASA
a major global integrated logistics Company. Our Bio-Pharmaceutical logistic service offers tailor made solutions for the Pharma industry
including export, import, distribution, fulfillment, and temperature controlled warehousing for: Diagnostic Specimens,
Medication/Vaccines, Experimental Drugs, Controlled Substances, Dangerous Goods, and Medical Supplies. www.ocasa.com
Supported by
3. al Trial Logistics Asia Pacific
-logistics.com/asia Day Two | 19th July 2011
8.30 Re- Registration & Coffee 1.50 Harnessing Distribution Opportunities for Cold Chain Products in
Asian Markets
9.00 Chairman's Opening Remarks • Project Management
Rodney Wee, Chief Executive Officer, ASIA COLD CHAIN CENTER • Operational processes
• Necessary infrastructure
Mubashir Hussain, Director Supply Chain, GETZ PHARMA PAKISTAN
9.10 Achieving High Performance with a Lean Inbound Supply Chain
• Key Parameters while considering a lean supply chain model 2.30 Best Practices – Strategic Developmental Sourcing from LCC
• Forecasting, Supplier Leadtimes and Transit Leadtimes (low-cost countries).
• Challenges - Managing with lean inventory • Setting a clear LCC strategy
• Leveraging best practice IT solutions • Improving supplier evaluation
Sundar Narasimhan, General Manager - Supply Chain Management, • Consider going direct
NEULAND LABORATORIES • Building relationships
• Conveying expectations clearly
• Intellectual property issues
9.50 New Product Introductions: TOC way of Project Management
• Creation of technology teams
• Understand how to apply TOC in project environment
• Compliance with ICH7QA guidelines and its impact on Generic
• What are the various paradigm changes
companies.
• What are the key do’s and don’ts which can help deliver the project • "Have TRUST, but verification is MUST"
as per due date • Need for Guanxi (A combination of business and personal
N. H. Kalyanakrishnan, Vice President Central SCM & Special relationships-An Important Chinese Business Element)
Projects, DR REDDY'S • There's more to global sourcing than China
Kauntey Sonrexa, General Manager- Global Sourcing, RANBAXY LABS
10.30 Morning Coffee Sponsored by
3.10 Afternoon Tea Sponsored by
11.00 Regulatory Requirements for Supply Chain in Biopharmaceuticals
3.40 Effective Supply Chain Strategies for Developing Markets
• Keeping up to date with the regulatory affairs
• Practical Considerations for Developing Market Logistics
• New legislation • Evaluating Critical SC Challenges in a Complex Distribution Market
• Licensing requirements • Key Logistics Strategies to enable a forward looking Supply Chain in
Shivraj Dasari, Vice President – Quality Management & Regulatory a Developing Marketplace
Affairs, INNOBIO VENTURES Chetan Kumria, Head of Supply Chain, BAXTER
11.40 Reviewing the Good Distribution Practice in India 4.20 Effectively Managing Cold Chain Distribution in India
• Optimising cold chain management • Developing successful strategies to manage and control your cold
chain
• Reducing risk
• Understanding climate conditions, temperatures and storage
• Contingency plan for delays in distribution regionally
• Best practices through case examples
Ashwani Singh, General Manager - Supply Chain and Procurement, Nitin Gokarn, Head- Logistics, Supply Chain Technical Operations,
WATSON PHARMACEUTICALS MERCK INDIA
12.20 Networking Lunch 5.00 Chairman’s Closing Remarks and Close of Conference
ely fax your registration to +44 (0)870 9090 712 or call +44 (0)870 9090 711
Who must attend
• Heads of Supply Chain
• Heads of Logistics
• Heads of Clinical Supply Operations
• Heads of Clinical Trials Logistics
• Heads of Clinical/Investigational Supplies
• Heads of Shipping and Distribution
• Heads of Clinical Labelling / Packaging
• Heads of Clinical Trials Material Management
• Heads of Clinical Supplies Manufacturing
• Heads of Clinical Quality Assurance/Quality Control
• Heads of Regulatory Affairs
• Sourcing and Procurement Managers
4. HALF-DAY POST-CONFERENCE WORKSHOP
Wednesday 20th July 2011
8.30am – 12.30pm
World Class Pharmaceuticals
Distribution in India
In association with
Workshop Overview
This workshop is designed to provide participants with an
overview of challenges in building a world class Distribution
Chain for Pharma products in India. The program focuses on
issues regarding statutory requirements, implementation of
internal financial controls sometimes with a statutory overlap,
typical gaps in infrastructure and processes that impact GDP
requirements, safety and security of assets and
employees/associates, and product quality. The workshop will
use real life examples from India to illustrate these issues.
Who Should Attend
Supply Chain Directors, Quality Directors, Finance and Legal
Heads for Pharma Companies
Agenda:
8.30 Registration and Coffee
9.00 Introduction and Aims of the Workshop
9.10 Statutory Requirements in India and Typical Gaps
• General Issues in the Distribution Industry
- Issues that can impact Business Continuity
• Issues Specific to Pharma Industry
10.30 Morning Coffee
10.45 GDP Compliance in India
• Infrastructure Gaps that can lead to gaps in GDP
compliance
• Other issues that can impact efficient Distribution
Operations
12.30 Q&A and Close of the Workshop
Saurabh Goyal, Founder and Managing Director, ThinkLink
Supply Chain Services
Saurabh is the Founder and Chief Executive at
ThinkLink Supply Chain Services (ThinkLink).
His Consulting and Management
Development Career has included working
with a number of globally renowned and
leading Indian organizations like DHL,
PepsiCo, Shoppers’ Stop, Heidelberg, Dell,
Nike, DB Schenker, Unilever, Solectron, Maxtor, Intel,
Safexpress, TransCare, MJ Logistic, Coca Cola, McDonald's,
Fosroc, Ceva etc. Saurabh has worked with Senior
Management at several major firms to design, develop and
deliver Supply Chain and Logistics Strategy, Build-out and
Reengineering projects especially in the fields of Supply Chain
Network Evaluation, Warehousing, Distribution Operations
and Aftermarket Services. He has a great understanding of
evolving Logistics Solutions, Concepts and Technology across
industry verticals. Previously Saurabh has work experience
with DHL in various roles across Sales, Consulting, Solutions,
and Project Management both in India and across Asia Pacific.
He hold a Bachelors in Technology from IIT Delhi
About the organisation:
ThinkLink Supply Chain Services (ThinkLink) is an India based
firm. Over the last five years they have worked with and served
more than 150 clients across Services and Verticals.
Through their Advisory, Infrastructure and Equipment
verticals they work with Clients and Partners in helping build
efficient businesses. They offer Advisory, Systems
Implementation, Turnkey Project Management and Talent
Development Services to their Clients. Through their
Equipment Vertical they provide World Class Equipment to
operate Modern Warehouses, Distribution Centers, Logistics
Parks, and Cold Stores.
5. PHARMACEUTICAL
FORWARD PLANNER
March 2011
30/31 Controlled Release
April 2011
13/14 Asthma & COPD
May 2011
11/12 Generics, Supergenerics
and Patent Strategies
16/17 Clinical Trial Logistics
June 2011
01/02 Pain Therapeutics
27/28 RNAi
29/30 Nanotechnology
29/30 Pharmaceutical Portfolio & Product
Lifecycle Management
29/30 KOL Europe (Munich, Germany)
July 2011
06/07 ADMET
06/07 Social Media in the Pharmaceutical Industry
11/12 BioBanking
18/19 Pharmaceutical and Clinical Trial Logistics
Asia Pacific (Singapore)
20/21 Pre-Filled Syringes Asia (Singapore)
All conferences take place in central London, UK –
unless indicated otherwise in brackets
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6. PHARMACEUTICAL AND CLINICAL TRIAL LOGISTICS ASIA PACIFIC
Conference: Monday 18th and Tuesday 19th July 2011, Grand Copthorne Waterfront Hotel, Singapore Workshop: 20th July 2011, Singapore
4 WAYS TO REGISTER
www.clinical-trial-logistics.com/asia
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