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Medical Device Regulatory Updates For Major Markets & Clinical Trials For IVD


Held in conjunction with Diagnostics Summit 2016

12 Oct 2016, at 09:00-12:15 in Singapore

Price:



Medical Device Regulatory Updates For Major Markets & Clinical Trials For IVD 

Join our team of international experts for our the Pre-Event Training Course covering Regulatory Updates for the Medical Device Industry in Europe, the USA, China and SE Asia. Plus the introductory session detailing the requirements in Clinical Trials for In Vitro Diagnostics. 
This course will provide you with a detailed overview of the regulatory requirements for all of the major global markets.

Who should attend?

The course content will be suitable for a range of attendees, working or interested in the Medical Device Industry, from final year graduate students and Phd candidates through to entrepreneurs, innovators, clinicians, research scientists and members of the medical regulatory profession.

Course objectives:

1.To provide a high level overview of the regulatory requirements for the major markets for medical device.

2.
To provide a high level overview of the requirements of clinical trials for IVD.

Course Agenda:

08:30 – 09:00 Registration

09:00 – 09:45 Clinical Trials For IVD – Danielle Giroud

09:45 – 10:30 Medical Device Regulatory Requirements For Europe/USA – Tan HweeEe

10:30 – 10:45 Coffee/Tea break

10:45 – 11:30 ASEAN MD Regulatory Development post ASEAN Economic Community  
            
– Fiametta Soenardi

11:30 – 12:15 Medical Device Regulatory Requirements For China – Eric Lam

Fiametta  S. Soenardi

Fiametta S. Soenardi, Senior Consultant / Chief of Operations, Sixmurs Group


Eric Lam

Eric Lam, Regulatory & Compliance Director, QARA Consultancy Ltd


Danielle  Giroud

Danielle Giroud, Founder, MD-Clinicals, Lausanne-Beijing


Hwee Ee Tan

Hwee Ee Tan, Principal Consultant/Director, DH RegSys Pte Ltd