Brochure GCP 2020(1) - final

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[email protected] 03-2698 0310 Participate Now! Govt Staff Non-Govt Staff RM 500.00 RM 650.00 Day 1 Day 2 Day 3 Clinical Research in Malaysia Overview of ICH/GCP ICH GCP / Malaysian GCP compared Overview of Ethics of Clinical Research, Ethical Principles & Requirements Independant Ethics Committee Ethical Problems in Clinical Research Clinical Trial Protocol & Investigator's Brochure Informed Consent Investigator's Responsibility * Group work Sponsor's Responsibility Adverse Events * Group work GCP Inspection & Regulatory Aspects of Clinical Trial in Malaysia GCP Examination Good Clinical Practice (GCP) is a set of rules & regulations provided by ICH; an international body that regulates clinical trials involving human subjects. It is standard for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials that provides assurance that the data & reported results are credible & accurate, as well as the rights, integrity and confidentiality of trial subjects are protected. Workshop GOOD CLINICAL PRACTICE (GCP) 2020 https://bit.ly/2FVm8qz

Transcript of Brochure GCP 2020(1) - final

Page 1: Brochure GCP 2020(1) - final

[email protected] 03-2698 0310

Participate Now!

Govt Staff

Non-Govt Staff

RM 500.00

RM 650.00

Day 1 Day 2

Day 3

Clinical Research in MalaysiaOverview of ICH/GCPICH GCP / Malaysian GCP comparedOverview of Ethics of ClinicalResearch, Ethical Principles &RequirementsIndependant Ethics CommitteeEthical Problems in ClinicalResearchClinical Trial Protocol &Investigator's BrochureInformed Consent

Investigator's Responsibility* Group workSponsor's ResponsibilityAdverse Events* Group work

GCP Inspection & Regulatory Aspects of Clinical Trial in MalaysiaGCP Examination

Good Clinical Practice (GCP) is a set of rules & regulations provided by ICH; an international body that regulates clinical trials involving human subjects. It is standard for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials that provides assurance that the data & reported results are credible & accurate, as well as the rights, integrity and confidentiality of trial subjects are protected.

WorkshopGOOD CLINICAL PRACTICE (GCP)

2020

https://bit.ly/2FVm8qz