Successful EU-US Clinical Drug Development: How to address both markets without

Successful EU-US Clinical Drug
Development:
How to address both markets without
duplicating work?
June 12th, 2014 - 14:00-17:30
EPFL - Innovation Park (Parc Scientifique)
Building D, Room "Pluton" (Ground Floor)
Lausanne, Vaud
FREE OF CHARGE
"The regulatory environment is one of the most important external
factors
affecting
a
company's
organization,
processes,
and
technological strategy"
With tangible differences in requirements from a market to another,
global drug development is often perceived as a daunting challenge.
Voisin Consulting Life Sciences invites you to an interactive
discussion on how to bridge FDA and EMA requirements, from the
design of global clinical development strategies to the adaptation of
implementation in each local market.
International regulatory experts will share their experience of dealing
with conflicting requests from regulators, to optimize the value of
clinical-stage drugs.
Successful EU-US Clinical Drug Development:
How to address both markets without dupkicating work?
Switzerland, and especially the Geneva lake area, remains the cradle of innovation for
the healthcare industry, offering amazing opportunities to biotech and
pharmaceutical companies to successfully develop and launch drugs. However, within
a constantly evolving regulatory environment, designing a global clinical development
strategy is becoming increasingly challenging!
Three main factors are proven to address disparate regulatory requirements across
the Atlantic, and hence to ensure successful clinical development:
•
•
•
Conducting global clinical development programs, from Phase 1 to the
market, bridging discrepancies across markets - including payers
considerations;
Continuously interacting with health authorities throughout clinical testing;
Addressing country-specific requirements, and benefiting from local market
incentives.
This interactive discussion will be based on real-life experience, gained both in the
industry and as advisors.
After a coffee break, the discussion will go on about the local execution of clinical
development strategies in each market, accounting for local regulatory frameworks
and opportunities to accelerate the setup of clinical studies in Europe and the US.
Participants will be invited to share individual experiences, and directly interact with
regulatory experts with a successful industry track record.
The workshop will be followed by a networking Aperitif.
June 12th, 2014 - 14:00-17:30
EPFL Innovation Park
Building D, Room "Pluton" (Ground Floor)
Lausanne, Vaud
14:00
Global clinical development strategy: obtain feedback
from regulators
15:30
Coffee Break
16:00
Adapt clinical study setup in each market
17:00
Networking Aperitif
For any questions, please call
021 693 92 71
Mark A. De Rosch, PhD.
Frederic Pailloux, Pharm.D.
Vice President,
Head of US Operations
& Regulatory Drugs/Biologics
Voisin Consulting Life Sciences,
Cambridge, MA, USA
Senior Director,
Head of Swiss Operations
& Deputy Qualified Person
Voisin Consulting Life Sciences,
Lausanne, Switzerland
Mark
is
responsible
for
the
management of projects involving the
design and implementation of global
regulatory
strategies
for
the
development,
registration,
and
maintenance of drug and Medtech
products. Mark has more than 20 years'
experience in the industry, especially in
preparing teams for and leading
discussions with regulatory agencies,
including FDA, EMA and EU National
Agencies.
Frederic leads projects involving the
design and implementation of global
regulatory
strategies
for
the
development, evaluation and marketing
of small molecules and biologics.
Over 15+ years of experience in the
pharmaceutical and biotech industry,
Frederic
gained
an
in-depth
understanding of the EU regulatory
landscape, and is versed into liaising with
the EMA and National Competent
Authorities, including Swissmedic.
Delphine Decker, M.Sc.
Director,
Head of Clinical Trials Management
Voisin Consulting Life Sciences,
Paris, France
Delphine leads activities related to Clinical Trials Applications, and became an expert in the
recent Voluntary Harmonized Procedure (VHP) as well as in navigating country-specific
requirements. She has extensive experience in designing and implementing regulatory strategies
for the clinical development and registration of drugs and innovative medicinal products.
Contact
Voisin Consulting Life Sciences
www.voisinconsulting.com
EPFL Innovation Park,
Lausanne, 1015, Switzerland
+41 (0)21 693 92 71
[email protected]
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