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- EAEPC-EFPIA-GIRP-PGEU working for better Patient Safety (26/01/2012)
At the occasion of a workshop organized today in Strasbourg by the European Directorate for the Quality of Medicines & Healthcare (EDQM) to present its “eTact” coding system, EAEPC, EFPIA, GIRP and PGEU would like to welcome EDQM’s involvement in the fight against counterfeit medicines entering the European supply chain.
- Joint Healthcare Industry Paper ‘The value of industry involvement in HTA’ (08/12/2011)
The Healthcare Industry is pleased to present today in the setting of the EUnetHTA Joint Action Conference in Gdansk, a jointly developed position paper on ‘The value of industry involvement in HTA’. The paper outlines the industry contribution to the HTA process, both in terms of inputting into the policy setting and methodology development, as well as the industry contribution in terms of specific assessments.
- EFPIA fully behind the idea of a European Council for Health Research (06/12/2011)
EFPIA, the voice of the research-based pharmaceutical industry in Europe, supports the idea to establish a “European Council for Health Research”, launched last week by the Alliance for Biomedical Research in Europe representing 16 leading European biomedical research societies (BioMed Alliance).
- Horizon 2020: “A new research framework for developing and sharing knowledge” (30/11/2011)
EFPIA, the voice of the research-based pharmaceutical industry in Europe, welcomes the launch today of the European Commission’s new Framework for Research and Innovation: Horizon 2020.
Commenting on today’s announcement, Richard Bergström, Director General of EFPIA, said: “The European Commission should be commended for their intention to further develop public-private partnerships (PPP)".
- EFPIA supports a “kick-start” process to revitalise antibiotic research (17/11/2011)
EFPIA, the voice of the research-based pharmaceutical industry in Europe, welcomes the publication today of the European Commission’s “Strategy and Action Plan to Tackle the Threat of Antibiotic Resistance”.
The threat to public health from antibiotic resistance requires bold thinking followed by bold action. Building on the initiative of the Swedish EU Presidency of 2009 in putting this issue on the table, today’s announcement follows a series of discussions over the course of this year and illustrates the strong will to address this issue in partnership.
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| EFPIA News & Commentary |
- Joint Healthcare Industry Paper: The value of industry involvement in HTA (08/12/2011)
According to the EUnetHTA definition1, health technology assessment (HTA) is a multidisciplinary process that summarises information about the medical, social, economic and ethical issues related to the use of a health technology in a systematic, transparent, unbiased, robust manner. Its aim is to inform the formulation of safe, effective health policies that are patient focused and seek to achieve best value.
- EFPIA welcomes today's European Court of Justice ruling in the Medeva case -- C-322/10 (24/11/2011)
The interpretation of the CJEU takes as back to the original intent of the SPC scheme: to stimulate innovation. The much narrower interpretation by the UK court disregarded the fact that components that are patented, such as one part of a combination vaccine, should be protected also when used in a combination. EFPIA welcomes this ruling as it creates clarity and confirms the importance of the SPC also when used in combinations.
To read the judgement of the Court, click here...
- Submission of comments on draft 'HMA/EMA guidance document on the identification of commercially confidential information and protection of personal data within the structure of the marketing authorisation (MA) dossier – release of information after granting of a marketing authorisation' (31/08/2011)
EFPIA welcomes and supports the European Medicines Agency (EMA) and Heads of Medicines Agencies (HMA) efforts to increase transparency within the European regulatory framework. It is important to agree a common European approach in this area and we would welcome further clarification in this regard (see comments made in relation to the fact that reference is made to national legislation in the draft guidance document).
- Summary Report: OHE/EFPIA Antibacterial Roundtable (6/07/2011)
Bacteria have developed resistance to almost every single antibacterial developed in the past 50 years or so – and the rate of resistance to new antibacterials is increasing rapidly, and new “superbugs” are emerging. The strain of E-coli responsible for the recent outbreak in Germany has been found to be resistant to 12 antibacterials in eight different classes. The danger of resistant bacteria is that without effective treatment, diseases with traditionally high cure rates, such as pneumonia, become more difficult to treat. And “routine” procedures, such as organ transplants and hip replacement surgery, which rely on antibacterials, may carry a greater risk of failure.
- European Medicines Agency’s Management Board nominates Guido Rasi as new Executive Director
(08/06/2011)
The European Medicines Agency’s Management Board has nominated Guido Rasi on 8 June 2011 as new Executive Director of the Agency. The Executive Director-designate has been invited to a hearing in front of the European Parliament Committee on Environment, Public Health and Food Safety on 13 July 2011. The Board will officially appoint the new Executive Director following his hearing and a positive response from the European Parliament.
For further details on the new EMA's Executive Director, click here...
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2-3 February 2011 - 2 March 2012
- IFB Biotech – Biopharma
masterclass: Third Edition (20 October 2011 - 2 March 2012)
Location: Brussels/Belgium
The third edition of the IFB
Biotech – Biopharma Masterclass is set up to help managers, entrepreneurs but also starters in translating their biotech inspirations into successful business ideas. The class focuses on the managerial and entrepreneurial skills for those who approach the life sciences, especially biopharma and red biotechnology, in an entrepreneurial way.
The Masterclass is composed of 4 modules of 2 days (residential) and will be taught in English.
- Module 3: 2-3 February 2012 - Crucial factors for success : financing and deal making
- Module 4: 1-2 March 2012 - Reimbursed products on the market and the future
The IFB brochure is available here.
Read more...
27 February 2012
- Open Info Day: 5th Call for proposals
(27 February 2012)
Location: Brussels/Belgium
The Innovative Medicines Initiative (IMI) will hold an Open Info Day: 5th Call for proposals at the Crowne Plaza – Le Palace Hotel in Brussels, Belgium on Monday 27 February 2012.
The day will include an overview of IMI’s funding and intellectual property (IP) rules, tips and testimonies from people involved in ongoing IMI projects, and a presentation of the 5th Call topic ‘European lead factory: Joint European compound library and screening centre’ by the Project Coordinator. In addition, there will be plenty of networking opportunities and IMI staff will be on hand to answer questions relating to the 5th Call and IMI’s application procedures.
IMI warmly encourages small and medium-sized enterprises, patient organisations, regulatory authorities, academic teams, industry, hospitals and other organisations with an interest in IMI projects to take part in the Open Info Day.
Read more...
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