DIA 2012 Collaborate to
Innovate
48th Annual Meeting
June 24-28,
2012
Philadelphia, PA
Pennsylvania Convention
Center
This forum will explore the challenges of biosimilars in light of the
recent policy developments in the US, EU, and Asia. Participants will
hear from a roundtable of authorities on how to address biosimilars and
the opportunities for the future.
Tracks: Track 08 - Regulatory Affairs and Submissions
Day: Monday, Jun, 25
Time: 1:30PM - 3:00PM
This session will provide enriched discussions on
the current status and unique challenges for drug development in China,
the increasing role of China in global development of drug products,
and opportunities for China's SFDA and pharmaceutical industry to
improve, succeed, and excel.
This session is hosted by Sino-American Pharmaceutical Professionals
Association (SAPA).
Tracks: Track 08 - Regulatory Affairs and Submissions
Day: Monday, Jun, 25
Time: 1:30PM - 3:00PM
The center of the global pharmaceutical industry is shifting. Part of
that shift is also the outsourcing of pharma R&D to Asia by various
means and models. This symposium will highlight that strategic move in
general but also discuss a clinical CRO alliance model and, furthermore,
zoom into the Chinese clinical CRO business.
Tracks: Track 03 - Innovative Partnering Models and Outsourcing Strategies
Day: Monday, Jun, 25
Time: 3:30PM - 5:00PM
Outsourcing and participation in clinical trials in China and other
Asian countries have expanded dramatically in recent years. Many global
companies now have ongoing or newly initiated collaboration with their
local subsidiaries or selected CRO in the Asia-Pacific region. Along
with the apparent advantages and fast-paced development, the global and
local project teams often face various unforeseen challenges that may
result from the cultural differences leading to misalignment and
frustration on both sides. In the sponsor-CRO collaboration, these
variances include different expectations and project management
practices ranging from project planning, risk management, and
communication. This session will discuss the key differences and
challenges of project management practice through case studies, and
identify better ways to optimize the project performance internally
within the matrix environment or when collaborating with a CRO.
Tracks: Track 02 - Project/Portfolio Management and Strategic Planning
Day: Tuesday, Jun, 26
Time: 10:00AM - 11:30AM
Representatives from the State Food and Drug Administration, P.R. China
will provide updates on initiatives, guidances, and regulations in their
country, and the audience will have an opportunity to address the
esteemed panel.
Tracks: Track 17 - Global Regulatory
Day: Tuesday, Jun, 26
Time: 1:30PM - 3:00PM
The symposium will discuss the current advancement of regulatory
pathway, the reform of related regulations, and the impact on industry.
The harmonization effort initiated by Global Harmonization Task Force
(GHTF), Asian Harmonization Working Party (AHWP), and the Regional
Harmonization Steering Committee of APEC Life Science Forum will be
discussed. Experience will be shared from industrial and regulatory
perspectives.
Tracks: Track 09 - Medical Diagnostics and Devices
Day: Wednesday, Jun, 27
Time: 10:00AM - 11:30AM
This tutorial will provide an overview of the regulatory system in
China, including the agencies and institutions at the central government
and provincial levels, as well as their roles and responsibilities.
Various regulations for product registration, clinical trials, and
safety reporting will be presented, and the regulatory pathways and
strategic considerations for clinical trial and marketing applications
will be discussed. A step-by-step roadmap of how to navigate the
regulatory system in China for clinical trial approval and product
registration will also be discussed. This discussion will include key
points to consider, strategies, and tactics.
Credits: IACET
Tracks: Track 08 - Regulatory Affairs and Submissions
Day: Sunday, Jun, 24
Time: 9:00AM - 5:00PM
