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.
Emergency: “No-pain No-gain”
Standard: “Plan Do Check & Act”
Pathfinders: B1: “Don’t Use & Don’t Tell”; no more!
B2: Every vertex can be a Tipping Point
G1: Same and Similar
G2: Synthesis & Analysis
The IFPAC Session: Controlling excipient impact during the product lifecycle.
Excipients enable the delivery of actives as a pharmaceutical product. Quality by Design requires that the impact of excipient variability on finished product quality be minimized, or, as paraphrased by Tobyn: - What matters doesn’t vary, and what varies doesn’t matter.
This parallels the current practice of categorizing excipients into critical vs non-critical, the assumption being that the latter do not impact the finished product Critical Quality Attributes. This binary classification of criticality has been criticized as too simple and it is not uncommon to observe excursions in finished product quality correlating with variability of a so-called non-critical excipient. The complexity of the excipients, and the products into which they are formulated, contributes to this uncertainty. For excipients, what varies may not have mattered prior to approval, but may come to matter later in the product lifecycle, especially for continuously manufactured products with real time release.
Excipients, even if fully compliant and manufactured under GMP, represent a reservoir of special cause variability in finished product quality. By definition this can only be addressed via the Control Strategy. Risk management requires continuous multivariate monitoring of finished product and raw materials to maintain quality and model fidelity.
Pharmaceutical quality decisions are made by multidisciplinary teams (a range of maturity), at different times and in various organizations; understanding of the QbD paradigm and methodology is derived experientially -One Quality Voice is hard to achieve!
Legacy challenges, various ontological assumptions, and weak epistemology curtails knowledge sharing, delays consensus and keeps us trapped in a reactive mode (3rd Order)
The risk of irrational decision making needs to be accounted. ”Cut-paste” or “check-the-box” practices are reminders that we are not achieving an optimal integration or practicing systems thinking.
A reactive approach (3rd Order) to filling the noted gaps poses risk of continued erosion in the confidence the public should have in our assurance of pharmaceutical quality
We need a thoughtful, planned approach to filling these gaps –NIPTE should take on this challenge! Will it?
Emergency: “No-pain No-gain”
Standard: “Plan Do Check & Act”
Pathfinders: B1: “Don’t Use & Don’t Tell”; no more!
B2: Every vertex can be a Tipping Point
G1: Same and Similar
G2: Synthesis & Analysis
The IFPAC Session: Controlling excipient impact during the product lifecycle.
Excipients enable the delivery of actives as a pharmaceutical product. Quality by Design requires that the impact of excipient variability on finished product quality be minimized, or, as paraphrased by Tobyn: - What matters doesn’t vary, and what varies doesn’t matter.
This parallels the current practice of categorizing excipients into critical vs non-critical, the assumption being that the latter do not impact the finished product Critical Quality Attributes. This binary classification of criticality has been criticized as too simple and it is not uncommon to observe excursions in finished product quality correlating with variability of a so-called non-critical excipient. The complexity of the excipients, and the products into which they are formulated, contributes to this uncertainty. For excipients, what varies may not have mattered prior to approval, but may come to matter later in the product lifecycle, especially for continuously manufactured products with real time release.
Excipients, even if fully compliant and manufactured under GMP, represent a reservoir of special cause variability in finished product quality. By definition this can only be addressed via the Control Strategy. Risk management requires continuous multivariate monitoring of finished product and raw materials to maintain quality and model fidelity.
Pharmaceutical quality decisions are made by multidisciplinary teams (a range of maturity), at different times and in various organizations; understanding of the QbD paradigm and methodology is derived experientially -One Quality Voice is hard to achieve!
Legacy challenges, various ontological assumptions, and weak epistemology curtails knowledge sharing, delays consensus and keeps us trapped in a reactive mode (3rd Order)
The risk of irrational decision making needs to be accounted. ”Cut-paste” or “check-the-box” practices are reminders that we are not achieving an optimal integration or practicing systems thinking.
A reactive approach (3rd Order) to filling the noted gaps poses risk of continued erosion in the confidence the public should have in our assurance of pharmaceutical quality
We need a thoughtful, planned approach to filling these gaps –NIPTE should take on this challenge! Will it?
Design is to do good not just be and look good: Bad Design is Smoke, Good Des...Ajaz Hussain
Design is to do good not just be and look good. "Design means being good, not just looking good." ~ Clement Mok. "A small change at the beginning of the design process defines an entirely different product at the end." ~ Jonathan Ive. "User-centered design means understanding what your users need, how they think, and how they behave - and incorporating that understanding into every aspect of your process." ~ Jesse James Garrett.
Compared to “one factor at a time” experiments, increased experimental efficiency, accounting interactions, multivariate predictive capability, minimization, maximization, optimization, graphical illustration for enhanced communication of complex topics.
"Design is intelligence made visible." -- Alina Wheeler
Totality of Evidence & Theraputic Equivalence 15 October 2016Ajaz Hussain
Put R back in R&D & recognize It is a “complex” product and process!
Invest smartly in analytics, mathematics & statistics, and large sample sizes; and in systems/integrative thinking and data integration
Get to know the RLD – multiple lots; open the door with large sample size
Build capability to justify measured RLD variability is relevant to development of the proposed generic/biosimilar
Exquisite regulatory communication strategy
This is not a ‘complicated process’ for which typical “good practices” will work seamlessly (e.g., typical project management approach); this is a complex process – with multiple interactions and “emergent properties”
Treat it as it is - a complex process and plan; anticipate and address “emergent issues” - in technical, regulatory and legal dimensions; at a certain point be prepared for stakeholder (payers, patient groups,..) communications
Question Based Development to Quality by Design to Continued Process Verification
Does your QbD program delivery confidence in CQA’s?
Does it reduce the risk of development failure?
Does it provide a process which is stable and ‘in control’?
Does it reduce risk of GMP noncompliance?
Are we asking the right question and at the right time?
Dr Venkateswarlu Memorial Lecture 2015Ajaz Hussain
Purpose of this talk is to request you to consider the following 4 Steps
1. Strengthening the ‘Culture of Quality’ – the focus of this talk
2. Improve efficiency with confidence in controls by integrating India’s engineering and statistical know-how and technologies
3. Working together – ‘One Quality for All’ to say proudly – Made in India: Pharmaceutical Factory to the World
4. Leverage India’s Wisdom Traditions to provide leadership in setting the standards for Integrative Medicine so as to deliver a model of ‘Health Care for All’: Pharmacy to the World.
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.
We are on a journey to make quality medicines affordable to all. In the 21st Century, this journey will be successful to the extent we recognize that quality has to be built-in by design and that it cannot be tested into products, utilize and improve a global Quality Management System (QMS), and implement science based risk assessment in our decision making. Pharmacopoeias are an integral part of this global QMS and have been setting public or market standards for medical products for many centuries. In the 21st Century, Pharmacopoeias can and should be a champion for the practice of quality by design. To do so most effectively it would be useful to recognize how, in the 21st Century, human factors help and hinder optimal development, and correct interpretation, of public or market standards in design, development, control and manufacturing decisions. To explore this aspect in this presentation, cognitive biases – blind spots or alleys – are collected and organized on topics relevant to this workshop: (a) Impurities & Contaminants, (b) Analytical Method Validation, and (c) Public/market standards and Release Testing. How to confront these biases will be discussed. Steps to help in maximally leveraging the Pharmacopoeias on the 21st Century journey will be highlighted.
From Roadblocks to Roadmap 2017, with a 2020 VisionAjaz Hussain
In 2015 FDA reorganized OPS to the Office of Pharmaceutical Quality (OPQ) and added an emphasis on One Quality Voice. In 2017 novel pharmaceutical technologies, the aspirational 21st Century Cures Act, and the President-elect Trump’s Administration are juxtaposed to re-shape, perhaps radically so, the Critical Path transformation underway since the beginning of this century. How will the Nation’s life-science research priorities change? What should be the next steps to optimally integrate 21st Century Quality, Cures and the Voice of Patients? What can/should NIPTE do next? Do better? Do more -be the third leg of the stool? This report, From Roadblocks to Roadmap 2017, with 2020 Vision, reviews and reflects on strategic directions emphasized by NIPTE in 2016. It recommends ways to strengthen the Voice of NIPTE to advocate its mission more persuasively and to facilitate its members apply their full potential in the interest of the Nation.
Pharmaceutical Quality Assurance in the 21st Century, Sharper Focus Needed on...Ajaz Hussain
An updated version of the article published in the Financial Express, Express Pharma on 16 May 2016. The picture below is based on a LinkedIn blog by the author entitled
“Pharmaceutical quality: Elephant in the Dark or Six Blind Men?” (September 8, 2015).
Part 1: FDA Trends
Background: The little secret – swept under the rug? No more!
Challenge or opportunity: Unprecedented juxtaposition – at the Tipping Point!
Questions: What consideration are needed for building your validation roadmap? Three options: Pathfinder, Standard or Emergency; what will you choose?
Part II: A higher level of confidence in quality assurance : State of Control (stability, capability with statistical confidence)
Case example: Challenges of implementing a roadmap to process capability for some currently commercialized products.
QbD and CoQ IDMA Mumbai 24 March 2015 slideshareAjaz Hussain
IDMA – UL SUMMIT 24 March 2015, Mumbai
"Evolving Quality Culture in Indian Pharmaceutical Industry“: Strengthening Our Culture of Quality
Organizational Culture, Good or Bad?
Equivalence Assessment and Maturity of Quality Management SystemsAjaz Hussain
Challenge: As a system or cohort, we can do more to adequately appreciate that “systems” proficiency is a stage in adult development that most struggle to achieve.
Sense of urgency, lessons learned, organizational alignment, team approach, training and an increasing engineering and statistical capability at CDER FDA can be expected to facilitate a move by industry towards continues manufacturing, FDA’s current emphasis on ‘statistical confidence’, Process Validation Guidance 2011, is likely to highlight certain issues (e.g., special causes) within current batch processing; these observation will need to be addressed in an appropriate risk-based manner
Ensuring that pragmatic consideration for specifications & control (intended use) is essential and importance of pragmatic decisions should not be forgotten (e.g., as in case of Design Space Vs. SUPAC), Effective regulatory communication (considering the engineering and statistical emphasis) will be crucial for ensuring regulatory uncertainty is managed in a timely manner,
Chemometrics, Pharmacometrics and Econometrics Dimensions_of_QualityAjaz Hussain
25 May 2012 Basel, Switzerland. A philosophical exploration - Scientific understanding and risk-based regulatory decisions on Quality by Design. How good are the scientific explanations in regulatory submissions? Scientific explanations yield understanding; quality of explanations differ.What role can Chemometrics, Pharmacometics and Econometrics play? Understanding multidisciplinary (cGMP, CMC, Clin. Pharm., Tox., Clinical, Public Health) perspectives on risk is important. Opportunities; only when the disciplinary divides are bridged. Within the regulatory realm how we set specifications and assess risk have progressed incrementally; at this rate the Vision 2020 may be expected to be visible broadly over time, by 2020?
On FDA’s Guidance on Pharmaceutical Process Validation (2011)lAjaz Hussain
Connectors between Culture – Metrics – Continued Process Verification in Process Validation?
Confidence is a critical quality attribute. CGMP violations erode confidence and increase nocebo effects. Currently – “breaches in assurance of data integrity” is a global concern. Have exposed the prevailing ‘regulator heterogeneity’. Re-building ‘epistemic trust” is difficult generally; more so with US FDA. Some thoughts on how to ....
Critical Path Initiative Challenges: FDA ACPS Meeting 19 October 2004Ajaz Hussain
Each section within P2 can have an impact on the other P2 sections and similarly other sections of a submission and to CGMP’s By recognizing this as a complex design system that involves multiple attributes, goals, constraints, multidisciplinary design teams (subsystems), different degrees of uncertainty, risk tolerance, etc., we wish to find opportunities to identify robust designs and design space that provides a sound basis for risk assessment and mitigation
Sharpen your Unique Sensing Proclivity: Dissolution is a process in mind and ...Ajaz Hussain
Self-authorship bridging the Academia to Industry (A2I) Gap. The challenge in our systems asking why signifies ignorance. Perhaps until a correction is needed. But after corrective and preventive actions (CAPA) often nothing changes. Errors reoccur and we acquire an “immunity to change.”
About UCI Applied Innovation:
UCI Applied Innovation is a dynamic, innovative central platform for the UCI campus, entrepreneurs, inventors, the business community and investors to collaborate and move UCI research from lab to market.
About the Cove @ UCI:
To accelerate collaboration by better connecting innovation partners in Orange County, UCI Applied Innovation created the Cove, a physical, state-of-the-art hub for entrepreneurs to gather and navigate the resources available both on and off campus. The Cove is headquarters for UCI Applied Innovation, as well as houses several ecosystem partners including incubators, accelerators, angel investors, venture capitalists, mentors and legal experts.
Follow us on social media:
Facebook: @UCICove
Twitter: @UCICove
Instagram: @UCICove
LinkedIn: @UCIAppliedInnovation
For more information:
cove@uci.edu
http://innovation.uci.edu/
CHIR Best Brains Exchange 22 January 2016Ajaz Hussain
Quality of drugs manufactured in emerging economies: Are cost containment strategies heightening the likelihood of substandard drugs in Canada?
What regulatory, policy, and/ or governance changes are needed to address new and increased risks?
How can Canada prevent and reduce health risks that emerge when the pharmaceutical industry adopts globalized production strategies?
Design is to do good not just be and look good: Bad Design is Smoke, Good Des...Ajaz Hussain
Design is to do good not just be and look good. "Design means being good, not just looking good." ~ Clement Mok. "A small change at the beginning of the design process defines an entirely different product at the end." ~ Jonathan Ive. "User-centered design means understanding what your users need, how they think, and how they behave - and incorporating that understanding into every aspect of your process." ~ Jesse James Garrett.
Compared to “one factor at a time” experiments, increased experimental efficiency, accounting interactions, multivariate predictive capability, minimization, maximization, optimization, graphical illustration for enhanced communication of complex topics.
"Design is intelligence made visible." -- Alina Wheeler
Totality of Evidence & Theraputic Equivalence 15 October 2016Ajaz Hussain
Put R back in R&D & recognize It is a “complex” product and process!
Invest smartly in analytics, mathematics & statistics, and large sample sizes; and in systems/integrative thinking and data integration
Get to know the RLD – multiple lots; open the door with large sample size
Build capability to justify measured RLD variability is relevant to development of the proposed generic/biosimilar
Exquisite regulatory communication strategy
This is not a ‘complicated process’ for which typical “good practices” will work seamlessly (e.g., typical project management approach); this is a complex process – with multiple interactions and “emergent properties”
Treat it as it is - a complex process and plan; anticipate and address “emergent issues” - in technical, regulatory and legal dimensions; at a certain point be prepared for stakeholder (payers, patient groups,..) communications
Question Based Development to Quality by Design to Continued Process Verification
Does your QbD program delivery confidence in CQA’s?
Does it reduce the risk of development failure?
Does it provide a process which is stable and ‘in control’?
Does it reduce risk of GMP noncompliance?
Are we asking the right question and at the right time?
Dr Venkateswarlu Memorial Lecture 2015Ajaz Hussain
Purpose of this talk is to request you to consider the following 4 Steps
1. Strengthening the ‘Culture of Quality’ – the focus of this talk
2. Improve efficiency with confidence in controls by integrating India’s engineering and statistical know-how and technologies
3. Working together – ‘One Quality for All’ to say proudly – Made in India: Pharmaceutical Factory to the World
4. Leverage India’s Wisdom Traditions to provide leadership in setting the standards for Integrative Medicine so as to deliver a model of ‘Health Care for All’: Pharmacy to the World.
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.
We are on a journey to make quality medicines affordable to all. In the 21st Century, this journey will be successful to the extent we recognize that quality has to be built-in by design and that it cannot be tested into products, utilize and improve a global Quality Management System (QMS), and implement science based risk assessment in our decision making. Pharmacopoeias are an integral part of this global QMS and have been setting public or market standards for medical products for many centuries. In the 21st Century, Pharmacopoeias can and should be a champion for the practice of quality by design. To do so most effectively it would be useful to recognize how, in the 21st Century, human factors help and hinder optimal development, and correct interpretation, of public or market standards in design, development, control and manufacturing decisions. To explore this aspect in this presentation, cognitive biases – blind spots or alleys – are collected and organized on topics relevant to this workshop: (a) Impurities & Contaminants, (b) Analytical Method Validation, and (c) Public/market standards and Release Testing. How to confront these biases will be discussed. Steps to help in maximally leveraging the Pharmacopoeias on the 21st Century journey will be highlighted.
From Roadblocks to Roadmap 2017, with a 2020 VisionAjaz Hussain
In 2015 FDA reorganized OPS to the Office of Pharmaceutical Quality (OPQ) and added an emphasis on One Quality Voice. In 2017 novel pharmaceutical technologies, the aspirational 21st Century Cures Act, and the President-elect Trump’s Administration are juxtaposed to re-shape, perhaps radically so, the Critical Path transformation underway since the beginning of this century. How will the Nation’s life-science research priorities change? What should be the next steps to optimally integrate 21st Century Quality, Cures and the Voice of Patients? What can/should NIPTE do next? Do better? Do more -be the third leg of the stool? This report, From Roadblocks to Roadmap 2017, with 2020 Vision, reviews and reflects on strategic directions emphasized by NIPTE in 2016. It recommends ways to strengthen the Voice of NIPTE to advocate its mission more persuasively and to facilitate its members apply their full potential in the interest of the Nation.
Pharmaceutical Quality Assurance in the 21st Century, Sharper Focus Needed on...Ajaz Hussain
An updated version of the article published in the Financial Express, Express Pharma on 16 May 2016. The picture below is based on a LinkedIn blog by the author entitled
“Pharmaceutical quality: Elephant in the Dark or Six Blind Men?” (September 8, 2015).
Part 1: FDA Trends
Background: The little secret – swept under the rug? No more!
Challenge or opportunity: Unprecedented juxtaposition – at the Tipping Point!
Questions: What consideration are needed for building your validation roadmap? Three options: Pathfinder, Standard or Emergency; what will you choose?
Part II: A higher level of confidence in quality assurance : State of Control (stability, capability with statistical confidence)
Case example: Challenges of implementing a roadmap to process capability for some currently commercialized products.
QbD and CoQ IDMA Mumbai 24 March 2015 slideshareAjaz Hussain
IDMA – UL SUMMIT 24 March 2015, Mumbai
"Evolving Quality Culture in Indian Pharmaceutical Industry“: Strengthening Our Culture of Quality
Organizational Culture, Good or Bad?
Equivalence Assessment and Maturity of Quality Management SystemsAjaz Hussain
Challenge: As a system or cohort, we can do more to adequately appreciate that “systems” proficiency is a stage in adult development that most struggle to achieve.
Sense of urgency, lessons learned, organizational alignment, team approach, training and an increasing engineering and statistical capability at CDER FDA can be expected to facilitate a move by industry towards continues manufacturing, FDA’s current emphasis on ‘statistical confidence’, Process Validation Guidance 2011, is likely to highlight certain issues (e.g., special causes) within current batch processing; these observation will need to be addressed in an appropriate risk-based manner
Ensuring that pragmatic consideration for specifications & control (intended use) is essential and importance of pragmatic decisions should not be forgotten (e.g., as in case of Design Space Vs. SUPAC), Effective regulatory communication (considering the engineering and statistical emphasis) will be crucial for ensuring regulatory uncertainty is managed in a timely manner,
Chemometrics, Pharmacometrics and Econometrics Dimensions_of_QualityAjaz Hussain
25 May 2012 Basel, Switzerland. A philosophical exploration - Scientific understanding and risk-based regulatory decisions on Quality by Design. How good are the scientific explanations in regulatory submissions? Scientific explanations yield understanding; quality of explanations differ.What role can Chemometrics, Pharmacometics and Econometrics play? Understanding multidisciplinary (cGMP, CMC, Clin. Pharm., Tox., Clinical, Public Health) perspectives on risk is important. Opportunities; only when the disciplinary divides are bridged. Within the regulatory realm how we set specifications and assess risk have progressed incrementally; at this rate the Vision 2020 may be expected to be visible broadly over time, by 2020?
On FDA’s Guidance on Pharmaceutical Process Validation (2011)lAjaz Hussain
Connectors between Culture – Metrics – Continued Process Verification in Process Validation?
Confidence is a critical quality attribute. CGMP violations erode confidence and increase nocebo effects. Currently – “breaches in assurance of data integrity” is a global concern. Have exposed the prevailing ‘regulator heterogeneity’. Re-building ‘epistemic trust” is difficult generally; more so with US FDA. Some thoughts on how to ....
Critical Path Initiative Challenges: FDA ACPS Meeting 19 October 2004Ajaz Hussain
Each section within P2 can have an impact on the other P2 sections and similarly other sections of a submission and to CGMP’s By recognizing this as a complex design system that involves multiple attributes, goals, constraints, multidisciplinary design teams (subsystems), different degrees of uncertainty, risk tolerance, etc., we wish to find opportunities to identify robust designs and design space that provides a sound basis for risk assessment and mitigation
Sharpen your Unique Sensing Proclivity: Dissolution is a process in mind and ...Ajaz Hussain
Self-authorship bridging the Academia to Industry (A2I) Gap. The challenge in our systems asking why signifies ignorance. Perhaps until a correction is needed. But after corrective and preventive actions (CAPA) often nothing changes. Errors reoccur and we acquire an “immunity to change.”
About UCI Applied Innovation:
UCI Applied Innovation is a dynamic, innovative central platform for the UCI campus, entrepreneurs, inventors, the business community and investors to collaborate and move UCI research from lab to market.
About the Cove @ UCI:
To accelerate collaboration by better connecting innovation partners in Orange County, UCI Applied Innovation created the Cove, a physical, state-of-the-art hub for entrepreneurs to gather and navigate the resources available both on and off campus. The Cove is headquarters for UCI Applied Innovation, as well as houses several ecosystem partners including incubators, accelerators, angel investors, venture capitalists, mentors and legal experts.
Follow us on social media:
Facebook: @UCICove
Twitter: @UCICove
Instagram: @UCICove
LinkedIn: @UCIAppliedInnovation
For more information:
cove@uci.edu
http://innovation.uci.edu/
CHIR Best Brains Exchange 22 January 2016Ajaz Hussain
Quality of drugs manufactured in emerging economies: Are cost containment strategies heightening the likelihood of substandard drugs in Canada?
What regulatory, policy, and/ or governance changes are needed to address new and increased risks?
How can Canada prevent and reduce health risks that emerge when the pharmaceutical industry adopts globalized production strategies?
SMi Group are thrilled to announce the return of Pre-Filled Syringes West Coast 2017 which arrives to California on June 5th & 6th.
Following on from sell-out shows in Europe and Boston, Pre-Filled Syringes West Coast will once again gather a global audience of medical device experts and PFS industry leaders to discuss new developments and showcase cutting edge advances, keeping you at the forefront of a booming industry.
The competitive PFS market has sparked great improvements as devices strive for higher quality, safety, and patient satisfaction. Innovation and excellence is requested at every level making Pre-Filled Syringes West Coast the perfect platform to strengthen knowledge in key principles such as human factor engineering, manufacturing and complex biologics, whilst honing in on emerging trends for parenteral devices, including auto injectors, pens, pumps and smart devices.
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.
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!
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
SMi Group's 6th annual Pre-Filled Syringes conference & exhibition is already Europe's leading event. This year it will be better than ever. Check out the programme.
SMi Group are thrilled to announce the launch of the Ophthalmic Drugs Conference, being held on the 28-29 November 2017 at the Copthorne Tara Hotel in London, UK. www.ophthalmicdrugs.com/slideshare
Similar to P 141 pre-filled syringes america revised (20)
With the total size of the healthcare cold chain logistic services market expected to expand further from its current figures of £4.3 billion to nearly £6.9 billion by 2016*, we're even more excited to present SMi's 10th Annual Cold Chain Distribution Conference and Exhibition on Thursday 3rd and Friday 4th December 2015 at the Victoria Park Plaza Hotel, London, UK.
With the important advances in real time data logging to be assessed, in addition to compliance, GDP and best practices in the pharma distribution environment; these are only just a couple of sessions to be covered at this two-day conference
Helicopter technology eastern europe 2015.brochure.Alia Malick
Welcome to Sikorsky Aircraft who have just signed up as a sponsor to the SMi Group's Helicopter Technology Eastern Europe Conference and Exhibition to be held in Prague this June.
E 060 oil gas cyber security north americaAlia Malick
Building on 8 years developing conferences in the Cyber Security space the SMi Group are delighted to announce launch their 6th in the series Oil and Gas Cyber Security North America. This conference will provide delegates with an information packed two day agenda with representatives from across the industry, giving a comprehensive overview of the market, looking at insider threats, the latest technology, live demonstrations, current and future threats, APT and much more.
The event will present itself as the perfect platform for learning about the real issues currently being faced by the industry. Hear from leading experts who are currently facing cyber threats. This is a unique opportunity to hear about cyber security expressed from government personal and the operators as well as understanding key market challenges, regulations, human behaviour and technology available.
Ethnobotany and Ethnopharmacology:
Ethnobotany in herbal drug evaluation,
Impact of Ethnobotany in traditional medicine,
New development in herbals,
Bio-prospecting tools for drug discovery,
Role of Ethnopharmacology in drug evaluation,
Reverse Pharmacology.
Operation “Blue Star” is the only event in the history of Independent India where the state went into war with its own people. Even after about 40 years it is not clear if it was culmination of states anger over people of the region, a political game of power or start of dictatorial chapter in the democratic setup.
The people of Punjab felt alienated from main stream due to denial of their just demands during a long democratic struggle since independence. As it happen all over the word, it led to militant struggle with great loss of lives of military, police and civilian personnel. Killing of Indira Gandhi and massacre of innocent Sikhs in Delhi and other India cities was also associated with this movement.
Welcome to TechSoup New Member Orientation and Q&A (May 2024).pdfTechSoup
In this webinar you will learn how your organization can access TechSoup's wide variety of product discount and donation programs. From hardware to software, we'll give you a tour of the tools available to help your nonprofit with productivity, collaboration, financial management, donor tracking, security, and more.
Model Attribute Check Company Auto PropertyCeline George
In Odoo, the multi-company feature allows you to manage multiple companies within a single Odoo database instance. Each company can have its own configurations while still sharing common resources such as products, customers, and suppliers.
How to Make a Field invisible in Odoo 17Celine George
It is possible to hide or invisible some fields in odoo. Commonly using “invisible” attribute in the field definition to invisible the fields. This slide will show how to make a field invisible in odoo 17.
The Art Pastor's Guide to Sabbath | Steve ThomasonSteve Thomason
What is the purpose of the Sabbath Law in the Torah. It is interesting to compare how the context of the law shifts from Exodus to Deuteronomy. Who gets to rest, and why?
How to Create Map Views in the Odoo 17 ERPCeline George
The map views are useful for providing a geographical representation of data. They allow users to visualize and analyze the data in a more intuitive manner.
Synthetic Fiber Construction in lab .pptxPavel ( NSTU)
Synthetic fiber production is a fascinating and complex field that blends chemistry, engineering, and environmental science. By understanding these aspects, students can gain a comprehensive view of synthetic fiber production, its impact on society and the environment, and the potential for future innovations. Synthetic fibers play a crucial role in modern society, impacting various aspects of daily life, industry, and the environment. ynthetic fibers are integral to modern life, offering a range of benefits from cost-effectiveness and versatility to innovative applications and performance characteristics. While they pose environmental challenges, ongoing research and development aim to create more sustainable and eco-friendly alternatives. Understanding the importance of synthetic fibers helps in appreciating their role in the economy, industry, and daily life, while also emphasizing the need for sustainable practices and innovation.
2024.06.01 Introducing a competency framework for languag learning materials ...Sandy Millin
http://sandymillin.wordpress.com/iateflwebinar2024
Published classroom materials form the basis of syllabuses, drive teacher professional development, and have a potentially huge influence on learners, teachers and education systems. All teachers also create their own materials, whether a few sentences on a blackboard, a highly-structured fully-realised online course, or anything in between. Despite this, the knowledge and skills needed to create effective language learning materials are rarely part of teacher training, and are mostly learnt by trial and error.
Knowledge and skills frameworks, generally called competency frameworks, for ELT teachers, trainers and managers have existed for a few years now. However, until I created one for my MA dissertation, there wasn’t one drawing together what we need to know and do to be able to effectively produce language learning materials.
This webinar will introduce you to my framework, highlighting the key competencies I identified from my research. It will also show how anybody involved in language teaching (any language, not just English!), teacher training, managing schools or developing language learning materials can benefit from using the framework.
2024.06.01 Introducing a competency framework for languag learning materials ...
P 141 pre-filled syringes america revised
1. BUSINESS BENEFITS FOR 2015:
• LISTEN to keynote addresses from the leaders in human
factors engineering with expert input on reaching
certain patient populations, considerations and
compliance in device design and how can we ensure
the drug product is administered safely and effectively
• LEARN about the critical issues surrounding safety
assessments of pre-filled syringes from extractables
and leachables to sterility and needle stick prevention
requirements – NEW FOR 2015
• ENHANCE your understanding of labelling and pricing
considerations with the competitive market for
biosimilars set to storm with patent expiries due
• ASSESS the future of pre-filled syringes with case study
led presentations addressing the challenges faced
with parenteral packaging innovations and reviewing
the strategies needed to overcome the hurdles with
importance insights into autoinjectors and pens
• ADDRESS the use of lyophilisation in pre-filled syringes,
is this the future vision?
SMi presents its 2nd annual conference and exhibition on...
PLUS TWO INTERACTIVE HALF-DAY POST-CONFERENCE WORKSHOPS
Wednesday 29th April 2015, Renaissance Woodbridge Hotel, Iselin, New Jersey, USA
27 - 28
APRIL
2015
Assessing the future of pre-filled syringes to improve innovation
and device development
Renaissance Woodbridge Hotel, Iselin, New Jersey, USA
Pre-Filled Syringes
America
www.pfsamericas.com
BOOK BY 27TH FEBRUARY AND SAVE $100
Register online or call +448709090711 to speak to an account executive
"Excellent, informative and good quality"
Delegate 2014
Advanced Delivery Systems to Enable
Personalised Medicines
Workshop Leaders: Ravi S. Harapanhalli, Vice President, ParExel and
Mr. Sall, Principal Consultant, ParExel
8.30am – 12.30pm
Will Drug Delivery in Coming Days be an Integral Part of DDM?
- Diagnose, Deliver and Monitor
Workshop Leaders: Chanderkanth Gautham, Domain Lead of Medical Device Team,
Beroe Inc. and Saikrishna Garrepalli, Procurement Management Representative,
Beroe Inc.
1.30pm – 5.30pm
CHAIRS FOR 2015:
Ravi Harapanhalli,
Vice President,
ParExel
William Beierschmitt,
Research Fellow, Drug Safety Research
and Development,
Pfizer Inc.
KEY SPEAKERS FOR 2015:
• Natalia Mazaeva, Usability Leader, Sanofi
• Stephen Barat, Executive Director, Forest Laboratories,
a subsidiary of Actavis
• Ed Israelski, Director of Human Factors, AbbVie
• Scott Brown, Device Development Lead, Merck
• Li-Chun Tsou, Global Device Technical Director,
AstraZeneca Pharmaceuticals
• Kiran Singh, Associate Director, Sandoz
• Michel Mikhail, Former Chief Regulatory Officer,
Executive Vice President, Global Regulatory -
Governmental Relations, Fresenius Kabi NV/SA
• Mark Tsai, Principal Engineer, Drug Delivery, Janssen
Pharmaceuticals
Plus many more...
BOOK BY
27TH FEBRUARY
AND SAVE $100
@SMIPHARM
#USAPFSSMI
Sponsored by
2. Pharmaceutical industry’s perspectives:
• Drug stability (minimize drug-syringe interactions by
mitigating leachables and extractables, flakes (lamellae)
or deposits, glass fragments, and lubricant particles)
• Syringe durability
• Cost
Manufacturer’s perspectives:
• Simplified manufacturing/assembly processes to mitigate
batch variances
• Consider stringent sterilization and packaging processes
• Compliance of the mandatory "safety" PFS
Healthcare industry’s perspectives:
• Avoid needlestick injuries
• User-friendly
• Eco-friendly (minimum residual of medicine,
recyclable device material)
Patient's perspectives:
• User-friendly (convenience and safety in preparation
and self-administration)
• Eco-friendly (minimum residual of medicine,
recyclable device material)
• Price-friendly
Pre-Filled Syringes America
Day One | Monday 27th April 2015
8.30 Registration & Coffee
9.00 Chair’s Opening Remarks
William Beierschmitt, Research Fellow, Drug Safety Research and
Development, Pfizer Inc.
HUMAN FACTOR STUDIES
OPENING ADDRESS
9.10 The importance of the patient and how each individual differs
• Reviewing the patient populations and the needs of certain
individuals in device design
• How can we enhance products to ensure they’re
specifically designed for the patient’s needs?
• Evaluating the best outcome for the patients, what
factors should be considered
Ed Israelski, Director of Human Factors, AbbVie
9.50 Success Criteria – How can the FDA’s requirements be met?
• Demonstrating safety and effectiveness in the hands of the user
• Reviewing the design requirements for validation purposes
• Are the customer requirements being met in design transfer?
• Post –market surveillance – What observations can
be made?
Natalia Mazaeva, Sr. Usability Leader, Global Usability
and Risk Management, Device Development, Sanofi
CASE STUDY
10.30 End user needs and perspectives for device assembly
End User Needs and Perspectives are critical for final device delivery.
This presentation will address the injectable device trends and flexibility
required for an assembly machine to adapt to new market challenges
while incorporating the ‘Human Factor’. This presentation will also focus
on recent Regulatory updates (11608) for Combination Products
The lecture will show:
• Injectable Device Trends
• Human Factor - Increased focus on safety, usability and handling studies
• Flexible standardized platforms to handle customized
assembly of pens and auto-injectors
• Gentle handling of the filled glass container during
assembly of the device using proven liquid fill finish
handling technology
Dena Flamm, Product Manager, Robert Bosch GmbH
11.10 Morning Coffee
KEYNOTE ADDRESS
11.40 Convenience and compliance: empower the user
through good design
• Reducing concerns by the end user is critical, what steps can be
taken to increase patient satisfaction?
• Precision and safety go hand in hand, let’s address considerations
to ensure the product designed is safe and effective
• How do we ensure the patient receives the exact
dose intended?
Ben Bartfeld, Human Factors and Industrial Design
Consultant, Otsuka Consultant Pharmaceutical Companies
12.20 What makes a pre-filled syringes ergonomic?
• Addressing the importance of human factor studies
in device development
• Assessing the possibilities to ensure the drug product
is administered safely and effectively
• Working with clients concentrating on the design
based strategies
Saikrishna Garrepalli, Procurement Management
Representative, Beroe Inc.
1.00 The New Frontier: Advancing the quality and functionality
of drug delivery
Paul Chao, Core Team Leader, R&D Staff Engineer and
Justin Wright, Senior Director, Strategic Innovation,
BD Medical - Pharmaceutical Systems
1.40 BREAKOUT SESSION & OPPORTUNTY TO NETWORK PRE-LUNCH
• Are we seeing a growing trend in drug delivery being administered
outside traditional medical settings?
• How can we ensure this is safe?
Host: William Beierschmitt, Research Fellow, Drug Safety
Research and Development, Pfizer Inc.
2.00 Networking Lunch
CRITICAL ISSUES: SAFETY ASSESSMENT
3.00 Safety Evaluation of Leachables for Pre-Filled Syringe Drug Products
• Background on leachables and pre-filled syringes
• Why safety assessment for leachables is necessary
• How to approach and conduct a leachable safety
evaluation
• Current best practice recommendations and
examples
Stephen Barat, Executive Director, Forest Laboratories,
a subsidiary of Actavis
3.40 The Risk Assessment of Extractables - A Toxicological Window of
Opportunity
• Ensuring compatibility of the profile of the pre-filled
syringe with the biologic
• Avoiding changes in product quality
• Material selection and final assessment of leachables
William Beierschmitt, Research Fellow, Drug Safety
Research and Development, Pfizer Inc.
4.20 Innovating for safety: Let's be sharp to protect end-users with safe
injectable devices
• Needle stick injuries concerns and regulations
• Syringes breakage concerns:
- plastic as a glass alternative?
- injection devices to reduce stress on glass prefilled syringes
• Examples from prefilled syringes safety devices,
implanters and auto-injectors
• Balance value propositions for the patients and the
pharmaceutical perspective
Isabelle Delcroix, Business Development Director, Nemera
5.00 Afternoon Tea
5.30 CASE STUDY
Identifying incompatibility causes and challenges
• Assessing drug delivery studies and reflecting on the
impact
of incompatibility
• Assessing the specific fit of LAV valves and specific
issues surrounding prefilled syringe design
Kiran Singh, Associate Director, Sandoz GmbH
6.10 Assessing the safety of needle devices
• Looking at the global demand of safety needle
devices
• What necessary steps should be taken to ensure
a successful safety pre-filled syringe
• Creative design of safety pre-filled syringes
Pei-Yang Phillip Hsu, Chief Executive Officer, SaferMed
Technologies Co. Ltd.
6.50 ROUND TABLE DISCUSSION AND NETWORKING OPPORTUNITY
• Discussing the safety challenges surrounding pre-filled
syringes
Host: Pei-Yang Phillip Hsu, Chief Executive Officer,
SaferMed Technologies Co. Ltd
7.20 Chair's Closing Remarks and Close of Day One
NEW FOR
2015!
NEW FOR
2015!
Register online at: www.pfsamericas.com • Alternatively fax yo
3. Pre-Filled Syringes America
Day Two | Tuesday 28th April 2015
8.30 Registration & Coffee
9.00 Chair’s Opening Remarks
Ravi S. Harapanhalli, Vice President, ParExel
ENHANCING DEVICE DEVELOPMENT
OPENING ADDRESS
9.10 Getting to market: Regulatory perspective
• Defining a pre-filled syringe as a product or device
and its impact on regulatory approval
• Insight into the FDA’s current thoughts
Ravi S. Harapanhalli, Vice President, ParExel,
former FDA Senior Executive
9.50 Biosimilars and Delivery Devices…here we go!
• Patent expiries for biologics are creating a new
competitive market for biosimilars in particular
Monoclonal antibodies
• How to differentiate from the innovator with a device
• Factors to Review: e.g. Interchangeability studies
Michel Mikhail, Former Chief Regulatory Officer,
Executive Vice President, Global Regulatory
- Governmental Relations, Fresenius Kabi NV/SA
10.30 Room Temperature Sterilization of Pre-Filled Syringes
• The need for sterilization of prefilled syringes to be administered in
the sterile field
• Sterilization using Nitrogen Dioxide for temperature
sensitive products
• Regulatory pathways for nitrogen dioxide sterilization
Evan Goulet, Director, Sterilization Operations, Noxilizer, Inc.
11.00 Morning Coffee
CASE STUDY
11.30 The partnership reviewed between a pharmaceutical company and
the manufacturer/supplier
• Overview of the relationship and how it was managed
•An explanation on why the products have been developed
Shun Ogawa, Research Manager, Mitsubishi Gas
Chemical Company, Inc.
12.10 Combination Product Considerations- Starting with the End in Mind
• Evolving trends for the pre-filled syringe and self-injection markets
• Industry/Supplier partnership is key to successful development
outcomes
• Patient considerations and building strong product brands through
innovation
Royce Brockett, Senior Product Manager, West Pharmaceutical
Services, Inc.
ROUND TABLE DISCUSSION
12.50 The partnership reviewed between a pharmaceutical
company and the manufacturer/supplier
• Choosing a partner: What are the decision criteria?
• Who owns what: Equipment, IP, regulatory
requirements?
• Managing the partnership
Scott Brown, Executive Director/ Device Development
Lead, Merck Research Laboratories
1.20 Networking Lunch
KEYNOTE ADDRESS
2.20 Parenteral Device Strategy for Patient-Centric
Therapeutics
• Advantages and Constraints of Pre-filled Syringes
in Designing Cutting Edge Devices
• Global Design Control Process in Meeting Country
Specific Regulatory Expectations
• Concurrent Engineering Commercialization Model
in Achieving Successful New Product Launch
Li-Chun Tsou, Global Device Technical Director,
AstraZeneca Pharmaceuticals
3.00 Product Line Management, sustaining activities
• Engineering change plan
• Product enhancement, material change, CAPA
• Post market risk management
• Design control, sustaining activities
Mark Tsai, Principal Engineer, Cell Therapy, Janssen R&D
3.40 BREAKOUT SESSION & OPPORTUNTY TO NETWORK
• Glass v Plastic
• The advantages and disadvantages
• Is once still more favourable, if so why? Discuss
Host: Ravi Harapanhalli, Vice President, ParExel
4.20 Afternoon Tea
CASE STUDY
4.50 Process Development studies to optimize process
parameters and finalize presentation format
Case studies included:
• Development study to evaluate hold times on the
filing line
• Stopper movement studies to evaluate effect of
headspace
Aarti Gidh, Senior Scientific Investigator,
GlaxoSmithKline
5.30 Electronics and Mobile Apps role in drug delivery
and dosage adherence
• How electronics and mobile apps in device development are
going to affect dosage areas in the medical device space
• Some of major development in patch front which has circuitry
embedment and other innovative add on
• Increasing penetration of electronics in drug delivery
• Vision of leading device manufacturers and their take on
electronics future
• Role of mobile apps in complimenting the growth of
electronics in device arena
Chanderkanth Gautam, Domain Lead and Medical
Device Community Leader, Beroe Inc.
6.10 Chairman’s Closing Remarks and Close of Day Two
Official Platinum
Media Partner
NEW FOR
2015!
NEW FOR
2015!
NEW FOR
2015!
Supported by
ur registration to +44 (0)870 9090 712 or call +44 (0)870 9090 711
PHARMA
• What worked
(Existing Actions)
Pharma companies
sometimes use mono-layer
plastic containers to prevent
the below problems, but all
of them don’t have enough
oxygen barrier.
• What could’ve been
improved?
(Existing Problems for Glass
Container
- Breakage
- Heavy Weight
- Difficulty of disposal
- Protein Adsorption
- Inorganic Extractable, etc.
• Moving forward, what would
you have done differently?
(Future actions)
Some antioxidizing agent
might be used for injectable
drugs.
SUPPLIER
• What worked
(Existing solutions by suppliers)
Some supplies provide mono-
layer plastic containers
instead of glass, but all of
them don’t have enough
oxygen barrier.
• What could’ve been
improved?
- Oxygen Barrier
• Moving forward, what would
you have done differently?
(Our solutions)
- We developed an oxygen
absorbing polymer.
- We also developed 3 layers-
containers
- The oxygen absorbing
polymer is used for
the middle layer
- COP which is well-
known as a high
moisture
4. HALF-DAY POST CONFERENCE WORKSHOP AM
Wednesday 29th April 2015 | 8.30am – 12.30pm | Renaissance Woodbridge Hotel, Iselin, New Jersey, USA
Advanced Delivery Systems to Enable Personalised Medicines
Workshop Leaders: Ravi S. Harapanhalli, Vice President, ParExel and
Mr. Sall, Principal Consultant, ParExel
Workshop overview:
Run by one of the US’s leading figures in regulatory approval processes
and drug delivery systems, Dr. Ravi Harapanhalli. This industry leading
workshop will help you plan for smooth regulatory approvals and help with
avoiding pitfalls that can cause expensive delays in taking your product to
market.
Who should attend this workshop:
R&D Scientists, Regulatory Affairs, Device specialists, Formulators,
Business Development Staff
HALF-DAY POST CONFERENCE WORKSHOP PM
Wednesday 29th April 2015 | 1.30pm – 5.30pm | Renaissance Woodbridge Hotel, Iselin, New Jersey, USA
Will Drug Delivery in Coming Days be an Integral Part of DDM?
- Diagnose, Deliver and Monitor
Workshop Leaders: Chanderkanth Gautham, Domain Lead of Medical Device Team, Beroe Inc. and
Saikrishna Garrepalli, Procurement Management Representative, Beroe Inc.
Overview of workshop:
Drug delivery device market would no longer exist as standalone entity. As
healthcare longs to address all the solution through single gateway,
technologies such electronic bandage, artificial pancreas pave their way
into the market. They provide a holistic solution by diagnostic, delivering and
monitoring. This is likely to be future of healthcare.
Why you should attend this workshop:
• To understand the platform that will be face of healthcare in coming days.
• To understand how fast are new technologies are advancing in the space of
Medtech,andhowconsiderablethesedeviceswereinaddressingthegapthe
currently prevails will be the focus of the workshop.
About the workshop hosts:
Chanderkanth Gautham A Medical Device Procurement
Management Representative (Sr. Research Analyst) with
experiences in R&D, Human Factors, Contract Research Services
facilitating Medical Devices, Pharmaceutical, Cosmetics and
Herbal Companies with Product development, Regulatory and
Post Marketing (Medical Affairs) and Business Development
support activities across global regions.
Saikrishna Garrepalli Procurement Management Representative
(Sr. Research Analyst) of leading medical device companies, Sai
has experience in R&D, Human Factors, Contract Research
Services and regulatory pathways. Currently he is analyst at
Medical device team at Beroe handles various client initiatives
such as supplier relationship, negotiations and others.
About Beroe Inc.
Beroe is procurement pioneer which addresses USD 15 Billion+ spend of its
clients globally. It carefully monitors the market for any sort of trend at
supplier or buyers end. And is very instrumental in benchmarking markets
and supplier capabilities across various facets of value chain ranging from
design to manufacturing. beroeinc.com
Programme
8.30 Registration & Coffee
9.00 Introductions and Opening Remarks
9.45 Session 1: Quality-by-Design in the development
of drug delivery systems
10.30 Session 2: Regulatory pitfalls to avoid
11.00 Coffee break
11.30 Session 3: New combination product regulations
and how to comply with them
12.00 Session 4: How to accelerate approval through FDA
12.30 End of Workshop
Why you should attend this workshop:
• Accelerate the time it takes to
take your drug delivery system to
market
• Find out how to navigate new
combination product guidelines
• Assess the right time to start thinking
about your drug delivery
mechanism
• Develop a strategy for product life
cycle management by switching
over to PFS
• Understand how to apply the FDA
Quality SystemRegulation to
delivery device development
• Know how to apply FDA Design
Controls to delivery device
development
• Get to appreciate how to selection
of a delivery device development
partner
• Perform risk analysis and Human
Factors assessment
About the workshop host:
Dr. Ravi Harapanhalli advises bio/pharmaceutical companies on
CMC regulatory strategies and Quality-by-Design approaches to
medicinal product development and flexible regulatory
approaches.
About the workshop co-leader:
Mr. Sall is a Principal Consultant with PAREXEL Consulting in
Waltham, MA. PAREXEL provides clinical trial, clinical data
management, medical and regulatory services to the
pharmaceutical and medical device industries.
About ParExel:
Over the past 30 years, ParExel has developed significant expertise to
assist clients in the worldwide pharmaceutical, biotechnology and
medical device industries with the development and launch of their
products in order to bring safe and effective treatments to the global
marketplace for the patients who need them. Headquartered near
Boston, Massachusetts, ParExel operates over 77 locations throughout
more than 51 countries around the world, and has over 14,400
employees. www.parexel.com
Programme
1.30 Registration and Coffee
2.00 Will drug delivery in coming days be integral part of DDM
<diagnose, deliver and monitor>
Areas Covered
• Introduction on these developments
• Some case studies indicating the inception of the trend
• Will developments in non-invasive sensor based
technologies and automatic modes of delivery increase
inclination of patients and physicians to home care
technologies.
• Do acquisition of monitoring device companies by
Medtech giants’ indicate bigger role of DDM platforms
in future?
3.30 Coffee Break
4.00 Will artificial pancreas penetration in market pave way for
non-conventional diabetic therapy?
Areas to be covered
• Will the aforementioned platform challenge the
conventional, glucose measurement and injection
therapy to a significant amount?
• Does this mean that conventional modes insulin delivery
via auto injectors, pen injectors now needs a massive
scale up technology wise?
• Who are those technology pioneers that need special
mention on their recent developments in same space?
5.30 End of Workshop
5. SPONSORED BY:
SPONSORSHIP AND EXHIBITION OPPORTUNITIES
SMi offer sponsorship, exhibition, advertising and branding packages, uniquely
tailored to complement your company’s marketing strategy. Prime networking
opportunities exist to entertain, enhance and expand your client base within the
context of an independent discussion specific to your industry.
Should you wish to join the increasing number of companies benefiting from
sponsoring our conferences please call: Alia Malick on +44 (0) 20 7827 6168 or
email: amalick@smi-online.co.uk
Pre-Filled Syringes Americas
BD Medical – Pharmaceutical Systems provides high-quality, customized, clinically-proven drug delivery systems
to help pharmaceutical and biotechnology customers’ injectable drugs reach their full potential. BD offers a
range of products, including glass and plastic prefillable syringes and a variety of systems for the self-
administration of injectables. With a broad range of innovative systems and services, BD provides
pharmaceutical companies with support and resources to help them achieve their goals. www.bd.com
Bosch Packaging Technology is the world leader in the design and manufacture of pharmaceutical processing
and packaging systems. Bosch offers a range of syringe filling systems in both nested and bulk styles of systems.
Bosch also now offers syringe pen assembly systems and single use dosing systems with scalable solutions. With
Bosch one supplier solutions are a real possibility. www.boschpackaging.com
Ginolis provides automation solutions for manufacturing, laboratories and end-user instruments for medtech,
pharmaceutical and diagnostic companies. Ginolis also develops customer-specific disposable platform
solutions for high-volume applications. The company is privately owned and headquartered in Oulu, Finland,
with a subsidiary in Uppsala, Sweden and a sales and service site in San Diego, California.
http://ginolis.com/company-introduction
Mitsubishi Gas Chemical (MGC) is well-known as an expert in unique polymers and oxygen absorbers. Based on
our experience and expertise, MGC has successfully developed multilayer plastic vial and syringe with oxygen
absorbing function. MGC believes they will be an only solution to replace glass with plastic. www.mgc.co.jp/eng
Nemera is one of the world leaders in the design, development and manufacturing of drug delivery solutions. Its
expertise covers all five modes of delivery: parenteral (injectors, pens, safety devices) and also ophthalmic
(preservative free droppers), nasal, buccal, auricular (sprays pumps, etc.), pulmonary (inhalers), dermal and
transdermal (dispensers). Nemera provides solutions for the pharmaceutical industry, including standard
innovative products such as passive safety device for prefilled syringes Safe’n’Sound®, development of custom
devices and contract manufacturing. www.nemera.net
Noxilizer, Inc. provides a proprietary room temperature nitrogen dioxide sterilization technology that offers many
benefits over traditional methods. NO2 sterilization has shorter cycles (approximately 2 hours including aeration),
operates with/without vacuum and is easily installed—an ideal solution for prefilled syringes and drug-device
combination products. Noxilizer provides contract sterilization services and sells sterilization equipment. Noxilizer
Inc. was founded in 2004 and has offices in the US, United Kingdom, and Japan. www.noxilizer.com
West works side by side with its healthcare partners from concept to the patient, designing and manufacturing
packaging, diagnostic and delivery systems that promote the efficiency, reliability and safety of their products.
Every day, West is leading the way with cutting-edge technologies and quality systems, a thorough
understanding of global regulatory compliance, and an unmatched and growing knowledge base of relevant
pharmaceutical product testing, development and packaging. Based in Exton, Pa., West supports its customers
from sales, manufacturing, customer support and research and development locations in North and South
America, Europe, Asia and Australia. www.westpharma.com
Want to know how you can
get involved?
Interested in promoting your
services to this market?
Contact Julia Rotar, SMi Marketing
on +44 (0) 207 827 6088, or email:
jrotar@smi-online.co.uk
WHO SHOULD ATTEND:
Those involved in the following:
• Pharma Development
• Engineering
• Manufacturing
Technology
• Biopharma Operations
• Regulatory Affairs
• Parenterals
• Packaging
• Formulation Aseptic
• Device Development
• Device Design
• Labelling
• Manufacturing
• Drug Delivery
• Formulation & Aseptic
Filling Technologies
• Chemistry Manufacture
Controls (CMC)
• Quality Assurance
• Safe Medication
Practice
11
2BREAKOUT SESSIONS
4CASE STUDIES
LEADING PHARMA
COMPANIES SPEAKING
2KEYNOTE ADDRESSES
100+ATTENDEES
2 ROUND TABLE
DISCUSSIONS
Attendee by Location
USA 71%
Europe 17%
India 5%
Canada 7%
KEY HIGHLIGHTS:
6. FAX your booking form to +44 (0) 870 9090 712
PHONE on +44 (0) 870 9090 711
POST your booking form to: Events Team, SMi Group Ltd, 2nd Floor
South, Harling House, 47-51 Great Suffolk Street, London, SE1 0BS, UK
PRE-FILLED SYRINGES AMERICA
Conference: Monday 27th & Tuesday 28th April 2015, Renaissance Woodbridge Hotel, Iselin, New Jersey, USA Workshops: Wednesday 29th April 2015, USA
4 WAYS TO REGISTER
www.pfsamericas.com
If you have any further queries please call the Events Team on tel +44 (0) 870 9090 711 or you can email events@smi-online.co.uk
Payment: If payment is not made at the time of booking, then an invoice will be issued and must be
paid immediately and prior to the start of the event. If payment has not been received then credit
card details will be requested and payment taken before entry to the event. Bookings within 7 days
ofeventrequirepaymentonbooking.AccesstotheDocumentPortalwillnotbegivenuntilpayment
has been received.
Substitutions/Name Changes: If you are unable to attend you may nominate, in writing, another
delegate to take your place at any time prior to the start of the event. Two or more delegates may
not ‘share’ a place at an event. Please make separate bookings for each delegate.
Cancellation: If you wish to cancel your attendance at an event and you are unable to send a
substitute, then we will refund/credit 50% of the due fee less a £50 administration charge, providing
that cancellation is made in writing and received at least 28 days prior to the start of the event.
Regretfully cancellation after this time cannot be accepted. We will however provide the
conferences documentation via the Document Portal to any delegate who has paid but is unable
to attend for any reason. Due to the interactive nature of the Briefings we are not normally able to
provide documentation in these circumstances. We cannot accept cancellations of orders placed
for Documentation or the Document Portal as these are reproduced specifically to order. If we have
to cancel the event for any reason, then we will make a full refund immediately, but disclaim any
further liability.
Alterations: It may become necessary for us to make alterations to the content, speakers, timing,
venue or date of the event compared to the advertised programme.
Data Protection: The SMi Group gathers personal data in accordance with the UK Data Protection
Act 1998 and we may use this to contact you by telephone, fax, post or email to tell you about other
products and services. Unless you tick here □we may also share your data with third parties offering
complementary products or services. If you have any queries or want to update any of the data that
we hold then please contact our Database Manager databasemanager@smi-online.co.uk or visit
our website www.smi-online.co.uk/updates quoting the URN as detailed above your address on the
attached letter.
Unique Reference Number
Our Reference LVP-141
Terms and Conditions of Booking
DELEGATE DETAILS
Please complete fully and clearly in capital letters. Please photocopy for additional delegates.
Title: Forename:
Surname:
Job Title:
Department/Division:
Company/Organisation:
Email:
Company VAT Number:
Address:
Town/City:
Post/Zip Code: Country:
Direct Tel: Direct Fax:
Mobile:
Switchboard:
Signature: Date:
I agree to be bound by SMi's Terms and Conditions of Booking.
ACCOUNTS DEPT
Title: Forename:
Surname:
Email:
Address (if different from above):
Town/City:
Post/Zip Code: Country:
Direct Tel: Direct Fax:
VENUE Renaissance Woodbridge Hotel, Iselin, New Jersey, USA
□ Please contact me to book my hotel
Alternatively call us on +44 (0) 870 9090 711,
email: hotels@smi-online.co.uk or fax +44 (0) 870 9090 712
EARLY BIRD
DISCOUNT
Payment must be made to SMi Group Ltd, and received before the event, by one of
the following methods quoting reference P-141 and the delegate’s name. Bookings
made within 7 days of the event require payment on booking, methods of payment
are below. Please indicate method of payment:
A/C Name SMI GROUP LTD Sort Code 300009,
Account Number 11775391 CCY USD
□ Wire Transfer Lloyds TSB Bank plc, 39 Threadneedle Street, London, EC2R 8AU
IBAN GB75LOYD30000911775391
BIC LOYDGB21013
□ Cheque We can only accept cheques in US Dollars.
□ Credit Card □ Visa □ MasterCard □ American Express
All credit card payments will be subject to standard credit card charges.
Card No: □□□□ □□□□ □□□□ □□□□
Valid From □□/□□ Expiry Date □□/□□
CVV Number □□□□ 3 digit security on reverse of card, 4 digits for AMEX card
Cardholder’s Name:
Signature: Date:
I agree to be bound by SMi's Terms and Conditions of Booking.
Card Billing Address (If different from above):
DOCUMENTATION
I cannot attend but would like to purchase access to the following Document
Portal/paper copy documentation Price Total
□ Access to the conference documentation
on the Document Portal £499.00 + VAT £598.80
□ The Conference Presentations – paper copy £499.00 - £499.00
(or only £300 if ordered with the Document Portal)
PAYMENT
VAT
VAT at 20% is charged on Document Portal and literature distribution for all UK customers and
for those EU Customers not supplying a registration number for their own country here.
______________________________________________________________________________________________
CONFERENCE PRICES
I would like to attend: (Please tick as appropriate) Fee
□ Conference & 2 Workshops $2997.00
□ Conference & 1 Workshop AM □ PM □ $2398.00
□ Conference only $1799.00
□ 2 Workshops only $1198.00
□ 1 Workshop only AM □ PM □ $599.00
PROMOTIONAL LITERATURE DISTRIBUTION
□ Distribution of your company’s promotional
literature to all conference attendees £999.00 + VAT £1198.80
The conference fee includes refreshments, lunch, conference papers, and access to the
Document Portal. Presentations that are available for download will be subject to
distribution rights by speakers. Please note that some presentations may not be available
for download. Access information for the document portal will be sent to the e-mail
address provided during registration. Details are sent within 24 hours post conference.
□ Book by 27th February 2015 to receive $100 off the conference price