Other Events of Interest
The European
Compliance Academy has developed additional
conferences and courses to address important aspects of Pharmaceutical
Development and IMP-Management:
23-24 September 2010, Vienna,
Austria
Objectives
During this Course, specialists from the
pharmaceutical industry and a former FDA
Compliance Officer will share their expert
knowledge about all important GMP aspects in
Pharmaceutical Development and IMP
Manufacturing. You will be able to elaborate and
discuss both EU and FDA requirements.
Background
Not only in the manufacturing of marketed
products (c)GMP-Compliance is mandatory. Also in
the manufacturing of IMP supplies, compliance
with the applicable GMP-Guidelines is
obligatory. But which GMP requirements are the
applicable ones? And do the requirements differ
from clinical phase 1 to phase 3? A lot of data
gained in the development studies will later be
documented in the CMC part of the submission and
many development lots are produced on the same
equipment where clinical trial batches are
manufactured.
Complex challenges have to be faced to guarantee
high quality products. The safety of the drug
and hence the patient should be in the focus.
Terminated studies or studies without usable
results will lead to extensive extra costs and
delays in the whole development and approval
process.
This course has been designed by the ECA to
broaden your knowledge and to consolidate the
various GMP aspects which need to be considered
in a successful development of a new
pharmaceutical product.
24-26 November 2010, London, UK
Dear Colleagues,
The European QP Association Forum has been
becoming a major event for European
Qualified Persons. Speakers from EMEA and
various national authorities as well as QPs have
been sharing their view of roles and
responsibilities of the Qualified Person.
Hoping to continue the success of the QP Forum,
the Advisory Board of the QP Association has set
up the programme at hand for the 2010 Forum to
give you an update about recent developments and
important matters to consider. Representatives
from the authorities as well as QPs and
well-known experts will present latest issues
and share their point of view. During the three
pre-conference workshops and the six parallel
sessions at the Forum, various case studies will
be presented and discussed to come up with
possible solutions.
Make use of this event by exchanging experiences
with your colleagues and by establishing
informal contact and networking.
I would like to invite you to this unique
opportunity, and I look forward to meeting you.
Best regards,
Dr Bernd Renger
Chairman of the Qualified Person Association
Background
Over the past few years the role and duties of
the Qualified Person keep increasing in
significance and scope. Being the key person in
the quality function of a pharmaceutical
company, the QP has to consider many issues to
fulfil the responsibilities and to comply
with the European legislation.
Objective
This Conference is designed by QPs for QPs as an
International Expert Forum with focus on sharing
information and experience and on discussing the
critical areas of the QP’s daily work.
Target Group The Forum is designed for all
Qualified Persons and aspiring Qualified
Persons. It also addresses upper management
functions and authority representatives who want
to be informed about the latest development
regarding the duties and responsibilities of
Qualified Persons.
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