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June
2005 - Issue 3
Go to EuropaBio home page
EuropaBio votes in new chairman and board, and welcomes a record
28 new members
At its Annual General Assembly, EuropaBio, the
European Association of Bioindustries welcomed the new members
and elected Dr. Hans KAST,
CEO of
BASF Plant Science as its new Chairman as well as the five new
chairs of its councils and new board members.
EuropaBio press release:
http://www.europabio.org/articles/AGM%20June%20%202005_050532.doc
EuropaBio roundtables on Co-existence in key Member States 20.06
– 15.07, 2005 in co-operation with ABE
EuropaBio is currently organising a series of
roundtables on “Co-existence of GM with conventional and organic
crops” in some key Members States in co-operation with ABE. The
roundtables will take place during the months of June and July
2005 in Czech Republic, Slovakia, Hungary, Portugal, Slovenia
and Poland. Participants including Government officials will
discuss co-existence and the benefits of growing GMO crops.
For more information please contact: Raffaella
Colombo r.colombo@europabio.org
EU-JAPAN Industrial & Environmental Biotechnology
(IEB) Summit - Japan- 3-10 September 2005
EuropaBio
and the Japan Biotech Association (JBA) invite you
to participate to the EU-Japan Industrial & Environmental
Biotechnology Summit that will be organised as part of the BioJapan
2005 event. The main goal of this Summit is to promote
Industrial and Environmental Biotechnology (IEB) as one of the
most import worldwide industrial segments allowing sustainable
and cost-effective bioproduction of pharmaceuticals, (fine)
chemicals, materials and fuels, and to stimulate collaboration
between European and Japanese Research Institutes and
industries.
For more information go to:
http://www.europabio.org/events/EU_JapanSummit/September3-10.htm
To register click here:
http://www.europabio.org/events/EU_JapanSummit/registrform.doc
EuropaBio Job Plaza – Life Science Careers in
Europe
The EuropaBio ‘Life Science Jobs in Europe’
database offers the possibility of posting job vacancies in the
European biotech industry. The database is open to all EuropaBio
website visitors; there is no registration or login required.
For more details: http://www.europabio.org/jobs.htm
Green week – Industrial biotech shows its contribution to the
environment
On the occasion of Green Week 2005,
organised by Directorate General Environment of the European
Commission, which took place in Brussels from 31 May to 3 June,
the Industrial biotech sector has shown its clear contribution
to respond to climate change, the central theme of the Green
week, this year.
EuropaBio press release:
http://www.europabio.org/articles/article_345_EN.doc
Technology Platform for Sustainable Chemistry
EuropaBio and ESAB developed a working document
to be used as input for the industrial biotechnology section of
the European Technology Platform for Sustainable Chemistry.
For more information:
http://www.europabio.org/ne_WBTP.htm
Europe biotechnology sector could compete with
the US
Europe could develop a biotechnology sector to compete with that
of the US, according to a comparative study that EuropaBio
commissioned from Critical I. For more info:
http://www.europabio.org/ne_criticalI.htm
Verheugen outlines new strategy for
pharmaceutical and biotech industries
Biotech companies in Europe welcome the European Commission’s
intentions to put the pharmaceutical and biotechnology
industries at the top of the political agenda. Commission
Vice-President Günter Verheugen has announced a new strategy for
the pharmaceutical and biotech industries aimed at closing the
gap with the US on innovation, research & development.
http://europa.eu.int/rapid/pressReleasesAction.do?reference=IP/05/641&format=HTML&aged=0&language=EN&guiLanguage=en
EMEA Biosimilars Guidelines
-
EMEA/CHMP/42832/05
Guideline on Similar Biological Medicinal Products containing
Biotechnology-Derived Proteins as Active Substance:
Non-Clinical and Clinical Issues (CHMP released for
consultation May 2005)
-
EMEA/CHMP/94528/05 Annex
Guideline on Similar Biological Medicinal Products containing
Biotechnology-Derived Proteins as Active Substance:
Non-Clinical and Clinical Issues - Guidande on Simular
Medicinal Products containing Somatropin (CHMP released
for consultation May 2005)
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EMEA/CHMP/32775/05 Annex
Guideline on Similar Biological Medicinal Products containing
Biotechnology-Derived Proteins as Active Substance:
Non-Clinical and Clinical Issues - Guidande on Simular
Medicinal Products containing Recombinant Human Insulin
(CHMP released for consultation May 2005)
Link to the
above mentioned guidelines:
http://www.emea.eu.int/htms/human/biosimilar/biosimilardraft.htm
The consultation period ends in October 2005.
EuropaBio
will post
the documents on the Forum so that the healthcare member
companies can start sending their comments:
http://www.members.europabio.org/Forum/
BIOSAFETY: UN meeting on the
Cartagena Protocol on Biosafety to adopt binding
rules on documentation to accompany GMOs traded as commodities
and on other matters
The Cartagena Protocol on Biosafety has now been
ratified by 119 Parties (118 countries and the European union).
In the opening plenary, the Global industry Coalition stressed
three major points; a) the need to implement the Protocol in a
timely manner, b) the need for effective Capacity Building in
Parties that are lesser developed countries, this to help them
in meeting their responsibilities under the Protocol, and 3) the
imperative need for an up to date and accurate Biosafety
Clearing House mechanism (the BCH) as this is essential for the
proper functioning of the Protocol. The 2nd
Conference of the Parties and Meeting of the Parties (COP/MOP 2)
held in Montreal 29th May to 3rd June did
manage to reach a number of decisions regarding the
implementation of the Protocol. These included recommendations
on how to move forward with capacity building and how to
facilitate greater public awareness and participation in
decision making. It was also agreed to establish an expert group
that would meet intersessionally to work on risk assessment and
risk management. However, on the main issue of deciding on
documentation requirements for GMOs used for food feed of for
processing, even after very lengthy discussions, there was no
agreement. Such an agreement should have been made before 11
Setember 2005 (two years after the coming into force of the
Protocol) but will now not be possible. The discussion on
documentation to accompany these GMO FFP’s will be further
discussed at COP/MOP3 to be held in Brazil 13 - 17 March, 2006.
A report from the Secretariat can be found at:
http://www.biodiv.org/doc/press/2005/pr-2005-06-03-bs-en.pdf
Tissue engineering: Commission consults
interested parties on how to regulate advanced therapies
Tissue engineering is an emerging field which
promises extraordinary advances in medical technology. Products
currently on the market include simple tissue products such as
skin, cartilage and bone but the technology could lead to the in
vitro construction of human organs. In May 2005, the Commission
launched a public consultation on the regulation of advanced
therapies that involve gene therapy, somatic cell therapy and
human tissue engineering.
This
consultation is part of the impact assessment of the upcoming
proposal. The EU Commission has asked EuropaBio to advise them.
Tissue engineering companies are invited to send comments to
EuropaBio and invited to become member of the working party at
EuropaBio.
http://europa.eu.int/rapid/pressReleasesAction.do?reference=IP/05/575&format=HTML&aged=0&language=EN&guiLanguage=en
Deadline for comments by all interested parties
are welcome until 20 June 2005 at:
http://pharmacos.eudra.org/F2/advtherapies/index.htm
EU Members States vote on new GM products
More GM products were submitted for approval to
the EU’s Regulatory Committee but still they fail to reach an
agreement.
EuropaBio press release:
http://www.europabio.org/articles/PR050517.doc
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