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Showing posts with label Europe. Show all posts
Showing posts with label Europe. Show all posts

Sunday, 30 June 2019

European cooperation on healthcare discussed at FPM-HPT conference at Erasmus University in Rotterdam

European cooperation is crucial for providing the highest possible quality of healthcare for the ~740 million citizens on the continent. Innovations in European healthcare also have a vital impact on global health.
Many international organizations and institutes participate in European projects and initiatives on research, clinical care and health policy to achieve health goals that would be unattainable when operating solely within one’s own country.
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Donald Singer, Carin Uyl-de Groot, Marlies Wijsenbeek, Liese Barbier, Ken Redekop and Lytske Bakker
There are also funding, ethical and political challenges to effective European cooperation on healthcare, including an impending possible Brexit. 

The latest Fellowship of Postgraduate Medicine conference was held at Erasmus University in Rotterdam in the Netherlands on 21st June 2019 to consider European Cooperation on Healthcare. The aim was to provide a forum for discussing best practice across the above key healthcare domains.

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Donald Singer, Ron de Winter, Marjan Hummel, Marcus Guardian, Lytske Bakker and Ken Redekop
The conference was jointly hosted by the FPM’s Elsevier-published journal Health Policy and Technology and the Erasmus School of Health Policy and Management (ESHPM), with as local organisers Associate Professor Ken Redekop (HPT Editor-in-Chief) and researcher Lytske Bakker (HPT Commissioning Editor).

Content from the meeting will appear in the HPT journal as Editorials, commentaries, review articles and Meet the Expert reports, with associated short video interviews with speakers posted on the HPT and FPM websites.

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Poster prize winner Vivian Reckers-Droog with Ken Redokop (L) and Donald Singer
Ron de Winter from the Department of Epidemiology at the University Medical Center in Utrecht, The Netherlands discussed combating multi-drug bacterial resistance in the multi-country European COMBACTE public-private partnership.

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Poster presenters and European Reference Network Project Managers Olivia Spivack and Renée de Ruiter.
Barbara Pierscionek, Associate Dean for Research at Nottingham Trent University discussed ethical and legal challenges when developing joint programmes involving European cooperation on healthcare. Issues include maintaining confidentiality when sharing real world data within Registries and other Big health Data.

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Pharmacist Liese Barbier, European Medicines Agency, discussed European Medicines Agency perspectives on regulating biosimilars. She stressed the importance of batch-level information when reporting any suspected adverse drug reactions from biosimilars or corresponding biological medicines.
Jorge Gonzalez, Spain, spoke on the EU funding supported inDemand model now operating in Spain, France and Finland, with additional network partners throughout Europe. InDemand makes a virtue of needs-driven rather than technology-driven project commissioning as a more reliable approach to ensuring adoption of new approaches into clinical practice. Examples included mobile health applications to reduce weight in obese children and e-health systems to support management of women in pregnancy.
Marcus Guardian, CEO of EUnetHTA, The European Network for Health Technology Assessment discussed his organisation’s role in cross-border assessment of health technology.

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Ines Hernando from the EURORDIS-Rare Diseases Europe organization discussed the initial impact of the 2017 European Reference Network Directive to improve the care of the ~ 30 million patients in Europe with rare diseases. The new European Reference Networks are already providing virtual common rare disease management support platforms for health professionals across the European region.
Marjan Hummel from Philips in Einthoven discussed early health technology assessment in the medical device industry and resulting international implications for streamlining development of new health technologies.

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Zoltan Kalo, Professor of Health Economics at Eötvös Loránd University (ELTE) in Budapest discussed ways to improve equity in allocation of healthcare research funds by the European Union. Currently there appears to be a disproportionate allocation of EU research awards to EU15 countries. This both disadvantages research capacity development in EU13 countries and leads to a ‘brain drain’ of researchers from EU13 to EU15 research centres.

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Local host Ken Redekop, Editor-in-Chief of the FPM’s Elsevier-published Health Policy and Technology journal, discussed themes and opportunities for publication in the journal on topics from across the diagnostics/drugs/devices/e-health spectrum complemented by papers on health technology adoption and associated health policy implications.



Donald Singer, President, Fellowship of Postgraduate Medicine, London discussed engaging with European health policy makers, including new networking opportunities between health professional and patient and consumer organisations and EU institutions such as the European Medicines Agency.


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 Carin Uyl-De Groot, head of health technology assessment at the Erasmus School of Health Policy & Management in Rotterdam discussed sustainability and affordability of innovative drugs. She described discussion with European policy makers on ways to reduce the cost of expensive biological treatments. Developing cross-border partnerships would create much greater bargaining power for purchasing medicines. For example, the EU region currently provides 40% of the market for most pharmaceuticals.

Respiratory physician Marlies Wijsenbeek from the Erasmus Medical Centre discussed patient registry development to improve management of and research into rare lung diseases, based on her work on idiopathic pulmonary fibrosis. She noted the potential value of developing cross-border patient registries for rare diseases, to ensure larger patient populations then possible within individual countries. She also illustrated some of the challenges, e.g. when common data sets are not agreed and when the same patients may feature within different registries.



Tuesday, 12 February 2019

Still time to submit an abstract for the EACPT Congress in Sweden: 29th June to 2nd July 2019

The next EACPT Congress will be held from 29th June to 2nd July in 2019 in Stockholm as a partnership between the EACPT and the Swedish Society for Pharmacology, Clinical Pharmacology and Therapeutics. 

The Congress will address Tomorrow’s Healthcare Challenges and will be held at the City Conference Centre – 5 minutes from Stockholm Central Station.

Abstract closing date extended to 14th March.

Register online 

The Congress Reception on the evening of Saturday 29th June, will be held at Stockholm City Hall, the venue of the Nobel Prize banquet.

The Keynote Opening Lecture will be given by the President at the Karolinska Institute, Professor Ole Petter Ottersen, on global health and clinical pharmacology.

Around 60 invited speakers are expected from throughout Europe and beyond. Congress keynote lectures, sessions and themes will include:
  • Advanced therapies
  • Chronic disease
  • Clinical pharmacologists versus computers
  • Closing the money gap
  • Drug regulation in the 2020’s
  • EACPT meets Asian Societies
  • EPHAR-EACPT joint symposium on personalised medicine
  • Ethics in clinical research
  • Global Health
  • How to become a clinical pharmacologist
  • How to measure drug exposure
  • How to measure drug use
  • How to perform a health economic study
  • Interprofessional exchange for better drug treatment
  • Misuse of medicines
  • Patient empowerment
  • Preparing tomorrow’s prescribers
  • Prescribing and deprescribing
  • Targeting small populations
  • The critically ill patient
  • Treating ageing populations
  • Treating cancer
  • Treating children
Major awards to be presented at the Stockholm Congress include the EACPT Lifetime Achievement Award and the biennial EACPT Scientific Award for best publication on a clinical pharmacology or therapeutic theme.

Opportunities for EACPT Associate Members include
* discounted registration fees for EACPT meetings
* networking with colleagues worldwide through the global EACPT network of Associate Members
* active involvement in EACPT Working Parties and other activities


Find out how to become an Associate Member of the EACPT

Future EACPT Congresses will be held in:
– 2021 Athens
– 2023 Rotterdam


The EACPT was founded in 1993 and now includes as members all national organisations for clinical pharmacology in Europe, as well as organisations from further afield internationally. The EACPT aims to provide educational and scientific support for the more than 4000 individual professionals interested in clinical pharmacology and therapeutics throughout the European region, with its congresses attended by a global audience. The EACPT also advises policy makers on how the specialty can contribute to human health and wealth.

Tuesday, 12 December 2017

Developing robust common data models to guide safety in medicines in Europe


The European Medicines Agency held a 2 day international workshop in London [11th -12th December 2017] to define the opportunities and challenges around implementation of a common health data model in Europe to support regulatory decision making. The expected outcome of the workshop was agreement of guiding principles for the development of a Common Data Model (CDM) in Europe, including key criteria for validation in the context of regulatory decision-making.

A common data model could help harmonise healthcare data across multiple data sets and provide a mechanism to conduct pan-European studies in a timely manner to address regulatory questions. At the same time, applying a common model to European data has multiple challenges. The meeting brought together regulators with academia, data holders and the pharmaceutical industry.

Sessions included talks from experts from North America (FDA, Harvard, Duke, Georgia Tech ...) and the European region (Erasmus, Utrecht, CBG-MEB, EMA ...) discussing lessons learned and current challenges in very large current clinical data resources, regulatory verification and related issues. Common data model case studies considered included Sentinel – the Harvard-based FDA system for accessing patient data from 16 health data partners across the USA and CNODES (the Canadian Network for Operational Drug Effect Studies) which can access data on 100 million patients – a similar scale to Sentinel.

The U.S. Food and Drug Administration's (FDA) Sentinel Initiative is a long term approach which uses a common health data model to improve the FDA’s ability to identify and explore safety issues for medical products. Sentinel actively surveys pre-existing electronic healthcare data from multiple sources.

Consistent themes included ensuring the relevance of evolving common data models to health policy, keeping timelines as short as practical, interoperability, consent and related ethical issues (data custodians, patient data protection and privacy), and careful internal and external validation of clinical definitions, data, software and analytical models.

From the perspective of health professionals, policy makers, regulators and the public, key questions included whether clinical outcomes from common data models are generalisable or only relevant to specific sub-populations based on geography, genetics, demographics and/or complex co-morbidity.  In the era of precision medicine there is the clear need is to avoid “right” answers from the wrong clinical populations and “wrong” answers from the right populations.

Further key points considered included: what is the cost of developing and maintaining validated CDMs; who should pay; whether updating existing databases is a sufficient approach or rather new more robust databases are needed.

Saturday, 20 October 2012

Meet Senior Policy makers in Health Policy and Technology


@HealthMed @FPGMed
The UK Fellowship of Postgraduate Medicine, in partnership with international publisher Elsevier, has launched a major new international journal - Health Policy and Technology, now coming to the end of its first year of publication

Initial issues have included papers on UK Biobank and on the pioneering new Centre for Health Technology Assessment of Devices and Diagnostics within the UK’s National Institute for Health and Clinical Excellence (NICE), and papers on health policy, and technology from drug discovery to personalised medicine and e-health from the USA, Europe, the Middle East and India. 

There is also a series of interviews in print, online and as podcasts, with international leaders in the field of health policy and technology.

Listen to the first 4 podcasts
Sir Michael Rawlins, Chairman of NICE
Since Sir Michael Rawlins was appointed its founding Chairman in 1999, NICE has released 800 individual pieces of guidance covering not just guidelines and technological appraisals but also public health matters. NICE has also recently started looking at medical devices started to assess diagnostics, and the quality, safety and effectiveness of new interventional procedures.

Gonzalo Calvo, Chairman of EACPT
The European Association of Clinical Pharmacology and Therapeutics represents the National Clinical Pharmacology Societies from the 29 established and accession countries in Europe and their ~4000 clinical pharmacologist members.

Alexander von Gabain, Chairman of EIT
The European Institute of Innovation & Technology is an Agency of the European Union established in 2008 to address Europe's innovation gap. The EIT budget from 2008-2013 is 308.7million.

Andrew Kicman on Drugs in Sport
Dr Andrew Kicman is Head of Research and Development in the Drug Control Centre, Kings College, London, which is a World Anti-Doping Agency accredited laboratory, dedicated to drug control in sport. 

Background to the new journal and to the FPM

Home page for Health Policy and Technology