This document provides information about the 8th Annual Adaptive Designs in Clinical Trials conference to be held on April 18-19, 2016 in London. The conference will focus on the latest developments and strategies in adaptive clinical trial design. It will include sessions on biomarker-driven trials, seamless phase designs, enrichment designs, and perspectives from regulators. There will also be a post-conference workshop on April 20 about using statistical software to design adaptive clinical trials. The target attendees are professionals in areas like clinical research, biostatistics, and drug development seeking to learn more about adaptive designs.
This document provides information about an upcoming conference on immunogenicity taking place from June 12-13, 2017 in London. The conference will focus on standardizing immunogenicity methods, regulatory considerations, novel approaches to reducing immunogenicity, developments for biologic drugs and immunogenicity predictions, and emerging solutions. It lists the program agenda with topics such as predictive tools for immunogenicity, reporting clinically relevant data, cut point setting, EU guidance, ADA-dependent reactions, personalizing therapy, tolerogenic nanoparticles, and a panel on human versus humanized antibodies. Speakers are from organizations like Regeneron, NIBSC, EpiVax, Novartis, Abbvie, Merck, Roche, and Immun
CHI's Immunogenicity and Bioassay Summit 2015James Prudhomme
This document summarizes an upcoming conference on immunogenicity assessment and clinical relevance for biopharmaceutical products. The conference will take place November 17-18, 2015 in Baltimore, MD and will include keynote speakers from the FDA and industry. It will feature sessions on regulatory expectations, preclinical studies and risk assessment, different assay formats and technologies, and challenges with immunogenicity assessment. Short courses on related topics will also be offered. The document provides an agenda with session topics, speaker names and affiliations, and descriptions of presentation topics.
10th International Conference Compound Libraries 2014Torben Haagh
VISIT THE CONFERENCE WEBSITE HERE:
http://bit.ly/CompoundLibrariesSlideshare
Maximizing information in early-phase R&D for an optimal library design and target selection
We are excited to conduct the 10th annual meeting of the formerly known Compound Libraries conference! Over the last decade we have provided the pharmaceutical R&D community with a wonderful platform for exchanging knowledge and ideas about how best to optimize the qualification of drug candidates.
We have hosted almost all major pharmaceutical companies and heard dozens of case-studies relating to important and acute issues. When returning back to the programs from previous years, it is interesting to look at the timeline of changing approaches, trends and market-related developments. Our topical spectrum ranged from compound management and acquisition to collaboration frameworks, open access, library design, screening and analysis.
This year we bring you 15 case studies about the most burning issues in early-stage discovery today and offer you a valuable trend-analysis and networking with peers and colleagues from pharmaceutical companies, biotechs, CROs and academic research institutes.
Don’t miss our 10th anniversary and join us in Berlin to take part at our legacy conference!
Benefit from participating in discussions about the following topics:
-10 years perspective on synthesizing and designing compound libraries
-What is the role of ligand efficiency metrics in drug discovery? Have your say in this controversial debate!
-Next generation library design - working towards better PPI and epigenetic libraries
-Exploration of bioactive and novel chemical space by application of privileged structure concept design
-Learn from Janssen’s experience with the assembly of the IMI European Lead Factory (ELF) library
-What is the real potential of macrocycles and are they the drugs of the future?
Outlining the proces and lessons learned in organising the technological infrastructure at the Radboud university medical center, to shape the Radboudumc Technology Centers, supporting our mission in enabling personalized healthcare.
A chemicals perspective on designing with sustainable plastics OECDOECD Environment
With global plastic production soaring over the last 50 years, it is more urgent than ever to continue developing sustainable plastic products from a chemicals perspective. Our new report “A Chemicals Perspective on Designing with Sustainable Plastics - Goals, Considerations and Trade-offs” and its four supporting case studies (biscuit wrappers, detergent bottles, flooring and insulation) look at the plastic material selection process from a chemicals perspective to enable the creation of inherently sustainable plastic products.
Developed with country delegates, designers, industry stakeholders and NGOs, it will help designers and engineers select sustainable plastic for their products by equipping them with the right knowledge of chemicals.
A webinar to discuss the key findings of the reports took place on 7 December. Watch the video replay below to hear perspectives from countries and industry on the value of the initiative.
Dr Brenda Dooley, Managing Director, AXIS Healthcare Consulting Ltd.IMSTA
Economic evaluation aims to inform decision making about new medical technologies but its impact on uptake is unclear. The UK's Medical Technologies Evaluation Programme (MTEP) evaluates devices but uptake is not mandatory and guidance may be outdated by long timelines. Efforts like the Health Technologies Adoption Program help uptake but lack metrics. For economic evaluation to increase uptake in Ireland, appropriate timelines and fit-for-purpose methodologies are needed, and a link between guidance and mandatory uptake should be established.
Nursing research aims to generate new knowledge through systematic inquiry to improve nursing practice and patient outcomes. It has evolved from a focus on education and administration to examining issues like health care delivery, quality of life, and evidence-based practice. Research follows a process including developing questions, designing studies, collecting and analyzing data, and communicating conclusions. Both quantitative and qualitative designs are used, with some focusing on discovery and others on verification. Findings must be critically appraised and implemented into practice to advance evidence-based care.
This document provides information about an upcoming conference on immunogenicity taking place from June 12-13, 2017 in London. The conference will focus on standardizing immunogenicity methods, regulatory considerations, novel approaches to reducing immunogenicity, developments for biologic drugs and immunogenicity predictions, and emerging solutions. It lists the program agenda with topics such as predictive tools for immunogenicity, reporting clinically relevant data, cut point setting, EU guidance, ADA-dependent reactions, personalizing therapy, tolerogenic nanoparticles, and a panel on human versus humanized antibodies. Speakers are from organizations like Regeneron, NIBSC, EpiVax, Novartis, Abbvie, Merck, Roche, and Immun
CHI's Immunogenicity and Bioassay Summit 2015James Prudhomme
This document summarizes an upcoming conference on immunogenicity assessment and clinical relevance for biopharmaceutical products. The conference will take place November 17-18, 2015 in Baltimore, MD and will include keynote speakers from the FDA and industry. It will feature sessions on regulatory expectations, preclinical studies and risk assessment, different assay formats and technologies, and challenges with immunogenicity assessment. Short courses on related topics will also be offered. The document provides an agenda with session topics, speaker names and affiliations, and descriptions of presentation topics.
10th International Conference Compound Libraries 2014Torben Haagh
VISIT THE CONFERENCE WEBSITE HERE:
http://bit.ly/CompoundLibrariesSlideshare
Maximizing information in early-phase R&D for an optimal library design and target selection
We are excited to conduct the 10th annual meeting of the formerly known Compound Libraries conference! Over the last decade we have provided the pharmaceutical R&D community with a wonderful platform for exchanging knowledge and ideas about how best to optimize the qualification of drug candidates.
We have hosted almost all major pharmaceutical companies and heard dozens of case-studies relating to important and acute issues. When returning back to the programs from previous years, it is interesting to look at the timeline of changing approaches, trends and market-related developments. Our topical spectrum ranged from compound management and acquisition to collaboration frameworks, open access, library design, screening and analysis.
This year we bring you 15 case studies about the most burning issues in early-stage discovery today and offer you a valuable trend-analysis and networking with peers and colleagues from pharmaceutical companies, biotechs, CROs and academic research institutes.
Don’t miss our 10th anniversary and join us in Berlin to take part at our legacy conference!
Benefit from participating in discussions about the following topics:
-10 years perspective on synthesizing and designing compound libraries
-What is the role of ligand efficiency metrics in drug discovery? Have your say in this controversial debate!
-Next generation library design - working towards better PPI and epigenetic libraries
-Exploration of bioactive and novel chemical space by application of privileged structure concept design
-Learn from Janssen’s experience with the assembly of the IMI European Lead Factory (ELF) library
-What is the real potential of macrocycles and are they the drugs of the future?
Outlining the proces and lessons learned in organising the technological infrastructure at the Radboud university medical center, to shape the Radboudumc Technology Centers, supporting our mission in enabling personalized healthcare.
A chemicals perspective on designing with sustainable plastics OECDOECD Environment
With global plastic production soaring over the last 50 years, it is more urgent than ever to continue developing sustainable plastic products from a chemicals perspective. Our new report “A Chemicals Perspective on Designing with Sustainable Plastics - Goals, Considerations and Trade-offs” and its four supporting case studies (biscuit wrappers, detergent bottles, flooring and insulation) look at the plastic material selection process from a chemicals perspective to enable the creation of inherently sustainable plastic products.
Developed with country delegates, designers, industry stakeholders and NGOs, it will help designers and engineers select sustainable plastic for their products by equipping them with the right knowledge of chemicals.
A webinar to discuss the key findings of the reports took place on 7 December. Watch the video replay below to hear perspectives from countries and industry on the value of the initiative.
Dr Brenda Dooley, Managing Director, AXIS Healthcare Consulting Ltd.IMSTA
Economic evaluation aims to inform decision making about new medical technologies but its impact on uptake is unclear. The UK's Medical Technologies Evaluation Programme (MTEP) evaluates devices but uptake is not mandatory and guidance may be outdated by long timelines. Efforts like the Health Technologies Adoption Program help uptake but lack metrics. For economic evaluation to increase uptake in Ireland, appropriate timelines and fit-for-purpose methodologies are needed, and a link between guidance and mandatory uptake should be established.
Nursing research aims to generate new knowledge through systematic inquiry to improve nursing practice and patient outcomes. It has evolved from a focus on education and administration to examining issues like health care delivery, quality of life, and evidence-based practice. Research follows a process including developing questions, designing studies, collecting and analyzing data, and communicating conclusions. Both quantitative and qualitative designs are used, with some focusing on discovery and others on verification. Findings must be critically appraised and implemented into practice to advance evidence-based care.
Based on the information provided, this item is testing the learner's ability to make a clinical decision by diagnosing the most likely cause of the patient's presentation based on the key laboratory findings provided in the stem. The stem provides sufficient relevant information to answer the question without being tricked or misled. The alternatives provided are plausible and independent diagnoses to consider. This item follows best practices for writing multiple choice questions that test clinical decision making abilities.
Partners Demonstration Project - HIV self testing update - Feb 2015SlidesShare_Foxtrot
The Partners Demonstration Project is studying the use of antiretroviral therapy (ART) and pre-exposure prophylaxis (PrEP) to prevent HIV among heterosexual couples in Kenya and Uganda. An ancillary study is evaluating the acceptability of HIV self-testing among individuals using PrEP in Kenya. Preliminary findings show high uptake of self-testing, with 96% of expected tests reported as used. Qualitative feedback indicates self-testing reduces anxiety and empowers individuals. Continued research will provide more data on experiences with self-testing and its potential as a cost-effective component of PrEP programs.
Cadth 2015 e4 adaptive design april 2015 final lourencoCADTH Symposium
Health Canada regulates clinical trials and drug approvals. Adaptive clinical trial designs are increasing and can modify aspects of ongoing trials using accumulating data. Health Canada's main concerns are appropriate scientific questions, error control, and avoiding bias. Examples seen include adaptive randomization, sample size changes, and seamless phase 2/3 designs. Case studies demonstrate increased complexity, new statistical methods, and more simulation use. Health Canada recommends early consultation and education on adaptive designs.
Cadth 2015 e4 lourenco adaptive design april 2015 finalCADTH Symposium
Health Canada regulates clinical trials and drug approvals. Adaptive clinical trial designs are increasing and can modify aspects of ongoing trials using accumulating data. Health Canada's main concerns are appropriate scientific questions, error control, and avoiding bias. Examples seen include adaptive randomization, sample size changes, and seamless phase 2/3 designs. Case studies demonstrate increased complexity, new statistical methods, and more simulation use. Health Canada recommends early consultation and education on adaptive designs.
Sharing and standards christopher hart - clinical innovation and partnering...Christopher Hart
Acknowledging the increasing need for cooperation and collaboration in data sharing and access. Describing the complexity that this can bring. Then describing some of the ways to simplify that.
Originally presented at Terrapin's Clinical innovation and partnering world March 8-9 2017.
http://www.terrapinn.com/conference/innovation-and-partnering/index.stm
Supervision, monitoring and evaluation of researchAshok Pandey
To train the health professionals on health system research proposal development,
To acquaint the participants with health research process, and
To train basic managerial skills required to manage proposed health research.
SMi is proud to present the 2017 19th annual Superbugs & Superdrugs conference, taking place on 20th and 21st March in Central London.
Expanding horizons on the growing threat of anti-microbial resistance for almost two decades, the flagship show in the global Superbugs portfolio of events will once again play host to an international audience of scientific leaders, funding bodies and drug discovery specialists, providing a focal point to push industry collaboration through updates on clinical advancements and investment opportunities.
SMi Group's Adaptive Designs in Clinical Trials conferenceDale Butler
This document summarizes an upcoming conference on adaptive designs in clinical trials taking place from April 20-21, 2015 in London. The conference will focus on topics such as Bayesian adaptive designs, subgroup selection in clinical trials, integrating real-world patient data into adaptive trials, and designing biomarker-driven multi-arm multi-stage cancer trials. Speakers will discuss challenges with adaptive designs and their use in different therapeutic areas like neurodegenerative diseases. Participants can also register for optional half-day workshops on April 22nd focusing on Bayesian clinical trial designs and navigating international regulatory landscapes for adaptive trials.
Aileen Lucia Fisher was an American writer and poet born in 1906 in Michigan. She received her bachelor's degree from the University of Michigan and became the director of the Women's National Journalist. Fisher wrote over 100 books for children and was known for her lyrical poetry about nature, animals, and plants. She won the National Council of Teachers of English Award for Excellence in Poetry for Children in 1978. Fisher's writing was inspired by the world around her and aimed to make nature playful and simple for children. She died in 2002 in Colorado.
El documento promociona un nuevo restaurante japonés llamado Roppon en Madrid, proporcionando su sitio web y página de Facebook para que los clientes puedan obtener más información y visitar el restaurante.
SMi Group's UAV Technology Eastern Europe 2016 conferenceDale Butler
SMi Group's UAV Technology Eastern Europe 2016 conference moves to Prague this September. Delivering greater situational awareness through the development of UAV capability
Shiv Kumar is seeking an opportunity with a growth-oriented company. He has a B.Com degree from C.C.S. University and qualifications in computer hardware, MS Office, DTP, and computer programming. He has work experience as a customer service executive at HCL Service Ltd and as an accounts assistant at PeopleStrong HR Services Pvt. Ltd. and CRIS. His responsibilities have included customer service, achieving targets, personnel duties, handling complaints, monitoring employees, payroll, and data entry. He is proficient in Windows, MS Office, SAP, and internet/email applications.
SMi Group's Fast Jet Pilot Training Eastern Europe 2016 conference sponsorshi...Dale Butler
The document is a prospectus for the "Fast Jet Pilot Training Event 2016" conference being held in Prague, Czech Republic on June 6-7, 2016. The conference is organized by SMi Group and will bring together senior military leaders from Central and Eastern European countries to discuss improving fast jet fighter training capabilities through cooperation. The prospectus outlines the goals of the conference, speaker lineup including high-ranking officers from various air forces, sponsorship opportunities, and contact information for the event organizers.
Metadata plays an increasingly central role as a tool enabling the large-scale, distributed management of resources. However, metadata communities which have traditionally worked in relative isolation have struggled to make their specifications interoperate with others in the shared web environment.
This webinar explores how metadata standards with significantly different characteristics can productively coexist and how previously isolated metadata communities can work towards harmonization. The webinar presents a solution-oriented analysis of current issues in metadata harmonization with a focus on specifications of importance to the learning technology and library environments, notably Dublin Core, IEEE Learning Object Metadata, and W3C's Resource Description Framework. Providing concrete illustrations of harmonization problems and a roadmap for designing metadata for maximum interoperability, this webinar will provide a bird's-eye perspective on the respective roles of metadata syntaxes, formats, semantics, abstract models, vocabularies, and application profiles in achieving metadata harmonization.
This document discusses the onboarding competency development needs of foreign-educated nurses (FENs) working in the United States healthcare system. It notes that nursing shortages are a recurring issue due to retirements and increasing demand. The purpose is to help FENs successfully transition and develop the competencies needed for safe, effective practice. A literature review found that FENs face challenges with variations in education, language barriers, unfamiliar technologies and equipment. The study uses a qualitative descriptive phenomenological design to understand the onboarding experiences of 6 FENs through semi-structured interviews. Analysis of the interviews identified 5 interrelating themes: socialization, orientation structure, nursing structure, cultural competence, and personal growth. The
El documento presenta información sobre un restaurante español lleno de clientes. El restaurante tiene éxito porque es popular y económico. Tiene un piso y se encuentra en España. Cuenta con dieciocho mesas y entre cinco y dieciocho personas trabajando como camareros.
A 59-year-old male presented with blurry vision in both eyes and eye pain in his left eye. He was diagnosed with mature cataracts in both eyes and age-related macular degeneration in his right eye. His left eye vision deteriorated to only light perception and he was diagnosed with narrow-angle glaucoma. His medical history was significant for hypertension. On examination, he had blurry vision, hypertension, and light perception only in his left eye.
Based on the information provided, this item is testing the learner's ability to make a clinical decision by diagnosing the most likely cause of the patient's presentation based on the key laboratory findings provided in the stem. The stem provides sufficient relevant information to answer the question without being tricked or misled. The alternatives provided are plausible and independent diagnoses to consider. This item follows best practices for writing multiple choice questions that test clinical decision making abilities.
Partners Demonstration Project - HIV self testing update - Feb 2015SlidesShare_Foxtrot
The Partners Demonstration Project is studying the use of antiretroviral therapy (ART) and pre-exposure prophylaxis (PrEP) to prevent HIV among heterosexual couples in Kenya and Uganda. An ancillary study is evaluating the acceptability of HIV self-testing among individuals using PrEP in Kenya. Preliminary findings show high uptake of self-testing, with 96% of expected tests reported as used. Qualitative feedback indicates self-testing reduces anxiety and empowers individuals. Continued research will provide more data on experiences with self-testing and its potential as a cost-effective component of PrEP programs.
Cadth 2015 e4 adaptive design april 2015 final lourencoCADTH Symposium
Health Canada regulates clinical trials and drug approvals. Adaptive clinical trial designs are increasing and can modify aspects of ongoing trials using accumulating data. Health Canada's main concerns are appropriate scientific questions, error control, and avoiding bias. Examples seen include adaptive randomization, sample size changes, and seamless phase 2/3 designs. Case studies demonstrate increased complexity, new statistical methods, and more simulation use. Health Canada recommends early consultation and education on adaptive designs.
Cadth 2015 e4 lourenco adaptive design april 2015 finalCADTH Symposium
Health Canada regulates clinical trials and drug approvals. Adaptive clinical trial designs are increasing and can modify aspects of ongoing trials using accumulating data. Health Canada's main concerns are appropriate scientific questions, error control, and avoiding bias. Examples seen include adaptive randomization, sample size changes, and seamless phase 2/3 designs. Case studies demonstrate increased complexity, new statistical methods, and more simulation use. Health Canada recommends early consultation and education on adaptive designs.
Sharing and standards christopher hart - clinical innovation and partnering...Christopher Hart
Acknowledging the increasing need for cooperation and collaboration in data sharing and access. Describing the complexity that this can bring. Then describing some of the ways to simplify that.
Originally presented at Terrapin's Clinical innovation and partnering world March 8-9 2017.
http://www.terrapinn.com/conference/innovation-and-partnering/index.stm
Supervision, monitoring and evaluation of researchAshok Pandey
To train the health professionals on health system research proposal development,
To acquaint the participants with health research process, and
To train basic managerial skills required to manage proposed health research.
SMi is proud to present the 2017 19th annual Superbugs & Superdrugs conference, taking place on 20th and 21st March in Central London.
Expanding horizons on the growing threat of anti-microbial resistance for almost two decades, the flagship show in the global Superbugs portfolio of events will once again play host to an international audience of scientific leaders, funding bodies and drug discovery specialists, providing a focal point to push industry collaboration through updates on clinical advancements and investment opportunities.
SMi Group's Adaptive Designs in Clinical Trials conferenceDale Butler
This document summarizes an upcoming conference on adaptive designs in clinical trials taking place from April 20-21, 2015 in London. The conference will focus on topics such as Bayesian adaptive designs, subgroup selection in clinical trials, integrating real-world patient data into adaptive trials, and designing biomarker-driven multi-arm multi-stage cancer trials. Speakers will discuss challenges with adaptive designs and their use in different therapeutic areas like neurodegenerative diseases. Participants can also register for optional half-day workshops on April 22nd focusing on Bayesian clinical trial designs and navigating international regulatory landscapes for adaptive trials.
Aileen Lucia Fisher was an American writer and poet born in 1906 in Michigan. She received her bachelor's degree from the University of Michigan and became the director of the Women's National Journalist. Fisher wrote over 100 books for children and was known for her lyrical poetry about nature, animals, and plants. She won the National Council of Teachers of English Award for Excellence in Poetry for Children in 1978. Fisher's writing was inspired by the world around her and aimed to make nature playful and simple for children. She died in 2002 in Colorado.
El documento promociona un nuevo restaurante japonés llamado Roppon en Madrid, proporcionando su sitio web y página de Facebook para que los clientes puedan obtener más información y visitar el restaurante.
SMi Group's UAV Technology Eastern Europe 2016 conferenceDale Butler
SMi Group's UAV Technology Eastern Europe 2016 conference moves to Prague this September. Delivering greater situational awareness through the development of UAV capability
Shiv Kumar is seeking an opportunity with a growth-oriented company. He has a B.Com degree from C.C.S. University and qualifications in computer hardware, MS Office, DTP, and computer programming. He has work experience as a customer service executive at HCL Service Ltd and as an accounts assistant at PeopleStrong HR Services Pvt. Ltd. and CRIS. His responsibilities have included customer service, achieving targets, personnel duties, handling complaints, monitoring employees, payroll, and data entry. He is proficient in Windows, MS Office, SAP, and internet/email applications.
SMi Group's Fast Jet Pilot Training Eastern Europe 2016 conference sponsorshi...Dale Butler
The document is a prospectus for the "Fast Jet Pilot Training Event 2016" conference being held in Prague, Czech Republic on June 6-7, 2016. The conference is organized by SMi Group and will bring together senior military leaders from Central and Eastern European countries to discuss improving fast jet fighter training capabilities through cooperation. The prospectus outlines the goals of the conference, speaker lineup including high-ranking officers from various air forces, sponsorship opportunities, and contact information for the event organizers.
Metadata plays an increasingly central role as a tool enabling the large-scale, distributed management of resources. However, metadata communities which have traditionally worked in relative isolation have struggled to make their specifications interoperate with others in the shared web environment.
This webinar explores how metadata standards with significantly different characteristics can productively coexist and how previously isolated metadata communities can work towards harmonization. The webinar presents a solution-oriented analysis of current issues in metadata harmonization with a focus on specifications of importance to the learning technology and library environments, notably Dublin Core, IEEE Learning Object Metadata, and W3C's Resource Description Framework. Providing concrete illustrations of harmonization problems and a roadmap for designing metadata for maximum interoperability, this webinar will provide a bird's-eye perspective on the respective roles of metadata syntaxes, formats, semantics, abstract models, vocabularies, and application profiles in achieving metadata harmonization.
This document discusses the onboarding competency development needs of foreign-educated nurses (FENs) working in the United States healthcare system. It notes that nursing shortages are a recurring issue due to retirements and increasing demand. The purpose is to help FENs successfully transition and develop the competencies needed for safe, effective practice. A literature review found that FENs face challenges with variations in education, language barriers, unfamiliar technologies and equipment. The study uses a qualitative descriptive phenomenological design to understand the onboarding experiences of 6 FENs through semi-structured interviews. Analysis of the interviews identified 5 interrelating themes: socialization, orientation structure, nursing structure, cultural competence, and personal growth. The
El documento presenta información sobre un restaurante español lleno de clientes. El restaurante tiene éxito porque es popular y económico. Tiene un piso y se encuentra en España. Cuenta con dieciocho mesas y entre cinco y dieciocho personas trabajando como camareros.
A 59-year-old male presented with blurry vision in both eyes and eye pain in his left eye. He was diagnosed with mature cataracts in both eyes and age-related macular degeneration in his right eye. His left eye vision deteriorated to only light perception and he was diagnosed with narrow-angle glaucoma. His medical history was significant for hypertension. On examination, he had blurry vision, hypertension, and light perception only in his left eye.
This document provides a curriculum vitae for Michael McAdam Clark, who has over 30 years of experience managing the design and construction of luxury real estate projects in Europe, Asia, and the Middle East totaling $3 billion. It outlines his roles and responsibilities on various projects, as well as his educational background and professional history working for organizations like Mace International, Qatar Project Management, and Holford Associates on hotels, resorts, mixed-use developments, and more.
SMi Group's 2nd annual Lyophilization USA 2016 conferenceDale Butler
This document summarizes a two-day conference on lyophilization taking place from April 27-28, 2016 in Iselin, New Jersey. The conference will discuss lyophilization technologies and techniques, with sessions on quality control, regulatory compliance, formulation, processing, and analytical methods. It will also feature two half-day workshops on April 29 on developing lyophilization cycles and tech transfer. The workshops will provide practical guidance on meeting QbD requirements and discuss challenges in developing lyophilized dosage forms.
Lär dig mer om Google My Business och lokala rankingfaktorer på Google. Kort genomgång av AdWords Express och lokal sökstatistik från Google Consumer Barometer 2016.
Presentatör: Anna-Karin Persson
TopVisible
Digital byrå
Kontaktuppgifter för frågor
anna-karin.persson@topvisible.se
0723-26 87 00
www.topvisible.se
SMi Group's Adaptive Designs in Clinical Trials 2019 Dale Butler
This document provides information about an upcoming conference on adaptive designs in clinical trials, including workshops, speakers, and program details. The conference will cover:
- The latest advances in adaptive designs from regulatory and industry perspectives.
- Two half-day post-conference workshops on the FDA's guidance on adaptive designs and designing digital technology trials.
- A program over two days addressing therapeutic applications of adaptive designs, regulatory outlook, and statistical approaches.
- Speakers from pharmaceutical companies, clinical research organizations, and regulatory agencies.
The document provides details on registration, speakers, workshop topics, and the overall agenda to give attendees an overview of the content that will be covered at the conference on adaptive designs in clinical trials
This document provides information about the 4th annual Biobanking conference taking place on June 23-24, 2014 in London. It includes the program agenda, speaker details, registration information and sponsorship opportunities. Some of the topics to be discussed are best strategies for using biosamples, enhancing sample quality, establishing biobanking structures, sample tracking and data management systems, ethics and regulation. Registration discounts are available by February 28th or March 31st.
SMi Group's Injectable Drug Delivery 2018 conferenceDale Butler
This document provides information about two half-day pre-conference workshops on injectable drug delivery taking place on May 15, 2018 in London. Workshop A from 8:30-12:30 will focus on creating a human factors and usability engineering file in accordance with FDA and IEC62366-1 standards. Workshop B from 13:30-17:30 will examine wearable injectors and their ability to meet clinical needs while reducing healthcare costs. Both workshops aim to equip attendees with practical knowledge and strategies for developing safer and more user-friendly drug delivery devices and technologies.
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This document is a program for the 3rd annual ADC Summit 2014 conference on antibody-drug conjugates taking place from May 19-21, 2014 in London. The conference will feature presentations from industry experts on topics related to developing antibody-drug conjugates, including payloads, linkers, manufacturing, and clinical trials. Attendees can learn about the latest developments and network with other professionals in the field. A pre-conference workshop on May 21st will focus on early phase development considerations for antibody-drug conjugates to support first-in-human clinical trials.
SMi Group's 11th annual Point of Care Diagnostics conferenceDale Butler
This document summarizes an upcoming two-day conference on point-of-care diagnostics taking place on October 27-28, 2014 in London. The conference will feature keynote speakers and panels discussing topics such as quality control of point-of-care testing, implementing point-of-care strategies, microfluidic technologies, and the future of point-of-care testing. Attendees can register online, by fax, phone, or mail. Early registration discounts are available before June 30 and July 18.
This document provides information about the 4th annual ADC Summit 2015 conference organized by SMi that will take place from May 18-19, 2015 in London. The conference will focus on advancing antibody-drug conjugate (ADC) and radioimmunotherapy (RIT) therapies, with sessions on payload development, clinical trials of ADCs, small molecule approaches, and intellectual property issues. There will also be a half-day workshop on May 20 about the regulatory requirements and development process for ADCs.
SMi Group's 9th annual Pre-filled Syringes Europe 2017 Dale Butler
This document provides information on two half-day pre-conference workshops on January 17th, 2017 regarding pre-filled syringes in London, UK. Workshop A from 8:30-12:30 will explore how personalized medicine, enhanced patient experience, and improved outcomes will drive the development of digital therapy management ecosystems and how this will impact future parenteral drug delivery devices. Workshop B from 13:30-18:15 will examine regulatory challenges at the interface of medicines and medical devices. Both workshops aim to provide insights on these important topics for professionals in the pre-filled syringes industry.
The document advertises and provides an agenda for the 6th Annual Conference on Pharmaceutical Microbiology taking place January 17-19, 2017 in London. It will feature presentations and workshops on topics such as endotoxin testing, rapid microbial detection methods, environmental monitoring, and contamination control. Registration discounts are available before certain dates.
This document provides an agenda for the 2nd Annual Conference on Highly Potent Active Pharmaceutical Ingredients taking place May 21-23, 2018 in London. The conference will address containment and cross-contamination issues related to HPAPIs. It will feature presentations and workshops on topics such as HPAPI project management, containment strategies, waste management, and regulations. Two half-day workshops on May 23rd will provide practical guidance on delivering HPAPI projects and preventing cross contamination and employee exposures. Over 150 professionals from pharmaceutical and biotech companies are expected to attend the conference.
SMi Group's Injectable Drug Delivery 2019 conferenceDale Butler
The document advertises the 2nd Annual Injectable Drug Delivery conference taking place May 14-16, 2019 in London. The conference will focus on innovations in injectable drug formulations and devices, with sessions on formulation development, device design, manufacturing, and regulatory issues. Speakers will discuss challenges and solutions for protein formulations, digital health technologies, long-acting injectables, pre-filled syringes and more. A pre-conference workshop on use-related risk analysis in product development will also be held. Attendees can register online or by phone.
SMi will host the 7th Pharmaceutical Microbiology West Coast conference on June 8-9, 2017 in San Diego, USA. The conference will address current challenges in sterility assurance, environmental monitoring, and rapid microbial methods. Over the two days, experts from companies like GSK, Amgen, Janssen, and Takeda will discuss topics like environmental monitoring trends and data analysis, challenges in endotoxin testing and sterility assurance, case studies on contamination control, and the validation and use of rapid microbial methods. Workshops on the day before will cover technologies for monitoring contamination control and case studies, as well as microbial requirements for terminal sterilization.
This document provides information about the 6th annual conference on chronic obstructive pulmonary disease (COPD) being held on October 20-21, 2014 in London. The conference will feature talks from industry and clinical experts on topics related to COPD treatment and management, including regulatory issues, comorbidities, exacerbations, clinical trial design, biomarkers, phenotyping, and the patient experience. An optional half-day post-conference workshop on October 22 will provide an introduction to COPD best practices for nurses and other clinical staff.
SMi Group's 8th annual Advances in Cell Based AssaysDale Butler
This document provides information about two half-day post-conference workshops on November 12, 2015 following the Advances in Cell Based Assays conference on November 10-11, 2015. Workshop A will focus on the latest generation microscopes for live cell imaging in high-throughput, high-content, and high-content analytical assays, featuring an interactive session with Nikon, UK. Workshop B will explore applying tissue engineering to develop 3D cell-based assays, focusing on generating in vitro disease models, led by Associate Professor Felicity Rose. Both workshops aim to discuss cutting-edge technologies and their applications to advance cell and tissue-based screening assays.
This document provides information about two half-day post-conference workshops on November 12, 2015 following the Advances in Cell Based Assays conference on November 10-11, 2015. Workshop A will focus on the latest generation microscopes for live cell imaging in high-throughput, high-content, and high-content analytical assays, featuring an interactive session with Nikon, UK. Workshop B will explore applying tissue engineering to develop 3D cell-based assays, focusing on generating in vitro disease models, led by Associate Professor Felicity Rose. Both workshops aim to discuss cutting-edge technologies and their applications to advance cell and tissue-based screening assays.
SMi Group's 3rd annual Prefilled Syringes East Coast 2016Dale Butler
This document provides information on the 3rd Annual Conference and Exhibition on Pre-Filled Syringes East Coast, taking place April 25-26, 2016 in Iselin, New Jersey. The conference will focus on key topics for pre-filled syringes (PFS) including eliminating extractables and leachables, incorporating human factors engineering, and the latest technologies for combination products, sterilization, and more. There will also be two half-day post-conference workshops on April 27th on human factors considerations for PFS development and regulatory submissions, as well as combination rule and CMC considerations for PFS and autoinjectors. The expert speaker panel will represent leading pharmaceutical companies. Attendees can
The document describes a team developing a technology to stabilize stem cells at room temperature, removing the need for freezing. The team includes Dr. Joanne Hackett, founder and CSO, with experience in regenerative medicine and business development, and Dr. Ryan MacDonald, project manager with a background in stem cell biology. The £100,000 investment would be used to protect intellectual property, undertake further studies, and provide seed funding to secure licensing deals and grants to further develop the technology.
The document describes a team developing a technology to stabilize stem cells at room temperature, removing the need for freezing. The team includes Dr. Joanne Hackett, founder and CSO, with experience in regenerative medicine and business development, and Dr. Ryan MacDonald, project manager with a background in stem cell biology. The £100,000 investment would be used to protect intellectual property, undertake further studies, and provide seed funding to secure licensing deals and grants to further develop the technology.
This document provides an overview and agenda for the 2nd annual conference on drug discovery taking place on March 21st-22nd, 2018 in London. The conference will feature presentations and discussions on:
1) New technologies to improve discovery cycles in chemistry and drug discovery processes, including the role of artificial intelligence and new modalities like PROTACs and antibodies.
2) Advances in small molecule therapeutics from Roche and challenges in validating targets with CRISPR from Epizyme.
3) The role of open access chemical probes from the SGC and how Bayer uses them in drug discovery.
4) How artificial intelligence can transform drug design and discovery efforts at companies like Exscient
This document provides an agenda for the 13th Annual Conference on Controlled Release to be held on April 18-19, 2016 in London. The conference will focus on uniting innovation and science to improve controlled release formulation and delivery for next generation drugs. It will feature speakers from pharmaceutical companies and regulatory agencies discussing topics like the use of Quality by Design in controlled release, innovations in oral and parenteral controlled release technologies, and formulation challenges. The document also lists upcoming conferences held by SMi on other pharmaceutical topics in 2016.
Similar to SMi Group's 8th annual Adaptive Designs in Clinical Trials 2016 conference (20)
SMi Group's Pharmaceutical Microbiology West Coast 2020 conferenceDale Butler
This document provides information on the Pharmaceutical Microbiology West Coast conference happening June 17-19, 2020 in San Diego. It outlines the chairs, speakers, highlights and agenda for the event. The conference will focus on novel approaches and best practices for tackling current industry contamination control challenges, and will include sessions on contamination control, guidance and regulations, detection and identification methods, and supporting pharmaceutical facilities and novel therapeutics. There will also be an optional pre-conference workshop on data integrity in environmental monitoring.
SMi Group's Pre-filled Syringes West Coast 2020 conferenceDale Butler
This document provides an agenda for the 5th annual Pre-Filled Syringes West Coast conference taking place June 15-17, 2020 in San Diego, CA. The conference will focus on innovations in device design and technology, advances in human factors engineering, combination product regulatory insights, and design controls and risk management. It will feature presentations from industry leaders at companies like Genentech and AstraZeneca as well as regulators from the FDA. There will also be two post-conference workshops on June 17th focusing on navigating FDA requirements for connected devices and digital health, and post-market safety reporting for combination products.
SMi Group's Military Robotics and Autonomous Systems USA 2020 conferenceDale Butler
This document advertises the Military Robotics and Autonomous Systems USA conference happening on June 22-23, 2020 in Arlington, Virginia. Attendees can save $400 by registering by February 28, $200 by registering by March 31, and $100 by registering by April 30. The conference will discuss topics like US Army robotics programs, Australian Army robotics development, unmanned vehicle programs, robotics supporting warfighters' mobility and sustainability, and integrating robotics into ground formations. Speakers will include representatives from the US and Australian militaries as well as academics working on relevant research.
SMi Group's Future Soldier Technology USA 2020 conferenceDale Butler
The document announces the 2nd Annual Future Soldier Technology USA conference on June 8-10, 2020 in Arlington, Virginia. The conference will focus on modernizing equipment for dismounted soldiers and marines, and feature speakers from the US and other militaries involved in soldier technology programs. Over 150 attendees are expected to discuss initiatives like NGSW-AR/R/FC, ISSP, and manned-unmanned teaming to enhance soldier lethality, mobility, and situational awareness.
SMi Group's Military Space USA 2020 conferenceDale Butler
This document provides an agenda for the 2nd Annual Military Space USA Conference supporting the US military space enterprise. The conference will include presentations from senior leaders in the US Space Force, Air Force, and other allied militaries on topics such as space acquisition reform through SMC 2.0, training the future space warfighting force, and leveraging disruptive commercial space technologies. A separate focus day will explore experimental smallsat capabilities, export controls for space technologies, advanced propulsion concepts, using LEO mega-constellations for bandwidth, in-orbit manufacturing, and accelerating commercial innovation. The event aims to connect disruptors and innovators with government to integrate new technologies rapidly into military space operations.
This document summarizes a conference focused on helicopter technology for Central and Eastern Europe being held in Budapest, Hungary on May 20-21, 2020. It will feature keynote speeches from military leaders from Hungary, Slovakia, Romania, Germany, and Croatia on developments and modernization efforts of their national helicopter fleets. Technical experts from the US, UK, Netherlands, and Czech Republic will also present. Sessions will discuss regional cooperation and interoperability, training standards, and enhancing capabilities like search and rescue. The goal is focused discussion on challenges facing helicopter program managers and informal networking for participants.
This document provides information about an upcoming conference on future armoured vehicles in Central and Eastern Europe in 2020. It outlines early registration discounts that decrease over time, as well as special rates for military and government representatives. The document details benefits of attending the conference, including hearing updates from armed forces in the region. It lists speakers from various countries who will discuss topics like armoured vehicle programmes, enhancing capabilities, and ensuring interoperability. The agenda outlines presentations over two days covering issues like future infantry fighting vehicles, enhancing mechanization capabilities, and modernizing ground platforms. The document promotes sponsorship opportunities at the event.
SMi Group's Unmanned Maritime Systems 2020 conferenceDale Butler
This document provides information about the 4th Annual Unmanned Maritime Systems conference taking place on April 13-14, 2020 in London. It discusses key reasons to attend like hearing from naval officers on integrating unmanned assets and learning about updates on unmanned platforms, anti-submarine warfare, mine countermeasures, and technological innovation. The agenda outlines presentations and speakers from military organizations like the Royal Navy, US Navy, Spanish Navy, and NATO who will discuss topics like developing unmanned systems, accelerating unmanned technologies, and using unmanned systems for mine countermeasure operations.
SMi Group's Military PNT 2020 conferenceDale Butler
The document summarizes the agenda for the "Military PNT 2020" conference to be held on May 18-19 in London. The event highlights include briefings from the US DoD on GPS and NTS-3 programs, understanding requirements for operating in degraded PNT environments, and engaging with industry and military leaders. The agenda covers topics such as UK PNT strategies, warfighter PNT considerations, legal perspectives on PNT resilience, and GNSS interference case studies. Keynote speakers include representatives from the US Air Force, Lockheed Martin, UK MoD, DGA, NPL, and BHO Legal.
This document provides an agenda for the Defence Aviation Safety conference taking place on April 23-24, 2020 in London. The agenda includes keynote presentations and panels on topics related to ensuring safety across defence aviation programs and platforms. Speakers will represent organisations such as the UK Ministry of Defence, US Air Force, German Military Aviation Authority, and NATO. Presentation topics will cover safety priorities, certification processes, training, accident investigation and lessons learned. A closing panel on day two will discuss the challenges of ensuring military aviation safety and cyber resilience.
SMi Group's Pre-filled Syringes East Coast 2020 Dale Butler
This document announces an interactive workshop on combination product development taking place on April 29th, 2020 in Boston, USA. The workshop will consist of three sessions focused on key topics in combination product development: combination product development strategies, drug delivery device testing solutions, and human factors validation studies. Speakers will include experts from major pharmaceutical companies such as AstraZeneca, Eli Lilly, Biogen, and regulatory agencies. The workshop aims to provide attendees insights and strategies for navigating challenges in combination product development from concept to approval.
SMi Group's Air Mission Planning and Support 2020Dale Butler
The document announces an upcoming conference on "Maximising Air Power through the Development and Integration of Innovative Support Systems" to be held in London on April 21-22, 2020. The conference will examine developments in air mission planning and focus on data management, fifth generation integration, and multi-domain command and control. It will feature expert military speakers from countries like the UK, US, Canada, France, Hungary, and Belgium representing air forces, NATO, and DARPA to discuss challenges and solutions.
SMi Group's Military Robotics and Autonomous Systems 2020 Dale Butler
This document provides information about the 3rd Annual Military Robotics and Autonomous Systems conference taking place on April 1-2, 2020 in London. It outlines the key topics to be discussed including UK and international perspectives on robotic and autonomous systems programs and strategies. Speakers will address topics such as unmanned ground vehicle development, autonomy for military robotic systems, and manned-unmanned teaming. The conference will explore delivering quality robotic systems to enhance operational effectiveness and discuss technology demonstrations.
This document advertises the 6th Annual Future Soldier Technology conference taking place March 9-11, 2020 in London. The conference will focus on dismounted soldier and marine technology, discussing key areas like dismounted capability. Military, procurement, and research experts from around the world will present on their soldier programs, challenges, and successes. Attendees can learn the latest developments, network with key speakers and decision makers, and gather intelligence to inform their projects. The conference aims to allow information sharing on equipping soldiers to maintain an advantage against evolving adversaries.
This document provides information about the 5th Annual Defence Logistics Central & Eastern Europe conference taking place on March 3-4, 2020 in Budapest, Hungary. The summary includes:
- The conference will bring together senior military, government, and industry personnel from Central and Eastern Europe to discuss developments in defence logistics and increase cooperation in the region.
- Over the two days, there will be keynote briefings and panels on topics like modernizing logistics structures, interoperability, operational capabilities of country logistics divisions, and industry roles. Speakers will represent militaries like Hungary, Czech Republic, Poland, and industry sponsors.
- Attendees can benefit from networking opportunities and learning about log
The document announces Space Week, consisting of the Small Satellites Conference from April 27-28 and the Military Space Situational Awareness Conference from April 29-30 in London. It provides details on the conferences, including chairpersons, speakers from various space agencies, companies, and militaries, and topics to be discussed such as small satellites, space insurance, disruptive approaches to space, space data, and military space situational awareness. The document aims to invite colleagues to participate in Space Week to explore developments in small satellites and how to track and manage space assets.
SMi Group's Superbugs and Superdrugs 2020 conferenceDale Butler
This document provides information about the Superbugs & Superdrugs conference on March 30-31, 2020 in London. The conference will focus on non-traditional approaches to fighting antimicrobial resistance and will feature speakers from companies and organizations working on alternatives to antibiotics, including those developing antibacterial proteins, agents that neutralize bacterial virulence, direct lytic agents, and immunomodulatory therapies. It provides details on the agenda, speakers, workshops, registration and sponsorship opportunities.
SMi Group's AI in Drug Discovery 2020 conferenceDale Butler
This document provides information about an upcoming conference on AI in Drug Discovery taking place from March 16-17, 2020 in London, UK. It includes details about the program, speakers, registration fees and deadlines. The conference will explore how machine learning and AI are being applied across the drug discovery process, from compound design and virtual screening to toxicity prediction. There will be case studies presented from major pharmaceutical companies on their experience integrating AI. The document also advertises sponsorship opportunities for the event.
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How to Manage Your Lost Opportunities in Odoo 17 CRMCeline George
Odoo 17 CRM allows us to track why we lose sales opportunities with "Lost Reasons." This helps analyze our sales process and identify areas for improvement. Here's how to configure lost reasons in Odoo 17 CRM
Executive Directors Chat Leveraging AI for Diversity, Equity, and InclusionTechSoup
Let’s explore the intersection of technology and equity in the final session of our DEI series. Discover how AI tools, like ChatGPT, can be used to support and enhance your nonprofit's DEI initiatives. Participants will gain insights into practical AI applications and get tips for leveraging technology to advance their DEI goals.
This slide is special for master students (MIBS & MIFB) in UUM. Also useful for readers who are interested in the topic of contemporary Islamic banking.
A review of the growth of the Israel Genealogy Research Association Database Collection for the last 12 months. Our collection is now passed the 3 million mark and still growing. See which archives have contributed the most. See the different types of records we have, and which years have had records added. You can also see what we have for the future.
The simplified electron and muon model, Oscillating Spacetime: The Foundation...RitikBhardwaj56
Discover the Simplified Electron and Muon Model: A New Wave-Based Approach to Understanding Particles delves into a groundbreaking theory that presents electrons and muons as rotating soliton waves within oscillating spacetime. Geared towards students, researchers, and science buffs, this book breaks down complex ideas into simple explanations. It covers topics such as electron waves, temporal dynamics, and the implications of this model on particle physics. With clear illustrations and easy-to-follow explanations, readers will gain a new outlook on the universe's fundamental nature.
This presentation was provided by Steph Pollock of The American Psychological Association’s Journals Program, and Damita Snow, of The American Society of Civil Engineers (ASCE), for the initial session of NISO's 2024 Training Series "DEIA in the Scholarly Landscape." Session One: 'Setting Expectations: a DEIA Primer,' was held June 6, 2024.
A workshop hosted by the South African Journal of Science aimed at postgraduate students and early career researchers with little or no experience in writing and publishing journal articles.
A Strategic Approach: GenAI in EducationPeter Windle
Artificial Intelligence (AI) technologies such as Generative AI, Image Generators and Large Language Models have had a dramatic impact on teaching, learning and assessment over the past 18 months. The most immediate threat AI posed was to Academic Integrity with Higher Education Institutes (HEIs) focusing their efforts on combating the use of GenAI in assessment. Guidelines were developed for staff and students, policies put in place too. Innovative educators have forged paths in the use of Generative AI for teaching, learning and assessments leading to pockets of transformation springing up across HEIs, often with little or no top-down guidance, support or direction.
This Gasta posits a strategic approach to integrating AI into HEIs to prepare staff, students and the curriculum for an evolving world and workplace. We will highlight the advantages of working with these technologies beyond the realm of teaching, learning and assessment by considering prompt engineering skills, industry impact, curriculum changes, and the need for staff upskilling. In contrast, not engaging strategically with Generative AI poses risks, including falling behind peers, missed opportunities and failing to ensure our graduates remain employable. The rapid evolution of AI technologies necessitates a proactive and strategic approach if we are to remain relevant.
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How to Fix the Import Error in the Odoo 17Celine George
An import error occurs when a program fails to import a module or library, disrupting its execution. In languages like Python, this issue arises when the specified module cannot be found or accessed, hindering the program's functionality. Resolving import errors is crucial for maintaining smooth software operation and uninterrupted development processes.
1. SMi Presents the 8th Annual Conference and Exhibition on...
18 - 19
APRIL
2016Holiday Inn Regents Park, London, UK
Adaptive Designs
in Clinical Trials
PLUS AN INTERACTIVE HALF-DAY POST-CONFERENCE WORKSHOP
Wednesday 20th April 2016, Holiday Inn Regents Park, London, UK
www.adaptivedesigns.co.uk
Register online or fax your registration to +44 (0) 870 9090 712 or call +44 (0) 870 9090 711
Bringing technological advances to patients
in the most efficient manner
@SMIPHARM
#smiadaptivedesigns
Design, Analysis and Simulation of Adaptive Clinical Trials Using ADDPLAN
Workshop Leader:
Silke Jörgens, Senior Statistical Consultant, ICON plc
8.30am - 12.30pm
• BOOK BY 18TH DECEMBER AND SAVE £400
• BOOK BY 29TH JANUARY AND SAVE £200
• BOOK BY 29TH FEBRUARY AND SAVE £100
HIGHLIGHTS FOR 2016:
• Discuss the European regulatory framework
and approaches to novel designs
• Evaluate the role of biomarker adaptive
designs in oncology
• Examine the role of an independent data
safety monitoring board
• Learn adaptive design in Bayesian statistic
• Explore the impact of adaptive changes in
clinical trials
• Study the development of new drugs in
orphan diseases
• Optimise dose finding design on oncology
CHAIRS FOR 2016:
Loïc Darchy,
Head of Statistical
Methodology Group,
Sanofi R&D
KEYNOTE SPEAKERS INCLUDE:
• Bo Huang, Director of Biostatistics, Pfizer USA
• Philip Hougaard, Vice President, Biometrics, Lundbeck A/S
• Giacomo Mordenti, Senior Director, Head of Biostatistics,
Grunenthal
• Frank Fleischer, Team Leader Clinical Biostatistics,
Boehringer-Ingelheim
• Bruce Turnbull, Professor of Statistics, Cornell University
Alex Sverdlov,
Associate Director
of Biostatistics,
EMD Serono
2. 8th Annual Adaptive Designs in Clinical Trials
Day One | Monday 18th April 2016
8.30 Registration & Coffee
9.00 Chairman's Opening Remarks
Loïc Darchy, Head of Statistical Methodology Group,
Sanofi R&D
LATEST DEVELOPMENTS IN ADAPTIVE DESIGNS
OPENING ADDRESS
9.10 Adaptive designs in practice
•Case studies of adaptive designs in practice
•Transforming a Phase II trial into a Phase II/III adaptive
design
•Usage of historical and within trial information for decision
making
•Adaptive trial examples in the early phase
Frank Fleischer, Team Leader Clinical Biostatistics,
Boehringer-Ingelheim
9.50 Seamless pPhase I/II dose finding designs with efficacy
and safety endpoints
•Advantages of pursuing seamless phase I/II trial designs
in the oncology setting
•Optimal and sequential adaptive designs to achieve
experimental objectives of phase I/II trials
•A simulation study to compare various state-of-the-art
phase I/II designs for bivariate binary efficacy-toxicity
outcomes
•Incorporating covariates to enable personalised dose-
finding
•Statistical software, information technology, and regulatory
aspects
Alex Sverdlov, Associate Director of Biostatistics, EMD Serono
10.30 Morning Coffee
11.00 Biomarker driven early phase oncology trials; opportunities
and challenges
•Pharmacodynamic biomarkers in early phase trials
•Immune monitoring
•Challenges in biomarker driven trials
Sidath Katugampola, Biomarker Drug Development
Manager, Cancer Research UK
11.40 Panel discussion: The role of biomarker-driven adaptive
designs in clinical development
•Early phase studies
•Clinical design strategies
•Patient perspectives
•Challenges and ongoing research developments
Loïc Darchy, Head of Statistical Methodology Group,
Sanofi R&D
12.20 Networking Lunch
LEADING STRATEGIES FOR CLINICAL DEVELOPMENT
1.30 Opportunities of adaptive enrichment designs in the era of
precision medicine
•Opportunities and challenges in the era of biomarker-
driven targeted therapies
•Overview of enrichment designs in statistical literature
•Case study 1: Bayesian predictive probability design for a
phase 2 POC study
•Case study 2: Adaptive enrichment with sample size
re-estimation for a phase 3 oncology study
Bo Huang, Director of Biostatistics, Pfizer
2.10 Optimising clinical trials in neuroscience
•Adaptive designs in neurology
•Integrating new biomarkers into clinical development
•Developing new strategies for testing multiple therapeutics
Richard Wyse, Director of Research and Development,
The Cure Parkinson's Trust
2.50 Afternoon Tea
3.20 Adaptive clinical trials: A DSMB perspective
•A series of vignettes will be presented based on the
speaker’s experiences from serving on the DSMB for
adaptive trials.
•Pitfalls that may occur during the conduct of an adaptive
trial; how they might be avoided.
•How members with differing interests interact at DSMB
meetings with each other, with the sponsor, with a CRO,
and with a “firewall”
Bruce W. Turnbull, Professor of Statistics, School of Operations,
Cornell University
4.00 Point estimates and confidence intervals for phase II/III
clinical trials when multiple endpoints are used to make
treatment selection
•Multi-arm and multi-stage
•Treatment selection
•Multiple endpoints
•Point estimation
•Confidence intervals
Peter Kimani, Assistant Professor, University of Warwick
4.40 Chairman's Closing Remarks and Close of Day One
Register online at: www.adaptivedesigns.co.uk • Alternatively fax
Attendees by Industry Sector –
Adaptive Designs in Clinical Trials 2015
WHO SHOULD ATTEND:
Directors, VPs, Chiefs, Heads,
Principals, Managers of
• Clinical trial managers
and associates
• Biostatisticians
• Directors of business
development
• Data managers
• Senior statisticians
• Professors of statistics
• Directors of Clinical trials
• Medical doctors
• Clinical scientists
UK 55%
Europe 35% Other 10%
Attendees by geo location –
Adaptive Designs in Clinical Trials 2015
Biostatistics 50%
Clinical
Science
20%
Data Manager
13%
Research &
Development 11%
Translational
medicine 6%
3. 8th Annual Adaptive Designs in Clinical Trials
Day Two | Tuesday 19th April 2016
8.30 Registration & Coffee
9.00 Chairman's Opening Remarks
Alex Sverdlov, Associate Director of Biostatistics, EMD Serono
CHALLENGES AND OBSTACLES OF ADAPTIVE DESIGNS
OPENING ADDRESS
9.10 Adaptive designs in proof-of-concept studies (Phase IIa)
and dose-finding studies (Phase IIb)
•Simultaneously doing proof-of-concept and finding the
dose(s) for future studies
•Finding the single best dose or a treatment window with
several acceptable doses?
•Choosing the most informative doses or the most promising
doses (the conflict between individual and collective
ethics)?
•Joint consideration of efficacy and safety
Philip Hougaard, Vice President, Biometrics, Lundbeck A/S
9.50 Be Adaptive: bright hope or buzz word? A mid-size company
perspective
•Adaptive design: what, where and why
•Adaptive development program
•Some cases studies in pain
Giacomo Mordenti, Senior Director, Head of Biostatistics,
Grunenthal
10.30 Morning Coffee
11.00 Early dialogue with regulatory agencies during development
and impact on programme and study design
•Facilitate the development of therapeutic that are
available to all patients across the EU
•Increase early dialogue between different stakeholders
•Increase patients' involvement
Bob Clay, Managing Director, Highbury Regulatory
Science Limited
11.40 Adaptive designs and Bayesian statistic
•The design of Bayesian Methods in clinical trials
•Sub group analysis
•Challenges of sample size estimation
Sophie Carr, MD and Principal Analyst, Bays Consulting Ltd
12.20 Networking Lunch
OPTIMISING DRUG DEVELOPMENTS
1.30 Improving adaptive designs
•Decision making during an adaptive design
•Deriving an efficient rule for sample size modification
•Optimising adaptive designs with treatment selection or
subset selection
•Assessing the benefits of an adaptive design – when are
these worthwhile?
Christopher Jennison, Professor of Statistics, University of Bath
2.10 Diagnosis and treatment of neurodegenerative dementia:
A clinical dilemma
•Overview and classification of degenerative dementia
•Diagnosis and overlaps of degenerative dementias
•Vascular cognitive impairment and its relationship with
degenerative dementias
•Pre-dementia stadium is the ideal target for treatment:
When and how
Filippo Baldacci, Medical Doctor, Department of Clinical and
Experimental Medicine, Neurology Unit, University of Pisa
2.50 Afternoon Tea
3.20 Improving covariate-adaptive designs
•The elements of covariate-adaptive randomisation
•Maintaining the type I error rate
•Likelihood-based inference following the designs
•Marginal and global balance
•Incorporating information on responses
Steve Coad, Reader in Statistics, School of Queen Mary,
University of London
4.00 Adaptive dose finding designs
•How to approach adaptive designs for non-statisticians
•Increasing productivity in Phase III trials by optimising
decision-making and trial efficiency
•Where do the greatest uncertainties lie?
•Improving patient experience
Senior representative, European Medical Agency*
4.40 Chairman’s Closing Remarks and Close of Day Two
Supported by
Want to know how you can get involved? Interested in promoting your services to this market?
Contact Anna Serazetdinova, SMi Marketing on +44 (0) 207 827 6180 or email: aserazetdinova@smi-online.co.uk
x your registration to +44 (0)870 9090 712 or call +44 (0)870 9090 711
*subject to final confirmation
4. INTERACTIVE HALF-DAY
POST-CONFERENCE WORKSHOP
Wednesday 20th April 2016
8.30am – 12.30pm
Holiday Inn Regents Park, London, UK
Design, Analysis and Simulation of
Adaptive Clinical Trials Using ADDPLAN
Leader:
Silke Jörgens, Senior Statistical Consultant, ICON plc
Overview of the workshop:
ADDPLAN is a statistical software package for the
design, simulation and analysis of adaptive clinical
trials. ADDPLAN's functionality covers all phases of
clinical drug development. It offers full insight into
operating characteristics of a wide range of
adaptive designs.
This workshop provides a short overview of
ADDPLAN’s, focusing on the design, simulation and
analysis of confirmatory adaptive designs with one
or more test treatment arms using ADDPLAN.
Key Benefits of Attending:
• Learn how to design confirmatory adaptive trials
• Get acquainted with ADDPLAN simulation
functionalities to support submissions of well and
less well understood adaptive designs
• See how ADDPLAN supports interim and final
analysis decision making
• Experience how to use ADDPLAN DF for innovative
dose-finding designs as MCPMod and CRMs
Programme
08.30 Registration and coffee
09.00 Session 1: Overview of ADDPLAN Modules
•Introduction
•ADDPLAN BASE, MC, PE and DF
09.30 Session 2: Two-armed Adaptive Clinical Trials
•Designing and Simulating a Trial
•Interim and Final Analysis
10.30 Coffee Break
11.00 Session 3: Overview of ADDPLAN DF
Functionalities
•Dose Escalation Designs
•Nonlinear modelling, contrast tests and
MCPMod
11.30 Session 4 title: Multi-armed Adaptive Clinical
Trials
•Design and Simulation
•Interim and Final Analysis
12.30 End of Workshop
About the Workshop Leader:
Dr. Silke Jörgens, Senior Statistical
Consultant, is part of ICON’s Innovation
Center which provides methodological
input into adaptive study designs and
also develops ICON’s proprietary
software for Adaptive Designs,
ADDPLAN®. She gained her PhD in adaptive trial
methodology at the Institute for Medical Statistics,
Informatics and Epidemiology (IMSIE), Faculty of
Medicine, Albertus-Magnus University Cologne,
Germany. Dr. Jörgens has more than 10 years’
experience in statistical consulting, biometrical
planning, and statistical evaluation of clinical trials,
along with experience in statistical lecturing and
training with a focus on adaptive design
methodology and relevant software.
About the Organisation:
ICON plc is a global provider of drug development
solutions and services to the pharmaceutical,
biotechnology and medical device industries. The
company specialises in the strategic development,
management and analysis of programs that support
clinical development - from compound selection to
Phase I-IV clinical studies. With headquarters in Dublin,
Ireland, ICON currently, operates from 77 locations in
38 countries and has approximately 11,700
employees.
5. SMi Pharmaceutical
2016 Planner:
JANUARY
Pharmaceutical Microbiology
20th - 21st January 2016
Holiday Inn Kensington Forum, London, UK
Social Media In The
Pharmaceutical Industry
20th - 21st January 2016
Holiday Inn Kensington Forum, London, UK
Pre-Filled Syringes
27th - 28th January 2016
Copthorne Tara Hotel,
London, UK
FEBRUARY
Parallel Trade
8th - 9th February 2016
Holiday Inn Kensington Forum, London, UK
Advances and Progress
in Drug Design
15th - 16th February 2016
Holiday Inn Kensington Forum, London, UK
RNAi Therapeutics
15th - 16th February 2016
Holiday Inn Kensington Forum, London, UK
MARCH
Superbugs & Superdrugs
- A Focus on Antibacterials
16th - 17th March 2016
Holiday Inn Kensington Forum, London, UK
Paediatric Clinical Trials
16th - 17th March 2016
Holiday Inn Kensington Forum, London, UK
APRIL
Asthma & COPD
11th - 12th April 2016
Holiday Inn Kensington Forum, London, UK
Controlled Release
18th - 19th April 2016
Holiday Inn Regents Park,
London, UK
Adaptive Designs
18th - 19th April 2016
Holiday Inn Regents Park,
London, UK
Pre Filled Syringes USA
25th - 26th April 2016
Renaissance Woodbridge,
New Jersey, USA
Lyophilisation USA
27th - 28th April 2016
Renaissance Woodbridge,
New Jersey, USA
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
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
ADAPTIVE DESIGNS IN CLINICAL TRIALS
Conference: Monday 18th & Tuesday 19th April 2016, Holiday Inn Regents Park, London, UK Workshop: Wednesday 20th April 2016, London, UK
4 WAYS TO REGISTER
www.adaptivedesigns.co.uk
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
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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 the attendance fees for all delegates. VAT is also 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 Total
□ Conference & 1 Workshop £2098.00 + VAT £2517.60
□ Conference only £1499.00 + VAT £1798.80
□ 1 Workshop only £599.00 + VAT £718.80
PROMOTIONAL LITERATURE DISTRIBUTION
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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.