Search This Blog

Loading...

Wednesday, 21 September 2016

Pharmacovigilance: update on activities by the European Medicines Agency



The European Medicines Agency is today holding its Tenth stakeholder forum on the pharmacovigilance legislation of the European Union.  This forum brings together regulators with patients, consumers, healthcare professionals and industry, to take stock of what the EMA has achieved and what needs to be the focus over the coming years.
The programme is being broadcast live with presentations thereafter available on the EMA website.

Fergus Sweeney (EMA) & June Raine (PRAC Chair)
Key presentations include:
-  a 3-year update on pharmacovigilance activities by Dr Helen Lee from the European Commission 
- a report on SCOPE (The Strengthening Collaboration for Operating Pharmacovigilance in Europe) by Dr June Raine, head of the EMA's PRAC (Pharmacovigilance Risk Assessment Committee)
- the Impact of pharmacovigilance by Almath Spooner from the Health Products Regulatory Authority, Ireland
- the PROTECT health project involving active information-sharing by patients
- the WEB-RADR project on harnessing mobile apps and geo-tagging from Philip Tregunno from the UK MHRA - using social media as a signal detection and strengthening tool
-  actions from the EMA Risk Minimisation Measures Topic Group from Jamie Wilkinson, PGEU (Pharmaceutical Group of the European Union)
The EACPT – the European Assocation for Clinical Pharmacology and Therapeutics – has 34 member countries in the EU region and beyond, and around 800 individual members. Considering some of the recent pharmacovigilance activities important for an organisation such as the EACPT, these include:
–      the 2013 black triangle scheme which concerns an evolving list of medicines under additional monitoring, building on UK experience of this approach to pharmacovigilance. Many EACPT members are directly or indirectly involved in reporting and monitoring issues related to safety of medicines
–      The EMA-ADR database of ~6 million reports - a growing resource for recording and assessing risk from medicines
–      Robust systems regarding the supply chain are vital to ensure safe medicines including from internet pharmacies. Falsified/contaminated/counterfeit medicines must be excluded both in established and newer members of the EU. This will be one of the– key themes at the next EACPT Congress in Prague in June in 2017.
Important drivers for change over the next five years include
- transparency and impact of EMA pharmacovigilance activities
- enabling partnerships, including through active EMA working parties involving healthcare professionals, patients and consumers
- Digital Media to complement current safety systems for evaluating medicines
 
Enhanced systems are needed for evaluating Real World health data across the EU region, for example analogous to the US Sentinel model – an HMO partnership with FDA and Harvard, and large Clinical Practice databases in the UK.

These Real World health data resources are needed to support evaluating signals from social media to complement existing systems for identifying and preventing adverse drug reactions, as well as to support development of medicines for patients with rare diseases.

Effective expanding use of social media will to enhance communications on PV from the EMA to its partner organisations: and through them tp health professionals, patients and other stakeholders. Systematic heterogenous use of social media provides great opportunities to enhance efficiency of effective delivery and monitoring adoption of safety messages – some of which were aired at the EMA earlier this week – presentations from the day will be on the EMA website. 




Tuesday, 20 September 2016

Register for EACPT Focus Meeting in Opatija, Croatia on How to Assess Medicines 6th - 9th October


There is still time to register for the next EACPT Focus Meeting which will be held from 6th to 9th October, 2016 in partnership with the Croatian Society for Clinical Pharmacology and Therapeutics.

The theme of the meeting is “How to Assess Medicines from Research to Clinical Practice”.

There is a bursary fund of 10,000 € to support abstract presenters.

Key dates

 
The main objectives of this Focus Meeting are to increase awareness, knowledge and use of critical assessment pillars for medicinal products in everyday clinical practice in order to improve healthcare outcomes in affordable manner.
The meeting will include a combination of scientific podium lectures, interactive workshops and guided poster sessions covering three main pillars important for the critical assessment of medicinal products - efficacy, effectiveness, and economics (3E assessment).

There will be a dedicated session for Young Pharmacologists during the meeting. There will be an EACPT Scientific Communication Award for the best presentation by a young scientist. 
Confirmed speakers and topics

JANNE TAPIO BACKMAN (Finland): Clinical drug-drug interaction studies: methods, pitfalls and interpretation
NADA BOŽINA (Croatia): The role of pharmacogenetics in individulized treatment choices
YLVA BOTTIGER (Sweden): National model for the introduction and follow-up of new, expensive drugs in Sweden
GONZALO CALVO (Spain): Accelerated approval paths. What they do mean and what they should not mean?
SIMON MAXWELL (UK): Safe introduction of new medicines into clinical practice
KEN PATERSON (UK): Rapid Health Technology Assessment of New Medicines - Lessons from 15 Years Experience in Scotland
WORKSHOP 2: EXCELLENCE IN CLINICAL RESEARCH - CLINICAL TRIAL DESIGN
IGOR FRANCETIĆ (Croatia): Effectiveness assessment: when pharmacokinetics makes a difference / macrolide and azalide examples
MATTHIAS SCHWAB (Germany): Pharmacogenomics and drug response: future challenges
EDUARDO SPINA (Italy): Efficacy of antidepressants: issues related to bias in clinical trials
TABASSOME SIMON (France): Key points for building succesful clinical trial
SINIŠA TOMIĆ (Croatia): The Role of the National Competent Authority (NCA) in the Assessment of Medicinal Products in the National Procedure
DONALD SINGER (UK): Personalised medicine approaches for identifying effective therapies
SLOBODAN VUKIČEVIĆ (Croatia): Current challenges and hurdles in new drug development

We will be guests in the Adriatic coastal town Opatija, Croatia. Opatija lies at the centre of the Kvarner Riviera with the longest tradition of providing quality conference venues in Croatia. Opatija’s very attractive geographic location, lush green scenery and a pleasant climate (45° 20’ north latitude) were some of the main reasons for its origins and the rapid development of its tourism from the end of the 19th century.  The venue – Grand Hotel 4 Opatijska Cvijeta –  is located in the very centre of Opatija and includes four buildings that were named after Opatija’s best-known flowers. The hotel has 223 rooms. The hotel also includes the large Tamaris congress centre, which has 7 multi-functional halls and the latest congress equipment.

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:
  • 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.

Monday, 19 September 2016

Digital Media for Health and the European Medicines Agency


The European Medicine Agency is today holding a Workshop on Social Media for its
Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP) and Healthcare Professionals’ Organisations. 

Social media is a group of electronic communication tools that have the potential to change how healthcare professionals, researchers, patients and consumers manage and share information in the digital age, including on the safe and effective use of medicines.

The Workshop opened with a keynote talk by M-K Looi, Wellcome Trust, on "Going viral: the state of play and potential of social media in 2016". This was followed by talks by S. Labbe, communications expert from the EMA and notes on experience of use of social media by the USA FDA presented by 2 FDA pharmacists – C. Chew and K Chiu.
 
The EMA Social Media topic group had previously identified areas and patterns of use of social media by PCWP and HCPWP member organisations in relation to the EMA and to their other key professional areas of interest and activity. In a new survey conducted over the summer of 2016, SWOT feedback has been obtained from health organisations currently active in use of social media and a further group of  organisations not currently active in use of social media.

An analysis of findings of the SWOT analysis will be presented and discussed followed by break-out sessions on best practice in use of social media experts. Further sessions will consider how digital information could be relevant to regulatory decision-making.  

The sessions are being recorded with presentations to be made available on the EMA website.

Friday, 13 May 2016

Submit abstracts for "How to Assess Medicines from Research to Clinical Practice": 6-9 October 2016. EACPT Focus Meeting - Opatija, Croatia.


The next EACPT Focus Meeting will be held from 6th to 9th October, 2016 in partnership with the Croatian Society for Clinical Pharmacology and Therapeutics.

The theme of the meeting is “How to Assess Medicines from Research to Clinical Practice”.

There will be a bursary fund of 10,000 € to support abstract presenters.

Key dates



 
The main objectives of this Focus Meeting are to increase awareness, knowledge and use of critical assessment pillars for medicinal products in everyday clinical practice in order to improve healthcare outcomes in affordable manner.
The meeting will include a combination of scientific podium lectures, interactive workshops and guided poster sessions covering three main pillars important for the critical assessment of medicinal products - efficacy, effectiveness, and economics (3E assessment).

There will be a dedicated session for Young Pharmacologists during the meeting. There will be an EACPT Scientific Communication Award for the best presentation by a young scientist. 
Confirmed speakers and topics

JANNE TAPIO BACKMAN (Finland): Clinical drug-drug interaction studies: methods, pitfalls and interpretation
NADA BOŽINA (Croatia): The role of pharmacogenetics in individulized treatment choices
YLVA BOTTIGER (Sweden): National model for the introduction and follow-up of new, expensive drugs in Sweden
GONZALO CALVO (Spain): Accelerated approval paths. What they do mean and what they should not mean?
SIMON MAXWELL (UK): Safe introduction of new medicines into clinical practice
KEN PATERSON (UK): Rapid Health Technology Assessment of New Medicines - Lessons from 15 Years Experience in Scotland
WORKSHOP 2: EXCELLENCE IN CLINICAL RESEARCH - CLINICAL TRIAL DESIGN
IGOR FRANCETIĆ (Croatia): Effectiveness assessment: when pharmacokinetics makes a difference / macrolide and azalide examples
MATTHIAS SCHWAB (Germany): Pharmacogenomics and drug response: future challenges
EDUARDO SPINA (Italy): Efficacy of antidepressants: issues related to bias in clinical trials
TABASSOME SIMON (France): Key points for building succesful clinical trial
SINIŠA TOMIĆ (Croatia): The Role of the National Competent Authority (NCA) in the Assessment of Medicinal Products in the National Procedure
DONALD SINGER (UK): Personalised medicine approaches for identifying effective therapies
SLOBODAN VUKIČEVIĆ (Croatia): Current challenges and hurdles in new drug development

We will be guests in the Adriatic coastal town Opatija, Croatia. Opatija lies at the centre of the Kvarner Riviera with the longest tradition of providing quality conference venues in Croatia. Opatija’s very attractive geographic location, lush green scenery and a pleasant climate (45° 20’ north latitude) were some of the main reasons for its origins and the rapid development of its tourism from the end of the 19th century.  The venue – Grand Hotel 4 Opatijska Cvijeta –  is located in the very centre of Opatija and includes four buildings that were named after Opatija’s best-known flowers. The hotel has 223 rooms. The hotel also includes the large Tamaris congress centre, which has 7 multi-functional halls and the latest congress equipment.

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:
  • 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 from Prague on the EACPT

The EACPT Executive Committee have met in Prague from 13th - 14th May to plan for
Charles Bridge - Prague

its future activities.

These include:
  1. A joint EACPT session with EPHAR in Istanbul, June 26-30th 2016.
  2. Our next Focus Meeting to be held in Opatija in Croatia from 6th - 9th October 2016
  3. The exciting programme shaping up for the EACPT Prague Congress (24-27 June 2017)
  4. Plans for major EACPT Awards due in 2017 (Lifetime Achievement - deadline 31st October, 2016; Scientific Award - deadline 31st January, 2017)
  5. Support by the EACPT of the new UEMS Clinical Pharmacology Section
  6. Activities of the EACPT Working Groups for Research, Education, Regulation and Young Pharmacologists.
October 6-9th 2016 EACPT Focus Meeting on how to assess medicines ...

The theme of the October 6-9th 2016 EACPT Focus Meeting is “How to Assess Medicines from Research to Clinical Practice? Efficacy, Effectiveness, and Economic – 3E Assessment”. 

The main objectives of this Focus Meeting are to increase awareness, knowledge and use of critical assessment pillars for medicinal products in everyday clinical practice in order to improve healthcare outcomes in affordable manner. 

Abstract deadline: June 15th 2016
Early registration deadline: June 30th 2016

EACPT Prague Congress - 24-27 June 2017

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.
Members of the EACPT Executive Committee in Prague: Back Row: Matthias Schwab (Germany), Donald Singer (UK), Edoardo Spina (Italy), Tabassome Simon (France), Caroline Samer (Switzerland), Marie Besson (Switzerland), Milan Grundmann (Czech Republic); Front ROw: Simon Maxwell (UK), Dinko Vitezic (Croatia), Janne Backman (Finland), Ylva Böttiger (Sweden), Gerard Rongen (Netherlands).

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


Click here to apply online for EACPT membership. 

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:
  • 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.

Clinical Therapeutics, the Official Journal of EACPT.

Wednesday, 9 March 2016

The EMA Launches new PRIority Medicines scheme - PRIME


The European Medicines Agency has today launched the new PRIME (PRIority MEdicines)
scheme to strengthen support for medicines that target an unmet medical need. The scheme focuses on medicines that may offer a major therapeutic advantage over existing treatments, or benefit patients with no treatment options.

A press release and further information on PRIME have been published on the EMA website, including details of how to apply. In the event of queries, a dedicated EMA e-mail box has been set up.

The EACPT, through its Working Group on Regulation of Medicines and Ethics will keep informed EACPT affiliated societies and associated members on any hot regulatory issue and other relevant information on medicines emerging from the EU regulatory framework.
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.


Wednesday, 23 December 2015

New Year plans for the EACPT

We wish all our national society and individual members all the best for the festive season and for 2016.

The New Year will see further major activities for the EACPT. These include:

The next EACPT Focus Meeting will be held from 6th to 9th October, 2016 in partnership with the Croatian Society for Clinical Pharmacology and Therapeutics. The theme of the meeting is “How to Assess Medicines from Research to Clinical Practice".
The main objectives of this Focus Meeting are to increase awareness, knowledge and use of critical assessment pillars for medicinal products in everyday clinical practice in order to improve healthcare outcomes in affordable manner.

Planning is already well underway for the next biennial EACPT Congress, to be held in Prague from 23rd – 27th June in 2017. As part of Congress preparations, the next meeting of the EACPT Executive Committee will be in May in Prague.

Following the launch of a new individual associate membership for the EACPT, further working groups have been launched, complementing the established EACPT Education Working Group.These working groups provide excellent opportunities to become actively involved in the running of the EACPT.

EACPT Working Groups:
  • Young Clinical Pharmacologists
  • Education
  • Ethics
  • Regulatory 
  • Research  
Click here to apply online for EACPT individual membership. 
 

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:
  • Active involvement in the EACPT  
  • 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
The EACPT was founded 23 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.