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Process validation

Establishing by objective evidence that a process consistently produces a result or product meeting its predetermined specifications.
GCP in China / Korea / India
Commonalities / Differences

Webinar

(Brought to you by GCPHelpdesk.com in conjunction with MakroCare)

Goal: Asia is a diverse place with diverse population and diverse economies. Growing number of clinical trials in Asia means continuous learning and education for Clinical Research Professionals. The purpose of this webinar is to assist CRAs, Project Managers, Regulatory teams, CRCs, and Quality Assurance in improving their exposure and their understanding of the GCP in different countries.

Objective: The goal will be accomplished through lecture facilitated by clinical research professionals with a combined industry experience of more than 30 years joining from 3 different regions. Information will be presented and discussed regarding GCP and International Conference on Harmonisation (ICH) guidelines with respect to these three countries.
 
Speakers
  
Dr. David Yang
Co-founder and CEO of MicroConstants, China
Mr. Rahul Gowda
Manager- Project Management for Global Clinical trials, LSK Global Pharma, South Korea
   
Facilitator
 
Laxman Jakkala, Ph.D
Global Clinical-QA, GCP Helpdesk
Date & Time
Date: Friday, 9th December 2011

Time:

5:30 PM to 7:00 PM (Singapore)
6:30 PM to 8:00 PM (KST/JST)
3:00 PM to 4:30 PM (IST)
10:30 AM to 12:00 PM (CET)
Key Topics
Implementing GCP in:
China
Korea
India
 

Webinar: From your own Desk (Internet connection and head set / speakers)

Cost: None

Who should participate?

Clinical Operations, Project Management, Monitors, Investigators, QA, Regulatory and all other clinical professionals

Email: Send your information for registration to This e-mail address is being protected from spambots. You need JavaScript enabled to view it

Limited Participants: Maximum 50 only

About GCP HelpDesk:

GCPHelpdesk is a public website that gives updates on GCP. Apart from an expert panel answering queries received from the world over, it also has forums, group discussions and document library. More details can be obtained from www.GCPHelpdesk.com

About MakroCare:

MakroCare is an international drug development and commercialization partner that is dedicated to efficient, high-level performance in combination with unparalleled client satisfaction. MakroCare has 5 subsidiaries/divisions – CRO, SMO, Consulting, DDi and Commercialization. MakroCare has teams positioned worldwide in these divisions supporting regulatory affairs, risk management, trial management (clinical, late phase), monitoring, biometrics (CDM, EDC, Biostatistics, SAS programming, medical writing), QA audits, drug safety/PV, site management, patient recruitment/retention, informatics (EDC, CTMS, IVRS), marketing/sales, branding, and contact center. More details can be obtained from www.makrocare.com