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- EFPIA Board Moves to Next Phase in Setting Up a Cost-Effective System For Medicines Verification with Stakeholders (02/05/2012)
EFPIA, the voice of the research-based pharmaceutical industry in Europe, is pleased to announce that on 27 April 2012 its Board formally adopted a Memorandum of Understanding (MoU) on medicines verification developed jointly with key supply chain partners representing pharmacists (PGEU), wholesalers (GIRP), and parallel distributors (EAEPC) at EU level.
- EFPIA launches tendering process for its European Medicines Verification System (EMVS) (11/04/2012)
EFPIA plans to prove the efficiency and to demonstrate the viability of the EMVS through real-life implementation ahead of the publication of the European Commission’s Delegated Act on Safety Features (expected by 2014). The stakeholder-governed solution proposed by EFPIA and its partners in the pharmaceutical supply chain is indeed likely to constitute the key solution for future implementation of the Falsified Medicines Directive.
- EFPIA supports full transparency of lobbying activities of itself and its members (29/03/2012)
Yesterday, Health Action International released a report claiming the lack of transparency of the pharmaceutical industry on the expenditures related to representation towards the European Institutions.
EFPIA, the voice of the research-based pharmaceutical industry has improved its procedures and reported for 2011 expenses of approximately 500.000 Euros in the EU Transparency Register.
- EFPIA supports a Europe-wide approach to increase transparency of clinical data (27/03/2012)
Today, the European Medicines Agency released a guidance on increased transparency and access to information included in companies' applications for marketing authorisation. EFPIA, the voice of the research-based pharmaceutical industry, welcomes all moves to remove perceived secrecy, as long as legitimate trade secrets are protected.
- Best Initiative of the Year in Pharmacy awarded to EFPIA-GIRP-PGEU for their core principles on European medicines verification (16/03/2012)
Representatives from three European associations (EFPIA, GIRP and PGEU) were in Madrid, Spain last Monday, to receive awards for the “2011 Best Pharmacy Initiatives of the Year”. The awards are given out by the Spanish newspaper Correo Farmaceutico in recognition of the EFPIA/GIRP/PGEU Ten Core Principles for their European Stakeholder Model (ESM).
- Revised Transparency Directive seeks to improve patient access but more is needed by Member States (01/03/2012)
Europe’s pharmaceutical industry welcomes the Commission proposal for a revised Transparency Directive but calls on European Institutions to set up the debate on solidarity among Member States on pharmaceuticals.
- 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.
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| EFPIA News & Commentary |
- Call for Tender - European Medicines Verification System (EMVS) (05/04/2012)
Anti-counterfeiting measures on packaging such as holograms do already exist. But these can be copied, and therefore cannot provide an insurmountable barrier to counterfeiting of medicines. This fact has made it increasingly clear that other solutions are required. The EU Falsified Medicines Directive (FMD) establishes a framework for pack level serial numbers and verification of each pack at the point of dispense.
The key stakeholders in manufacturing, distribution and dispensing of medicines developed a technology-based solution that meets the requirements of the Directive. It consists of individually marking each medicine pack with a unique code at the point of manufacture, and verifying this code in the pharmacy immediately prior to the release of the pack to the patient. This is known as the “Point-of-Dispense (PoD) Verification” concept. Such a solution would provide the end user with more confidence in the supply chain and the product, and facilitates the establishing of routine activities under the Directive.
- UCB CEO to chair Innovative Medicines Initiative board
(07/03/2012)
The Innovative Medicines Initiative (IMI) announced today that Roch Doliveux, CEO of the biopharmaceutical company UCB, has been appointed Chairman of the Governing Board of IMI. IMI is a public-private partnership between the European Union and the European Federation of Pharmaceutical Industries and Associations (EFPIA). UCB has been involved in IMI since its initiation, and Roch Doliveux has been a member of the IMI Governing Board since May 2010.
- 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...
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26 - 27 June 2012
- EFPIA Annual Meetings 2012 (Renaissance Hotel - Brussels)
Location: Brussels/Belgium
Online Registration is open until 6 June!
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On the 27th June 2012, the European Federation of Pharmaceutical Industries and Associations, EFPIA, will host its annual Public Conference and has the pleasure to invite all its stakeholders and members. |
This year’s interactive Public Conference “Working Together for Europe’s Future”will explore the challenges facing the industry as Europe seeks to emerge from the austerity crisis. Leading experts in healthcare policy, innovation and economy will describe emerging trends and outline how industry should respond in order to best contribute to improved healthcare and economic growth in Europe. Conference attendees will be tasked with identifying what changes industry should make in its thinking and its engagement with key stakeholders.
In the afternoon, attendees will have the unique opportunity to learn the most recent developments in science and its impact on medical research and development during the Educational Symposium “Healthcare Revolution with the New Science”.
Join us for this must-attend networking opportunity and candid discussion on new perspectives touching tomorrow’s healthcare!.
Read more...
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14-16 May 2012
- Sixth International Pharmaceutical Regulatory and Compliance Congress and Best Practices Forum
Location: Budapest/Hungary
Evolving developments in law and regulation applied to the pharmaceutical industry, public opinion on standards of ethical behavior and the global economic situation make this a challenging time to be a compliance professional or legal counsel responsible for ensuring adherence to applicable laws, regulations and codes of practice within our industry.
The Sixth International Pharmaceutical Regulatory and Compliance Congress and Best Practices
brings together senior global compliance and ethics professionals and legal counsel from the European Union (EU), Central and Eastern Europe (CEE) and Middle East and Africa (MEA) to share experiences and best practices to clarify these challenges and discuss potential responses to them.
The agenda is available here.
Registration details are available here
If you have any questions about the EFPIA discount, please email registration@hcconferences.com
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4-8 June 2012
- Certificate in Healthcare Compliance Ethics & Regulation
Location: Paris/France
The Certificate in Healthcare Compliance Ethics & Regulation has been designed for Compliance Officers and Compliance Managers. It presents European and International Laws in the Healthcare Sector to provide a thorough understanding of the current stakes of the industry and increase participants’ knowledge and skills. Participants from all over the world will be immersed during a whole week into the legal framework of healthcare industries. They will discuss industry codes and work on cases and settlements with world-renown professionals. Organised with Seton Hall Law School, this program also takes place in the United Sates at Seton Hall Law School, Newark, NJ.
Next session, European immersion at Sciences Po in Paris, June 4th to 8th 2012
The agenda is available here.
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30 June 2012
- EPAA Science Award 2012: Deadline for submission of applications
Location: Brussels/Belgium
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The biannual EPAA Science Award aims to promote the transition from innovative and experimental alternative approaches towards their industrial application and regulatory acceptance.
In 2010, the EPAA granted its first Science Award. The EPAA is now offering the Science Award for the second time to support the optimization and regulatory acceptance of 3Rs alternative methods. The award provides young scientists with the opportunity to cooperate with experienced scientists from various industry sectors and the European Commission. |
Financial support of up to €100 000 will be provided to the institution of the successful candidate to allow the extension of an existing research contract for a period of up to one year in order to promote the transition from existing innovative alternative approach/method from the experimental stage towards regulatory acceptance and industrial application.
All applications for the 2012 call for proposals should be sent by 30 June 2012 to entr-epaa@ec.europa.eu
Read more...
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