The document discusses various ways that the pharmaceutical industry is working with patients and healthcare professionals to increase patient involvement in medicine development. It provides examples of patient groups being more involved in clinical trials and discussions earlier in the process. It also discusses efforts by the industry to increase transparency, such as publishing payments to healthcare professionals and sharing clinical trial data with researchers. There has been steady improvement in disclosure rates for clinical trial results.
The future of healthcare is an exciting one. With innovations in genomics, healthcare data, advanced therapies and innovative technologies, our industry will continue to progress and provide hope to people so they can live longer, healthier and productive lives.
Trailblazing scientists who are the backbone of our industry. These are the people that discover the molecules and develop the medicines to tackle the toughest diseases we face in society.
The document discusses the importance of manufacturing to the UK pharmaceutical industry and the life sciences sector. It outlines the goals of the Medicines Manufacturing Industry Partnership (MMIP) in making the UK an attractive location for medicines manufacturing through initiatives like skills development programs. The document also notes industry's significant financial contributions to the NHS through the Pharmaceutical Price Regulation Scheme, and the importance of ensuring a regulatory framework that supports innovation as the UK leaves the EU.
The UK is at the forefront of the global pharmaceutical industry. As well as developing new medicines for many diseases, the pharmaceutical industry in the UK provides many other benefits to the British economy, including income, employment, expertise and major investment.
The UK is at the forefront of the global pharmaceutical industry. As well as developing new medicines for many diseases, the pharmaceutical industry in the UK provides many other benefits to the British economy, including income, employment, expertise and major investment.
These slides offer a useful, referenced resource for members and visitors to our website who wish to share the story about the value of medicines. They complement existing resources available on the ABPI website and will be updated regularly as the ABPI updates other data and content.
Medicines and vaccines have helped deliver improvements in patient health. History shows us the great advances we have made - today we continue to see the potential to eradicate disease and improve health outcomes when we invest in science and adopt and use new medicines.
The document summarizes HealthBIO 2021, Finland's largest annual life science event taking place on its 15th year and bringing together over 200 companies and academics. It also provides details about FIB (Finnish Bioindustries), the biotechnology industry association established in 1997 to promote networking and information sharing in the life science sector. FIB helps commercialize new biotechnology areas and supports national and international cooperation for legislation related to the field. Finally, it outlines Forendo Pharma's focus on women's health through development of HSD17B enzyme inhibitors for conditions like endometriosis and PCOS, with one drug entering phase 2 trials in 2022 and another starting phase 1.
HealthBIO 2021_Cancer I/O Translating immuno-oncology into health actions_Jer...Business Turku
This document provides a summary of an introduction to cancer immuno-oncology. It discusses utilizing the immune system to kill cancer cells and the increasing uptake of immuno-oncology drugs. It outlines the goals of the Cancer IO Office to facilitate immuno-oncology uptake through strategic foresight, societal discussion, and Finnish immuno-oncology research. The document describes the Cancer IO Office's themes of immuno-oncology in society, research, and healthcare which include developing 3D cancer culture models, utilizing real-world data to identify super responders, and analyzing immuno-oncology uptake in Finnish hospitals.
The future of healthcare is an exciting one. With innovations in genomics, healthcare data, advanced therapies and innovative technologies, our industry will continue to progress and provide hope to people so they can live longer, healthier and productive lives.
Trailblazing scientists who are the backbone of our industry. These are the people that discover the molecules and develop the medicines to tackle the toughest diseases we face in society.
The document discusses the importance of manufacturing to the UK pharmaceutical industry and the life sciences sector. It outlines the goals of the Medicines Manufacturing Industry Partnership (MMIP) in making the UK an attractive location for medicines manufacturing through initiatives like skills development programs. The document also notes industry's significant financial contributions to the NHS through the Pharmaceutical Price Regulation Scheme, and the importance of ensuring a regulatory framework that supports innovation as the UK leaves the EU.
The UK is at the forefront of the global pharmaceutical industry. As well as developing new medicines for many diseases, the pharmaceutical industry in the UK provides many other benefits to the British economy, including income, employment, expertise and major investment.
The UK is at the forefront of the global pharmaceutical industry. As well as developing new medicines for many diseases, the pharmaceutical industry in the UK provides many other benefits to the British economy, including income, employment, expertise and major investment.
These slides offer a useful, referenced resource for members and visitors to our website who wish to share the story about the value of medicines. They complement existing resources available on the ABPI website and will be updated regularly as the ABPI updates other data and content.
Medicines and vaccines have helped deliver improvements in patient health. History shows us the great advances we have made - today we continue to see the potential to eradicate disease and improve health outcomes when we invest in science and adopt and use new medicines.
The document summarizes HealthBIO 2021, Finland's largest annual life science event taking place on its 15th year and bringing together over 200 companies and academics. It also provides details about FIB (Finnish Bioindustries), the biotechnology industry association established in 1997 to promote networking and information sharing in the life science sector. FIB helps commercialize new biotechnology areas and supports national and international cooperation for legislation related to the field. Finally, it outlines Forendo Pharma's focus on women's health through development of HSD17B enzyme inhibitors for conditions like endometriosis and PCOS, with one drug entering phase 2 trials in 2022 and another starting phase 1.
HealthBIO 2021_Cancer I/O Translating immuno-oncology into health actions_Jer...Business Turku
This document provides a summary of an introduction to cancer immuno-oncology. It discusses utilizing the immune system to kill cancer cells and the increasing uptake of immuno-oncology drugs. It outlines the goals of the Cancer IO Office to facilitate immuno-oncology uptake through strategic foresight, societal discussion, and Finnish immuno-oncology research. The document describes the Cancer IO Office's themes of immuno-oncology in society, research, and healthcare which include developing 3D cancer culture models, utilizing real-world data to identify super responders, and analyzing immuno-oncology uptake in Finnish hospitals.
HealthBIO 2020 Aino Kalervo Tilt BiotherapeuticsBusiness Turku
TILT Biotherapeutics develops oncolytic immunotherapies to enable T cell therapies and checkpoint inhibitors. Its lead product TILT-123, a cytokine-armed oncolytic virus, has shown 100% cure rates in vivo and is currently in a Phase 1 clinical trial in Europe. TILT aims to explore licensing agreements to support the commercialization of its pipeline of oncolytic viruses, which have the potential to make T cell therapies and checkpoint inhibitors more effective for cancer treatment. The company has a strong international team and funding to advance its clinical programs through 2022.
The document discusses the regulatory environment for medicines in Ireland and Europe. It outlines how the Irish Medicines Board operates within the European system, providing resources to the European Medicines Agency and participating in evaluation, supervision, and inspection. It also discusses the IMB's international involvement, including partnerships with other agencies and participation in initiatives to enhance public health protection globally. Finally, it evaluates factors that contribute to the IMB becoming a "world-class" regulatory body.
IPI - Developing Global Solutions for Product SafetyKCR
The document discusses recent changes and developments in pharmacovigilance (PV) legislation and practices in the European Union and globally. It summarizes that since 2012, the EU PV legislation has improved safety data quality, credibility and transparency. The European Medicines Agency (EMA) is finalizing the implementation of this legislation and introducing enhancements to the EudraVigilance database. EMA is also extending international cooperation to facilitate safety data exchange. Harmonization of standards and legislation as well as open access to safety data supports global collaboration and innovations in medicine development.
HealthBIO 2021_Orion’s new strategy and industry trends seen from a midsize p...Business Turku
This presentation provides an overview of Orion's new strategy from a midsize pharmaceutical perspective. It discusses Orion's business segments and key financial metrics. It then summarizes major pharmaceutical industry trends, including aging populations, advances in technology, and increased regulation. Finally, it outlines Orion's strategic growth target of €1.5 billion in net sales by 2025 and focus areas to achieve this, such as delivering its late-stage portfolio, building its pipeline, maximizing the value of existing assets, and exploring new partnerships and technologies.
The document discusses the UK's commitment to becoming a global leader in stratified medicine. Some key points:
- Stratified medicine aims to optimize treatment for individual patients rather than broad disease groups, improving outcomes and unlocking business opportunities.
- The UK offers world-leading research expertise, data and infrastructure like large patient datasets and biobanks to help businesses develop and deliver stratified medicine products.
- There are significant market opportunities for stratified medicine and companion diagnostics globally. The UK can help businesses prepare for and access this growing market.
The Regulatory Policy Institute, based in Oxford, holds an annual conference on competition and regulation. At this year’s conference, OHE’s Jon Sussex described how the prescription medicines market in England is regulated for innovation.
The regulatory problem for the pharmaceutical market is different from that for utilities markets, transport, financial services and indeed markets for all other types of goods and services. The source of the regulatory problem for prescription medicines in the NHS is that the consumer (patient) neither decides which medicine is prescribed nor is responsible for paying for it. For other goods and services, the consumer decides and pays, as well as consumes. In the pharmaceutical market under the NHS, it is the payer who effectively decides the value of an innovation, not the patient.
The cost and risk in drug development are high. To determine how best to target its R&D efforts, the pharmaceutical industry needs clear signals about what innovation the health care payer, the NHS, values. The recent history of such signalling has been dominated in England by the actions of the National Institute for Health and Care Excellence (NICE), whose assessments also have considerable influence internationally. Moreover, although England represents only 2% of the world pharmaceutical market, its prices are use as a reference for pricing in other markets.
How NICE expresses the value of medicines can be viewed as a mean of regulating innovation. NICE always has based its decisions about value on the incremental cost to the tax-funded health and social care services of the additional quality-adjusted life years a new medicine offers to patients. During the last year, NICE has been consulting on ways to broaden its assessment of value, particularly on whether to take account of the burden of disease and wider societal impacts beyond QALYs. The decisions have not yet been made and the signal to potential pharmaceutical innovators remains fuzzy.
HealthBIO 2021_Finnish biotech year 2021_Tero Piispanen Business Turku
Finnish biotech year 2020-2021 saw the creation of 12 new companies in areas like drug development, diagnostics, and medtech. The health tech industry in Finland continues to grow with record exports in 2020. Several Finnish companies had successes including clinical trial progress, partnerships, and facility expansions. However, venture capital investment in Finnish life sciences remains low compared to Europe, with Finnish companies often only receiving seed funding.
HealthBIO 2021,_The InFlames Flagship_Timo VeromaaBusiness Turku
The document provides an overview of the InFLAMES Research Flagship program at the University of Turku in Finland. Some key points:
- InFLAMES brings together over 300 researchers from the University of Turku and Åbo Akademi University focused on immunology research.
- The program aims to make breakthroughs in drug development, diagnostics, and precision immune medicine through discovery, testing, and utilization of novel immunological findings.
- It provides researchers access to high-quality open access research infrastructure facilities like the Turku Bioscience Centre, Turku PET Centre, and Auria Biobank to support both academic and industry collaborations.
- Measuring impact, InFLAMES
Μάκης Παπαταξιάρχης - 6th Clinical Research ConferenceStarttech Ventures
Ομιλία: Μάκης Παπαταξιάρχης, Διευθύνων Σύμβουλος Janssen Ελλάδος, Pharmaceutical Companies of Johnson & Johnson, Πρόεδρος του PhRMA Innovation Forum, Πρόεδρος του AmCham Pharmaceutical Committee
HealthBIO 2021_PerkinElmer, leading with innovation - from COVID success into...Business Turku
This document provides an overview of PerkinElmer, a company focused on diagnostics, life sciences, food, and applied markets. It discusses their mission of innovating for a healthier world, with over 80 years of innovations including a COVID-19 PCR kit launched in 2020. The company's diagnostics segment focuses on reproductive health, immunoassays, and applied genomics. PerkinElmer has global capabilities across molecular diagnostics, imaging, automation, and more. It is pursuing growth in areas like single-cell analysis, therapeutics, digital solutions, and decentralized testing. The company's strategy focuses on detection, decentralization, and digitization to drive profitable growth.
HealthBIO 2020_Tero Piispanen_Turku Science ParkBusiness Turku
- 12 new biotech companies were created in Finland between June 2019 and October 2020, the smallest number in years, due to the COVID-19 pandemic.
- Total Finnish health tech export was €2.4 billion in 2019, with China as the largest export market thanks to strong demand for diagnostic equipment.
- Several Finnish biotech companies had successful clinical trials, funding rounds, partnerships and FDA/EMA approvals in areas such as oncology, neurology, rare diseases and COVID-19 vaccines.
The document summarizes healthcare systems in the United Kingdom and Germany. It discusses funding models for prescription drugs in England, including Clinical Commissioning Groups (CCGs) and the National Institute for Health and Care Excellence (NICE). It also describes the Cancer Drugs Fund in England and reforms to drug pricing in Germany under the AMNOG process.
A Trust-Centric Healthcare Journey | Full Presentation of PharmaLedger's 1st ...PharmaLedger
In this #1 Open Webinar | A trust-centric healthcare journey presentation, you will find:
An introduction to the PharmaLedger project presented by Lynn Wang (Johnson & Johnson)
Topic 1 | Clinical Supply Traceability presented by Francesco Spoto (Novartis) and Chad Sklodosky (Pfizer)
Topic 2 | Finished Goods Traceability presented by Dr Jan Wortmann (Bayer) and Bernhard Salb (Roche)
Topic 3 | ePI – Electronic Product Information presented by Patrick Maher (Novartis) and Ken Thursby (MSD)
Topic 4 | Anti-Counterfeiting presented by Daniel Fritz (Novartis) and Alberto Lòpez (Imprensa Nacional Casa da Moeda)
This project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 853992. This Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA.
Disclaimer: Any information on this presentation solely reflects the author’s view and neither IMI nor the European Union or EFPIA are responsible for any use that may be made of the information contained herein.
How PerkinElmer became world's market leader?, Marika KaseBusiness Turku
PerkinElmer has become the world leader in newborn screening through long-term investments, partnerships focusing on customer needs, and expanding their product range and geographic coverage. They have screened over 522 million babies cumulatively. Currently, PerkinElmer screens 37 million babies annually and helps save around 24,000 babies per year from various treatable conditions. PerkinElmer provides a complete solution for newborn screening including sample collection, processing, measuring, data processing and consulting services to support screening programs around the world.
Best Practices in the Field of Serialization and Safe Supply Chain László Árvai
GS1 – and global standards • ABC – Argentina, Brasil, China and other countries – what is the world doing beyond Europe? • Serialisation – how and when? • Visibility in the supply chain – reality or myth • Patient Safety and the “Level below the Each”
Clinical Trial eRecruitment | Topic #1 of PharmaLedger's 2nd Open Webinar PharmaLedger
In this Clinical Trial eRecruitment Use Case presentation, you will find:
An introduction to Clinical Trial eRecruitment use case presented by: Despina Daliani (Onorach) and Ken Nessel (Pfizer)
The current Clinical Trial Recruitment process
Pain points of the Clinical Trial eRecruitment
PharmaLedger’s Clinical Trial eRecruitment solution for the future state
Value added by PharmaLedger per actor involved
This project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 853992. This Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA.
Disclaimer: Any information on this presentation solely reflects the author’s view and neither IMI nor the European Union or EFPIA are responsible for any use that may be made of the information contained herein.
This document discusses pricing and reimbursement systems for pharmaceuticals in Germany and the Netherlands. It provides timelines for reimbursement processes, data requirements for dossiers submitted for assessment and reimbursement, how incremental clinical benefit is assessed, the role of health economics analyses, exceptions to rules, and implications. The key lessons are that incremental clinical benefit evidence from RCTs is crucial for successful reimbursement outcomes, health economics is gaining importance in Germany with new legislation, dossiers must be prepared well in advance, and following scientific advice can help optimize applications. Exceptions apply for orphan drugs in both countries.
R&D, Competition and Diffusion of Innovation in EU: The Case of Direct Acting...Office of Health Economics
An OHE research studies the role of R&D incentives and market competition in facilitating the diffusion of pharmaceutical innovation across European countries. The research studies the case of the DAA treatments for hepatitis C. Methods and results were presented and discussed at EUHEA conference 2018 held in Maastricht, The Netherlands, 11-14 July. The analysis concludes that (i) R&D incentives may have encouraged in-patent competition of DAAs and (ii) competition had a positive impact on uptake and adoption of DAA treatments in the countries studied (top-5 European plus Portugal).
Author(s) and affiliation(s): Mikel Berdud (OHE), Phill O'Neill (OHE), Martina Garau (OHE), Adrian Towse (OHE)
Conference/meeting: EUHEA Conference 2018
Location: Maastricht, The Netherlands
Date: 12/07/2018
Keeping with its promises, Association of the British Pharmaceutical Industry has launched a clinical-trial disclosure toolkit to help its member businesses observe with transparency needs for information from or about clinical trials.
Keeping with its promises, Association of the British Pharmaceutical Industry has launched a clinical-trial disclosure toolkit to help its member businesses observe with transparency needs for information from or about clinical trials.
HealthBIO 2020 Aino Kalervo Tilt BiotherapeuticsBusiness Turku
TILT Biotherapeutics develops oncolytic immunotherapies to enable T cell therapies and checkpoint inhibitors. Its lead product TILT-123, a cytokine-armed oncolytic virus, has shown 100% cure rates in vivo and is currently in a Phase 1 clinical trial in Europe. TILT aims to explore licensing agreements to support the commercialization of its pipeline of oncolytic viruses, which have the potential to make T cell therapies and checkpoint inhibitors more effective for cancer treatment. The company has a strong international team and funding to advance its clinical programs through 2022.
The document discusses the regulatory environment for medicines in Ireland and Europe. It outlines how the Irish Medicines Board operates within the European system, providing resources to the European Medicines Agency and participating in evaluation, supervision, and inspection. It also discusses the IMB's international involvement, including partnerships with other agencies and participation in initiatives to enhance public health protection globally. Finally, it evaluates factors that contribute to the IMB becoming a "world-class" regulatory body.
IPI - Developing Global Solutions for Product SafetyKCR
The document discusses recent changes and developments in pharmacovigilance (PV) legislation and practices in the European Union and globally. It summarizes that since 2012, the EU PV legislation has improved safety data quality, credibility and transparency. The European Medicines Agency (EMA) is finalizing the implementation of this legislation and introducing enhancements to the EudraVigilance database. EMA is also extending international cooperation to facilitate safety data exchange. Harmonization of standards and legislation as well as open access to safety data supports global collaboration and innovations in medicine development.
HealthBIO 2021_Orion’s new strategy and industry trends seen from a midsize p...Business Turku
This presentation provides an overview of Orion's new strategy from a midsize pharmaceutical perspective. It discusses Orion's business segments and key financial metrics. It then summarizes major pharmaceutical industry trends, including aging populations, advances in technology, and increased regulation. Finally, it outlines Orion's strategic growth target of €1.5 billion in net sales by 2025 and focus areas to achieve this, such as delivering its late-stage portfolio, building its pipeline, maximizing the value of existing assets, and exploring new partnerships and technologies.
The document discusses the UK's commitment to becoming a global leader in stratified medicine. Some key points:
- Stratified medicine aims to optimize treatment for individual patients rather than broad disease groups, improving outcomes and unlocking business opportunities.
- The UK offers world-leading research expertise, data and infrastructure like large patient datasets and biobanks to help businesses develop and deliver stratified medicine products.
- There are significant market opportunities for stratified medicine and companion diagnostics globally. The UK can help businesses prepare for and access this growing market.
The Regulatory Policy Institute, based in Oxford, holds an annual conference on competition and regulation. At this year’s conference, OHE’s Jon Sussex described how the prescription medicines market in England is regulated for innovation.
The regulatory problem for the pharmaceutical market is different from that for utilities markets, transport, financial services and indeed markets for all other types of goods and services. The source of the regulatory problem for prescription medicines in the NHS is that the consumer (patient) neither decides which medicine is prescribed nor is responsible for paying for it. For other goods and services, the consumer decides and pays, as well as consumes. In the pharmaceutical market under the NHS, it is the payer who effectively decides the value of an innovation, not the patient.
The cost and risk in drug development are high. To determine how best to target its R&D efforts, the pharmaceutical industry needs clear signals about what innovation the health care payer, the NHS, values. The recent history of such signalling has been dominated in England by the actions of the National Institute for Health and Care Excellence (NICE), whose assessments also have considerable influence internationally. Moreover, although England represents only 2% of the world pharmaceutical market, its prices are use as a reference for pricing in other markets.
How NICE expresses the value of medicines can be viewed as a mean of regulating innovation. NICE always has based its decisions about value on the incremental cost to the tax-funded health and social care services of the additional quality-adjusted life years a new medicine offers to patients. During the last year, NICE has been consulting on ways to broaden its assessment of value, particularly on whether to take account of the burden of disease and wider societal impacts beyond QALYs. The decisions have not yet been made and the signal to potential pharmaceutical innovators remains fuzzy.
HealthBIO 2021_Finnish biotech year 2021_Tero Piispanen Business Turku
Finnish biotech year 2020-2021 saw the creation of 12 new companies in areas like drug development, diagnostics, and medtech. The health tech industry in Finland continues to grow with record exports in 2020. Several Finnish companies had successes including clinical trial progress, partnerships, and facility expansions. However, venture capital investment in Finnish life sciences remains low compared to Europe, with Finnish companies often only receiving seed funding.
HealthBIO 2021,_The InFlames Flagship_Timo VeromaaBusiness Turku
The document provides an overview of the InFLAMES Research Flagship program at the University of Turku in Finland. Some key points:
- InFLAMES brings together over 300 researchers from the University of Turku and Åbo Akademi University focused on immunology research.
- The program aims to make breakthroughs in drug development, diagnostics, and precision immune medicine through discovery, testing, and utilization of novel immunological findings.
- It provides researchers access to high-quality open access research infrastructure facilities like the Turku Bioscience Centre, Turku PET Centre, and Auria Biobank to support both academic and industry collaborations.
- Measuring impact, InFLAMES
Μάκης Παπαταξιάρχης - 6th Clinical Research ConferenceStarttech Ventures
Ομιλία: Μάκης Παπαταξιάρχης, Διευθύνων Σύμβουλος Janssen Ελλάδος, Pharmaceutical Companies of Johnson & Johnson, Πρόεδρος του PhRMA Innovation Forum, Πρόεδρος του AmCham Pharmaceutical Committee
HealthBIO 2021_PerkinElmer, leading with innovation - from COVID success into...Business Turku
This document provides an overview of PerkinElmer, a company focused on diagnostics, life sciences, food, and applied markets. It discusses their mission of innovating for a healthier world, with over 80 years of innovations including a COVID-19 PCR kit launched in 2020. The company's diagnostics segment focuses on reproductive health, immunoassays, and applied genomics. PerkinElmer has global capabilities across molecular diagnostics, imaging, automation, and more. It is pursuing growth in areas like single-cell analysis, therapeutics, digital solutions, and decentralized testing. The company's strategy focuses on detection, decentralization, and digitization to drive profitable growth.
HealthBIO 2020_Tero Piispanen_Turku Science ParkBusiness Turku
- 12 new biotech companies were created in Finland between June 2019 and October 2020, the smallest number in years, due to the COVID-19 pandemic.
- Total Finnish health tech export was €2.4 billion in 2019, with China as the largest export market thanks to strong demand for diagnostic equipment.
- Several Finnish biotech companies had successful clinical trials, funding rounds, partnerships and FDA/EMA approvals in areas such as oncology, neurology, rare diseases and COVID-19 vaccines.
The document summarizes healthcare systems in the United Kingdom and Germany. It discusses funding models for prescription drugs in England, including Clinical Commissioning Groups (CCGs) and the National Institute for Health and Care Excellence (NICE). It also describes the Cancer Drugs Fund in England and reforms to drug pricing in Germany under the AMNOG process.
A Trust-Centric Healthcare Journey | Full Presentation of PharmaLedger's 1st ...PharmaLedger
In this #1 Open Webinar | A trust-centric healthcare journey presentation, you will find:
An introduction to the PharmaLedger project presented by Lynn Wang (Johnson & Johnson)
Topic 1 | Clinical Supply Traceability presented by Francesco Spoto (Novartis) and Chad Sklodosky (Pfizer)
Topic 2 | Finished Goods Traceability presented by Dr Jan Wortmann (Bayer) and Bernhard Salb (Roche)
Topic 3 | ePI – Electronic Product Information presented by Patrick Maher (Novartis) and Ken Thursby (MSD)
Topic 4 | Anti-Counterfeiting presented by Daniel Fritz (Novartis) and Alberto Lòpez (Imprensa Nacional Casa da Moeda)
This project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 853992. This Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA.
Disclaimer: Any information on this presentation solely reflects the author’s view and neither IMI nor the European Union or EFPIA are responsible for any use that may be made of the information contained herein.
How PerkinElmer became world's market leader?, Marika KaseBusiness Turku
PerkinElmer has become the world leader in newborn screening through long-term investments, partnerships focusing on customer needs, and expanding their product range and geographic coverage. They have screened over 522 million babies cumulatively. Currently, PerkinElmer screens 37 million babies annually and helps save around 24,000 babies per year from various treatable conditions. PerkinElmer provides a complete solution for newborn screening including sample collection, processing, measuring, data processing and consulting services to support screening programs around the world.
Best Practices in the Field of Serialization and Safe Supply Chain László Árvai
GS1 – and global standards • ABC – Argentina, Brasil, China and other countries – what is the world doing beyond Europe? • Serialisation – how and when? • Visibility in the supply chain – reality or myth • Patient Safety and the “Level below the Each”
Clinical Trial eRecruitment | Topic #1 of PharmaLedger's 2nd Open Webinar PharmaLedger
In this Clinical Trial eRecruitment Use Case presentation, you will find:
An introduction to Clinical Trial eRecruitment use case presented by: Despina Daliani (Onorach) and Ken Nessel (Pfizer)
The current Clinical Trial Recruitment process
Pain points of the Clinical Trial eRecruitment
PharmaLedger’s Clinical Trial eRecruitment solution for the future state
Value added by PharmaLedger per actor involved
This project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 853992. This Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA.
Disclaimer: Any information on this presentation solely reflects the author’s view and neither IMI nor the European Union or EFPIA are responsible for any use that may be made of the information contained herein.
This document discusses pricing and reimbursement systems for pharmaceuticals in Germany and the Netherlands. It provides timelines for reimbursement processes, data requirements for dossiers submitted for assessment and reimbursement, how incremental clinical benefit is assessed, the role of health economics analyses, exceptions to rules, and implications. The key lessons are that incremental clinical benefit evidence from RCTs is crucial for successful reimbursement outcomes, health economics is gaining importance in Germany with new legislation, dossiers must be prepared well in advance, and following scientific advice can help optimize applications. Exceptions apply for orphan drugs in both countries.
R&D, Competition and Diffusion of Innovation in EU: The Case of Direct Acting...Office of Health Economics
An OHE research studies the role of R&D incentives and market competition in facilitating the diffusion of pharmaceutical innovation across European countries. The research studies the case of the DAA treatments for hepatitis C. Methods and results were presented and discussed at EUHEA conference 2018 held in Maastricht, The Netherlands, 11-14 July. The analysis concludes that (i) R&D incentives may have encouraged in-patent competition of DAAs and (ii) competition had a positive impact on uptake and adoption of DAA treatments in the countries studied (top-5 European plus Portugal).
Author(s) and affiliation(s): Mikel Berdud (OHE), Phill O'Neill (OHE), Martina Garau (OHE), Adrian Towse (OHE)
Conference/meeting: EUHEA Conference 2018
Location: Maastricht, The Netherlands
Date: 12/07/2018
Keeping with its promises, Association of the British Pharmaceutical Industry has launched a clinical-trial disclosure toolkit to help its member businesses observe with transparency needs for information from or about clinical trials.
Keeping with its promises, Association of the British Pharmaceutical Industry has launched a clinical-trial disclosure toolkit to help its member businesses observe with transparency needs for information from or about clinical trials.
ICH GCP guidelines for mpharmacy 2nd sem 204T subject.
topic include the brief description regarding ICH GCP
THE GOOD CLINICAL PRACTICES AND
THE INTERNATIONAL CONFERENCE OF HORMONIZATION.
THAT INCLUDE the regulation of all pharmaceutical industries.
OxfordSM's pharma case studies - providing a call to actionOxfordSM
Brand teams have to be increasingly innovative when finding ways to prompt patients and physicians to intervene at the right time.
Campaigns such as GSK’s Greatest Season Ever for FLONASE®, implemented last year in the United States which made the decision to prepare for the allergy season easier for patients by linking the proactive purchase of the brand to the start of the baseball season.
Providing A Call To Action:
We find that examples from within and outside of healthcare can often prompt this innovation. They act as a way of bringing in new perspectives and allowing teams to explore new avenues and new ideas.
So, in the spirit of hoping this will prompt some new ideas in your brand team, here are our favourite case studies that speak to the need to provide a call to action.
7th Pharmacovigilance 2014 “Ensuring safer drugs to market by analyzing latest developments in pharmacovigilance, drug safety and risk management" 21st November 2014, Kohinoor Continental Hotel, Mumbai, India Greetings from Virtue Insight, I am happy to invite you and your colleagues to be a sponsor / delegate for our upcoming conference. The “Ensuring safer drugs to market by analyzing latest developments in pharmacovigilance, drug safety and risk management” at 7th Pharmacovigilance 2014 on 21st November 2014, Kohinoor Continental Hotel, Mumbai, India.Contact:-Tel: +91 9677590192 Email: dinesh@virtueinsight.co.in
The document provides information about the 7th Pharmacovigilance conference taking place on November 21st, 2014 in Mumbai, India. The conference will discuss ensuring safer drugs through analyzing developments in pharmacovigilance, drug safety, and risk management. Key speakers from various pharmaceutical companies will discuss topics like signal detection, risk management plans, data collection and management, and regulatory expectations and updates. The conference is aimed at professionals in pharmacovigilance, drug safety, clinical research, and regulatory affairs. It will provide a platform for stakeholders to discuss best practices and challenges in the field.
I am writing to make you aware of our upcoming event:- 7th Pharmacovigilance 2014 taking place on 21st November 2014, Kohinoor Continental Hotel, Mumbai, India.
Introduction to the workshop and EUPATI updateEUPATI
The European Patients' Academy (EUPATI) project aims to educate patients and the public about medical research and development. It provides training to help patients become experts who can actively partner with researchers. The project is led by patients and involves various stakeholders. It has made progress in developing educational materials in multiple languages and establishing national networks. The first training course for patient experts recently began. EUPATI seeks to build understanding and empower patients to more actively engage in research.
The document discusses setting up a National Learning Team (NLT) to establish a European Patients' Academy (ENP) in their country to implement the EUPATI program before the end of 2015. Key points discussed include finding champions in patient organizations, academia, and industry; creating effective partnerships between these stakeholders; developing strategic links and growing networks; and emphasizing the benefits EUPATI can provide like training opportunities and access to resources to promote patient public involvement.
Value in healthcare aims to improve patient outcomes while lowering costs. It rewards providers for quality rather than quantity of care. While some progress has been made through examples like integrated systems in India and Germany that lower costs through better processes, value-based care has not been widely adopted due to barriers like entrenched financial incentives that prioritize volume over value. Fully realizing value-based care requires health informatics to track outcomes, benchmarking to share best practices, alternative payment models, and delivery innovations to better coordinate care.
1) The document summarizes recommendations from the 18th International Conference of Drug Regulatory Authorities held in Dublin, Ireland in 2018.
2) Key themes of discussion included promoting regulatory collaboration, convergence and harmonization; improving coordination and reliance; enabling access to innovative medical products; and strengthening regulatory systems.
3) Recommendations called on WHO and member states to finalize guidance on good regulatory practices, harmonize application formats, consider conditional approvals during public health emergencies, and improve communication on risk and benefits of medical products.
The document summarizes recommendations from the 18th International Conference of Drug Regulatory Authorities held in 2018. Key recommendations include:
1) Promoting regulatory collaboration, convergence, and harmonization across the entire product life cycle, including manufacturing, authorization, and pharmacovigilance.
2) Advocating for electronic certification of pharmaceutical products templates to streamline information sharing between authorities.
3) Supporting regulatory preparedness for public health emergencies through measures like conditional approvals and reliance on networks during emergencies.
The document discusses the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guideline.
ICH-GCP is an international ethical and scientific quality standard for clinical trials involving human subjects. It aims to ensure trials are scientifically sound and respect the rights, safety and well-being of participants. The guideline was developed in response to medical tragedies and the need for harmonized standards across regions to facilitate global drug development. It outlines principles for conducting clinical trials, including obtaining informed consent and ensuring confidentiality. Adherence to ICH-GCP provides assurance that clinical trial data are credible and that participants are adequately protected.
The document discusses international harmonization in the pharmaceutical industry. It defines regulatory harmonization as making technical guidelines uniform across countries. It describes international organizations that work on harmonization, like ICH which brings together regulators from Europe, Japan, US, and others. Harmonization has benefits like faster drug approvals and reduced costs, but also risks like potentially weakening public health protections and limiting competition. The document also discusses pharmaceutical regulation and harmonization challenges in Pakistan, like weak domestic regulation, an emphasis on price controls over quality, and lack of investment in quality and GMP compliance.
The document provides information about the 7th Pharmacovigilance 2014 conference happening on November 21st, 2014 in Mumbai, India. The conference will discuss ensuring safer drugs to market through analyzing developments in pharmacovigilance, drug safety, and risk management. It will feature key speakers from various pharmaceutical companies and have panels on topics like improving patient safety, using new technologies in pharmacovigilance, and keeping updated on opportunities in drug safety research. The event aims to help pharmaceutical and biotech companies improve their pharmacovigilance strategies and compliance.
To recap the previous month's pharma highlights to Pharma Uptoday members, Monthly magazine Volume 6 has been released with
News Uptoday
New Guidance
New MAPP Release
Audit Findings
483 Observations
- 483 of Impax Laboratories
- 483 of Ipca Labs
- 483 of Bausch & Lomb Inc
- 483 of Alexion
Warning Letters
- Marck Biosciences Ltd.
- The Compounding Shop Inc.
- Zions Rx Formulations Services LLC.
EMA Non-Compliance Reports
- Renown Pharmaceuticals Pvt. Ltd., India
- VETPROM AD, Bulgaria
- SCM PHARMA LIMITED, UK
Guest of the Month
Dr. M Damodharan - Vice President Global Quality & Regulatory
Regulations of the Month
§ 211.180 Subpart J--Records and Reports - General Requirements
§ 211.182 Subpart J--Records and Reports - Equipment cleaning & use log
Presentation in the framework of the International Conference "10th anniversary of the Spanish Network of Health Technology Assessment Agencies. Towads patient and public engagement in HTA" Zaragoza 27-28 April 2017
A Trust-Centric Healthcare Journey Part II | Full Presentation of PharmaLedge...PharmaLedger
In this presentation, you will find:
An introduction to the PharmaLedger project presented by Maria Eugenia (Xenia) Beltran | Project Coordinator / DRA and Use Case co-lead (Universidad Politécnica de Madrid)
Topic 1 | Clinical Trial eRecruitment | Despina Daliani (Onorach) and Ken Nessel (Pfizer)
Topic 2 | Clinical Trial eConsent | Hernando C. Giraldo (Boehringer Ingelheim) and Despina Daliani (Onorach)
Topic 3 | Health Data IoT Medical Device | Disa Lee Choun (UCB) and Francesca Rocchi (Bambino Gesù Children Hospital)
Topic 4 | Health Data Personalised Medicine | Beatriz Merino (Universidad Politécnica de Madrid) and Christos Kontogiorgis (Democritus University of Thrace)
You can also learn more about our #2 Open Webinar on Clinical Trials & Health Data by rewatching our video recording including the Q&A by clicking on the button below:
This project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 853992. This Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA.
Disclaimer: Any information on this presentation solely reflects the author’s view and neither IMI nor the European Union or EFPIA are responsible for any use that may be made of the information contained herein.
EUPATI 2013 Conference: Building Knowledge & Competences for Patients’ Involv...EUPATI
EUPATI 2013 Conference: Building Knowledge & Competences for Patients’ Involvement in Medicines R&D, “Bring to life with EUPATI examples”, by Niels Westergaard, PhD, DSc Biopeople, University of Copenhagen, Denmark
Does Over-Masturbation Contribute to Chronic Prostatitis.pptxwalterHu5
In some case, your chronic prostatitis may be related to over-masturbation. Generally, natural medicine Diuretic and Anti-inflammatory Pill can help mee get a cure.
Rasamanikya is a excellent preparation in the field of Rasashastra, it is used in various Kushtha Roga, Shwasa, Vicharchika, Bhagandara, Vatarakta, and Phiranga Roga. In this article Preparation& Comparative analytical profile for both Formulationon i.e Rasamanikya prepared by Kushmanda swarasa & Churnodhaka Shodita Haratala. The study aims to provide insights into the comparative efficacy and analytical aspects of these formulations for enhanced therapeutic outcomes.
Histololgy of Female Reproductive System.pptxAyeshaZaid1
Dive into an in-depth exploration of the histological structure of female reproductive system with this comprehensive lecture. Presented by Dr. Ayesha Irfan, Assistant Professor of Anatomy, this presentation covers the Gross anatomy and functional histology of the female reproductive organs. Ideal for students, educators, and anyone interested in medical science, this lecture provides clear explanations, detailed diagrams, and valuable insights into female reproductive system. Enhance your knowledge and understanding of this essential aspect of human biology.
Osteoporosis - Definition , Evaluation and Management .pdfJim Jacob Roy
Osteoporosis is an increasing cause of morbidity among the elderly.
In this document , a brief outline of osteoporosis is given , including the risk factors of osteoporosis fractures , the indications for testing bone mineral density and the management of osteoporosis
Cell Therapy Expansion and Challenges in Autoimmune DiseaseHealth Advances
There is increasing confidence that cell therapies will soon play a role in the treatment of autoimmune disorders, but the extent of this impact remains to be seen. Early readouts on autologous CAR-Ts in lupus are encouraging, but manufacturing and cost limitations are likely to restrict access to highly refractory patients. Allogeneic CAR-Ts have the potential to broaden access to earlier lines of treatment due to their inherent cost benefits, however they will need to demonstrate comparable or improved efficacy to established modalities.
In addition to infrastructure and capacity constraints, CAR-Ts face a very different risk-benefit dynamic in autoimmune compared to oncology, highlighting the need for tolerable therapies with low adverse event risk. CAR-NK and Treg-based therapies are also being developed in certain autoimmune disorders and may demonstrate favorable safety profiles. Several novel non-cell therapies such as bispecific antibodies, nanobodies, and RNAi drugs, may also offer future alternative competitive solutions with variable value propositions.
Widespread adoption of cell therapies will not only require strong efficacy and safety data, but also adapted pricing and access strategies. At oncology-based price points, CAR-Ts are unlikely to achieve broad market access in autoimmune disorders, with eligible patient populations that are potentially orders of magnitude greater than the number of currently addressable cancer patients. Developers have made strides towards reducing cell therapy COGS while improving manufacturing efficiency, but payors will inevitably restrict access until more sustainable pricing is achieved.
Despite these headwinds, industry leaders and investors remain confident that cell therapies are poised to address significant unmet need in patients suffering from autoimmune disorders. However, the extent of this impact on the treatment landscape remains to be seen, as the industry rapidly approaches an inflection point.
- Video recording of this lecture in English language: https://youtu.be/Pt1nA32sdHQ
- Video recording of this lecture in Arabic language: https://youtu.be/uFdc9F0rlP0
- Link to download the book free: https://nephrotube.blogspot.com/p/nephrotube-nephrology-books.html
- Link to NephroTube website: www.NephroTube.com
- Link to NephroTube social media accounts: https://nephrotube.blogspot.com/p/join-nephrotube-on-social-media.html
share - Lions, tigers, AI and health misinformation, oh my!.pptxTina Purnat
• Pitfalls and pivots needed to use AI effectively in public health
• Evidence-based strategies to address health misinformation effectively
• Building trust with communities online and offline
• Equipping health professionals to address questions, concerns and health misinformation
• Assessing risk and mitigating harm from adverse health narratives in communities, health workforce and health system
These lecture slides, by Dr Sidra Arshad, offer a simplified look into the mechanisms involved in the regulation of respiration:
Learning objectives:
1. Describe the organisation of respiratory center
2. Describe the nervous control of inspiration and respiratory rhythm
3. Describe the functions of the dorsal and respiratory groups of neurons
4. Describe the influences of the Pneumotaxic and Apneustic centers
5. Explain the role of Hering-Breur inflation reflex in regulation of inspiration
6. Explain the role of central chemoreceptors in regulation of respiration
7. Explain the role of peripheral chemoreceptors in regulation of respiration
8. Explain the regulation of respiration during exercise
9. Integrate the respiratory regulatory mechanisms
10. Describe the Cheyne-Stokes breathing
Study Resources:
1. Chapter 42, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 36, Ganong’s Review of Medical Physiology, 26th edition
3. Chapter 13, Human Physiology by Lauralee Sherwood, 9th edition
Adhd Medication Shortage Uk - trinexpharmacy.comreignlana06
The UK is currently facing a Adhd Medication Shortage Uk, which has left many patients and their families grappling with uncertainty and frustration. ADHD, or Attention Deficit Hyperactivity Disorder, is a chronic condition that requires consistent medication to manage effectively. This shortage has highlighted the critical role these medications play in the daily lives of those affected by ADHD. Contact : +1 (747) 209 – 3649 E-mail : sales@trinexpharmacy.com
Our backs are like superheroes, holding us up and helping us move around. But sometimes, even superheroes can get hurt. That’s where slip discs come in.
8 Surprising Reasons To Meditate 40 Minutes A Day That Can Change Your Life.pptxHolistified Wellness
We’re talking about Vedic Meditation, a form of meditation that has been around for at least 5,000 years. Back then, the people who lived in the Indus Valley, now known as India and Pakistan, practised meditation as a fundamental part of daily life. This knowledge that has given us yoga and Ayurveda, was known as Veda, hence the name Vedic. And though there are some written records, the practice has been passed down verbally from generation to generation.
2. The pharmaceutical industry is working in different ways
with patients and healthcare professionals
Industry is working in different ways to engage
with healthcare professionals, patients and
patient groups as the science changes.
Patient groups are ‘at the table’ earlier in
discussions, becoming more involved in
clinical trials and transparency is increasing.
Increasingly patients and patient groups are
actively engaging in the process of how
medicines are developed to provide valuable
insight.1
More and different groups are taking
responsibility for putting together the evidence
and undertaking the assessment
of medicines.
As the Accelerated Access Review recognises
‘Patients should be involved in horizon
scanning and prioritisation, and this
involvement should continue along the whole
innovation pathway. The NHS should use a
common set of principles describing what
good partnership with patients and the public
looks like along the whole innovation
pathway.2
1. https://www.eupati.eu/
2. The Accelerated Access Review: https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/564145/AAR_final_A.pdf
49
3. Patients First Conference – AMRC and ABPI
501. http://www.abpi.org.uk/media-centre/newsreleases/2016/Pages/Patients-health-and-research-experts-unite-to-put-patients-first-in-medical-research.aspx
Patients and representatives from across the medical research sector came
together in November 2016 at the inaugural Patients First Conference, hosted
jointly by the Association of Medical Research Charities (AMRC) and the
Association of the British Pharmaceutical Industry (ABPI), to explore how
medical research can deliver better outcomes for patients.
The event brought together over 300 delegates – including patients, charities,
industry, research bodies, funders and government – who, with a shared
recognition that patients play a vital role in medical research, explored how
they can collaborate to put patients first, involving them in research and
development through to care and access to treatment, to ultimately deliver
them the best outcomes.1
4. Patient involvement in medicine
development - from theory to reality1
1. https://www.eupati.eu/ 51
5. We are committed to transparency, setting and following
high standards for how we behave
All ABPI members are required to adhere to the ABPI Code of
Practice for the Pharmaceutical Industry and has strong
support from the MHRA who have agreed to abide by the
ABPI Code of Practice.
It also applies to non-members who have agreed to abide by
the ABPI Code of Practice
Administered by the Prescription Medicines Code of Practice
Authority (PMCPA) , a self-regulatory body operates the code
at arm’s length from the ABPI.
The PMCPA is a not-for-profit body which was established by
the ABPI on 1 January 1993.
The code includes specific requirements on relationships with
patient organisations under Clause 27.
The ABPI Medical Representatives Exam is taken by
representatives who call upon healthcare professionals. An
appropriate examination must be taken by all representatives
working for companies who have agreed to abide by the ABPI
Code within one year of employment and passed within two
years.
PMCPA. http://www.pmcpa.org.uk/thecode/Documents/Code%20of%20Practice%202016%20.pdf
52
6. We launched the ABPI Patient Organisation Forum
(POF) in 20141
To identify areas of mutual interest
To promote understanding
To develop joint working on policy and
practice, where appropriate
By facilitating ongoing dialogue, open discussions and
information sharing on issues of common interest,
including healthcare policy
Aims
Supported by steering group of patient groups
and company representatives
All meetings co-chaired by a member company
representative and patient group representative
Transparency: Summaries of meetings and
attendance published on the ABPI website 1
Strong governance
and co-operation
Brings together representatives of the pharmaceutical industry and patient and charity groups in an open forum
1. ABPI. Patient Organisation Forum. www.abpi.org.uk/our-work/patient-organisation-forum
53
7. Together we produced the ‘Patient Guide’
ABPI and National Voices jointly produced a guide to
collaboration between pharmaceutical companies and charities.
The guide aims to promote transparency and accountability in
collaborative working and to serve as a practical 'how to' guide
for all parties. This has also been part of the ABPI Code of
Practice since 2006.
It has been led by a steering group, chaired by Harry Cayton
CBE, Chief Executive of the Professional Standards Authority.
The project included two workshops, a survey and a series of
interviews to consult stakeholders and help shape the guide.
The guide was published in July 2015.
Together the pharmaceutical industry is actively engaging in
activities that support patients
54
1. National Voices and ABPI ‘Working together, delivering for patients: A guide to collaboration between charities and pharmaceutical
companies in the UK ‘ http://www.abpi.org.uk/our-work/library/Documents/ABPI_NV_Guide_FINAL.pdf
1
8. Transparency in partnership with healthcare
professionals and healthcare organisations
In June 2016, pharmaceutical companies started to publish
details of certain payments made to individual, named,
healthcare professionals.
This information is published on a central UK database, fully
accessible to members of the public. Patients can search for
the name of their doctor or other healthcare professionals,
health care organisations, to see what payments an
individual may have received, from which company, for what
type of activity.
The new requirements are part of an industry-wide initiative
in 33 European countries, bringing greater transparency to
the interactions between healthcare professionals and
pharmaceutical companies.
The new initiative builds on existing requirements in the
ABPI Code of Practice which has, since 2012, seen
companies publish the total, aggregate amount they pay to
healthcare professionals.
Click here1 to search the database.
55
1. ABPI: Disclosure UK Database: http://www.abpi.org.uk/our-work/disclosure/Pages/DocumentLibrary.aspx
9. Advancing science and improving
care, Astellas, Bayer, Boehringer Ingelheim,
Daiichi Sankyo, Eisai, GSK, Lilly, Novartis, Roche,
Sanofi, Takeda, UCB and ViiV Healthcare all
sponsor ClinicalStudyDataRequest.com5 which
allows researchers to request access to anonymised
patient-level data from clinical studies to conduct
further research.
GSK was the first company to sign
up to All Trials in 2013, which calls for
the registration of clinical trials and the disclosure of
trial results and clinical study reports5 (CSRs). CSRs
are the formal study reports that we prepare, to
provide more detail on the design, methods and
results of our clinical trials.
Transparency in clinical trials
The ABPI is a strong advocate for transparency in clinical trial
information. It is a requirement of the ABPI Code of Practice and has
been for several years. This is included in the EFPIA Code of
Practice.1
Companies are required to publish all clinical trial results within one
year of marketing authorisation and publically register new clinical
trials within 21 days of the first patient being enrolled.
In February 2013 the ABPI launched a disclosure toolkit for
companies to help them meet the requirements for clinical trial
transparency under the ABPI Code of Practice.2
This toolkit provides good practice guidelines, disclosure checklists
and a template standard operating procedure for pharmaceutical
companies.
These materials are updated regularly in line with changes to
international regulatory requirements.
Companies have also signed up to the EFPIA-PhRMA principles3 for
responsible clinical trial data sharing to enhance research and data
sharing efforts by making additional information available to the
public, patients who participate in clinical trials and qualified
researchers.4 Ultimately this move aims to benefit patients and foster
scientific discovery.
56
1. EFPIA Code. http://transparency.efpia.eu/the-efpia-code-2
2. ABPI Clinical Trial Disclosure Kit. http://www.abpi.org.uk/our-work/library/guidelines/Pages/ABPI-disclosure-toolkit.aspx
3. EFPIA.Joint EFPIA-PhRMA Principles for Responsible Clinical Trial Data Sharing Become Effective.
http://efpia.eu/mediaroom/132/43/Joint-EFPIA-PhRMA-Principles-for-Responsible-Clinical-Trial-Data-Sharing-Become-Effective
4. EUPATI. Clinical development and trials. https://www.eupati.eu/category/clinical-development-and-trials/
5. Clinical Study Data Request: https://clinicalstudydatarequest.com/
10. Improvements in clinical trial transparency
Research shows industry commitment to greater
transparency of company-sponsored current and
future clinical trials is making a difference.
The disclosure rates of results for clinical trials for
medicines licensed in Europe between 2009-
2013 has seen a steady improvement from71%
in 20091 to 90% in 20132.
Companies are developing innovative processes
and solutions to share clinical trial data with
researchers to enable greater advances in
scientific discovery and patient care.3
The EFPIA responsible transparency platform
provides a gateway to many of these solutions.
“
”
We are seeing a sustained trend towards
improved disclosure of industry-sponsored trials
associated with new medicines.4
Dr Bryan Deane
1. Rawal B & Deane BR. 2014. read Clinical trial transparency: an assessment of the disclosure of results of company-sponsored trials associated with new medicines approved recently in
Europe. http://www.tandfonline.com/doi/abs/10.1185/03007995.2015.1047749
2. Deane BR & Sivarajah J. Nov 2016. Clinical trial transparency update: an assessment of the disclosure of results of company –sponsored trials associated with new medicines approved
in Europe in 2013 https://www.ncbi.nlm.nih.gov/pubmed/27869482
3. EFPIA Clinical Trial Data Portal Gateway
4. ABPI Press Release - http://www.abpi.org.uk/media-centre/newsreleases/2016/Pages/90-per-cent-of-pharmaceutical-industry-led-clinical-trials-now-published,-says-new-study.aspx 57
11. Slide Title Source
The pharmaceutical industry is working in different ways
with patients and healthcare professionals, slide 49
The Accelerated Access Review:
The pharmaceutical industry is working in different ways
with patients and healthcare professionals, slide 49
European Patients Academy (EUPATI)
Patients First Conference – AMRC and ABPI, slide 50 ABPI Media Centre
Patient involvement in medicine development - from theory to reality, slide 51 European Patients Academy (EUPATI)
We are committed to transparency, setting and following high standards for how
we behave, slide 52
Prescription Medicines Code of Practice Authority
We launched the ABPI Patient Organisation Forum (POF) in 2014, slide 53 ABPI. Patient Organisation Forum.
Together we produced the ‘Patient Guide’, slide 54 National Voices and ABPI ‘Working together, delivering for patients: A guide to
collaboration between charities and pharmaceutical companies in the UK‘
Transparency in partnership with healthcare professionals and healthcare
organisations, slide 55
ABPI: Disclosure UK Database
Transparency in clinical trials, slide 56 The EFPIA Code.
Transparency in clinical trials, slide 56 ABPI clinical trial disclosure toolkit
Transparency in clinical trials, slide 56 EFPIA. Joint EFPIA-PhRMA Principles for Responsible Clinical Trial Data
Sharing Become Effective
Sources
58
12. Slide Title Source
Transparency in clinical trials, slide 56 EUPATI. Clinical development and trials.
Transparency in clinical trials, slide 56 Clinical Study Data Request.
Improvements in clinical trial transparency , slide 57 Rawal B & Deane BR. 2014. Clinical trial transparency: an assessment of
the disclosure of results of company-sponsored trials associated with new
medicines approved recently in Europe.
Improvements in clinical trial transparency, slide 57 Deane BR & Sivarajah J. Nov 2016. Clinical trial transparency update: an
assessment of the disclosure of results of company sponsored trials
associated with new medicines approved in Europe in 2013
Improvements in clinical trial transparency, slide 57 EFPIA Clinical Trial Data Portal Gateway.
Improvements in clinical trial transparency, slide 57 ABPI. 90% of pharmaceutical industry led clinical trials now published.
Sources
59