Speakers Presentations   # Speakers Presentations 1. Overview of ICH GCP and Malaysian GCP 2. ICH GCP & Malaysian GCP Guideline Compared 3. Overview of Ethics of Clinical Research 4. Independent review by Institutional Review Board(IRB)/ Independent Ethics Committee (IEC) 5. Informed Consent 6. Case Studies and some Ethical Problems in Clinical Research 7. Clinical Trial Protocol & Investigator’s Brochure 8. Investigator’s Responsibility 9. Working with the Sponsor 10. Adverse Event Monitoring & Reporting 11. Clinical Research in Malaysia 12. Oversight & Funding For Clinical Research In The Ministry Of Health (MOH) 13. Legal Issues in Collaborative Clinical Research 14. Regulatory Aspects of Clinical Trial in Malaysia