| April
2006 - Issue 11
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40% increase to EU R&D budget
The European
Parliament and the Austrian Presidency reached a compromise on
the financial perspective 2007-2013 on 4 April 2006. Following
this compromise, an extra 300 million euros will be allocated to
FP7 compared to the amount decided by the European Council in
December 2005.
http://www.euractiv.com/Article?tcmuri=tcm:29-154294-16&type=News
Commission
must safeguard Europe’s rules for ag biotech products
The College of Commissioners' debate on the EU’s regulatory
approval process for products developed using agricultural
biotechnology appeared to question the scientific role of the
EFSA in the safety assessment of these products.
EuropaBio Press release
http://www.europabio.org/articles/PRECstatement_120406.doc
In a letter to the EU Commission President José Manuel Barroso,
the European agricultural biotechnology industry asks the
Commission to fully take up its role to safeguard the treaties
and European legislation.
Full letter content:
http://www.europabio.org/positions/ToBarroso040406.pdf
European
Parliament hearing on Advanced Therapies set for May 11th
EuropaBio's Advanced Therapies Working Group have two experts,
Gil Beyen (Tigenix) and Detlef Niese (Novartis), speaking in the
Parliamentary hearing on Advanced Therapies organized by the
Rapporteur Miroslav Mikolásik and MEP Peter
Liese on 11/05. Other key speakers include Georgette Lalis,
Director in DG Enterprise and Johann Kurtz from the Austrian
Presidency as well as representatives from patient
organizations, the medical device industry and EFPIA.
EuropaBio Members wishing to participate in the
Advanced Therapies Hearing please contact:
n.moll@europabio.org
New remit for
EuropaBio EMEA Working Group
At its
meeting on March 24th, the Healthcare Council agreed
to extend the remit of the EMEA Working Group to cover other
related legislative issues such as pediatrics, clinical trials
and conditional approval, with subtopics such as
pharmacovigilance, variations, EMEA SME office and Telematic
Implementation. The new Working Group will be called "Legislative
Working Group".
EuropaBio Members wishing to participate in the new Legislative
Working Group please contact:
a.vandeputte@europabio.org
Consultations on Pharmacovigilance systems and on
"Variations" Regulations
On March 22nd, the European Commission launched a public
consultation on the European Community system of
pharmacovigilance. The newly created EuropaBio Legislative
Working Group, and its Pharmacovigilance sub-group, will develop
a response within the deadline of 12/05. The Commission is
considering a possible revision of the Regulations for
Variations (No.1084/2003 and No.1085/2003) following the
adoption of recent ICH guidelines and feedback received from
stakeholders, including EuropaBio. EuropaBio is working on
inputs to the Commission and will organise meetings with the
concerned officials in order to contribute to the first round of
public consultation by the end of 2006.
EuropaBio Members wishing to contribute to the consultations
please contact:
a.vandeputte@europabio.org
Heads of
Medicines Agencies: Launch of a consultation
On March 22nd, "The Heads of Medicines Agencies Strategy
Paper on the European Medicines Regulatory Network" was launched
for consultation. The paper is a complement to the EMEA 2010
Road Map and offers the perspectives of the Head of
national competent authorities in dealing with the challenges of
the EU Regulatory System. Specific themes such as
Communication and Information, Scientific
Resources, Scientific Assessment Process,
Pharmacovigileance, Inspection,
Laboratory Control and Enforcement and IT Information
systems are covered. The EuropaBio Legislative Working
Group will develop a response in time for the consultation
meeting between authorities and stakeholders planned for 12th
May.
EuropaBio Members wishing to contribute to the consultation
please contact:
a.vandeputte@europabio.org
European
Union approves new alternatives to animal testing of drugs and
chemicals
The Scientific Advisory Committee of the European Centre for
the Validation of Alternative Methods (ECVAM) has approved six
new alternative testing methods that will reduce the need for
certain drugs and chemicals to be tested on animals. The new
tests are biotech based and use cell cultures rather than
animals to establish the toxicity of cancer drugs and identify
contaminated drugs. The new tests will not only reduce the
number of animals needed for testing, but will also increase the
accuracy of the tests, thereby making the products concerned
safer.
http://europa.eu.int/rapid/pressReleasesAction.do?reference=IP/06/347&format=HTML&aged=
0&language=EN&guiLanguage=en
Governments adopt international rules on trade in GMOs
The Third meeting of the 132 Parties to the Cartagena
Protocol on Biosafety (MOP3) was concluded on 17 March in
Curitiba, Brazil. It adopted a landmark decision on detailed
documentation requirements for genetically modified organisms in
the international trade of agricultural commodities. In the
final hours of negotiations, trade implications of documentation
requirements were the main focus of major players such as Mexico
and Brazil.
http://europa.eu.int/rapid/pressReleasesAction.do?reference=IP/06/335&format=
HTML&aged=0&language=EN&guiLanguage=en
Speakers
Plaza - Register your profile online!
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like to be considered to present at one of our upcoming
conferences? Do you want to take the opportunity to share ideas
with other colleagues involved in your sector? Do you have
expertise in specific fields and would like to share your
experience and knowledge? Then fill in our electronic form to
submit your application.
http://www.europabio.org/speakers.asp
EuropaBio Job PLAZA – Post your vacancies Free-of-Charge
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EuropaBio Life Science Jobs in Europe database offers the possibility of
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open to all European biotech companies; there is no registration or
login required.
Surf to and post at:
http://www.europabio.org/jobs.htm
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