Date: 6 July 2009 1-day symposium Registrati on fees: RM600 (USD350)
Malaysia is developing its early phase clinical development capability. A seminar on this topic is most welcome to raise awareness on many of the issues and challenges in this new initi ati ve. And we are grateful to the various experts including clinical pharmacologists from industry who has agreed to help put his event together.
Topics shall include:
Early drug development
Overview of early drug development and decision paths . Translati onal Medicine as a discipline. The First-into-Human study, and what did Te-Genero teach us? Regulatory Approval for early clinical development studies Setting up a Phase 1 Unit: What it takes? And what sponsors look for? Healthy volunteers & pati ent-volunteers, the value of different populations
Cardiovascular safety in drug evaluation
The long QT syndromes, an interesti ng history of a recent awareness Pre-clinical evaluation of drug candidates Evaluating cardiovascular drug toxicity in early clinical development The FDA approach to QTc evaluati on and implicati ons for drug development Techniques to monitor cardiovascular drug safety in the Phase I Unit
Limited to 50 participants only. REGISTER NOW!
Advanced Good Clinical Practice Workshop
Date: 7-8 July 2009 1 ½ day course Registration fees: RM800 (USD450)
This course provides a detailed understanding of the latest developments and requirements of ICH GCP, and gives practical advice.
By the end of this course, you will understand:
Diverse GCP concepts relevant to sites and monitors Compliance with consent requirements Management of monitoring and audit Resoluti on of ethical challenges Concepts of pharmacovigilance Preparation of research publications
Each theme will cover a brief presentation and case studies
GCP is the internati onal quality standard for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials. Compliance with GCP provides assurance that the data and reported results are credible and accurate, and that the rights, integrity and confidentiality of trial subjects are protected. Malaysia adopted GCP in 1999, and since then doctors are required to undergo training on GCP leading to certificati on prior to participation in clinical trials. This highly popular course is specifically designed to meet this requirement.
Limited to 60 participants only. REGISTER NOW!
Clinical Trial Management Workshop
Date: 7-8 July 2009 2-day course Registration fees: RM650 (USD400)
This course is designed for site coordinators/study nurses, clinical professionals, CRAs or any other professionals who aspires to be clinical research professionals managing clinical trial at research sites. It provides the practical approach on how to manage a clinical research site professionally.
Topics shall include : Pre-study Management
o Roles & Responsibiliti es of Site Coordinator o Prepare for Sponsors pre-study visit o Laboratory issues o Study Initiation
Study Execution Audit
Limited to 50 participants only. REGISTER NOW!
Other planned events, Mark your calendar please:
Date
Workshop/ Seminar/ Event
1.
8 July 5-7pm
AGM ACRP Malaysian chapter
2.
9 July 5-7pm
Mid-year Dialogue with Investigators and Industry sponsors for clinical trial
3.
To be announced
Pharmaceutical Medicine seminar: Plants to Medicines
4.
To be announced
Drugs for Neglected diseases
Health & Pharmaco-economics Workshop
Date: 7 July 2009 1-day workshop Registrati on fees: RM450 (USD250)
This course is designed for clinicians and managers to achieve a basic understanding of health economics, in parti cular the concept of cost eff ecti veness as means to describe the comparati ve value of a health care product or service in terms of its ability to achieve a desired health outcome for a given unit of resources.
Topics that will be covered include:
Health outcome assessment: Quantity & Quality of Life, Utility & QALYs Resource use & costing Measure of cost-effectiveness Pharmaco-economic evaluati on of a new drug and medical device Economic evaluati on of a healthcare program
Limited to 50 participants only. REGISTER NOW!
Research, Publications & Citations
Date: 7 July 2009 1-day seminar Registrati on fees: RM450 (USD250)
This workshop discusses the significance of research and publicati ons as indicators of knowledge producti on. It explains the important link between publications and citations which are now used to indicate the quality and international recognition of the published knowledge. In the modern era of information explosion, scientists and researchers should be aware of strategies in obtaining the right informati on from the right informati on provider so as to ensure they have the good start in research and publicati ons that will lead to citations and recognition.
Target audience: Clinical investi gators and Researchers, Research supervisors, Research funders & administrators, Policymakers, University Librarians, Managers of Informati on Services, Journal Editors and Reviewers, Editorial Board members of journals,
Key topics:
Research, Publications and Citations The ISI Journal Selection Process, Impact Factors and the Journal Citation Report on the ISI Web of Knowledge Web of Science, EndNote, Researcher ID Investigator Portal and Translational Research Publication ethics
Limited to 50 participants only. REGISTER NOW!
Healthcare Economics Workshop
Date: 8 July 2009nccr 1-day workshop Registrati on fees: RM600 (USD350)
Another introductory course designed for payers, managers & providers on healthcare economics, which is concerned with informing healthcare policy on expenditure & fi nancing, health service provision and distribution to achieve healthcare quality, efficiency & equity goals.
Course Contents Topics shall include:
Healthcare expenditures & healthcare fi nancing (Tax funding, health & social insurance, Employers benefi ts, OOP) MOH healthcare budget, service delivery and scope for private sector participati on in service provision & contracting Health manpower needs & projecti on Expenditures on and utilization of medicines & medical technologies Financing & healthcare equity Healthcare efficiency: Trading off quality? Healthcare quality: Trading off efficiency? Public-private roles in healthcare Healthcare regulati on: Quality at what cost?
Limited to 50 parti cipants only. REGISTER NOW!
Continuing Education on Research Ethics cum Forum for Ethics Review Committees in Malaysia (FERCIM)
This year, we are taking the opportunity to initiate Continuing Education on Research Ethics in the morning, to be followed by the annual Forum for Ethics Review Committees in Malaysia (FERCIM), in the afternoon.
We have invited an experienced faculty to present on:
Best practices for IRB/IECs: Constitutions, SOPs development, Role of a dedicated professional IRB administrator, Training for IRB members, Accreditation of IRB/IEC Challenges for Ethics committees in Malaysia
The Helsinki Declaration revisited: Whats new in the Oct 2008 revision? Research misconduct: Fraud, Confl ict of interest, Publication ethics & Clinical trial registration Whats new in Informed Consent:
Concept of assent, Special situati ons (Legally incompetent, Illiterate or subjects who are unable to read, Nontherapeutic trial, Emergency situation, Vulnerable subjects), Waiver of informed consent
Limited to 55 parti cipants only. REGISTER NOW!
ANNOUNCEMENT
NCCR 09 SCIENTIFIC POSTER COMPETITION.
Entries are now open, for instructions and submissions please contact:
Ms Nurul Huda Tel : 603-26980310 Email: nurulhuda@crc.gov.my
Ms Balqissiah Tel : 604-7407391 Email: balqissiah@crc.gov.my
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