China Medical Trials & Safety Surveillance

9th-10th July 2009

[Marriott Hotel West] Beijing

Sponsors

Event Photos

The Speakers

Past Healthcare Speakers Include:
	Frank Shen, PHD Head of Biometrics, Roche
	Frank Jiang, MD PHD Associate Vice President, Clinical Operations,Sanofi-Aventis
	William Wang Associate Director Merck
	Robert W. Pollard, Director Synovate Healthcare China
	Eileen Long Marketing Director Wyeth
	Philip Xiao CEO Profex
	Yang LIN CRM Solution Manager Microsoft
	James Fan GM Jowin Communications
	Victor Lam Managing Director Elsevier Greater China & Korea

Event Brief

The China Medical Devices Trials Vision:

China is actively building its fundamental medical infrastructure by aggressively investing in the healthcare industry, which will promote the wellbeing of 1.3 billion people. Pioneering medical device manufacturers are contributing to this historic process by manufacturing and introducing sound patient-care products to China’s market. However, guaranteeing that the products hit the market in time, poses great challenges for the newcomers as well as for those already established in China. In the meantime, the State Food and Drug Administration is enforcing stringent regulations and acting to strengthen the registration and safety surveillance of the devices. Consequently, vital questions are being raised such as: how can the registration procedure be accelerated, how should a successful and responsible trial be conducted and how are the SFDA’s safety requirements monitored?

Despite the challenges, China’s market is extremely promising and the real question is, “How Will You Capitalize On the Opportunities In China’s Medical Device Industry?”

With eminent speakers from regulatory departments, investment companies, hospitals of Grade III Level A, leading manufacturers and other industry stakeholders, Noppen presents the most informative and influential gathering for the medical device industry.

Benefits

Key themes

· Sesion A: Best Practice Of Successful Medical Device Trials
· Session B: Sell Your Trial Study Design To IRB
· Session C: How To “Meet Biostatistics Requirements”
· Session D: Shorten The Registration Procedure
· Session E: Meet The Requirements Of The SFDA And FDA For Safety Surveillance
· Session F: Medical Ethics Discussion: How To Balance Risks And Benefits For The Patients
· Session G: How CROs Assist You In Registration And Clinical Trials
· Session H: Collaboration Among Hospitals, Manufacturers And CROs To Promote The Total Delivered Value

Educational sessions
In-depth case-studies delivering top-level insights and the latest data. Useful practical
Information for your corporate strategies.

Conference sessions
Industry experts, authorities and professionals from China and abroad bring their expertise in
carefully prepared keynote addresses.

Networking opportunities
Enjoy gourmet luncheons and dynamic networking functions at a 5-star event venue.

For New Comers In China

For Companies Already In China

> Understand SFDA regulations for medical devices registration, trials and safety surveillance
> Hear successful case studies form the China market
> Learn the best ways to accelerate the registration procedure
> Receive the full benefits of choosing the right CRO
> Network with 50+ experts from the major manufacturers in China
> Meet the Clinical Development Directors from the best hospitals in China

> Prepare for stricter regulations on device registration, trials and safety surveillance
> Learn tips for accelerating the registration procedure directly from the SFDA
> Optimize trial management skills
> Train your new clinical staff
> Hear success stories about collaboration among the hospital, patient, CRO and manufacturer
> Learn how to sell your study design to hospitals
> Understand how to “meet biostatistics requirements”

Key Topics

Testimonials

>Learn about the newest updates in Phase IV regulations from the SFDA

> Ensure drug safety through Phase IV trials

>Learn the best practices for dealing with adverse drug effects

>Hear the best Post-Approval Trials case studies in China

>Understand the new development in overseas Post-Approval Trials

>Identify new product demand through Post-Approval Trials

>Optimize multi-site Phase IV clinical trials in China

"Well-organized, professional and meaningful."
- Roche

"High level and efficient."
- Sanofi-Aventis

"The workshop topics are very focused. Attendees are covering all related backgrounds."
- Quintiles

"Good, with a clear-cut theme."
- Tigermed

"Very fresh as the format is exclusive for this topic in China."
- AstraZeneca

Venue Information

Other Series Events

Crowne Plaza Century Park, Shanghai

For assistance with room reservations click here

One-to-one Meetings

	China Adaptive Trial Design Workshop [Sofitel Pudong] Shanghai, China 10th-11th April, 2008
	Post-Approval Trials [Crowne Plaza Century Park] Shanghai, China 5th-6th, March, 2009

contact tel: +8621 6085 1000· fax: +8621 6192 1908 · visit the website: www.noppen.com.cn