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.

Central to the conversation, Caitriona will share her experiences regarding Annex 16 now that it is almost 18 months post implementation and how this has impacted Almac’s operations, including:

• Defining how Annex 16 places more responsibility on the Sponsor and Qualified Persons to ensure that supply chains are known and secure
• Preparing Sponsors on the documentation requirements for QP Certification to ensure compliance
• Finding new ways to ensure timely QP Certification as a result of regulatory changes
• Defining how Annex 16 can have a knock-on effect on other elements of supply operations, such as forecasting
• Industry Feedback and Regulatory Findings

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.