|
|
|
|
November 20, 2025 -Thursday |
|
|
|
 |
| |
|
|
P1RP - DEVELOPMENT OF PHASE 1 CLINICAL TRIAL GUIDELINE
Monday 16/05/2016
P1RP - Development of Phase 1 Clinical Trial Guideline will be held as follows :
Day / Date : Friday 20 May 2016
Time : 3.00pm - 6.00pm
Venue : Meeting Room 2 & 3, Shangri-La Hotel Putrajaya
VIPs : YB Datuk Seri Dr. S. Subramaniam, Minister of Health, Malaysia
Ybhg. Datuk Dr. Noor Hisham Abdullah, Director General of Health, Malaysia
Dr. Akhmal Yusof, Chief Executive Officer, Clinical Research Malaysia
About P1RP
This workshop is an important milestone towards the Phase 1 Realization Project, also known as the P1RP. The development of the Phase 1 guideline marks an important step in the P1RP blueprint which has four other pillars to it; People Development, Capability Development, Preparation of Sites and Risk Management.
Malaysia is fast becoming the preferred destination for industry sponsored clinical trials; from 143 trials in 2010 to 201 trials in 2015, a 41% increase. However, of the 201 clinical trials conducted in 2015, only one Phase 1 study was conducted, with the majority of the rest of the studies being in Phase III.
Phase 1 Clinical Trial Guideline Committee are represented by the various MOH hospitals, public/private institutions and regulatory body that are able to advise and give invaluable input to the development of Malaysia’s first Phase 1 Clinical Trial Guideline.
About Clinical Research Malaysia
Clinical Research Malaysia (CRM) is a non-profit company wholly owned by the Government of Malaysia’s Ministry of Health. CRM was established in June 2012 to position Malaysia as a preferred global destination for industry-sponsored research (ISR) and to function as an enabler and facilitator to the industry and medical fraternity for the conduct of clinical trials.
By working with other stakeholders, CRM strives to improve the local ecosystem to support growth in ISR, facilitate the needs and requirements of industry players, grow the pool of capable investigators, support staff and trial sites, and improve their capabilities and capacities to conduct ISR.
With the Ministry of Health’s backing and clear knowledge of the local research environment, CRM is able to provide sponsors (primarily from the pharmaceutical, biotech and medical device industries) and contract research organizations (CRO) with an extensive range of services that includes feasibility studies, investigator selection, placement and development of study coordinators, management of trial budget, review of clinical trial agreements and updates on local laws, guidelines and regulations. CRM also undertakes marketing and promotional activities to build industry awareness about the opportunities for ISR in Malaysia, and create public and patient awareness of clinical trials.
For more information, please visit http://www.clinicalresearch.my
Click here for Programme
You are cordially invited to send a reporter and photographer/cameraman to attend and cover the event.
Source : Clinical Research Malaysia (CRM)
FOR MORE INFORMATION, PLEASE CONTACT:
Name:Syed Hamzah Syed Noordin
Tel :03 – 7960 5153 Ext 120
Email:hamzah@clinicalresearch.my
Website:http://www.clinicalresearch.my
-BERNAMA
|
|
|
|
|
|
