Event Calendar

International Trials and ICH

Download Breakout Session Overviews   | Download Schedule of Breakout Sessions   | View Pre-Conference Workshops   | View Conference Schedule

2018 Agenda

2019 Agenda Coming Soon! 

Saturday, September 29, 8:30-9:15                                       

Now It's Time for a Change - What You Should Know About the EU Regulation for Clinical Trials  

It is important to know the new procedures associated with clinical trials in the EU-region. The current system for clinical trials in the EU will be shortly reviewed, before the changes under the new Clinical Trial Regulation will be addressed. The new Regulation will change the way pharmaceutical companies handle clinical trials with sites located in the EU, and sponsors and investigators need to be prepared for it. 617

Presenter: Gerhard Fortwengel, PhD, MPH, MSc,  Professor, University of Applied Sciences and Arts, Hannover 

Track: International Trials and ICH

Saturday, September 29, 9:20-10:05                                      

Challenges In Managing Clinical Trials in Asia 

Escalating research costs and limited patient pools have forced biotech and pharmaceutical companies to seek out emerging markets in Asia. However, the successful implementation of clinical trials in Asia can be impeded by issues arising from managerial, ethical, clinical/scientific, and regulatory aspects, as well as physicians/investigators and research participants. This talk will focus on efficient trial management strategies from the Asian perspective, and how various stakeholders related to clinical research can take a proactive approach to shape the emerging markets in Asia and ride this changing wave of drug discovery. 619

Presenter: Xinmei Shi, MS, CCRP, CCRA, Research Manager, National University Cancer Institute, Singapore

Track: International Trials and ICH

Saturday, September 29, 10:50-11:35                                      

The History of Clinical Research in Jamaica West Indies and Nutraceutical Development Including Cannabinoid Therapy 

This talk will review historical studies and therapeutic areas researched in Jamaica, the emergence of medical marijuana research in Jamaica, and operating a CRO in this new environment. 621

Presenter: Francine Campbell-Hakim, BSc, CEO/Founder, Caribbean Clinical Research Associates, Limited 

Track: International Trials and ICH

Saturday, September 29, 11:40-12:25                                       

Self-Medication - A Little Too Regarded Aspect In Medical Research? 

Self-medication is a common form of healthcare practiced in most parts of the world. It can lead to waste of health resources, drug resistance and adverse reactions. The presentation focuses on a development of a calculation model and results of a study in which the model was applied to investigate the antibiotic self-medication rate in several geographical areas of a predefined country. 623

Presenter: Dnyanesh Limaye, MPharm, PhD, Professor and Scientist, University of Applied Sciences and Arts  

Track: International Trials and ICH