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Healthcare Professionals and Social MediaExL Pharma
Presentation delivered by Within 3 at the Digital Pharma West Conference, June 28-29th, Parc 55 Hotel in San Francisco. For additional information, please visit www.exlpharma.com/digitalpharma
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The document summarizes the 2010 vintage experience at Matariki Wines Ltd. It discusses the location of the winery and vineyards. It notes that grapes are processed from up to 15 growers, totaling just under 900 tons of fruit for the vintage. The winery has tanks from 21,000L to 2,000L and open top fermenters from 5,000L to 1,000L. The vintage began with the first fruit arriving - Pinot Gris from Auckland. Red cap management and pumpovers were a major part of the work. Bottling and a beard growing competition concluded the vintage.
This document discusses how to automate business processes in SharePoint using workflows. It introduces Nintex Workflow as a tool for automating workflows through a drag-and-drop interface without coding. The document outlines how Nintex can model existing workflows, avoid repetitive tasks, and allow fewer people to do more work. It then compares Nintex to other workflow tools like SharePoint Designer, Visio, and Visual Studio. Finally, it provides a case study of a company that saw benefits like end-user control, process visibility, and integration with SharePoint by implementing reusable Nintex workflows.
This document warns of various dangers one may encounter when walking through the park, including sticks, glass, ponds, falling down, ducks, mud, bike riders, rivers, prickles, puddles, broken tiles, boogie monsters, getting lost, and the importance of sticking together for safety.
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Presentation delivered by Within 3 at the Digital Pharma West Conference, June 28-29th, Parc 55 Hotel in San Francisco. For additional information, please visit www.exlpharma.com/digitalpharma
Matariki Winery experience - Richard BottRichardBott
The document summarizes the 2010 vintage experience at Matariki Wines Ltd. It discusses the location of the winery and vineyards. It notes that grapes are processed from up to 15 growers, totaling just under 900 tons of fruit for the vintage. The winery has tanks from 21,000L to 2,000L and open top fermenters from 5,000L to 1,000L. The vintage began with the first fruit arriving - Pinot Gris from Auckland. Red cap management and pumpovers were a major part of the work. Bottling and a beard growing competition concluded the vintage.
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The document summarizes key topics from the 2nd Digital Pharma Europe conference in 2010. It discusses the growing influence of social media and digital technologies on the pharmaceutical industry, including how patients use online health information and social networks. It also outlines different approaches companies can take to engage with social media, from monitoring to direct participation, as well as challenges in using new digital tools for areas like market research.
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To scan documents for a portfolio:
- Make sure the scanner is connected and turned on. Prepare materials by removing staples and flattening pages. Create a portfolio folder on your computer.
- Be careful when scanning multiple pages since they will scan in reverse order. The last page should be at the bottom of the pile.
- Orient pages by holding from the top left corner and rotating 180 degrees. This orients it correctly for scanning.
- After scanning, check the orientation is correct before saving the file with a descriptive name in your portfolio folder.
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2011 Hyundai Equus For Sale at Keffer Hyundai in Charlotte, North CarolinaCourtney Boone
The 2011 Hyundai Equus is a fabulous luxury Hyundai model with a ton of premium features. The Hyundai Equus has an incredibly sleek look with premium wood trim, leather seats, driver's chair massage, heating, cooling and humidity control. Not to mention the engine in the Equus. Interested in taking this beauty for a spin? Come into Keffer Hyundai in North Carolina today! (http://kefferhyundai.com/inventory/view/Model/Equus/New/Records0/SortBy0/)
9010 E.Independence Blvd
Matthews NC 28105
800-670-1923
Presentation: eSubmissions in Australia - Part 1TGA Australia
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Highlights from ExL Pharma's 2nd Digital Pharma EuropeExL Pharma
The document summarizes key topics from the 2nd Digital Pharma Europe conference in 2010. It discusses the growing influence of social media and digital technologies on the pharmaceutical industry, including how patients use online health information and social networks. It also outlines different approaches companies can take to engage with social media, from monitoring to direct participation, as well as challenges in using new digital tools for areas like market research.
This document outlines an agenda for a communication skills workshop. It includes a review of a drawing activity, notes on communication barriers, a short video, and an impromptu practice activity. The document discusses two types of barriers to communication: internal barriers like fatigue and emotions, and external barriers such as noise and environment. Participants are asked to take notes during a video presentation.
The document discusses 3 case studies of companies using SL Corporation's RTView Enterprise Monitor to solve challenges monitoring TIBCO applications across 3 industries. A retail company used it to monitor TIBCO applications across 4,000 stores. A transportation company used it to monitor heterogeneous applications including TIBCO. An insurance company used it to monitor shared TIBCO services. RTView provided centralized monitoring and alerting for TIBCO applications.
To scan documents for a portfolio:
- Make sure the scanner is connected and turned on. Prepare materials by removing staples and flattening pages. Create a portfolio folder on your computer.
- Be careful when scanning multiple pages since they will scan in reverse order. The last page should be at the bottom of the pile.
- Orient pages by holding from the top left corner and rotating 180 degrees. This orients it correctly for scanning.
- After scanning, check the orientation is correct before saving the file with a descriptive name in your portfolio folder.
Real-Time Coherence Monitoring in Integrated EnvironmentsSL Corporation
In this presentation, Everett Williams, SL’s Oracle Coherence Expert, discusses problems with analyzing host metrics and Oracle Coherence metrics within a cluster using the current tool sets. He also discusses how to integrate statistics to solve problems that relate between the two in an integrated and intelligent manner. Users of SL’s Oracle Coherence Monitor can address these issues and understand if their Coherence issues are related to issues within the underlying hardware, or whether they reside somewhere else.
2011 Hyundai Equus For Sale at Keffer Hyundai in Charlotte, North CarolinaCourtney Boone
The 2011 Hyundai Equus is a fabulous luxury Hyundai model with a ton of premium features. The Hyundai Equus has an incredibly sleek look with premium wood trim, leather seats, driver's chair massage, heating, cooling and humidity control. Not to mention the engine in the Equus. Interested in taking this beauty for a spin? Come into Keffer Hyundai in North Carolina today! (http://kefferhyundai.com/inventory/view/Model/Equus/New/Records0/SortBy0/)
9010 E.Independence Blvd
Matthews NC 28105
800-670-1923
Presentation: eSubmissions in Australia - Part 1TGA Australia
The document discusses eSubmissions in Australia and the transition to electronic common technical document (eCTD) format. It provides an overview of the past activities, current activities and next steps in implementing eCTD capability at the Therapeutic Goods Administration (TGA). It also summarizes the eCTD pilot phase, current business protocol for submitting eCTDs, and general advice for eCTD submissions.
This document summarizes proposals to improve the classification system for shellfish harvesting areas in England and Wales. Some short-term proposals could be implemented within a year, such as using sampling data from harvesters and allowing a blanket C classification for product undergoing heat treatment. Medium-term proposals over the next few years include developing a new approach for dealing with high sample results and reviewing sampling schedules. Long-term proposals requiring further research are using indicator species to classify whole production areas and enabling active management of shellfish beds. The overall goal is to develop a more risk-based, flexible and resource-efficient classification system.
The document discusses common conflicts and pains that can lead to delays in the drug registration process from a commercial point of view. It identifies several key challenges, including lacking a project plan, regulatory intelligence, and issues with CMC data for both drug substances and drug products. Specific problems are outlined, such as invalid certificates, missing documentation, and inconsistencies between dossier sections. Recommendations are provided on how to address these challenges to minimize timelines and cut costs in the registration process.
The document outlines a presentation discussing Medica clinic's current paper-based medical records system and issues with it. It then details requirements for a new, computerized solution including secure storage of patient information, appointment scheduling, and reporting. Two potential solutions are examined: an off-the-shelf system or custom system. A custom system is ultimately chosen to fully meet Medica's needs, provide local support, and allow for future expansion.
This document discusses managing the extended research and development (R&D) supply chain for clinical trials. It presents challenges at different stages of the supply chain from active pharmaceutical ingredient (API) manufacturing through investigational medicinal product (IMP) delivery. Key challenges include forecasting and planning given variable patient enrollment, ensuring visibility and integration across outsourced manufacturing steps, translating complex packaging needs from protocols, and managing drug distribution globally. The article presents different models for R&D supply chains, including fully outsourcing the physical chain or adopting a more patient-oriented model.
This document provides guidance for the storage and transport of pharmaceutical products that require temperature control. It outlines requirements for port handling, customs clearance, warehouse site selection and layout, storage building construction, temperature control during storage and transport, calibration of monitoring devices, transport qualifications, and quality management procedures. The goal is to minimize risks to these temperature-sensitive drugs from factors like theft, temperature excursions, improper storage or transport conditions.
Intelligent Clinical Supply Forecasting and Simulations through IRT-March02-2...Praveen Chand
This document discusses using intelligent clinical supply forecasting and simulations through an interactive response technology (IRT) system. It highlights trends and challenges in clinical trials that increase pressure on sponsors and CROs. Simulation and forecasting tools that integrate with an IRT system can help optimize drug supply planning, reduce costs from overages, and improve efficiency. Real-time data from the IRT on enrollments, visits, and inventory levels allows frequent reforecasting to reduce supply chain risks and costs. The presentation provides an overview of how analytics and simulations using IRT data can help various stakeholders with challenges around forecasting demand, optimizing distribution, and efficient planning of drug supplies.
SPLC 2019 Summit: Purchasing for Zero Waste: 3 Case Studies from Higher Educa...SPLCouncil
Slides from Sapna Thottathil, Associate Director of Sustainability, Office of the President, University of California, Office of the President, presented at the Sustainable Purchasing Leadership Council’s 2019 Summit in Portland, OR.
Michael Cea ISSCR 2015 Stem Cell Research Guideline Review Commentsms emporda
Michael Cea, an analyst/advocate, submitted comments on the ISSCR 2015 Draft Guidelines for Stem Cell Science and Clinical Translation. Some of his general comments included: (1) suggesting consolidating the informed consent sections for research and therapeutic use; (2) balancing language between deriving knowledge and prudent research; (3) providing an interactive online/offline version of the final draft. Cea also provided over 30 specific comments and recommendations, primarily addressing informed consent processes, definitions, clinical trial guidelines, and communication standards.
Electronic compliance monitoring (ECM) uses technology embedded in packaging to record patient dosing history electronically. ECM provides more accurate dosing data than patient self-reports. ECM data can help determine who is a non-responder versus a non-complier, and better assess effective and maximum tolerated doses. Planning for ECM should start early to allow for additional logistical and regulatory steps. Major ECM solution providers include Aardex, IMC, MWV, and Stora Enso.
Key Considerations in Stability Studies for BiopharmaceuticalsSGS
Conducting stability studies in accordance with regulatory requirements requires technical expertise, established infrastructure and compliant facilities. There are multiple contractors available to offer these services and often the selection of a lead contractor is based on top level quotes and business development feedback. However, based on such selection strategies, once the studies are established at a contract site, additional factors may arise that further impact the overall costs and timelines for your project. These include hidden costs due to factors such as data mining, trending and investigations required during an established study.
Factors that affect timelines include flexibility required to ensure relevant data is available as required for key submission dates. If this is not the case, this will result in reduced shelf life assignment and may have a direct impact on product development timeline.
This talk will look at key points to consider in the selection process and provide tools to aid in selection of a lead contractor.
Inventing, developing and commercialising targeted small-molecule drugs for p...Laura Berry
Mark Boys presented on Array BioPharma's experiences with collaborations and outsourcing from a small company perspective. Some key points:
- Array has utilized various collaboration structures, including research deals with options to license resulting drugs and partnering clinical assets.
- Successful collaborations involve mutual engagement in research, timely generation of candidates, and milestone payments.
- Array's collaboration with Genentech lasted over 10 years and resulted in development of multiple clinical candidates.
- A collaboration with Celgene produced clinical and preclinical candidates but Celgene did not exercise its license options.
- Array now looks for platform research deals and licenses late-stage assets, utilizing strategic outsourcing for its development activities.
IRIDA: Canada’s federated platform for genomic epidemiology, ABPHM 2015 WHsiaoIRIDA_community
This document summarizes the IRIDA platform, a federated genomic epidemiology platform for Canada. IRIDA aims to bridge gaps between advances in genomic epidemiology and real-time application in public health. It is developing solutions such as building a user-friendly analysis platform, implementing security and role-based sharing of genomic data, and using ontologies to standardize inconsistent information representation and address the complexity of genomic data interpretation. The IRIDA platform is in beta testing and plans continued development and training workshops.
IRIDA: Canada’s federated platform for genomic epidemiology William Hsiao
This document summarizes the IRIDA platform, a federated genomic epidemiology platform for Canada. IRIDA aims to (1) build a user-friendly analysis platform to process genomic data, (2) enable more efficient information sharing between public health agencies, and (3) standardize inconsistent information representation through the use of ontologies. The platform is a partnership between various public health and academic institutions to bridge gaps between genomic research and applications in public health outbreak investigations.
Premarket Notification The 510(k) ProcessMichael Swit
June 5, 2012 presentation to the Food & Drug Law Institute Introduction to Medical Device Law Conference, Palo Alto, CA, focusing on:
I.The Legal Framework For 510(k) Determinations
II.510(k) Preparation – From Planning to Content
A. Predicates: researching predicates, combination predicates, and pre-amendment predicates
B. Strategy: choosing the right claim and introducing new features
C. Assessing data requirements/pre-IDE meetings
III. Device Modifications - Choosing The Right Regulatory Mechanism
IV.The FDA Review
V.What To Do When Your Substantial Equivalence Argument Is Rejected
V. Special Topics: User Fees, Combination Products
VI. Lessons Learned: Seeing The 510(k) From The Reviewer’s Perspective
VII. Recent Trends, 510(k) Reform
VIII. Case Study
Blood collection system - Asia SourcingJohn William
Blood collection system Asia sourcing helps to identify the blood bag system suppliers in Asia before publishing the tender. Here you will get complete information on blood collection system. To know more visit: http://www.dragonsourcing.com/asia-sourcing/
End of Internship Presentation Slides (Geomatika University College)Darshini Perumalsivam
Overall, this internship was a useful experience. I have gained new knowledge, skills and met many new people. I achieved several of my learning goals, however for some the conditions did not permit.
Throughout my internship, I could understand more about the definition of Good Clinical Practice and the way of applying it in the Clinical Study as well as the importance of Drug Regulation. This provide me to prepare myself to become a responsible and an ambitious Clinical Research Associate (CRA) in the future. Along my training period, I realise that observation and time management is a main element in order to identify and to complete the study.
During the task assigned, I corporate with my colleagues to determine the problems. This indirectly helped me to learn independently, discipline myself, be considerate/ patient, self-trust, take initiative and ability to solve problems. Besides, my communication skill is strengthened as well when communicating with others. During training period, I have received advices from supervisors and colleagues when mistakes were made. Those advices are useful guidance for me to change myself and avoid myself making the same mistakes again.
In sum, the activities and tasks assigned that I have done as well as learned during my industrial training are really useful for me in future to face challenges in a working environment.
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24. Drop out rateNumber of Visits Another obvious core of demand; visit windows can impact the packaging amounts needed in a study Number of Centers Each center that needs an initial shipment adds to the forecasted demand Number of Countries Every country with a local distribution depot adds to the demand due to loss in flexibility in supplies 7
25. Drug / Packaging Properties Component Restrictions Humidity conditions Availability / Limited Distributors of components (e.g., foil envelopes, blister pack plastic) Cold Chain Out of temperature shipments; need to pack more Dosing Restrictions Limits in available strengths to make up the dose can also add to the forecast – use of multple unit kits 8
26. Efficient and Fit for Purpose To lessen the amount forecasted, when possible Simple packaging Multi-protocol packaging Multi-language booklet labels Avoid expiration dates on the labels Ease ‘switch-out’ when replacing expiring stocks Bar-coding Ease fulfilment (pick and pack) of orders The more flexible supplies are, the less overage is needed in the forecast 9
27.
28.
29.
30. Components used to handle a drug’s stability conditions (e.g., humidity) may not be capable of supporting the legal requirements (foil envelopes)12
41. What Does Pooling of Clinical Supplies Mean? Supplies that are primary packaged so that they can be used across multiple protocols Supplies that are primary packaged and labeled for multiple protocols and distributed for predetermined study Supplies that are primary packaged and labeled and distributed to allow for use across multiple protocols All of the Above
42. Pooling Definition All of the above – Pooling Definition- use of an allocated pool of supplies that are uniquely labeled such that they can be used across sites within a protocol and across protocols within a program.
43. Agenda What is Program Pooling Key Considerations in Executing an Effective Pooling Plan Uncovering what the Potential Cost Savings are to Clinical Supplies Working with Regulators to Ensure Complaint Pooling Activities Key Take Home Messages
45. What Does Pooling of Clinical Supplies Mean? Supplies that are primary packaged so that they can be used across multiple protocols Supplies that are primary packaged and labeled for multiple protocols and distributed for predetermined study Supplies that are primary packaged and labeled and distributed to allow for use across multiple protocols
46. Pooling until Shipment Subject 1001 Protocol A, Site 1 Shipment Dispensing Protocol 1252 Protocol 1253 Protocol 1254 Container is commutable until shipment Labeling Options Protocol ID added to label when shipping (via ancillary label) All Protocol IDs associated with the pool on label, specify protocol when shipping (via circle or highlight) Container is “married” to the protocol and site at Shipment, System must be designed to capture protocol specificity for container at shipping Re-supply algorithm is protocol-specific IVRS system is not needed Protocol: 1253
54. Re-supply algorithm considers needs of all protocols running at site in poolAdvantageous when same sites are running multiple protocols in the pool
55. Overview of Program Level Supplies A500 Pooled Supply A500_____________ (Program # on Label) Upon protocol approval IVR adds it to its list of “approved protocols for shipping studies” Study 1 Study n Study 2 Study 4 Study 5 Study 3 Site 1 Upon site approval IVR adds site to its list of “approved sites for dispensing” to the POOLED supplies Site 2 Site 3 Protocol number added manually to label at study sites AFTER IVR links container # and protocol # at the time of drug assignment Bottle Labels Labeled supplies ready to use in study
58. Investigator specifies Protocol, Subject and Visit and system selects suitable container (i.e., container ID is “married” to Protocol ID at dispensing)
59. Label can provide space to record or apply ancillary label with specific protocol ID upon dispensing, if deemed important
60.
61. Key Considerations Distribution / Labeling From which depot will the supplies for each country originate? What are the label requirements for each country? Are there additional unique labeling requirements?
62. Common Logistical Concerns Alignment of invoices with shipping documents and import license. Multiple investigators at a single site without central pharmacy Proper interpretation of shipping documentation Clinical supply reconciliation Contractors seeking verification of any dossier updates prior to shipment.
63. Other Pooling Challenges Regulatory Acceptability (pooling not well understood) Annex 13 (section 26) Local Laws Labeling options must be agreed to by each country in advance. May need to have separate pools due to differences in expiry dating or other labeling variations. IVR/IWR must be designed to support pooling approach
65. Pooling Benefits Supply commutability translates to flexibility and responsiveness. Protocols can be ramp up rapidly using a pre-exiting pool New Protocols can be added to pool downstream (dependent on labeling approach) Fewer packaging & labeling campaigns to prepare and release. Generally will achieve some supply savings (reduction of waste)
66. Where will you see a reduction in cost API Directly correlated with overall drug product savings Drug Product Demand quantities Packaging/labeling Campaigns Container types Containers Label Prints
67. Where will you see a reduction in cost QA Decrease number of releases Distribution Number of shipments if multiple protocols at same site Value Added Tax (VAT) Time = money Takes Supply Chain off of critical path when clinical plan changes
68. 4 protocols in pool, 2 dosage forms,35 countries, over 350 sites
70. Partnering with Regulators Know your facts Regulation or interpretation Many countries look to Europe What have other companies done Ensure regulators understand and are comfortable with IVR technology Provide information on concept and controls associated with system High light benefits not in terms of cost but in terms of patient safety Present solutions to challenges Small steps can bring you to your goal Pilot one program Company specific waiver Resources ISPE
71. Key Take Home Messages Pooling can be done many different ways There can be logistical and Importation Challenges but they can be overcome Pooling adds greater flexibility in your program Many benefits NOT just cost
72. Still have any questions? For additional information on ExLPharma’s Clinical Supply Forecasting Summits, please visit www.exlpharma.com