Date: 16 May 2017
Craigavon, N.I., Almac Group, the global contract pharmaceutical development and manufacturing organisation, has announced that two of its key clinical supply experts will deliver presentations at leading global conferences in May.
Heather Bogle, Supply Chain Solutions Manager, will speak at this years’ Temperature Controlled Logistics in Biopharmaceuticals conference being held in Princeton, NJ, 16-17 May 2017. Her presentation, titled “GDP Compliance: Are you keeping your cool or trending towards an excursion?” will take place at 2:00 pm 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:
- The impact of the GDP regulations and the latest news on inspection to prepare in advance
- The challenges faced by sponsors and clinical sites when transporting and storing temperature sensitive pharmaceuticals
- How new technologies can deliver effective temperature management solutions
Heather Bogle joined Almac in 2001 and has first-hand experience in managing the supply chain for studies across the globe with temperature sensitive products. She has expert knowledge on the challenges with temperature management throughout the supply chain, and extensive experience developing robust, efficient, and innovative solutions.
Caitriona Lenagh, QP Services Manager, will co-host a workshop at the upcoming Clinical Trial Supply West Coast conference being held in San Francisco, CA, 24-25 May 2017. The workshop, titled “Changes and key strategies to address QP requirements and their impact on releasing IMP in Europe” will take place at 2:15pm on day one of the conference where she will discuss how Almac continues to adapt to a changing regulatory environment in Europe.
Central to the conversation, Caitriona will share her experiences regarding Annex 16 and how this has impacted Almac’s operations, including:
- Finding new ways to manage costs as a result of regulatory changes
- Defining how Annex 16 will place more responsibility on Qualified Persons to ensure that supplies are being thoroughly checked with the introduction of a QP declaration
- Preparing QP teams for the regulatory changes to ensure their preparedness for impending MHRA audits
- Defining how Annex 16 could have a knock-on effect on other elements of supply operations, such as forecasting
Caitriona Lenagh joined Almac in 2009 and has first-hand experience in all QP requirements in the world of Global Clinical Trials. She has worked with international teams, educating and mentoring them in the requirements of EU legislation, particularly the roles and responsibilities of the Qualified Person. She has extensive experience in a number of dosage forms and has performed audits of manufacturing, testing and packaging sites throughout the world, imparting knowledge on the regulatory requirements and industry expectations.
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 almost 50 years and now employs in excess of 5,000 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).