Pharma, Medical Devices, Regulatory issues in China - learning opportunities at DIA2012

 

DIA 2012 Collaborate to Innovate 48th Annual Meeting
June 24-28, 2012
Philadelphia, PA
Pennsylvania Convention Center

Regulatory Roundtable on Biosimilars

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

 

Challenges and Opportunities for Drug Development in China

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 

 

Pharma R&D in Asia: Opportunities, Models, and Challenges

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 

Optimizing Performance in Outsourced Projects in China and Other Asian Countries

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 

 

SFDA Town Hall

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 

 

Current Advancement of Regulatory Reform for Medical Devices in Asia Pacific and Its Strategic Impact

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 

 

#40: Understanding and Navigating the Regulatory System in China

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