Training & Education

2018

CRCS-CRP Forum

07 Dec 2018
 

• Looking back at 2018 (Slides Pending)

• Looking back at 2018  |  Ms Sumitra Sachidanandan, Regulatory Consultants - GCP Unit, Innovation Office & Clinical Trials Branch, Medicinal Products Pre-market Cluster, Health Products Regulation Group, HSA

• Post Activation of Human Biomedical Research Act: Compliance and Risks  |  Dr Yeo Jing Ping, Director, Office of Research Integrity, Compliance and Ethics, SingHealth

• Monitoring Programme for Human Biomedical Research Studies |  Ms Jaslin Tan Shen Fong,  Senior Executive, Research Quality Management Unit, Research & Development Office, National Healthcare Group (NHG)

14 Sep 2018
 

• CRCs/CRPs And CIS: Developing Sound Communication And Interpersonal Skills (CIS) Is Essential For Success  |  Dr Aamir Shaikh, MD, DPBM, Founder, Health Care Consultant, Assansa

• Conflict Management / Problem Solving  |  Mr Nelson Wong, Founder & Director, CSI Medical Research

• Why Service Excellence Matters and How to EXC3ITE (Execute) It?  |  Mr Chan Peng, Tech Observer Asia Pacific

2017

 
CRCS-CRP Forum

1 Dec 2017

Implications for Investigator Initiated Trials - Risk Based Approaches in Managing Clinical Trials - Ms Lisa Marie Saldanha, IQVIA

The presentation shared by HSA can be accessed here:
http://www.hsa.gov.sg/content/hsa/en/Health_Products_Regulation/Clinical_Trials/Industry_Communication.html

The following topics can be accessed from the ‘Presentations’ section of HSA website:

• Looking Back at the Changes in Clinical Trials and CRM Regulations
• IMDA Briefing to HSA Clinical Trials Stakeholders

The following topic can be accessed from the ‘Presentations – Common GCP Inspection Findings’ section of the website/
• Common GCP Inspection Findings in 2017

CRCS-CRP Forum

25 Aug 2017

• Issue Management / Quality Risk Management Implications with ICH GCP E6 (R2) and ISO 31000 and Implementation within Quality System
   

• Data integrity in Clinical Research - Expectations and Considerations for Quality Control and Assurance
   

• Identification of Critical Data and Processes in Clinical Trial and Incorporation of Risk Mitigation into Protocol
   

• Ensuring GCP Compliance in Investigator Initiated Trials (IITs) - A Case Study

2016

 
CRCS-CRP Forum

9 Dec 2016

• Risk-based monitoring: After Years of talking about it, where are we now?  | Slides
   
• Human Biomedical Research Act: Scope and Regulatory Framework  | Slides

CRCS-CRP Forum

26 Aug 2016

• PDPA Updates: Management and Protection of Patients’ Data (Mr Benjamin Cheong, Rajah & Tann Singapore LLP) | Slides  
   
• Considerations for Using Electronic Medical Records (EMR) in Clinical Trials (Mr Alex Goh, GlaxoSmithKline Pharmaceuticals) | Slides  
   
• Management of Electronic Trial Master Files and Essential Documents in Pharma and CROs (Ms Jingyi Lin, PAREXEL) | Slides
   
• Using Electronic Patient-Reported Outcomes (ePRO) in Clinical Trials: Lessons Learnt (Ms Chong Pei-Fen, Quintiles) | Slides

2015

CRCS-CRP Forum

3 Dec 2015

• Updates from the GCP Inspection Team, Ms Sumitra Sachidanandan, Health Sciences Authority | Slides (from HSA)

CRCS-CRP Forum

28 Aug 2015

• Ethically and scientifically sound: Actual reviews of applications involving vulnerable populations (Dr Patricia Yap, IMH) | Slides

• Research in Children: Challenges (Prof Quak Seng Hock, NUH) | Slides

• The Process of Obtaining Informed Consent in Vulnerable Population (Prof Swapna Verma, IMH) | Slides

2014

CRCS-CRP Forum

12 Dec 2014

• Common GCP Inspection Findings for 2014 (Ms Sumitra Sachidanandan, HSA) | Slides

• Serious Breaches (Ms Poh Cuiqin, HSA) – The Guidance on Serious Breaches will be released by HSA at a later date.

CRCS Forum

25 July 2014

• Conducting Monitoring Visit for Investigator-Initiated Studies (Mr Xia Yu, SCRI)  | Slides 

• Quality Control for Phase I Trials – Site Perspectives (Ms Yew Lay Hwa, CGH) | Slides 

• Impact of Privacy Laws in Clinical Trials (Ms Rebecca Chew, Rajah & Tann LLP) | Slides