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Friday, 14 April 2017

Pharmacology and therapeutics education in the EU needs harmonisation and modernisation


The EACPT has supported a European study of clinical pharmacology and therapeutics education which has now just been published in the journal Clinical Pharmacology & Therapeutics.

Effective teaching in pharmacology and clinical pharmacology and therapeutics (CPT) is necessary to make medical students competent prescribers. However, the current structure, delivery and assessment of CPT education in the European Union (EU) is unknown. 

In this study, the authors evaluated the current structure, delivery and assessment of clinical pharmacology and therapeutics education in the European Union. The authors conclude from a cross-sectional survey among 185 medical schools in 27 countries that pharmacology and therapeutics education in the EU needs harmonisation and modernisation. 

The manuscript is now freely accessible as an abstract and as a full paper through the journal.



Charles Bridge, Prague
22 sessions with Keynote Lectures on current issues for research, education and clinical practice on safe and effective use of medicines  
- almost 500 oral and poster presentations from the European Region and around the world  
- opportunity to network with global experts and trainees in the fields of research, clinical practice, the biotechnology sector, regulation and health policy  
- update on the activities of the EACPT Working Groups for Research, Education, Regulation and Young Pharmacologists.



Anyone from anywhere in the world with a professional interest in clinical pharmacology and/or therapeutics can now join the EACPT as an Individual Associate member. 

There are reduced joining fees for Individual Associate members who are already members of a national or international organisation relevant to clinical pharmacology and therapeutics.

Friday, 7 April 2017

Register for updates on safety and effectiveness of medicines at EACPT Prague Congress - 24-27 June 2017


Rotterdam 7th April, 20017

The EACPT Executive Committee are meeting in Rotterdam to agree final details of the next EACPT Congress to be held in Prague from 24-27 June 2017.


Early registration deadline 17 April
Standard registration deadline 16 June
Highlights of the Congress will include

22 sessions with Keynote Lectures on current issues for research, education and clinical practice on safe and effective use of medicines  
- almost 500 oral and poster presentations from the European Region and around the world  
- opportunity to network with global experts and trainees in the fields of research, clinical practice, the biotechnology sector, regulation and health policy  
- update on the activities of the EACPT Working Groups for Research, Education, Regulation and Young Pharmacologists.
 
Charles Bridge - Prague

The programme will provide an international scientific and educational forum for discussion of clinical pharmacology and therapeutics, including personalised pharmacotherapy.
Themes will include the latest developments on effectiveness and safety of medicines, clinical pharmacology in clinical practice, pharmacokinetics/systems pharmacology, including in special populations, innovative techniques, eHealth, biomarkers, education, advanced practices in topics such as drug discovery, drug development, biological therapies, global health with a focus on access to safe medicines, new pharmacology and pharmacotherapy, safety in prescribing and updates on personalised medicines, as well as updates on specific therapeutic areas, including cardiovascular disease, infectious disease, nephrology, oncology, neurology and psychiatry.


Anyone from anywhere in the world with a professional interest in clinical pharmacology and/or therapeutics can now join the EACPT as an Individual Associate member. 
There are reduced joining fees for Individual Associate members who are already members of a national or international organisation relevant to clinical pharmacology and therapeutics.

Membership benefits include:
* Discounted registration fees for EACPT meetings
* Online access to the Official EACPT Journal - Clinical Therapeutics
* Access to the EACPT’s worldwide network of Individual Associate Members
* Active involvement in EACPT

The 2019 EACPT Congress will be held in Stockholm and the 2021 EACPT Congress in Athens.

The EACPT was founded 25 years ago 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.

Clinical Therapeutics, the Official Journal of EACPT.

Tuesday, 14 March 2017

Personalised Medicines and the European Medicines Agency

London, 14th - 15th March
The European Medicines Agency is hosting workshops for its Working Parties of  Patients', Consumers' and Health Professionals' organisations.

The 14th March workshop aims to create awareness among these organisations of how the work of the European Medicines Agency (EMA) relates to personalised medicines

The 15th March workshop provides updates on other EMA and relevant external acfivities including feedback on topic groups on Social Media and on Risk Minimisation from medicines, European Antibiotic Awareness, Action plans on Biosimilars, feedback from key EMA committees and synergies with other organisations.

Key aims
- understanding how European and global landscapes are shaping policy developments
- illustrating how activities of the European medicines regulatory network contribute to personalised medicine with existing legislation and regulatory tools
- discussing how clinical practice and public participation can support personalised medicine in the context of European Union (EU) regulatory activities
- identifying areas requiring attention from EU regulators, patients, healthcare professionals and civil society at large
- reflection by the working parties on priority areas for future contributions in broader multi-stakeholder discussions. 

Speakers include:  
- Sandra Kweder from the US Food and Drugs Administration, discussing  the US precision medicine initiative. She highlighted the need to personalise medicines with cancer a key driver - only 80% of patients estimated to respond better when individual genomic and proteomic information is available.

- briefings from EMA's Scientific Committees e.g.  PRAC chair June Raine discussing pharmacogenomics in pharmacovigilance e.g. preventing serious skin reactions to abacavir in HIV patients and limiting toxicity of anti-cancer agents e.g. 5-fluoro-uracil and capecitabine

- updates from research organizations e.g. Denis Lacombe from EORTC  (European Organisation for Research and Treatment of Cancer) on changing clinical research pathways, very expensive drugs and data-driven healthcare from "-omics" to "economics".
 
- developing diagnostics and treatments for rare diseases e.g. from Julian Isla on improving management of Dravet Syndrome - a rare, catastrophic, lifelong form of epilepsy that begins in the first year of life with frequent and/or prolonged seizures. 

- Ulrich Jäger from the European Haematology Association https://www.ehaweb.org/ on health professional perspectives on precision medicine, including practical challenges to applying precision medicine within a typical 7-12 minute consultation.    

- Dominique Monnet from the ECDC [European Centre for Disease Prevention and Control] reported on progress in developing European Antibiotic Awareness days, held annually on 18th November. The ECDC is mandated to monitor current and potential future risks to human health from communicable disease. Individual EU member states are responsible for risk management of established communicable disease.






The EACPT was founded 24 years ago 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.

Thursday, 16 February 2017

2017 EACPT Lifetime Achievement Award to go to Professor Pertti Neuvonen from Finland


The EACPT is  delighted to announce that the 2017 Lifetime Achievement Award of the European Association of Clinical Pharmacology and Therapeutics will go to Professor Pertti J. Neuvonen from Finland for his outstanding contribution to the national and international benefits of clinical pharmacology for medicine, health care and patient safety.
The Award, which includes the EACPT silver medal, will be presented to Professor Neuvonen during the 13th EACPT Congress in Prague. The Congress runs from 24th - 27th June 2017.

Professor Emeritus Pertti J. Neuvonen
Professor Emeritus Pertti J. Neuvonen, whose research focuses on drug safety and individual variability in drug response, particularly on drug interactions and their mechanisms, is one of the most cited clinical pharmacologists in the world, with over 20,000 citations. He has been listed by Thomson Reuters for years as an ISI Highly Cited Researcher in Pharmacology. He has authored over 500 original articles and reviews. Of the original papers, 92 have been published in the journal Clinical Pharmacology & Therapeutics. He has supervised around 50 Doctoral (PhD) thesis projects. 
Since 1970, Neuvonen´s research group has found more than 200 previously unrecognized, clinically important drug-drug interactions and several significant food-drug interactions. Furthermore, his group demonstrated, already in the 1980-90s, the efficacy of activated charcoal as gastric decontaminator, compared with induced emesis and gastric lavage. The drug interaction studies in humans were deepened by in vitro studies to explore mechanism, predictability and avoidance of the interactions. His group observed that inhibition and induction of CYP3A4/5-enzyme could cause over 10-fold changes in exposure to several drugs (midazolam, triazolam, buspirone, felodipine, simvastatin, lovastatin). 
Furthermore, his group discovered among generally used drugs many previously unrecognized inhibitors of drug metabolism (itraconazole: CYP3A4; gemfibrozil and clopidogrel: CYP2C8) and unexpected victim substrates (tizanidine: CYP1A2; cerivastatin, repaglinide, pioglitazone, rosiglitazone, loperamide, montelukast: CYP2C8). In addition to drug metabolizing enzymes, also membrane transporters (e.g., OATP1B1, P-glycoprotein, BCRP), and their pharmacogenetics and interactions were found to affect pharmacokinetics (e.g., statins) and drug response. Many of the original findings made by Neuvonen and his research groups have been adopted into textbooks, guidelines (e.g., FDA) and product information texts.
Pertti Neuvonen was born in Kirvu (Finland) on 25. August 1943. He is married and has five adult children. He studied medicine at the University of Helsinki between 1964 and 1970, and defended his doctoral thesis at this University in 1971. From 1971 to 1972, he was as a fellow of the Alexander von Humboldt-Foundation in Hannover Medical School (Germany). From 1972-1985, he was Senior Lecturer/Assistant Professor/Consultant of Clinical Pharmacology, and from 1986-1988 Acting Professor and Head Physician of Clinical Pharmacology at University of Helsinki and University Central Hospital, including the National Poison Information Centre. Between 1988 and 1991, he was Professor and Chairman of Pharmacology at University of Turku. From 1992 to 2011, he was Professor and Head of Clinical Pharmacology at University of Helsinki and University Central Hospital. After his retirement in 2011, he continues his studies at the Department of Clinical Pharmacology as a free researcher. In 2011, he received the BCPT Nordic Prize in Basic & Clinical Pharmacology & Toxicology, and the Medal of the FDA Office of Clinical Pharmacology.
The EACPT was founded 24 years ago 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, 17 January 2017

ADAPTSMART: Accelerated Development of Appropriate Patient Therapies -

London, EMA, 17th January 2017: ADAPT SMART is a  platform funded by the European Union's IMI (Innovative Medicines Initiative) for the coordination of Medicines Adaptive Pathways to Patients (MAPPs) activities, involving multi-stakeholder approaches from research through to treatment outcomes.

MAPPs seek to foster access to beneficial treatments for the right patient groups at the earliest appropriate time in the product life-span in a sustainable fashion.

The European Medicines Agency is today hosting at Canary Wharf in London an expert workshop on ADAPTSMART, with delegates from throughout the European Region, from the Japanese medicines agency and elsewhere.

Topics include:

- appropriate use of medicines

- timely access to innovative medicines and other interventions

- early access medicine schemes

- protected therapeutic schemes e.g. cancer access funds

 - compassionate use

- expanded access pathways

- shortened timelines for approvals

- international comparisons for consequences of inappropriate prescribing - non-compliance with treatment guidelines. Differences will be considered where reimbursement is linked to compliance with prescribing guidelines.

See more on the ADAPTSMART website about key work packages and other aspects.

Wednesday, 4 January 2017

EACPT supports first study of essential competencies in prescribing among European medical students


EACPT has funded the first study of Essential Competencies in Prescribing among European medical students. The study was led by the Working Group on Education of the EACPT and involved 895 Final-Year Medical Students attending 26 medical schools in 17 European countries.  
European medical students should have acquired adequate prescribing competencies before graduation, but prior to this study it was not known whether this is the case. In this international multicenter study, the researchers evaluated the essential knowledge, skills, and attitudes in clinical pharmacology and therapeutics (CPT) of final-year medical students across Europe. In a cross-sectional design, 26 medical schools from 17 European countries were asked to administer a standardized assessment and questionnaire to 50 final-year students. 

Although there were differences between schools, results showed an overall lack of essential prescribing competencies among final-year students in Europe. Students had a poor knowledge of drug interactions and contraindications, and chose inappropriate therapies for common diseases or made prescribing errors.

These important findings results suggest that undergraduate teaching in CPT is inadequate in many European schools, leading to incompetent prescribers and potentially unsafe patient care. A European core curriculum with clear learning outcomes and assessments should be urgently developed.



The EACPT was founded 24 years ago 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.

Thursday, 8 December 2016

Adaptive pathways for medicine evaluation and unmet medical need: the access v. evidence dilemma


adaptive pathways at its Canary Wharf London headquarters: a hot topic with around 150 delegates from healthcare, patient and consumer organisations, academia, industry and regulatory bodies.



The European Medicines Agency is organising this workshop in collaboration with the European Commission to gather views and proposals from stakeholders on the adaptive pathways approach, in light of the practical experience gained during the pilot project EMA ran between March 2014 and August 2016, and to plan the next steps in the exploration of this concept. 



The basis for considering adaptive pathways for evaluating medicines is to meet the challenges underlying how to resolve high unmet medical need with then aim of licensing products likely to have a major impact on patient morbidity and/or life expectancy.



The desire is to find ways to reduce unavoidable uncertainties as rapidly as possible for serious/rare debilitating and life-shortening illnesses. There are clear ethical and scientific challenges in using novel approaches to evaluate medicines without a decline in the quality of evidence on the effectiveness and safety of new treatments. 



Products which might be considered for use of adaptive evaluation pathways include both conventional medicines and advanced therapy medicinal products (ATMPs). ATMPs are medicinal product which involve either a gene therapy medicinal, a somatic cell therapy or a tissue engineered product [see more on ATMPs at Directive 2001/83/EC as amended by the ATMP Regulation 1394/2007].



Adaptive pathways contribute to an expanded  toolbox for evidence generation where conventional randomized controlled trials are not-appropriate or practical. Principles include using processes to allow rapid reaction to uncertainty by iterative development based on ongoing analysis of  pathway data [“rapid cycle analysis”]. As secondary end-points are welcomed, these pathways require pre-planning across the entire product life-span, including the post-marketing paths ie active monitoring and management of on-market use.

The adaptive pathway approach is dependent on earliest stage and ongoing multi-stakeholder networking, underpinned by risk management plans. 



Critical issues include

- resolving scientific trust in real world data and the need to develop mature, robust registries

- defining and prioritising unmet medical needs

- agreement on acceptable risks and benefits early access worth it (vs.

- maintaining safety standards

- ensuring that benefits outweigh risks

- avoiding unrealistic expectations

- establishing practical criteria for reimbursement, especially when secondary outcome measures form the basis for market authorization   











The EACPT was founded 24 years ago 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.