Unit Head Prequalification Unit (PQT) Regulation & Prequalification Department
World Health Organization
How Do You Implement Agile Methodology When You Don’t Have the Option of Releasing Parts of the System to the Users?
Watch this clip to hear from Elizabeth McLellan, VP, Compliance & Quality and Data Protection Officer, Suvoda, as she answers this question during the closing Q&A of the #ISPEAM21 session “GAMP® 5 - Critical Thinking, Agile Methods, and IT Infrastructure Control.”
Membership and Awards Breakfast
Meet ISPE leadership and colleagues while learning about significant achievements made by industry in the past year. Be among the first group to recognize the Overall Winner of the 2021 Facility of the Year Awards (FOYA), and celebrate with your peers as the ISPE International Honor Award and the International Student Poster Competition Award winners are presented.
2021 Category Winner for Project Execution & Overall Winner
The final session of the 2021 ISPE Annual Meeting & Expo was the Global Regulatory Town Hall. It brought together regulators from around the world to provide insights about current issues including harmonization and convergence. This year’s panel session was heavily flavored by inputs about lessons learned by regulators during the pandemic, and what may change (or not) after pandemic.
The needs of patients must always be at the forefront of what we do.
Many of our colleagues are taking on the challenge of rethinking the old ways. They are collaborating with each other and the regulatory agencies to take effective steps to remain at the forefront of regulatory science and innovation. Why? In order to ensure the continued delivery of effective medicines.
It’s hard to believe we are more than halfway through 2021 and how 2020 is such a distance memory yet so ingrained into our minds it feels like it was yesterday. As COVID continues to be prevalent in society and with our continued focus on life saving medicines we as an industry must maintain our “Agility, Collaboration, Innovation”. The facility and engineering track would like to invite you...
This year’s ISPE Annual Meeting & Expo will be a combination of in-person presentations and events with virtual access to the presentations for those who cannot yet travel. The importance of information systems for our industry has evolved at an even faster rate. Digitalization is more important than ever, enabling us to work remotely effectively when needed and facilitates business...
I am very excited to be leading the Supply Chain, Operations, and Packaging Excellence (SCOPE) track this year at the 2021 ISPE Annual Meeting & Expo. Just like its name, this track will cover a wide...
The past year has been unprecedented for the manner in which the world’s population has adapted to living with the changes brought about by COVID. The life sciences sector has always been to the fore at unleashing scientific innovation to make life better for humanity, and that creativity went into overdrive as the industry pivoted to meet those challenges.
What a year to be agile for collaboration and innovation! Our industry has been driving unprecedented success for patients this year, which is fitting for the 2021 ISPE Annual Meeting & Expo theme, “Agility. Collaboration. Innovation.”