Updates on the EACPT from the UK

The EACPT Executive Committee is meeting in early September 2018 in Birmingham in the UK West Midlands to plan for future activities. This coincides with the latest EACPT Focus meeting: Innovations in CPT Education - which is being held at the University of Birmingham from 7-8 September 2018. Delegates for the Focus meeting are expected from a wide range of countries, including Finland, Germany, Ireland, The Netherlands, Sweden, Switzerland, Lithuania, Poland, Italy, Spain, Romania, Malta and the UK.

EACPT EC in Birmingham

Key matters for discussion by the EACPT EC included:

1. Future EACPT Congresses - the next is due to 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.
The Keynote Opening Lecture will be given by the President at the Karolinska Institute, Professor Ole Petter Ottersen, on global health and clinical pharmacology.

Congress 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

2. New EACPT Awards for Best Scientific Paper in the previous 12 months on a clinical pharmacology or therapeutics theme. Authors may be from any discipline and do not have to be members of the EACPT. These awards will be launched in September 2018 and awarded initially every 2 months (6 times a year) from November 2018. 

Award winners will receive a free one year Individual Associate Membership (IAM) of the EACPT. Winners who are already EACPT IAMs will receive a 100€ prize. Papers which receive an EACPT Scientific Paper Award will be eligible to be considered for the biennial EACPT Scientific Award.

3. EACPT working groups on Education, Research, Young Professionals, and Regulation and Ethics.

4. New EACPT web series on Meet the Clinical Pharmacologists

5. Opportunities from links with international organisations such as the European Medicines Agency, IUPHAR, EPHAR and UEM|

6. Opportunities for Individual Associate Members including:
* 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  

The EACPT Executive Committee meets 6 monthly, with regular additional discussions by teleconference on key EACPT strategy and activities.

Future EACPT Congresses will be held in:
- 2019 Stockholm
- 2021 Athens
- 2023 Rotterdam

The EACPT was founded in 1993 - 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.

Updates on digital media and health at the European Medicines Agency

Safe and effective healthcare matters for society as a whole.

Digital media and health is the key theme of the latest joint meeting of the European Medicines Agency (EMA) Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP) and Healthcare Professionals’ Organisations (HCPWP) being held in London on 17^th and 18^th April 2018. Digital media and health topics are being discussed, including recent learning and trends with regard to mHealth, social media, real-word evidence and electronic product information.

Katja Neubauer from the European Commission opened the session with an update on EU initiatives with regard to digital health. She considered 3 priority areas on digitizing health and care: access of the citizen to his or her data for example in electronic medical records and electronic prescribing; access to big data to improve health policy and regulatory decisions; and using digital health make policy decisions more patient-centred.

She discussed clinical use studies, including development of European Reference rare diseases, applying digital health to anticipating epidemics and EU-wide infectious threats and applying Real World Data in medicines development.

An EC report on Digital Single Market strategy is due to be published on 25^th April.

Hans-Georg Eichler from the EMA went on to discuss the relevance of real world evidence to regulation of medicines, including understanding efficacy and monitoring for unexpected risk and for long-term risk. In particular, he considered use of real world evidence to match the speed of science progress with timely integration of innovations into clinical practice.

He considered case studies on accelerating drug development, contrasting findings from real world evidence with those from classical randomized clinical trials; applying real world evidence to monitoring potential long term adverse effects of medicines – for example from risks of insertional mutagenesis following gene therapy for thalassaemia which needs surveillance for decades; and applying real world evidence to understanding therapeutic complexity – for example deciphering combinatorial complexity in oncology treatment with regard to differences in therapeutic impact from treatment order, dose and washout duration between treatments.

He also discussed applying learning for health care from other sectors (aviation, automotive …), including data-driven innovation from rapid feedback loops.

Alison Cave from the EMA discussed key points from recent workshops hosted by the Agency. She stressed the need for a common data model for Europe. A key theme arising from discussion of EMA registries had been the need for common core data elements, checks on data quality (consistency, accuracy and completeness), long-term curation, availability and governance.

Jane Mosely discussed how real-world evidence and patient registries can be used to support early access to medicines, risk-benefit analysis and provide rapid replication within different populations of initial findings. She noted that there are currently limited requests for data from real-world evidence to support pre-authorisation decisions and post-authorisation questions about safety and efficacy. Some aspects which need to be considered include eligibility of participants, outcome definition, patient safety, and extrapolation of findings throughout the EU.

Alexios Skarlatos (EMA) and Dr. César Hernández García (Spanish Agency of Medicines and Medical Devices) discussed Electronic Product Information. Steps include consultation on revising Patient Leaflet content and adding agreed new content, including targeted messages for relevant subgroups of patients. There are already case studies from the Netherlands (Watchyourmeds), quick guides for patients in Norway and in Spain structured product information accessible e.g. by scanned quick response (QR) codes. International standards are needed and transition to a Digital first model.  There will be a European Commission-EMA-HMA multistakeholder workshop on the use of electronic Summary of medical Product Characteristics (SmPC)/Patient Leaflets (PL) on 28^th – 29^th November 2018.

Further speakers will discuss from health professional, regulator, patient, consumer perspectives Real World Evidence (Kieran Breen, Patient Representative on the EMA Committee for Advanced Therapies), mHealth (Kathi Apostolidis, European Cancer Patient Coalition) and Social Media (Caroline Morton, International Bureau for Epilepsy).

More about the meeting and the presentations can be found on the EMA website.

EACPT - 2018 Updates from Stockholm

EACPT Executive Committee meeting in Stockholm

The EACPT Executive Committee is meeting in early April 2018 in Stockholm to plan for future activities.

Key matters for discussion include

1. Future EACPT Congresses - the next is due to be held 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.
2. The next EACPT Focus meeting: Innovations in CPT Education - to be held at the University of Birmingham 7-8 September 2018.
3. New EACPT Awards for Best Scientific Paper in the previous 12 months. These awards will be launched on 1st June 2018 and awarded initially every 2 months (6 times a year) from August 2018. Award winners will receive a free one year Individual Associate Membership (IAM) of the EACPT. Winners who are already EACPT IAMs will receive a 100€ prize. Papers which receive a EACPT Scientific Paper Award will be eligible to be considered for the biennial EACPT Scientific Award.
4. EACPT working groups on Education, Research, Young Professionals, and Regulation and Ethics.
5. New EACPT web series on Meet the Clinical Pharmacologists
6. Opportunities from links with international organisations such as the European Medicines Agency, IUPHAR, EPHAR and UEM
7. Opportunities for Individual Associate Members including:
* discounted registration fees for EACPT meetings
* online access to the official EACPT Journal - Clinical Therapeutics
* 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  

The EACPT Executive Committee meets 6 monthly, with regular additional discussions by teleconference on key EACPT strategy and activities.

Future EACPT Congresses will be held in:
- 2019 Stockholm
- 2021 Athens
- 2023 Rotterdam

The EACPT was founded in 1993 - 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.