This document provides information about the Geriatric Safe Medicines Summit conference taking place on September 16-17, 2013 in London. It outlines the schedule of speakers and topics to be discussed over the two days. Day one will focus on increasing representation of older people in clinical trials and addressing adherence issues. Day two will discuss improving safety in geriatric clinical trials and providing guidance on medical research involving older patients. The document provides contact information for those interested in attending, sponsoring or exhibiting at the event.
1) Drug development involves multiple phases of clinical trials in humans (phases I-IV) to test dosing, safety and efficacy in an increasing number of patients before regulatory approval and market access.
2) Patient involvement in clinical research is important to ensure trials address patient priorities and perspectives on risk/benefit, endpoints, and trial design elements like inclusion criteria.
3) Key elements of a clinical trial protocol include type of comparisons, randomization, blinding, endpoints, inclusion/exclusion criteria, schedule of events, informed consent process, and patient reported outcomes.
2014 Berlin_ Operational Excellence in Clinical TrailsKaren Radley
The document summarizes an upcoming two-day conference on operational excellence in clinical trials taking place March 12-13, 2014 in Berlin, Germany. It outlines the conference agenda, topics, and speakers. Over 20 speakers are listed from pharmaceutical and clinical research organizations who will address topics like study feasibility, patient recruitment and retention, social media in recruitment, clinical project management, and conducting global clinical trials. The document provides an overview of the conference objectives, sessions, and opportunities for networking and discussion between professionals in clinical operations and research.
This document discusses challenges in interpreting health-related quality of life (HRQOL) findings across cancer clinical trials. Two hypothetical trials that tested the same treatment showed conflicting HRQOL results. This was because the trials may have assessed different HRQOL areas, endpoints, handling of missing data, and analysis populations. To address this, international collaboration is needed to set standards for HRQOL analyses in cancer trials. This would help ensure HRQOL questions, designs, analyses and interpretations are consistent across trials.
The document discusses how patients can find, select, and shape clinical trials in order to identify research that is most beneficial. It emphasizes that patients should: understand their treatment options and scientific landscape; carefully evaluate trial design and motivations; and recognize that various stakeholders have competing interests. The goal is not just increasing the number of trials, but improving trial quality so they answer patients' needs. Patients are encouraged to engage with research groups long-term to help guide trial design toward options that offer meaningful benefit.
PharmaCon2007 Congress, Dubrovnik, Croatia "New Technologies and Trends in Pharmacy, Pharmaceutical Industry and Education" http://www.pharmacon2007.com
Abstract is available at http://www.pharmaconnectme.com
This document discusses patient-reported outcomes and quality of life measures that are important for evaluating the impact of disease and treatment from the patient's perspective. It provides background on common quality of life domains assessed and examples of generic, disease-specific, and symptom-specific patient-reported outcome measures. The document also describes Myeloma UK's experience developing a myeloma-specific patient-reported outcome scale called MyPOS to capture aspects beyond just symptoms that are important to myeloma patients' quality of life.
This document discusses biobanks and registries, their value for research, and opportunities for patient involvement. It describes how biobanks store biological samples and associated data to support research. Registries collect standardized clinical data on patient populations over time. Both require governance and quality management. The document presents two cases where patient organizations were involved in biobank and registry co-creation and governance to help advance research.
This document discusses guidelines for pan-Canadian newborn screening. It defines screening as applying tests to asymptomatic populations to identify those who need further investigation or treatment for better outcomes. Diagnosis involves evaluating symptomatic patients to confirm or rule out disease. The document outlines elements of an effective screening system, including education, testing, follow-up, data management, and governance. It discusses the use of dried blood spot samples, and notes work by a federal-provincial-territorial group to establish consensus on minimum screening panels and policies around sample storage and secondary use.
1) Drug development involves multiple phases of clinical trials in humans (phases I-IV) to test dosing, safety and efficacy in an increasing number of patients before regulatory approval and market access.
2) Patient involvement in clinical research is important to ensure trials address patient priorities and perspectives on risk/benefit, endpoints, and trial design elements like inclusion criteria.
3) Key elements of a clinical trial protocol include type of comparisons, randomization, blinding, endpoints, inclusion/exclusion criteria, schedule of events, informed consent process, and patient reported outcomes.
2014 Berlin_ Operational Excellence in Clinical TrailsKaren Radley
The document summarizes an upcoming two-day conference on operational excellence in clinical trials taking place March 12-13, 2014 in Berlin, Germany. It outlines the conference agenda, topics, and speakers. Over 20 speakers are listed from pharmaceutical and clinical research organizations who will address topics like study feasibility, patient recruitment and retention, social media in recruitment, clinical project management, and conducting global clinical trials. The document provides an overview of the conference objectives, sessions, and opportunities for networking and discussion between professionals in clinical operations and research.
This document discusses challenges in interpreting health-related quality of life (HRQOL) findings across cancer clinical trials. Two hypothetical trials that tested the same treatment showed conflicting HRQOL results. This was because the trials may have assessed different HRQOL areas, endpoints, handling of missing data, and analysis populations. To address this, international collaboration is needed to set standards for HRQOL analyses in cancer trials. This would help ensure HRQOL questions, designs, analyses and interpretations are consistent across trials.
The document discusses how patients can find, select, and shape clinical trials in order to identify research that is most beneficial. It emphasizes that patients should: understand their treatment options and scientific landscape; carefully evaluate trial design and motivations; and recognize that various stakeholders have competing interests. The goal is not just increasing the number of trials, but improving trial quality so they answer patients' needs. Patients are encouraged to engage with research groups long-term to help guide trial design toward options that offer meaningful benefit.
PharmaCon2007 Congress, Dubrovnik, Croatia "New Technologies and Trends in Pharmacy, Pharmaceutical Industry and Education" http://www.pharmacon2007.com
Abstract is available at http://www.pharmaconnectme.com
This document discusses patient-reported outcomes and quality of life measures that are important for evaluating the impact of disease and treatment from the patient's perspective. It provides background on common quality of life domains assessed and examples of generic, disease-specific, and symptom-specific patient-reported outcome measures. The document also describes Myeloma UK's experience developing a myeloma-specific patient-reported outcome scale called MyPOS to capture aspects beyond just symptoms that are important to myeloma patients' quality of life.
This document discusses biobanks and registries, their value for research, and opportunities for patient involvement. It describes how biobanks store biological samples and associated data to support research. Registries collect standardized clinical data on patient populations over time. Both require governance and quality management. The document presents two cases where patient organizations were involved in biobank and registry co-creation and governance to help advance research.
This document discusses guidelines for pan-Canadian newborn screening. It defines screening as applying tests to asymptomatic populations to identify those who need further investigation or treatment for better outcomes. Diagnosis involves evaluating symptomatic patients to confirm or rule out disease. The document outlines elements of an effective screening system, including education, testing, follow-up, data management, and governance. It discusses the use of dried blood spot samples, and notes work by a federal-provincial-territorial group to establish consensus on minimum screening panels and policies around sample storage and secondary use.
Sightseeing Pharmacy practice - The way forwardinemet
The document discusses future options for community pharmacy practice and trends influencing those options. It outlines four potential models for future pharmacy practice: a shop model focused on over-the-counter sales; a commercial chain model with limited professional services; a "MacPharmacy" model focused only on fast-moving prescriptions; and a professional practice/clinic model providing complex patient care services in collaboration with other health providers. Each model is described and questions are posed about how each option would impact patients, the profession, and monopoly over pharmacy services. Implementation of new practice models is discussed as requiring change management and addressing barriers through a stepwise project plan.
Bettina Ryll presented at the Melanoma Bridge meeting in Naples on patient participation in clinical research. She discussed the importance of involving patients in clinical trial design, management, and recruitment to ensure trials address relevant questions for patients. Ryll also emphasized the need for ethical trials that respect patient interests as outlined in the Helsinki Declaration and innovative trial models like adaptive licensing to help advance promising new therapies for melanoma while generating real-world evidence. Her goal is for evidence-based medicine to improve patient care and outcomes rather than be the ultimate aim.
Clinical research training - Deirdre Hyland, RCSI - Dec 7th 2016ipposi
Clinical research in Ireland can be categorized into patient-oriented research, epidemiological/behavioral studies, and outcomes/health services research. It commonly occurs in hospitals and academic institutions. Researchers include pharmaceutical companies, medical device companies, clinicians, and academic researchers who may receive funding from various sources like government research grants. Regulations and guidelines help ensure research quality and ethics. Patients participate in clinical trials to potentially access new treatments, increased healthcare access, and to contribute to medical progress, though they should be fully informed of risks and consent.
The role of patients and healthcare providers in translational medicinejangeissler
The role of patients and healthcare providers in translational medicine, presented by Jan Geissler at the European Commission's Personalized Medicine Conference 2016 on 1 June 2016 in Brussels
Presentation for EPEMED Webinar (11-27-12) FinalStig Albinus
This document discusses strategies for communicating the potential of personalized medicine to stakeholders in Europe. It begins by setting the context of the complexity of personalized medicine and the European healthcare landscape. It then examines stakeholders' current perceptions and initiatives related to personalized medicine. Several hypotheses are presented for how to advance adoption, including that social change is a major barrier, personalized medicine encompasses more than just genomics, and that a new health paradigm is needed. The document concludes by offering thought starters for communications strategies, such as humanizing genomics and demonstrating the new value model of personalized medicine. The desired future is for stakeholders like patients, physicians and policymakers to see personalized healthcare as empowering and improving outcomes while reducing costs.
A presentation delivered by Derick Mitchell, IPPOSI CEO at the event to celebrate International Clinical Trials Day on May 10th, 2018 in the Mansion House, Dublin, organised by HRB-CRCI.
2014 07-08 Selectbio Biomarkers 2014, CambridgeAlain van Gool
The document discusses biomarkers in personalized healthcare from discovery to clinical diagnostics, providing an overview of the speaker's experience in academia, pharmaceutical industry, and applied research focusing on biomarkers and omics technologies. It also describes the Radboud University Medical Center's focus on personalized healthcare through its technology centers and biomarker research on conditions like metabolic syndrome. The discussion emphasizes how biomarkers are evolving from diagnosis to tools that enable personalized and participatory healthcare approaches.
Results of an Online Survey of Stakeholders Regarding Barriers and Solutions ...John Reites
The survey found that the most significant barrier to clinical trial recruitment according to stakeholders was finding patients who meet eligibility criteria. The next most significant barriers were insufficient staff time for recruitment activities, followed by the length and complexity of consent forms, and protocol requirements other than eligibility criteria. Suggestions to overcome barriers included broadening eligibility criteria, improving planning, using effective recruitment methods and technology, simplifying processes, and improving staff support. Most stakeholders were optimistic that national recruitment rates would increase over the next 5-10 years if effective partnerships were formed between sectors like patient advocates, researchers, sponsors, and regulators.
Overview of the Patient-Centered Outcomes Research Institute (PCORI), how PCORI views Patient-Centered Outcomes Research and how this is related to PCORI’s major funding mechanisms.
PPPI - the involvement of patients or people in the design and development o...ipposi
Dr Jean Saunders, University of Limerick, and IPPOSI Board Member (Science) presents at the 5th World Congress on Advanced Clinical Trials and Clinical Research on public and patient involvement in clinical trials.
The document discusses three principles for European community pharmacy: monopoly on distributing medicine, ownership of pharmacies restricted to pharmacists, and geographical distribution of pharmacies. It then examines how the political, economic, and scientific landscape has changed since these principles were established. Finally, it argues that knowledge and the ability to apply knowledge will be key to addressing modern healthcare challenges in both developing and affluent countries.
This document discusses major advancements in precision oncology and immuno-oncology, including increasing the number of targeted drugs and biomarkers to expand rational treatment approaches. It also addresses combining therapies like PD1/PD-L1 inhibitors with chemotherapy or novel immune modulators to increase efficacy. As biomarkers proliferate, challenges arise around conducting clinical trials in fragmented populations and relying on liquid biopsies. Ongoing questions center on balancing earlier access to treatments with stronger evidence requirements in regulatory approval.
- Patient recruitment for clinical trials is a major challenge, estimated to be a $1.2-1.8 billion market. Recruitment costs average 6% of trial costs and are a primary factor in delays.
- Less than 5% of patients are aware of clinical trials, and only 2-3% actually enroll. However, over 90% of participants have a positive experience and would participate again.
- There is significant opportunity to improve recruitment through more patient-centric approaches leveraging data, technology, and analytics to identify more eligible patients and improve the recruitment process. However, this will require changes to traditional models.
Our main involvement with your clinical research recruitment program concludes with processing the responses to your mailer. As our staff members direct the respondents to your site, you can begin conducting final interviews to complete the clinical trial recruitment process.
The document summarizes the program for the 2nd edition of the Value-Based Health Care Prize. It includes:
- Welcome messages from the chairman and honorary chairman Prof. Michael Porter
- Presentations on enabling VBHC implementation challenges and best practices
- Nominees for the prize across various VBHC initiatives
- Announcement of award winners for patient outcomes, cost-effectiveness and collaboration
- "Value-based care for Parkinson's disease" project wins the overall prize
Making Value-Based Healthcare in Cataract a Reality Insights from VBHCAT Pr...Alexandre Lourenço
Alexandre Lourenço's keynote on "Making Value-Based Healthcare in Cataract a Reality - Insights from VBHCAT Project in Portugal", at the 44th World Hospital Congress organized by the International Hospital Federation, in November 8th 2021.
Clinical trials are necessary for medical research. Producing new medicines to the market depends on the strength of research organizations and drug companies to test and verify their work vigorously through their Clinical Trials, but finding people willing to participate is notoriously tricky.
This document discusses human-centered design (HCD) and its importance, especially in the medical device industry. It provides an overview of Achilles, a design firm, and their approach to HCD. They believe the user experience should consider emotional, rational, and physical factors. HCD helps improve existing products, enable new innovations, and dramatically improve people's lives. In medicine, HCD is even more crucial due to the many users involved, complex abilities, distance from development, and safety-critical nature. Achilles utilizes tools like observations, prototyping, and personas to incorporate users throughout the design process. The document highlights case studies of medical products Achilles has helped develop.
Sightseeing Pharmacy practice - The way forwardinemet
The document discusses future options for community pharmacy practice and trends influencing those options. It outlines four potential models for future pharmacy practice: a shop model focused on over-the-counter sales; a commercial chain model with limited professional services; a "MacPharmacy" model focused only on fast-moving prescriptions; and a professional practice/clinic model providing complex patient care services in collaboration with other health providers. Each model is described and questions are posed about how each option would impact patients, the profession, and monopoly over pharmacy services. Implementation of new practice models is discussed as requiring change management and addressing barriers through a stepwise project plan.
Bettina Ryll presented at the Melanoma Bridge meeting in Naples on patient participation in clinical research. She discussed the importance of involving patients in clinical trial design, management, and recruitment to ensure trials address relevant questions for patients. Ryll also emphasized the need for ethical trials that respect patient interests as outlined in the Helsinki Declaration and innovative trial models like adaptive licensing to help advance promising new therapies for melanoma while generating real-world evidence. Her goal is for evidence-based medicine to improve patient care and outcomes rather than be the ultimate aim.
Clinical research training - Deirdre Hyland, RCSI - Dec 7th 2016ipposi
Clinical research in Ireland can be categorized into patient-oriented research, epidemiological/behavioral studies, and outcomes/health services research. It commonly occurs in hospitals and academic institutions. Researchers include pharmaceutical companies, medical device companies, clinicians, and academic researchers who may receive funding from various sources like government research grants. Regulations and guidelines help ensure research quality and ethics. Patients participate in clinical trials to potentially access new treatments, increased healthcare access, and to contribute to medical progress, though they should be fully informed of risks and consent.
The role of patients and healthcare providers in translational medicinejangeissler
The role of patients and healthcare providers in translational medicine, presented by Jan Geissler at the European Commission's Personalized Medicine Conference 2016 on 1 June 2016 in Brussels
Presentation for EPEMED Webinar (11-27-12) FinalStig Albinus
This document discusses strategies for communicating the potential of personalized medicine to stakeholders in Europe. It begins by setting the context of the complexity of personalized medicine and the European healthcare landscape. It then examines stakeholders' current perceptions and initiatives related to personalized medicine. Several hypotheses are presented for how to advance adoption, including that social change is a major barrier, personalized medicine encompasses more than just genomics, and that a new health paradigm is needed. The document concludes by offering thought starters for communications strategies, such as humanizing genomics and demonstrating the new value model of personalized medicine. The desired future is for stakeholders like patients, physicians and policymakers to see personalized healthcare as empowering and improving outcomes while reducing costs.
A presentation delivered by Derick Mitchell, IPPOSI CEO at the event to celebrate International Clinical Trials Day on May 10th, 2018 in the Mansion House, Dublin, organised by HRB-CRCI.
2014 07-08 Selectbio Biomarkers 2014, CambridgeAlain van Gool
The document discusses biomarkers in personalized healthcare from discovery to clinical diagnostics, providing an overview of the speaker's experience in academia, pharmaceutical industry, and applied research focusing on biomarkers and omics technologies. It also describes the Radboud University Medical Center's focus on personalized healthcare through its technology centers and biomarker research on conditions like metabolic syndrome. The discussion emphasizes how biomarkers are evolving from diagnosis to tools that enable personalized and participatory healthcare approaches.
Results of an Online Survey of Stakeholders Regarding Barriers and Solutions ...John Reites
The survey found that the most significant barrier to clinical trial recruitment according to stakeholders was finding patients who meet eligibility criteria. The next most significant barriers were insufficient staff time for recruitment activities, followed by the length and complexity of consent forms, and protocol requirements other than eligibility criteria. Suggestions to overcome barriers included broadening eligibility criteria, improving planning, using effective recruitment methods and technology, simplifying processes, and improving staff support. Most stakeholders were optimistic that national recruitment rates would increase over the next 5-10 years if effective partnerships were formed between sectors like patient advocates, researchers, sponsors, and regulators.
Overview of the Patient-Centered Outcomes Research Institute (PCORI), how PCORI views Patient-Centered Outcomes Research and how this is related to PCORI’s major funding mechanisms.
PPPI - the involvement of patients or people in the design and development o...ipposi
Dr Jean Saunders, University of Limerick, and IPPOSI Board Member (Science) presents at the 5th World Congress on Advanced Clinical Trials and Clinical Research on public and patient involvement in clinical trials.
The document discusses three principles for European community pharmacy: monopoly on distributing medicine, ownership of pharmacies restricted to pharmacists, and geographical distribution of pharmacies. It then examines how the political, economic, and scientific landscape has changed since these principles were established. Finally, it argues that knowledge and the ability to apply knowledge will be key to addressing modern healthcare challenges in both developing and affluent countries.
This document discusses major advancements in precision oncology and immuno-oncology, including increasing the number of targeted drugs and biomarkers to expand rational treatment approaches. It also addresses combining therapies like PD1/PD-L1 inhibitors with chemotherapy or novel immune modulators to increase efficacy. As biomarkers proliferate, challenges arise around conducting clinical trials in fragmented populations and relying on liquid biopsies. Ongoing questions center on balancing earlier access to treatments with stronger evidence requirements in regulatory approval.
- Patient recruitment for clinical trials is a major challenge, estimated to be a $1.2-1.8 billion market. Recruitment costs average 6% of trial costs and are a primary factor in delays.
- Less than 5% of patients are aware of clinical trials, and only 2-3% actually enroll. However, over 90% of participants have a positive experience and would participate again.
- There is significant opportunity to improve recruitment through more patient-centric approaches leveraging data, technology, and analytics to identify more eligible patients and improve the recruitment process. However, this will require changes to traditional models.
Our main involvement with your clinical research recruitment program concludes with processing the responses to your mailer. As our staff members direct the respondents to your site, you can begin conducting final interviews to complete the clinical trial recruitment process.
The document summarizes the program for the 2nd edition of the Value-Based Health Care Prize. It includes:
- Welcome messages from the chairman and honorary chairman Prof. Michael Porter
- Presentations on enabling VBHC implementation challenges and best practices
- Nominees for the prize across various VBHC initiatives
- Announcement of award winners for patient outcomes, cost-effectiveness and collaboration
- "Value-based care for Parkinson's disease" project wins the overall prize
Making Value-Based Healthcare in Cataract a Reality Insights from VBHCAT Pr...Alexandre Lourenço
Alexandre Lourenço's keynote on "Making Value-Based Healthcare in Cataract a Reality - Insights from VBHCAT Project in Portugal", at the 44th World Hospital Congress organized by the International Hospital Federation, in November 8th 2021.
Clinical trials are necessary for medical research. Producing new medicines to the market depends on the strength of research organizations and drug companies to test and verify their work vigorously through their Clinical Trials, but finding people willing to participate is notoriously tricky.
This document discusses human-centered design (HCD) and its importance, especially in the medical device industry. It provides an overview of Achilles, a design firm, and their approach to HCD. They believe the user experience should consider emotional, rational, and physical factors. HCD helps improve existing products, enable new innovations, and dramatically improve people's lives. In medicine, HCD is even more crucial due to the many users involved, complex abilities, distance from development, and safety-critical nature. Achilles utilizes tools like observations, prototyping, and personas to incorporate users throughout the design process. The document highlights case studies of medical products Achilles has helped develop.
Key stakeholders in clinical research include study sponsors, investigators and site personnel, monitors, institutional review boards (IRBs), study subjects, and regulators. Sponsors are responsible for the design and oversight of studies, including selecting investigators and monitoring sites. Investigators conduct the research and ensure ethical and safe treatment of subjects. IRBs and ethics committees review studies to protect subject safety and rights. Monitors verify compliance and safety on behalf of sponsors. Subjects participate in studies after providing informed consent. Regulators such as the FDA and CDSCO approve studies and ensure compliance.
Presented at the Zurich Frontend Conference (http://2014.frontendconf.ch/) on August 29th, 2014. Here I presented ideas on the integration of user experience in the growing trends of Internet of Things (IoT) devices and wearable sensors.
The document outlines the key steps in the medical device design and development process as required by ISO 13485. This includes establishing procedures for design and development stages, planning with target dates and reviews, determining inputs, producing outputs like drawings and bills of materials, conducting reviews and verification to ensure outputs meet inputs, performing validation to ensure the product meets requirements, and controlling any changes to the design.
Common Mistakes in the Medical Device Development ContinuumNAMSA
Getting a medical device to market is a long process made up of multiple stages. Each stage requires a number of elements that need to be considered before progress can be made with the device. And even after market approval has been obtained, there is a continuous need to reevaluate and test the device to maintain safety and efficacy.
Throughout this development process, several steps can be missed that may result in submission refusal, or possibly a faulty device.
Carolien Creemers and Maarten Bressinck work as functional designers at Nobel Biocare, focusing on user experience and interaction design for digital dental solutions. They discussed challenges with designing medical software due to strict regulations and outlined Nobel Biocare's process, which incorporates agile development methods and user research like field studies and usability testing to ensure safety and meet regulations. They provided examples of their solutions, like using cards to visualize dental lab workflows and mapping surgical cuts onto a digital tool.
FDA Design Controls: What Medical Device Makers Need to KnowGreenlight Guru
The document provides an overview of a presentation on FDA Design Controls. It introduces the two presenters, David Amor and Jon Speer, who are experts in medical device quality systems and design controls. The presentation will cover topics related to design controls regulations, including intended use, user needs, design inputs, design reviews, risk management, design outputs, design verification and validation, and regulatory submissions. It is meant to help medical device companies understand and comply with FDA design control requirements.
Easy UX Process Steps Must follow by every UX Designer Think 360 Studio
User experience (UX) and user interface (UI) designers are essential for any startup business. The ordinary generalization for ux designer is that they are regular graphic or visual designers. UX designers wear numerous caps in a startup. This includes showcasing, arranging, planning, imparting and testing. Every UX designer should follow these simple process.
UX design (or user experience design) is becoming an increasingly important field for business owners around the world. Good UX design can make a website many times more profitable, while poor UX design can put a company out of business in the right situations. It's worth taking a look to determine if YOUR business could be furthered by some great user experience design.
This document is a presentation by Prince Pal about common mistakes in UX design. It provides humor and levity by listing signs of a "stupid UX designer" including claiming wireframes are complete design work, only learning during live use, and prioritizing creativity over technical skills. It also shares jokes about problematic design decisions like prioritizing certain colors in testing or demanding cross-browser compatibility with outdated browsers. The presentation concludes by crediting various sources for the UX humor and jokes.
This document discusses heart sounds and murmurs and provides information on auscultating the heart. It describes the normal heart sounds and where to best auscultate each heart valve. It discusses abnormalities in heart sounds that can indicate various heart conditions. It also covers extra heart sounds like S3, S4, clicks, and gallops and what medical conditions they may suggest. The document is intended to educate medical students and residents on evaluating and interpreting heart sounds during a physical exam.
This document summarizes a conference on paediatric clinical trials taking place from March 24-25, 2015 in London. It provides information on registration discounts, key speakers from regulatory agencies and pharmaceutical companies, and the daily agendas which will focus on regulatory frameworks, clinical trial design and conduct, formulation challenges, and innovations in paediatric research. Attendees will learn about population pharmacokinetic modelling, challenges in rare disease trials, and strategies for optimizing patient participation in clinical studies.
This document provides information about an upcoming conference on orphan drugs that will take place on October 18-20, 2016 in London. It includes details about the interactive workshops on the first day and key sessions over the two main conference days that will discuss topics such as regulatory challenges, developing treatments for rare diseases, pediatric orphan drug development, and partnerships in the orphan drug field. Information is provided on registering for the event and sponsorship opportunities.
This document provides information about an upcoming conference on orphan drugs taking place on October 18-20, 2016 in London. It includes details about two pre-conference workshops on developing orphan drug strategies and achieving orphan drug market access. The main conference will discuss regulatory developments, reducing costs, and innovations in orphan drugs. It will address challenges such as developing drugs for rare diseases in emerging markets and for pediatric populations. Featured speakers will represent organizations such as NICE, Alexion, Mereo BioPharma, and Abeona Therapeutics. The conference aims to facilitate discussion on improving access to treatments for rare diseases.
This document provides information about the 9th annual conference on ADMET (Absorption, Distribution, Metabolism, Excretion and Toxicity) enhancing drug quality by ADMET optimisation in discovery that will take place from June 30th to July 2nd 2014 at the Marriott Regents Park Hotel in London. Key information includes:
- Discounts are available for booking by March 31st (save £300) and April 30th (save £100).
- The conference will focus on integrating ADMET and toxicity data to enhance drug safety prediction, drug transporters, predictive toxicology, and computational/in vitro ADMET approaches.
- There will be presentations from industry leaders at companies like
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.
This document summarizes a conference on orphan drugs and rare diseases that will take place from October 20-21, 2014 in London. The conference will focus on enhancing development pathways for orphan drugs and rare diseases, gaining early market access, and enhancing patient recruitment. Key topics will include the Early Access to Medicines Initiative, adapting licensing pathways, assessing regulatory tools to gain early access, and creating a culture of innovation. There will also be interactive workshops on commercial aspects, developing novel biologic therapies, and regulatory requirements for orphan drugs.
This document provides information about the "Patient Adherence and Compliance Masterclass" conference organized by Fleming Europe on February 25-26, 2016 in Amsterdam. The two-day conference will address improving patient adherence through collaboration between various stakeholders in healthcare. Day 1 will focus on understanding non-adherence from the patient perspective and exploring digital solutions. Day 2 will discuss stakeholder cooperation and ways to create effective patient support teams. The event will feature a diverse speaker panel of industry executives, medical professionals, and patient advocates.
This document summarizes a two-day masterclass on patient adherence and compliance organized by Fleming Europe. Day 1 will feature discussions on understanding adherence from the patient's perspective, patient empowerment, preparing for effective patient engagement, the challenges of living with a chronic illness, and using digital media and mHealth to improve adherence. Day 2 will focus on stakeholder collaboration to improve adherence, an award-winning case study on connecting nurses, and pharmacy-based interventions. The event will bring together patients, medical professionals, pharmaceutical industry representatives, and others to discuss improving medication adherence.
The Role of Patients & their Challenges in Clinical TrialsKathi Apostolidis
What are clinical trials
Myths about clinical trials
What patients want
The role of patients in clinical trials
How to communicate trial information
How to communicate trial results
SMi Group's Orphan Drugs and Rare Diseases 2019Dale Butler
This document provides information about the 9th Annual Conference on Orphan Drugs & Rare Diseases taking place from October 15-17, 2019 in London. The conference will discuss key challenges to advancing commercialization and patient access of orphan drugs. It will include sessions on market access, regulation, patient advocacy, and case studies. A half-day post-conference workshop on October 17th will provide an interactive deep dive into strategies for accelerating patient access of orphan drugs.
This document discusses improving patient involvement in clinical research. It outlines potential advantages of patient involvement including better understanding patient needs, identifying trial hurdles and relevant outcomes, and improving trial protocols and recruitment. Challenges to patient involvement include a lack of experience, unclear rules for collaborating with advocacy groups, and balancing patient wishes with feasibility. The document describes Janssen collaborating with advocacy groups on a prostate cancer trial after they identified recruitment issues. It also discusses overcoming barriers through codes of practice and measuring outcomes of collaboration developed with EUPATI.
Day 1: Challenges and opportunities for better detection, diagnosis and clini...KTN
The focus of this session is to explore how the UK health system is currently responding to the increasing number of patients with multiple long-term conditions and the impacts of healthcare inequalities on patient outcomes. We will also explore opportunities for businesses to bring about much needed innovations in the prevention, early diagnosis and management of multi-morbidity.
A presentation delivered by IPPOSI CEO, Derick Mitchell at the University College Dublin PharmTox Society event on Clinical Trials in Ireland on March 6th, 2017
This document discusses patient involvement at the Medicines Evaluation Board (MEB) in the Netherlands. It makes three key points:
1. The MEB focuses on involving patients throughout the entire life cycle of a medicinal product to ensure the patient perspective is considered. Meetings are held 3-4 times per year and minutes are published online.
2. Strategies for patient involvement at the MEB include having a board member represent the patient perspective, consulting patient organizations on regulatory decisions and guidelines, and creating an online portal for patients.
3. Eliciting individual patient preferences could help identify subgroups with similar preferences to better tailor regulatory decisions and highlight situations where regulator and patient values differ requiring improved communication.
The document discusses a webinar series from the Patient Experience Network (PEN) focusing on what is working well in patient experience. The webinars will cover various initiatives and case studies from the UK that have improved patient experience. They will discuss topics like initiatives driven by passion, the importance of organizational support, measuring impact, and partnership working. The webinars are part of promoting the PEN National Awards which recognize excellence in patient experience.
SMi Group's 5th annual Drug Safety 2018 conferenceDale Butler
This document provides information about an upcoming drug safety conference to be held from June 11-13, 2018 in London. The conference will focus on strategies for maintaining global pharmacovigilance systems and managing adverse drug effects. It will include presentations from regulatory and pharmaceutical industry speakers on topics such as risk management, signal detection, patient involvement in drug safety, and the impact of Brexit on drug safety regulations. The interactive post-conference workshop on June 13 will address evaluation of risk minimization strategies.
Border Security -2014 attendees include leading border/homeland security and control, immigration, police and law enforcements specialists, foreign affairs officials and security systems providers from Bulgaria, UK, Germany, Switzerland, Romania, Hungary, Italy, Brazil, China, Belgium, Netherlands, Nigeria, Chezh Republic, Afghanistan,Tajikistan and other countries.
European smart grid cyber and scada securityYulia Rotar
European Smart Grid Cyber and SCADA Security Conference by the SMi Group, London, UK, 10-11 March 2014.
Get in touch with us via mmalik@smi-online.co.uk
The document advertises the 8th annual Pre-Filled Syringes Americas conference and exhibition taking place from March 31st to April 2nd, 2014 in Iselin, New Jersey. The conference will bring together over 85 key decision makers from leading biotechnology and pharmaceutical companies to discuss developments in pre-filled syringes and injection devices over the course of two days of presentations, panel discussions, and workshops. Attendees will have the opportunity to network with industry leaders, evaluate solutions from exhibitors, and return to their businesses with the information and contacts needed to make decisions for their products.
This document provides information about the "Biosimilars & Biobetters USA 2014" conference to be held on April 7-8, 2014 in Iselin, New Jersey. The conference will focus on regulatory issues, commercialization strategies, and product development for biosimilars and biobetters in the US market. It includes an agenda with speaker information, session topics, and registration details. There will also be two post-conference workshops on April 9th on differentiation strategies for generics and launching biosimilars. The document promotes the conference and workshops as an opportunity to gain industry insights, network with leaders, and learn how to successfully develop and launch biosimilar products in the US.
Infographic pfs industry survey resultsYulia Rotar
The document summarizes the results of an industry survey on the future of pre-filled syringes. According to the survey, experts believe the biggest problems currently facing the pre-filled syringe industry are materials questions, difficulty preventing leachables and extractables into drug products, and usability from a patient focus. When asked about regulatory factors, experts highlighted new FDA guidelines for combination products and the interpretation of analytical results. A majority of respondents believed the future of development lies with plastic syringes rather than glass. The biggest advancements in the pre-filled syringe industry were seen as attaining high patient safety in self-administration and meeting changing therapeutic demands.
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The report *State of D2C in India: A Logistics Update* talks about the evolving dynamics of the d2C landscape with a particular focus on how brands navigate the complexities of logistics. Third Party Logistics enablers emerge indispensable partners in facilitating the growth journey of D2C brands, offering cost-effective solutions tailored to their specific needs. As D2C brands continue to expand, they encounter heightened operational complexities with logistics standing out as a significant challenge. Logistics not only represents a substantial cost component for the brands but also directly influences the customer experience. Establishing efficient logistics operations while keeping costs low is therefore a crucial objective for brands. The report highlights how 3PLs are meeting the rising demands of D2C brands, supporting their expansion both online and offline, and paving the way for sustainable, scalable growth in this fast-paced market.
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L'indice de performance des ports à conteneurs de l'année 2023SPATPortToamasina
Une évaluation comparable de la performance basée sur le temps d'escale des navires
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Le développement de l'ICPP repose sur le temps total passé par les porte-conteneurs dans les ports, de la manière expliquée dans les sections suivantes du rapport, et comme dans les itérations précédentes de l'ICPP. Cette quatrième itération utilise des données pour l'année civile complète 2023. Elle poursuit le changement introduit l'année dernière en n'incluant que les ports qui ont eu un minimum de 24 escales valides au cours de la période de 12 mois de l'étude. Le nombre de ports inclus dans l'ICPP 2023 est de 405.
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P 113 geriatric
1. www.geriatricsummit.com
BOOK BY 31ST MAY AND SAVE £300 / BOOK BY 28TH JUNE AND SAVE £100
Register online or fax your registration to +44 (0) 870 9090 712 or call +44 (0) 870 9090 711
FEATURED SPEAKERS:WHY ATTEND THIS EVENT:
• Discover the benefits of performing clinical
trials in older people
• Identify the key challenges and
considerations when conducting clinical trials
in older people
• Address reasons for clinical trial retention
difficulties
• Discuss how modelling and simulation
along with new patient reporting systems
support clinical trials in older people
• Explore new market gaps and discover new
market strategy
• Focus on the EMA geriatric medicines
strategy
• Solange Rohou, Director of Regulatory Affairs,
AstraZeneca
• Barbro Westerholm, Member of Parliament, Sweden,
Liberal Party
Novartis
• Michael Richardson, VP International and QPPV EU
GPV&E, Bristol Myers Squibb
• Eva Bredberg, Director Global Clinical Pharmacology,
AstraZeneca
• Peter Crome, Professor, Department of Primary Care
and Population Health, University College London
• Anthea Tinker, Professor of Social Gerontology,
Kings College London
SMi Presents their Inaugural 16 - 17
SEPT
2013Marriott Hotel, Regents Park, London, UK
Geriatric Safe
Medicines Summit
• Florian Von Raison, Global Programme Head,
• Nina Barnett, Consultant Pharmacist,Northwest
• Philippe Guillet, Chief Geriatrician,TSU Ageing,
Sanofi R&D
London Hospitals Trust
2. Want to know how you
can get involved? Interested
in promoting your
pharmaceutical services
to this market?
Contact Margaret Mugema,
SMi Marketing on
+44 (0) 207 827 6072,
or email
mmugema@smi-online.co.uk
Register online at: www.geriatricsummit.com • Alternatively fax yo
• Pharmacovigilance Specialists
• QPPV
• Consultant Pharmacologist
• Recruitment and Retention
Managers
• Head of Medicine and Society
• Medical Advisor
WHO SHOULD ATTEND:
08.30 REGISTRATION & COFFEE
09.00 CHAIRMAN’S OPENING REMARKS:
Solange Rohou, Director of Regulatory Affairs, AstraZeneca
KEY NOTE
09.10 Patient Perspectives on Healthy Ageing
• Most important is to be regarded as a resource, to feel
needed
• Not to meet ageism/age discrimination
• Effective and safe treatment when in need
Barbro Westerholm, Member of Parliament, Sweden,
Liberal Party
Increasing the Representation of Older People in Clinical Trials
09:50 Representation of Older People in Clinical Trials:
Results and recommendations of the PREDICT Study
• The systematic reviews confirmed the continued unjustified
exclusion of older people from clinical trials and that
clinicians treating older people and other professional
believed that older people were disadvantaged as a result
• Focus groups held in the 9 participating countries confirmed
that older people and their countries supported a more
robust system for including older people in clinical trials
Peter Crome, Professor, University College London
10.30 MORNING COFFEE
11.00 Why do older people drop out of longitudinal health
studies and how can they be encouraged to continue to
participate?
• The evidence from longitudinal studies abut older people
who drop out of studies
• A case study of the Whitehall research on drop out including
what would encourage participation
• A personal perspective on involvement in 3 longitudinal
studies
Anthea Tinker, Professor of Gerontology, Kings College
London
Addressing Adherence Issues
11.40 What can we learn from non adherence in the Clinical
Trial
• Adherence as a key to achieve the therapeutic outcomes
• Reasons for non-adherence: a patient perspective
• Understanding non-adherence as a source for product
enhancement early on
Sven Stegemann, Director, Capsugel
12.20 NETWORKING LUNCH
13.30 A coaching approach to medication adherence
• Changing the consultation paradigm - the imperatives
• Practical and perceptual approaches to adherence
• Coaching and medication adherence
• Managing short consultations
Nina Lee Barnett, Consultant Pharmacist, Older People
North West London Hospitals Trust and E&SE England
Specialist Pharmacy Services
14.10 Are low treatment uptake rates due to polymorbidity
and polymedication issues: perspectives from the
osteoporosis treatment gap in France and the UK.
• Evolution of guidelines and clinical practices in the
management of osteoporosis
• Current osteoporosis guidelines and treatment gap
• Reasons for treatment decline, uptake and withdrawal
Jonathan Guillemot, Gerontologist, Kings College London
14.50 AFTERNOON TEA
15.20 Can elderly people use new technologies to record their
own data?
• Where are we with ePRO in general, and specifically with
elderly?
• What is our experience with elderly?
• What is to be considered in Clinical Trials with elderly when
they have unsupervised data collection?
• Case studies
Valdo Arnera, General Manager, PHT Corp
16.00 Formulation development of orally disintegrating
tablets: An opportunity to address swallowing
difficulties in geriatric patients
• The formulation approaches used to overcome medication
non adherence in geriatric patients and the paradigm of
patient-centered dosage forms
• The emerging pharmaceutical orally disintegrating dosage
forms and their significance in the increasingly ageing
society
• Various technologies and cost-effective strategies for orally
disintegrating tablet formulation
• Novel atomic force microscopy applications which provide an
insight into molecular aspects of orally disintegrating tablets
formulation development
Ali Al-Khattawi, Researcher in Pharmaceutical
Sciences/Drug Delivery, Aston University
16.40 Chairman’s Closing Remarks and Close of Day One
• Program Heads
• Clinical Trial Design
Manager
• Gerontologists
• Geriatrician
• Clinical Trials Manager
• Academics
DAY ONE | 16TH SEPTEMBER 2013 Geriatric Safe Medicines Summit
Supported by
• Research Scientists
• Pharmaceutical
regulators
• Stakeholders and those
with an interest in
Geriatric medicine
3. our registration to +44 (0)870 9090 712 or call +44 (0)870 9090 711
DAY TWO | 17TH SEPTEMBER 2013
08.30 REGISTRATION & COFFEE
09.00 CHAIRMAN’S OPENING REMARKS:
Solange Rohou, Director of Regulatory Affairs, AstraZeneca
Improving Safety Within Geriatric Clinical Trials
09.10 Geriatric Syndromes: What are they?
Why do they matter?
• Old Old Adults (75+) is the fastest growing segment of
population
• Old Old subject to specific Geriatric Syndromes (Frailty,
Delirium,...), which change the way acute situations
manifest themselves (including drug effects and toxicities),
needing specific screening, diagnosis & treatment
approaches
09.50 Modelling & simulation to support evaluation of safety
and efficacy of drugs in older patients
• Strategic considerations in drug development regarding
the elderly
• Changes in PK and PD with age
• What value can M&S provide to improve understanding
of risk benefits in older people?
• Two examples from AstraZeneca
Eva Bredberg, Director Global Clinical Pharmacology,
AstraZeneca
10.30 MORNING COFFEE
11.00 What has been done since the revision of the ICH E7
guideline? The Companies' view
• The revision of ICH E7
• EFPIA interactions at the workshop organised by the EMA in
March 2012
• How to optimise clincial development in the elderly?
• What companies are planning/doing to collect data in this
special growing population
Solange Rohou, Director Regulatory Affairs, AstraZeneca
11.40 Early identification of co-morbidities and the challenges
of prescribing in this patient population due to drug-
drug interactions
• Cognitive impairment as a barrier to treatment
• The impact of co-mobidities on a Clinical Trial
• Developing effective patient reporting systems as a way to
improve patient compliance
Mark Baxter, Geriatric Consultant, Spire Sussex Hospital
12.20 NETWORKING LUNCH
Importance of Guidance on Medical Research
in Geriatric Patients
13.30 Proposal for guidance on medical research for and with
older people in Europe
• There is an evident lack of consistent ethical guidance on
medical research for and with older people in Europe
• Workshops with stakeholders from academia, investigators,
patient representatives and pharma were held to develop
a consensus on principals
• The aim of the guidance is to facilitate clinical research for
and with the older patient population
Florian Von Raison, Global Program Head, Novartis
Pharma
14.10 Information for rational drug prescribing to older
patients - from pre-authorisation to post-marketing
• Older patients in pre-authorisation trials – number,
exclusion criteria and representability
• Available information for adequate prescribing to older
patients – product information and handbooks
• What information for adequate prescribing about older
patients is needed? – views of clinical and non-clinical
professionals
Erna Beers, MD, Clinical Pharmacologist, UMC Utrecht
14.50 AFTERNOON TEA
15.20 Effective risk-management planning in older people
• Effectiveness of post-authorisation studies
• Important considerations in prescribing
• Predicting adverse drug reactions: Key predictor outcomes
Michael Richardson, VP International and QPPV EU GPV&E,
Bristol Myers Squibb
16.00 The use of body monitoring devices to monitor Geriatric
drug absorption rates
• Body monitoring devices as a useful tool to detect
absorption rates
• Assessment of patient reaction to drug substances
• Body monitoring devices: an effective effective method of
assessing in real-time a patients reaction to dosage forms
Jean Cuine, Chief Scientific Officer, NextPharma
16.40 Chairman’s Closing Remarks and Close of Day Two
Geriatric Safe Medicines Summit
SPONSORSHIP
AND EXHIBITION
OPPORTUNITIES
SMi offer sponsorship,
exhibition, advertising and
branding packages, uniquely
tailored to complement your
company's marketing
strategy. Should you wish to
join the increasing number of
companies benefiting from
sponsoring our conferences
please call:
Anuja Raut, SMi Sponsorship
on +44 20 7827 6128 or
email: araut@smi-online.co.uk
SMi PHARMACEUTICALS FORWARD PLANNER 2013
MAY
Generics, Supergenerics
and Patent Strategies
13 - 14 May 2013, London
Pain Therapeutics
20 - 21 May 2013, London
ADC Summit
20 - 21 May 2013, London
Clinical Trial Logistics
22 - 23 May 2013, London
JUNE
RNAi & Nanotechnology
5 - 6 June 2013, London
Biobanking
24 - 25 June 2013, London
JULY
Pharmacovigilance
1 - 2 July 2013, London
Cell Culture
3 - 4 July 2013, London
ADMET
10 - 11 July 2013, London
SEPTEMBER
Cancer Vaccines
18 - 19 September 2013,
London
OCTOBER
Biosimilars & Biobetters
1 - 2 October 2013, London
Diabetes
1 - 2 October 2013, London
Orphan Drugs
14 - 15 October 2013, London
COPD: Novel Therapeutics
and Management Strategies
16 - 17 October 2013, London
European Pharmaceutical
Pricing & Reimbursement
21 - 22 October 2013, London
Point of Care Diagnostics -
Market Opportunities and
Technology Trents
23 - 24 October 2013, London
NOVEMBER
Cell Based Assays
18 - 19 November 2013,
London
Clinical Trials in CNS
18 - 19 November 2013,
London
DECEMBER
Cold Chain Distribution
3 - 4 December 2013, London
Philippe Guillet, Ageing Therapeutic Strategic Unit, Sanofi
4. GERIATRIC SAFE MEDICINES SUMMIT
Conference: Monday 16th and Tuesday 17th September 2013, Marriott Hotel, London, UK
4 WAYS TO REGISTER
FAX your booking form to +44 (0) 870 9090 712
PHONE on +44 (0) 870 9090 711
www.geriatricsummit.com
POST your booking form to: Events Team, SMi Group Ltd, 2nd Floor South,
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If you have any further queries please call the Events Team on tel +44 (0) 870 9090 711 or you can email them at events@smi-online.co.uk
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payment has been received.
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Regretfully cancellation after this time cannot be accepted. We will however provide the
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