Exploring Human Food Clinical Trials and ICH GCP Standards
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Duration: 25 min
Abstract: In highly competitive industries, differentiation is key. The alimentary and nutraceutical sector has faced multiple challenges within the last few years, particularly, in terms of the regulation around the marketing of functional foods and their associated health claims. With the market expecting to reach a value of $ 300,000 million by 2022, overcoming these hurdles is a must for those companies willing to compete for success.
The first step for differentiation is to prove the health benefits potentially associated with functional foods, beverages, probiotics or medical foods. Randomised Controlled Trials (RCT’s) are considered the gold standard method for the scientific substantiation of claims by EFSA & FDA. Join us to unveil the secrets of RCT’s within the nutraceutical industry.
Aoife Hayes | Regulatory Manager at Atlantia
Aoife Hayes is a key member of the Atlantia Operations team. She coordinates aspects of the clinical trials programme in Atlantia while providing project, managerial, organisational and administrative support to the clinical research staff. Aoife uses her experience in the academic sector to ensure that processes with Atlantia allow for a high scientific standard across all trials.
Kevin O'Regan | Clinical Manager at Atlantia
Kevin O'Regan with a background in Nutrition and Health Science has been working in Atlantia since 2016.He joined the team as a Clinical Trials Assistant and has since worked as a Team Lead over several Food clinical trials. During his time in Atlantia, Kevin completed his qualification in Quality Management and was responsible for the development of Atlantia’s QMS as Quality Manager. Kevin has gained experience in the running of many food clinical trials in accordance with ICH-GCP and applicable regulatory requirements and now plays a key role as Clinical Manager for the Chicago Clinic Site.
Julie Scanlon | Quality Manager at Atlantia
Julie Scanlon started with Atlantia as a Research Assistant in 2017. Having previously gained invaluable experience in the nutritional analysis software industry, she learned the advantages of a cross-discipline approach to combine technology and clinical data. This approach was the key to a more efficient data management process for clinical trials. She is now responsible for the management of Atlantia’s QMS as Quality Manager.