[e-drug] Unethical clinical trials report WEMOS & SOMO

e-drug
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E-DRUG: Unethical clinical trials report WEMOS & SOMO
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Dear E-druggers

A campaign has started in the Netherlands on Unethical Clinical Trials in
Developing Countries.

To start the discussion, a report was produced by 2 NGOs:

SOMO (Centre for Research on Multinational Corporations;
http://www.somo.nl/index_eng.php) and

WEMOS (Working group for Medical Development Aid;
http://www.wemos.nl/en-GB/content.aspx)

The report highlights 22 cases of unethical clinical trials in developing
but also developed countries. The english report is downloadable from:
http://www.wemos.nl/Documents/clinical_%20trials_%20report.pdf or from
http://www.somo.nl/html/paginas/pdf/Examples_of_unethical_trials_nov_2006_NL
.pdf

From the report:

"Even though the overview below is necessarily incomplete and biased towards
unethical trials that have caught some publicity, some general observations
can still be made.

Firstly, unethical trials have occurred around the world, in both developed
and developing countries. In some cases, the trials had not been approved by
an ethical review committee or institutional review board, or approval had
be given for an unethical trial design. Hence there appear to be flaws, and
sometimes rather serious ones, in the regulatory systems of various
countries.

Secondly, the research organizations involved range from relatively unknown
local companies to leading multinational corporations. This might be
surprising, given that large multinational corporations usually have clear
public commitments to high ethical standards in clinical trials.

Thirdly, some of the unethical trials are of a recent date, some were even
being carried out in 2005 or 2006. Although it is sometimes argued that
instances of unethical clinical trials are isolated and outdated, this is
not always true. Note that some older cases have been included in the
overview as well, mainly because the developments following these trials are
still going on.

And finally, the nature of ethical concerns appears to be rather diverse and
relates to all paragraphs of the DoH summarized above. The lack of
voluntary, informed participation and adequately informed consent are
probably the most common problems. Trials with experimental drugs of which
the safety for testing in humans had not yet been established may be among
the most alarming examples."

A working group has been formed in the Netherlands to discuss the issue. For
more information, contact:

Annelies den Boer, project coordinator pharmaceuticals, Wemos, Tel
+31-20-4352050, mobile +31-6-30051233, e-mail annelies.den.boer@wemos.nl;

Francis Weyzig, SOMO researcher, Tel +31-20-6391291, mobile +31-6-27511852,
e-mail f.weyzig@somo.nl

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E-DRUG: Labelling GMP
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Dear E-druggers,

I am looking for information on specific interpretation of GMP guidelines on
labelling where manufacturing unit is different from marketing unit.

Under the circumstances where a manufacturing unit is producing a drug on
contract for another company that is marketing the drug, can the marketing
company put its name as manufacturer on the drug label?

Thanks and Regards

Vineet Bhatia, MD
Procurement Manager,
India Resource Centre,

International Union Against Tuberculosis and Lung Disease (The Union)
2nd Floor, YMCA Centre for Special Education,
Station Road, Nizamuddin East,
Delhi - 110013, India
Tel: + 91-11-24350241/ 42 (ext 16)
Mobile: +91-9811304577
Fax: + 91-11-24350244
vbhatia@iuatld.org
website: www.iuatld.org

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E-DRUG: International Conference on Assessing Quality in Higher Education
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First International Conference on Assessing Quality in Higher Education
(ICAQHE 2006) is being organized at Hotel Pearl Continental Lahore from
11-13th December 2006. Prime Minister of Pakistan Mr.Shaukat Aziz will
inaugurate the conference.Organizers of the conference are Institute of
Quality & Technology Management University of the Punjab, Higher Education
Commission Pakistan, Asia Pacific Quality Network, UNESCO and UMT Lahore.

This is going to be a truly international event, first of its kind in
Pakistan with more then 30 distinguished scholars from all over the world
and 200 eminent educationists from throughout Pakistan.

Following topics related to Medical education will also be discussed in
detail by the speakers of international repute.

1) Assessment Of Teaching And Learning In Medical Education

2) Role Of Professional And Statutory Bodies In Medical Education

For more information about conference and registration visit
www.icaqhe2007.org.pk or contact the undersign. Last date for registration
is 5th December 2006.

Thanks & best regards

Muhammad Usman Awan
Secretary Organizing Committee
ICAQHE 2006
Lecturer / Ph.D. Scholar
Institute of Quality & Technology Management
New Campus, University of the Punjab
Lahore --- Pakistan
Cell # 0300 9402748
usman@iqtm.pu.edu.pk

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E-DRUG: Labelling GMP (2)
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Dear Mr. Bhatia

If any a manufacturing company is producing a drug for a 2nd company
marketing the product , then the marketing company cannot label itself as
manufacturer -which is not acceptable as per GMP- , and drug should be
labelled as

Manufactured by XX company
Marketed by YY company

Thanks & Best regards

D.Parthasarathi
Scientist - Regulatory Affairs
APL-Research Center
Ext : 245
Tel: + 91-40-2304-1461
Fax: +91-40-2304-2932
Email: parthasarathi@aurobindo.com