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Showing posts with label regulating medicines. Show all posts
Showing posts with label regulating medicines. Show all posts

Wednesday, 22 November 2017

European Medicines Agency to move from London to Amsterdam

After a final round dead-heat vote by member states on Monday 20th November, following the drawing of lots, Amsterdam has been confirmed as the new home for the European Medicines Agency. On current plans, the EMA will be operating in Amsterdam from April 2019.


The EMA's Patients and Consumers Working Party annual meeting
Meantime the EMA's Patients and Consumers Working Party (PCWP) is holding its annual meeting with all EMA eligible patient/consumer consumer organisations to consider relocation preparedness, patient and consumer involvement in EMA activities, highlights from major EMA committees and updates on pharmacovigilance, information on medicines and future work programmes in 2018 and 2019 for the PCWP and the EMA's Healthcare Professionals Working Party.

The European Medicines Agency is concerned with regulation of medicines and other advanced therapies for humans and animals for 28 countries across the European Union.

The EMA has established mechanisms for involving patients in regulatory assessment: patients’ value perception and value systems. The EMA also has an increasing remit to engage with stakeholder organisations and to improve transparency in its activities for the ~510 million citizens of the European Union. Furthermore the EMA has a major role in educating patients, carers and health care professionals about medicines.  

There remain many decisions and actions for the coming months needed to ensure the smooth relocation of the EMA to Amsterdam and either to develop systems to retain UK expertise for the EMA or replace that expertise. For the EMA, these include:
  • maximising staff retention
  • maintaining capacity to continue the work of the EMA 
  • continuing productive engagement with stakeholder groups: patients, carers, healthcare professionals ...
  • maintaining the capacity of the EMA to engage with the public
For the UK, there are pressing questions regarding the future regulation of medicines in the UK post-Brexit, the impact of loss of international influence of UK regulators and other experts on medicines and the impact of loss of biotech and pharmaceutical companies from London to Amsterdam.

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, 25 November 2015

Join EACPT to access new video library of talks on medicines from 2015 Madrid Congress


The EACPT has just released a library of almost 60 videos of talks from the 2015 Madrid
Plaza Major, Madrid
Congress. These videos are now available for EACPT members within the members’ pages of the EACPT website. See below for the list of speakers and their topics, ranging from Alzheimer's to cancer, treating children, regulating medicines, the patient's voice, medicines for low resource global settings, biosimilars, and patient safety.
Access to the videos is free for Individual Associate members of the EACPT.
To view the videos as an existing EACPT member, open the ‘Publications’ drop down menu on the members' pages of the website.


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.
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 
If you are an existing Individual Associate member of the EACPT and have any query regarding your membership login details for the website, please contact eacptmembership@kenes.com.
This new portfolio of videos enriches the existing library of videos of talks available on the EACPT members’ website from the EACPT Cardiovascular focus meeting held in Nijmegen in 2014.
Main topics and speakers
Biosimilar medicinal products. How to enhance healthcare systems sustainability without compromising clinical practice.
Martina Weise (Germany), Cristina Avendaño-Solá (Spain), Aleksandra Grozdanova (Macedonia)
Debate on therapeutic innovation: Does industry research meet the needs of society?
Xavier Carné (Spain) vs. Ruth Diazaraque (United Kingdom)
Debate on pharmacoepidemiology databases
Miriam CJM Sturkenboom (The Netherlands) vs. Tom MacDonald (United Kingdom)
Current challenges in cancer treatment.
Luis Paz Ares (Spain)
Novel insights in ADME
Janne Backman (Finland), Amin Rostami (United Kingdom)
Handling medicines in special populations
- Renal function in older people: Emmanuelle Vidal-Petiot (France)
- Rational pharmacotherapy in children: Imti Choonara (United Kingdom)
- Appropriate prescribing in older patients: Beatriz Montero (Spain)
Medicines and Global Health
Nicola Magrini (WHO, Switzerland), Lembit Rägo (WHO, Switzerland). Raj Long (Bill and Melinda Gates Foundation, UK), Antoni Plasencia (Spain)
Drug development for regulatory approval and reimbursement decisions
Beate Wieseler (Germany), Pierre Demolis (France), Bruno Flamion (Belgium)
Key factors for successful research in Europe
Rafael de Andrés Medina (Spain), Jacques Demotes (France), Javier Urzay (Spain)
Implementation of Pharmacogenetics and Personalised Medicine in Clinical Practice
Raul A. Kiivet (Estonia)
Interventions that improve the use of medicines in clinical practice
Tormod K Bjånes (Norway), Romaldas Maciulaitis (Lithuania), Milan Grundmann (Czech Republic), Espen Jimenez-Solem (Denmark), Carl-Olav Stiller (Sweden), Mikkel Christensen (Denmark), Cornelis Kramers (Netherlands), Kirstine Moll Harboe (Denmark), Cándido Hernández-López (Spain)
Biomarkers in Alzheimer clinical research
Claudio Babiloni (Italy)
Medicines regulation, access to medicines and the patient’s voice
Denis Pouchain (France), Nick Meade (United Kingdom), Toni Gilabert (Spain)
Heterogeneity in drug response
Juan Tamargo (Spain), Caridad Pontes (Spain), Eduard Vieta (Spain)
Immunopharmacology of TNF-alpha: disease-transcending therapies
Roman Fischer (Germany), Johannan Brandse (The Netherlands), Marie-Christophe Boissier (France)
Pharmacovigilance - Risk communication to health professionals and citizens
Barbara Rath (Germany), Almath Spooner (Ireland), Frederic Bouder (Netherlands)
Drug Information and Decision Support Systems to support rational drug treatment
Robert Vander Stichele (Belgium), Ylva Böttiger (Sweden)
Hepatitis B reactivation. How to manage the risk?
José Luis Calleja (Spain)
Progressive multifocal leukoencephalopathy. Risk perception in the therapeutic context
Brigitte Keller-Stanislawski (Germany)
Registries for long-term risks
Ignacio García Doval (Spain)
Drug Induced Liver Injury
Raúl Andrade (Spain), Paul Watkins (USA), Michael Merz (Switzerland), Herve Le Louët (France)
Training on medicines regulation
Arantxa Sancho, Martina Weise, Jorge Camarero, Antonio Gomez-Oute