Introduction to Phase 1 Trial & COVID-19 vaccine trial experience sharing

Introduction to Phase 1 Trial & COVID-19 vaccine trial experience sharing

This is the first webinar in the new season of Webinar Series on Demystifying Clinical Trials & Updates in COVID-19. No need to register. It's free. Join us live on 14 July 2021 at 3 PM (GMT+8). You can type your questions below. 

If you would like to add this webinar to your calendar, click here to sign up.

Video

Link: https://www.youtube.com/watch?v=5j0VU-y9TNg

Q&A: Do you have questions to ask?

Click 'join event' and type your questions below.


Moderators:

Dr. Kalaiarasu M Peariasamy is the Director for the Institute for Clinical Research, National Institutes of Health, with responsibilities for 36 Clinical Research Centres with the Ministry of Health Malaysia. In this role, he chairs the Vaccine Selection Technical Working Group (TWG) of the special COVID-19 vaccine committee (JKJAV) Malaysia. 

Dr. Kalaiarasu has led the development, implementation and conduct of numerous clinical research and trials for healthcare programs. He is an internationally featured speaker on topics related to cleft lip and palate and traumatology. Dr. Kalaiarasu has published in indexed journals and authored chapters in textbooks. In 2017, he was admitted as Fellow of Royal College of Surgeons Edinburgh without examination and in 2020 as Adjunct Professor at Taylor’s School of Medicine, Malaysia


Dr. Akhmal Yusof graduated from the Royal College of Surgeons in Ireland in 1992 and practised medicine in the public and private hospital for almost 10 years. He later worked with the American International Assurance, one of the biggest medical insurance provider in Malaysia as Medical Manager. Later in he was head-hunted to lead the Medical Department in AstraZeneca, a global research-based biopharmaceutical, for over 13 years. His main forte in the pharmaceutical industry are clinical research management & regulatory, medical and government affairs. He now leads Clinical Research Malaysia (CRM) as their Chief Executive Officer since 2015. CRM is a Malaysia Ministry of Health owned-company established in 2012 to promote Sponsored Research to come to Malaysia.

Panellists for this week:

Dr Cheah Wee Kooi is a Physician in Internal Medicine and Geriatrician, currently the Head of Medical Department and Clinical Research Center (CRC) of Taiping Hospital. He is a dedicated clinician, passionate teacher and keen researcher. He is very active in clinical research and holds several professional positions at National and State level. Just to name several, he is currently the committee member of the COVID-19 Vaccine Selection Subcommittee, Ministry of Health and the Taiping Hospital site Principal Investigator for the phase III Clinical trial of SARS-CoV-2 Vaccine developed by the Institute of Medical Biology Chinese Academy of Medical Sciences (IMBCAMS).


Mr. Chew Chun Keat is a pharmacist graduate from University Science Malaysia. He also has a Master in Clinical Research Methods and Diploma in Computer Studies. Through a collaboration between a phase 1 clinical trial organization and Ministry of Health, he has learned from the expert on the conduct of phase 1 clinical trial at Plymouth, UK and Ahmedabad, India. He is the pioneer team to develop a Phase 1 Clinical Trial Centre under Institute for Clinical Research in Hospital Ampang. The centre has conducted over 30 pharmacokinetic/pharmacodynamic studies determining bioavailability of study compound, food drug effect, drug formulation effect and bioequivalence studies between original drugs and generic drugs.

He also played an instrumental role in some of the national phase 3 clinical trials in collaboration with international organization like World Health Organization (WHO) and Drug for Neglected Disease initiative (DNDi). He has been invited by foreign organizations to share experiences on clinical trial related matter.

He has participated in few expert panels and working groups in development of few instrumental guidelines and books, namely Malaysian Guideline for Phase 1 Unit Inspection & Accreditation Programme, Malaysian Phase 1 Clinical Trial Guideline, and A Guide to Conducting Clinical Trials in Malaysia.

He has been appointed as Board Member of Medical Research and Ethics Committee (MREC) for the Ministry of Health, Malaysia since 2015. He also helped to develop and enhance the monitoring of pharmacovigilance in clinical research approved under MREC via an online reporting platform for Serious Adverse Reaction (SAE) and Suspected Unexpected Serious Adverse Reaction (SUSAR).

His past working experience as Drug Enforcement Officer, and Regulatory Officer in National Pharmaceutical Regulatory Agency (NPRA) has made him understand the fundamental requirement of local Acts and Regulations pertaining to pharmaceutical products.

His field of interest include early phase clinical trials, bioavailability/bioequivalence studies, study design, pharmacovigilance, and research bioethics.


Dr Alan Fong Yean Yip is Consultant Cardiologist at the Sarawak Heart Centre, Kota Samarahan, and Head of the Clinical Research Centre, Sarawak General Hospital, Kuching. He is member of the Executive Council and Scientific Advisory Board of the Asian Pacific Society of Cardiology. He is the current Vice President of the National Heart Association of Malaysia. He is the International Governor for Malaysia – for the American College of Cardiology and the International Society of Cardiovascular Pharmacology. He is also a member of the Sarawak Research and Development Council.

He is the current chair of the Malaysian National Cardiovascular Disease (NCVD) – ACS Registry, and directly in the publications of its Reports. He is involved in regional collaboration with similar Registries in the Asia Pacific Region. His other appointments are Adjunct Professor, Swinburne University of Technology and Adjunct Lecturer, University Malaysia Sarawak (UNIMAS).

He is currently participating in over 20 Phase I to IV Clinical Trials. He is the National Coordinator for two international multicenter studies. He is actively conducting investigator-initiated research and published over 40 articles in international journals, including the European Heart Journal, American Heart Hospital Journal and European Journal of Radiology.

He has co-written chapters of the National Medicines Use Survey 2005-2011 and various National Guidelines on cardiovascular disease. He is also reviewer on the Malaysian National Medical Research Register and on the editorial board for various international journals.

His areas of research interests include Cardiovascular Imaging and Biomarker Research, particularly in acute coronary syndrome (ACS); and in cardiovascular pharmacology. He advocates individualized therapies and precision medicine initiatives in contemporary clinical practice.

Slide Presentation:

Introduction and Malaysia’s Experience in Phase 1 Clinical Trials by Dr Alan Fong & Mr Chew Chun Keat (click here)

COVID-19 Vaccine Trials: Why we still need them? by Dr Cheah Wee Kooi (click here)


Podcast:

Links: 


Other materials:


How to register?

To make life easy, no need to register. Just tune in on the designated date and time.


How to join the webinar?

There are 8 ways to watch the webinar live every Wednesday at 3:00 PM (GMT+8). You can join us live using your preferred social media account or one of the options below. Don't forget to use app.sli.do to ask questions. As usual, our event code is #hcsmMY

P/S: If you are going to watch the webinar using mobile phone or tablet, it will be better to join via:

As we put the live video, live Q&A and chat on the website for easier viewing and participation.

How to get CPD points?

We will broadcast the online attendance form during the live webinar, and we will broadcast the attendance form after the webinar finished for another 5 minutes. The link will also be posted on our Twitter, Facebook, LinkedIn and YouTube. Please double-check your email address before submitting. Any mistake in your email address, you will not get the certificate of attendance.

The certificate of attendance is issued to those who participated live (in real-time). We do not give a certificate to those watching the replay/recorded video/podcast.

Looking forward to seeing you live!

Note:

If you need more information about this season webinar: the weekly CME programme, CPD point and other info, please go to this webpage: https://clinupcovid.mailerpage.com/resources/r0x8r9-webinar-series-on-demystifying-cl

This is a weekly live webinar is organized by Institute for Clinical Research (ICR), NIH Malaysia.

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