4 in 1 (◕‿-)

for this January, we are going to have new mOdule for this BesT programme, Technical mOdule

this 8 days for Technical mOdule was conducted by CReST EvendZ 

(Clinical Research Skills Training & Events)

we got a lot of theory about the given topic, it is very useful to us when we working one day...

10 jan 2011

session 1 : Intellectual Property Protection in Malaysia

by Assc Prof Rohazar Wati Zuallcobley

• intangible rise & Intellectual Property protection
• patent
• trade mark
• confidential information & trade secret

11 jan 2011

session 2 : Introduction to Clinical Research & Ethics

by Dr Sia Koon Ket

• what is Clinical Research?
• phases of Clinical Research / Trial
• Biomedical Ethics
• Research ethics
• Balancing principle 

12 jan 2011

session 3 : Sponsor's role

by Ms Adeline Kwok

• ICH-GCP
• Role of the sponsor - ICH-GCP
• Role of the investigator - ICH-GCP
• Adverse Event Surveillance

13 jan 2011

session 4 : 

Regulatory Practices in Msia & GXP

by 2 speaker : Dr Kamaruzaman Saleh & Dr Tajuddin Akasah

Dr Kamaruzaman Saleh

• Regulatory aspects of drug development in Msia
• Compliance Monitoring Authority
• Clinical trial import licence (CTIL)
• clinical trial exemption (CTX)
• quality assurance QA
• quality control QC
• audit in Good clinical practice (GCP)
• Good laboratory practice (GLP)

Dr Tajuddin Akasah

• Quality & Good Manufacturing Practice(GMP)