Safer medicines in children and adults: video discussions from the international 2016 EACPT Focus Meeting in Opatija

From the EACPT Focus Meeting on How to Assess Medicines, Opatija, 6-9 October 2016. 

In these videos, Donald Singer discusses with speaker Suzana Mimica Matanovic evaluation of drugs in the pediatric population with an update on the impact of recent initiatives from the European Medicines Agency and discusses with Janne Backman from Helsinki how to identify and minimise risk of drug-drug interactions.

 

Discussants

- Suzana Matanovic: Assistant Professor of Clinical Pharmacology, School of Medicine, University of Osijek, Croatia and PCO alternate delegate at the European Medicines Agency

- Janne Tapio Backman: Professor in Clinical Pharmacology and Individual Medicine, University of Helsinki, Finland

- Professor Donald Singer: member of the Executive Committee of the European Association for Clinical Pharmacology and Therapeutics and EACPT delegate on the European Medicines Agency Health Professionals Working Party. 

Here is a summary of the key points from Professor Backman's  talk at the EACPT Focus Meeting in Opatija: 

Drug-drug interactions can either markedly reduce or enhance the therapeutic or adverse effects of drugs by causing alterations in the pharmacokinetics or pharmacodynamics of drugs. If such interactions are not understood or accounted for in patient care, they can have harmful, even hazardous clinical consequences. 

Drug-drug interactions have been a major cause of drug withdrawals from the market. Regulatory agencies, including the European Medicines Agency (EMA) have therefore published guidance documents that are designed for the industry to guide their DDI studies during drug development. In particular, detailed scientific recommendations can be given concerning pharmacokinetic interactions, because such interactions can be mediated via mechanistic changes in absorption, distribution, metabolism and excretion of drugs. 

Specific approaches are suggested concerning cytochrome P450 enzymes (CYPs), non-CYP enzymes and membrane transporters. In addition, current guidance also recommends use of modelling approaches, such as physiologically based pharmacokinetic (PBPK) models to design and extend the interpretation of preclinical and clinical drug-drug interaction studies. For designing clinical drug-drug interactions studies, detailed preclinical in vitro and early clinical pharmacokinetic information is necessary. 

Despite detailed guidelines, there are many challenges in characterization of the interaction potential of a drug, both as a perpetrator and as a victim of the interaction. Such challenges arise from complex interaction mechanisms, eg, simultaneous involvement of transporters and drug metabolizing enzymes, autoinhibition and autoinduction of metabolism, time-dependent inhibition and involvement of major drug metabolites. 

Understanding the challenges and pitfalls of drug-drug interaction studies is thus necessary in interpretation of the results of studies. In this lecture, basic methods of clinical drug-drug interaction studies will be reviewed, with examples of potential pitfalls and basic principles of interpretation.

The next EACPT biennial congress will be held in Prague Congress from 24th - 27th June 2017. The programme will provide an international scientific and educational forum for discussion of clinical pharmacology and therapeutics, including personalised pharmacotherapy. See more on our website. 

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

Membership benefits include

* Access to videos of talks from EACPT Meetings

* 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 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.

Update on biosimilars from the European Medicines Agency

The European Medicines Agency has just released an update on biosimilars - the latest in its series of  multimedia briefing sessions. The videos were recorded at a joint briefing session for EMA's Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP) and Healthcare Professionals’ Organisations (HCPWP). 

Sessions include
- an introductory briefing by Professor Sir Kent Woods
- an overview of the science behind biosimilars
- how they are evaluated by regulators
- how to bridge the scientific evaluation with clinical reality
- public acceptability of biosimilars
- promoting better understanding of biosimilars 

View the videos:

 

The European Association for Clinical Pharmacology and Therapeutics (EACPT) was founded 22 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.

The 12th biennial Congress of the EACPT is being held in Madrid from 27th to 30th June 2015.

EACPT Lifetime Achievement Award for Professor Michel Eichelbaum

The 2015 Lifetime Achievement Award of the European Association of Clinical Pharmacology and

Therapeutics will go to German researcher Professor Michel Eichelbaum 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 Eichelbaum during the 12th EACPT Congress in Madrid on Saturday 27th June 2015.

Michel Eichelbaum's primary research interest is pharmacogenetics of drug metabolizing enzymes and transporter proteins. He was a pioneer in the study of the stereochemistry of drugs,  use of stable isotopes in clinical pharmacology, and intestinal metabolism and transport of drugs. 

In 1975, he discovered a genetic polymorphism in the oxidation of the antiarrhythmic and oxytocic drug, sparteine, which later became known as CYP2D6 polymorphism. This is considered his single most important scientific discovery. Later, he became involved in research on factors involved in the regulation of drug-metabolizing enzymes and transporters with special emphasis on nuclear receptors.

See more about Professor Eichelbaum in my blog on the EACPT site.

The EACPT was founded 22 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.

Spotlight on excellent EACPT summer cardiovascular focus meeting 3-5 July in Holland

You are still in time to register for 2014 EACPT Focus Meeting on 'Drugs to Fight Cardiovascular Damage' from organised by the the European Association for Clinical Pharmacology and Therapeutics [EACPT] .

Registration  - with a preferential accommodation rate - is available through the Focus Meeting website.

The 2014 EACPT Focus Meeting takes place from July 3rd - 5th at the Radboud University Medical Center in Nijmegen in the Netherlands.

Reasons to come to this outstanding meeting

• excellent tradition of EACPT in providing outstanding meetings for young and senior clinicians and researchers
• great opportunities for networking with your peers and senior members of the international clinical pharmacology community
• easy access to senior researchers on the international speaker faculty 
• opportunity to have first hand news on major developments for EACPT
• meet Dr Richard Shader, the editor of the EACPT's Official Journal - Clinical Therapeutics 
• expert session from Dr Shader on how to publish

In addition to state-of-the-art lectures from international cardiovascular experts, over 60 delegate abstracts are due be presented  from around the world. The top 5 ranked abstracts will be provided with free registration. All abstracts presented at the meeting will be published in Clinical Therapeutics, the peer-reviewed Official Journal of the EACPT. 

This focus meeting follows on from the highly rated  EACPT international summer school in 2013 in Edinburgh.

The 2014 EACPT Focus Meeting will provide you with the opportunity to attend state of the art lectures from leading professionals and researchers, including hands-on workshops. 

Radboud University Medical Centre, Nijmegen 

Topics include ultrasound imaging of vascular injury (including a hands-on workshop), the microbiome and inflammation in the metabolic syndrome, targeting inflammation to prevent and treat atherosclerosis, diagnosis and therapy of adrenal hypertension, and protection against ischaemia-reperfusion injury.

This EACPT Cardiovascular Focus Meeting is of interest to clinical pharmacologists, pharmacologists, and other young scientists and clinicians interested in drug treatment of cardiovascular disease. 

You can listen here to podcasts with international delegates at the last EACPT summer meeting in Edinburgh in 2013.

See the Scientific Programme is now online on the Focus Meeting website. 

Visit the Clinical Therapeutics website.

Policy, pharmacology and the European Association of Clinical Pharmacology and Therapeutics

The EACPT is in a prime position to foster an environment of exchange between research and policy within the field of clinical pharmacology and therapeutics.

The European Association of Clinical Pharmacology and Therapeutics (EACPT) includes all

the national scientific and professional organisations and societies for clinical pharmacology and therapeutics in Europe. It aims to provide educational and scientific support for the more than 4,000 individual professionals interested in clinical pharmacology and therapeutics throughout the European region.

All medicines have risks of adverse effects, in addition to their expected health benefits. The EACPT is very well placed to provide up-to-date briefings and recommendations to policy makers on how pharmacology can contribute positively to human health and wealth, through a clear understanding of the clinical and cost benefit/risk ratio of medicines.

The EACPT is also in a strong position to advise on the support needed for clinical pharmacology and therapeutics, and its underpinning pharmacology, to ensure that established experts and emerging CPT professionals in academia, the clinical domain, governance, industry and other roles can continue to develop and use medicines effectively to meet current and new challenges to human health.

Read the full article

For more information on the Policy Community journal where this article was published please visit www.paneuropeannetworks.com

Young pharmacologists from 5 continents at EACPT Clinical Pharmacology Summer School

Over 120 young and senior pharmacologists from 5 continents attended the EACPT Summer School in Edinburgh 4-6 July: half the young clinicians and researchers from the UK and half from around the world: continental Europe, from Estonia and Lithuania to Denmark and Spain, 16 from China, others from Australia and elsewhere. 

Hear the podcast from delegates at the EACPT Summer School from 6 European countries talking about why they came and how useful they found the EACPT Summer School in Edinburgh: Eglė Svitojūtė, Lithuania; Morten Rix Hansen, Odense, Denmark; Aurelija Noreikaite, Lithuania; Gareth Barnes, London, UK; Alexandra Androu, Romania; Madli Pintson, Tartu, Estonia; Julia Daragrjati, Padua, Italy.

Blogs from delegates from 8 countries

EACPT Summer Schools consist of keynote presentations and workshops on all aspects of clinical pharmacology by invited expert speakers, poster presentations, and social events. There is a strong interactive element and ample opportunity for delegates to network with speakers. 

See also information on the 11th EACPT Congress in Geneva: 28th - 31st August, 20

EACPT Awards to be presented at August Geneva Congress

The EACPT has announced its awards for 2013, to be presented at the 11th EACPT Congress in Geneva 28th - 31st August 2013. 

The Special Award for services to the EACPT goes to Professor Michael Orme, who co-founded the EACPT 20 years ago in 1993. Professor was EACPT founding secretary then Chairman and played a major role in growing EACPT into a major international organisation representing all clinical pharmacology societies in Europe and their over 4000 clinical pharmacologist members.

The  2013 EACPT Scientific Award goes to Dr David Devos from the Department of Medical Pharmacology at the Université Lille Nord de France. The EACPT Scientific Award is for the report by Dr Devos, using methylphenidate as a new approach to treating Parkinson's disease. 

The paper, for which Dr Devos was corresponding author, was published in the July 2012 issue of 
the high impact international journal -  Lancet Neurology. The prize includes a 2000 € award.

The 2013 Lifetime Achievement Award of the European Association of Clinical Pharmacology and Therapeutics goes jointly to Professor Sir Michael Rawlins and to Professor Carlo Patrono, for their outstanding contributions to the national and international benefits of clinical pharmacology for medicine, health care and patient safety.

 EACPT website. 

Official EACPT journal - Clinical Therapeutics. 

Updates from the European Association Clinical Pharmacology & Therapeutics

@HealthMed The EACPT is planning two major events in the Summer of 2013. 

Professors David Webb and Simon Maxwell are organizing an EACPT Summer School for young researchers to be held in their home city, Edinburgh, 6 - 8 July, 2013. The programme includes keynote talks by invited expert speakers, workshops, poster presentations, free communications and social events. 

And August 28 - 31, 2103, the 11th EACPT Congress takes place in Geneva, hosted by the Swiss Society for Clinical Pharmacology and Toxicology. Over 900 participants are expected to attend including health professionals, scientists, policy makers, biotechnology and pharmaceutical professionals and others with an interest in basic and clinical pharmacology, pharmacotherapy, drug discovery and development, regulatory affairs and related areas.

11th EACPT Congress website 

11th EACPT Congress updates

EACPT Summer School details