EuroMEEting - Genetic Alliance UK

HOT TOPICS | STAND ALONE SESSIONS
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This is the advance programme. New speakers and sessions will be added. Visit www.diahome.org for the most recent additions to the programme.
18:00-19:30 Session 1900
SWISS SATELLITE SESSION: COOPERATION BETWEEN SWISSMEDIC AND
WHO
Session Chair :
To be confirmed
Establishing and maintaining a well-functioning network between international
armonization like the WHO and Regulatory Authorities is key to address public
health issues in a globalised world. It also elaborates on the potential impact
of cooperation between WHO and regulators to the industry. This Satellite
Symposium looks at how WHO works with Regulators in general and in
particular with the Swiss Agency for Therapeutic Products, Swissmedic. We
will look at how the cooperation works, what challenges had to be addressed
and what the outcome finally was by presenting two practical examples taken
from the field of pharmacovigilance and counterfeit drugs.
Introduction: How the WHO works with regulators
Overview of Cooperation between Swissmedic and the WHO
Real-time Pharmacovigilance: The development of Paniflow
Counterfeit Drugs: The way forward
Wednesday, 30 March 2011
09:00-12:30 Session 1605/1606
GCP FORUM: THE CHALLENGES FOR REGULATORS AND SPONSORS WHEN
DEALING WITH CLINICAL TRIALS IN A GLOBAL SETTING
Session Co-Chairs:
Gabriele Schwarz, Head, GCP Inspection Services, BfArM, Germany
Beat Widler, Global Head, Clinical Quality Assurance, F. Hoffman-La Roche
AG, Switzerland
The number of clinical trials involving sites and patients outside of or in
addition to the “traditional” Western European and North American research
areas and submitted to drug agencies in different regions for marketing
armonization has been increasing for a number of years. To deal with this
challenge, the European Medicines Agency (EMA) as well as the US Food
and Drug Administration (FDA) have started several activities to establish an
international network of clinical trial regulators. The objectives of the network
are to promote capacity building, information exchange and cooperation.
EMA and FDA launched a joint initiative to collaborate on international GCP
inspection activities, which started with an 18-month pilot phase on 1 September
2009. The initiative appreciably contributes to a mutual understanding of the
GCP inspection processes armoniz in the EU/EEA and US and to a sharing of
best-practice knowledge.
In parallel to this, strengthened collaboration between Health Authorities
that not only leads to a more armonizat approach to inspections but also to
a closer supervision through inspections sponsor companies embark in larger
trials, move trial activities to “new territories” and engage in all kind of formal
and not so formal collaborations (licensing agreements, supported trials, etc.).
This requires a much more structured approach to quality and compliance
that goes beyond the traditional monitoring and auditing. Quality and hence
GCP compliance in a mega-trial, for instance, can only be ensured if the right
checks and balances are built into the protocol design and study program as
the result of a collaborative efforts of all stakeholders concerned.
This session will provide an up-date of the current armonization efforts of
Health Authorities and also insight on how a “quality by design” approach
to clinical development can allow sponsors, investigators and regulators to
address the current unsatisfactory outcomes of today’s approach to quality
and compliance.
FDA's International Collaborative Activities to Exchange Scientific,
Regulatory and Ethical Information in the Conduct of Clinical Trials
Cynthia Kleppinger, Medical Officer, Division of Scientific Investigations, Office
of Compliance, CDER FDA, USA
International Cooperation on GCP and Ethical rRquirements for Clinical Trials
- Current EMA activities
Fergus Sweeney, Head of Sector, Compliance and Inspection, European
Medicines Agency, EU
International Clinical Trials – Current Afssaps activities
Pierre-Henri Bertoye, Inspectorate and Companies Associate Director, Afssaps,
France
Risk-Based Quality Management in Clinical Trials- A European Regulator’s
View
Gabriele Schwarz, Head, GCP Inspection Services, BfArM, Germany
Industry / CRO delegates invited
14:00-15:30 Session 1607
WHO-TDR: AN UPDATE
Session Chair :
Juntra Karbwang Laothavorn, Clinical Coordinator, TDR, WHO, Switzerland
Switzerland WHO-TDR has a long-standing experience in conducting trials in
so-called diseases of poverty also referred to as neglected diseases. WHO-
TDR has managed an impressive trial program in regions where commercial
sponsors have rarely placed trials. This session will review how WHO-TDR
has coped with the practical and logistic challenges of such trials and what
measures have been and are taken to ensure patients’ safety, integrity and
rights in very different cultural and societal contexts and also how quality and
compliance can be ensured. One important mission of WHO TDR is capacity
building in the regions they operate in. The SIDCER and FERCAP efforts
leading to certification of local IRBs / IECs through structured training and
survey programs have not only benefitted WHO clinical programs but also
represent a significant benefit for any sponsor. Building on the success of the
IRB / IEC certification program WHO-TDR is developing a survey program
allowing local laboratories to partake in a quality proficiency program and to
receive an acknowledgment thereof that tailors standard quality proficiency
programs known in the industrialised countries such as CAP to the needs of
these regions.
This session will provide an overview on the achievements of a clinical research
program in neglected therapeutic areas, what has been accomplished to ensure
patients’ safety and deliver quality results when conducting trials in regions
with limited exposure to GCP trials, and how these efforts can benefit also
commercial sponsors as well as how the later could learn from this experience.
Session under development
16:00-17:30 Session 1608
ENCEPP
Session Chair :
Noël Wathion, Head of Public Health Protection, European Medicines Agency,
EU
Peter Arlett, Head of Pharmacovigilance and Risk Management, European
Medicines Agency, EU
Session under development