Date: 14 March 2017
Craigavon, N.I., 14 Mar 2017– Almac Group, the global contract pharmaceutical development and manufacturing organisation, has announced that a number of its key clinical supply experts will deliver presentations at leading global conferences throughout March and April.
Heather Bogle, Supply Chain Solutions Manager will speak at this years’ Clinical Trial Supply Europe Conference being held in Barcelona, 15-16 Mar 2017. Her presentation, entitled “Regulatory Impact: Technology, Tools, and Insight to Mitigate Risk”, will take place at 4pm on day one of the conference where she will share the stage with a growing list of other industry experts from across the globe.
During her talk, Heather will share her expertise and in-depth knowledge on a range of key considerations such as how, today, both the drug manufacturer and the clinical sites face an increased number of challenges to stay compliant in the realm of temperature management. Heather will review real-life case studies to show how processes, technology and tools were implemented across global studies to reduce errors, improve efficiencies and improve compliance.
Olive McCormick, Head of Quality & QP will deliver a presentation on 23 March at 8.55am at the CRISP Spring meeting in San Francisco. Focusing on “Annex 16”, introduced in April 2016, Olive will discuss how the QP certification and batch release regulations have impacted clinical supplies and share her experiences in overcoming challenges associated with implementing the new requirements and how to ensure continued compliance.
In addition, on 23-24 April, Olive will join Mark Hanly, Strategic Business Analysis Manager and Paul O’Connor, Global Vice President Quality to host a number of workshops during the GCSG annual conference in New Mexico. This time Olive will focus on raising the awareness of the various regulatory labelling and custom requirements affecting clinical supplies in Asia whilst Mark and Paul will discuss a range of other pertinent clinical supply chain topics including “The benefit of integrated supply chain systems” and “Brexit and the potential impact to Clinical Supplies”.
Paul O’Connor has been with Almac Group for over 20 years and is responsible for overseeing the quality assurance, compliance and control processes, globally for Almac Clinical Services. He possesses a wealth of experience in all aspects of quality and regulatory practices and how they are applied in various regions.
Heather Bogle joined Almac in 2001 and has first-hand experience in managing the supply chain with temperature sensitive products for studies across the globe. She has expert knowledge on the challenges with temperature management throughout the supply chain and extensive experience developing robust, efficient and innovative solutions.
With extensive industry experience spanning over 20 years, Olive McCormick’s expert knowledge and deep understanding of quality procedures has established her as a thought leader in the industry.
Working with Almac for almost a decade, Mark Hanley has partnered with a number of clients to oversee key projects and drive efficiencies. He has vast experience, knowledge and expertise within project management and supply chain management including interactive response technologies.
To find out more about these events and request a meeting or information please visit: https://www.almacgroup.com/events/
About Almac Group
‘Partnering to Advance Human Health’
The Almac Group is an established contract development and manufacturing organisation that provides an extensive range of integrated services to the pharmaceutical and biotech sectors globally. The services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, IXRS® technology (IVRS/IWRS) through to commercial-scale manufacture.
The international company is a privately owned organisation that has organically grown over 40 years and now employs in excess of 4,500 highly skilled personnel. Almac is headquartered in Craigavon, Northern Ireland with operations in the UK, Ireland, across the US (Pennsylvania, North Carolina and California) and in Asia (Singapore and Tokyo).