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. 

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.

See meeting programme

Key dates

Online Meeting Registration Deadline - September 30, 2016  

 

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:

• 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.

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.