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Objective and goals of the Bulgarian Association of Drug Information (BADI) www.badibg.org [email protected] 1st Balkan Clinical Truial Conference 2011 3-5 October 2011, Hilton g Assos. Prof. Tatyana Benisheva PhD, DSci, MDRA Chairman of the BADI 11/6/2011 1 prepared by T. Benisheva [email protected]

Objective and goals of the Bulgarian Association of Drug

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Microsoft PowerPoint - Why to became a member of BADI.Hilton.3-5.11.2011.pptInformation (BADI)
3-5 October 2011, Hilton
Chairman of the BADI
[email protected]
www.badibg.org founded in 2010
for Drug Information www.badibg.org
[email protected]
Main focus is the collaboration
among the members in term drug regulatory and
clinical trials affairs
[email protected]
due to Regulation 1235 and Directive 2010/84/EC
need to be in force in each MSs till July 2012.
We strated in advance with that issue in June 2011 – see
(pictures from the PhV Workshop 28 June 2011 on the
homepage www.badibg.org
[email protected]
www.badibg.org
between
analogous or similar activity
requalification of specialists within the legal frames of
both Bulgaria and the EU 11/6/2011 5prepared by T. Benisheva
[email protected]
the scope of:
affairs
other products of value for public health above in order
to achieve the objectives referred to
11/6/2011 6prepared by T. Benisheva
[email protected]
The Association shall achieve its objectives through the organisation
of legal activities within the scope of the Statutes by organising work
group meetings, seminars, lectures, conferences, qualification courses,
etc. aimed at the improvement and development of qualification of the
Association members in the fields of these objectives.
Maintenance of communication and exchange of experience with the
competent domestic and European authorities, universities, industry,
professional and non- governmental organisations for the fulfilment of
the Association’s objectives.
[email protected]
[email protected]
Members
and relevant Sub laws - twice a week updated
11/6/2011 9prepared by T. Benisheva
[email protected]
non-governmental organisations and other associations both in
Bulgaria and abroad, participation in scientific projects.
Organisation of a professional educational centre in the field of drug
information with a view to sharing experience and qualification
Creation, maintenance, and dating of a regulatory data base for the
professional qualification of the members.
Creation of a web site and provision of immediate and topical
information on the activity and the achievement of the objectives of the
Association
[email protected]
Topics which should be covered
• The Idea is to discuss hot regulatory issues and topics in the
regulatory field of :
• To prepare statement on draft and guidelines and to discuss
them with
• Competent authority
[email protected]
initiative is a testimony of BADI’s
commitment to build a long-term relationship
• with companies and
11/6/2011 12prepared by T. Benisheva
[email protected]
and individuals representing patient groups,
• academia, industry,
• regulatory authorities,
medical devices, cosmetics food supplements,
and products related to public health.
11/6/2011 13prepared by T. Benisheva
[email protected]
BADI Member?
• BADI provides a unique meeting place for decision- making the fields of regulatory and science of pharmaceuticals, cosmetics, medical devices, food supplements, and all other products related to public health.
• The participation of you or your organisation in forums will contribute to the advancement of research in an environment that puts patient’s interest first.
11/6/2011 14prepared by T. Benisheva
[email protected]
• individuals representing patient groups,
devices, cosmetics food supplements, and
products related to public health.
11/6/2011 15prepared by T. Benisheva
[email protected]
• Your BADI membership will allow you to benefit from:
• Membership packages are available to suit all types and sizes of organizations with benefits such as:
• Visibility on the BADI website; present
• Data base of Regulations And Ordinances
• Complimentary copies of all BADI publications;
• Complimentary registrations to conferences and events with reduced participant fees up to 50%;
• Discounts on BADI in-house training courses;
• Networking opportunities.
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till November 2011
30
15
1
44
Jan 10 Feb. Mar Apr May June July Aug Sept Total
Corporate members Individual Members
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Series1
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Conclusions
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or meetings, teachings, workshops and
seminars in term of clinical trials and drug
regulatory affairs ---- to achieve expected
results
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