Brix Bayuga is Senior Manager Global Regulatory Affairs (CMC/Strategy) at Pfizer, where he has worked for more than 12 years. He has more than 16 years of professional experience in dealing with Health Authorities globally, expertise in authoring dossier submissions (new submissions, lifecycle management, BOH responses), developing and executing regulatory strategies, and compliance, as well as a hands-on operational experience working with manufacturing sites.
Case Study
Thursday, July 18
12:45 pm - 01:15 pm
Live in Singapore
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The presentation provides practical insights into the implementation of quality guidelines at Pfizer, by highlighting the implications of ICH Q12 especially for the manufacturing process. Departing from general regulatory considerations on Product Lifecycle Management, the talk will address various issues related to PQS, GMP compliance and management of manufacturing changes and outline the main improvements that result from this. Finally, by sharing practical experiences of how to apply the new guidelines, the talk will include some thoughts on the regulatory dimension of further advancements on the way to smart manufacturing.
In this session, you will learn more about
Panel discussion
Thursday, July 18
05:30 pm - 06:30 pm
Live in Singapore
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This panel convenes esteemed industry leaders, and MES authorities, to underscore the imperative of Manufacturing Execution Systems (MES) in fortifying compliance, operational efficiency, and data veracity within (GMP) environments. Central to this discourse is the emphasis on strategic planning and the deployment of MES, defining and monitoring successful implementation Key Performance Indicators (KPIs), advocating for a ‘doing it right the first time’ ethos as the cornerstone of any MES project strategy. The conversation will pivot to the strategic design of digital processes to foster reusable elements, thereby expediting organizational scaling and the seamless onboarding of new processes.
(4) Guideline Café
Friday, July 19
11:00 am - 03:00 pm
Live in Singapore
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Friday, July 19
03:30 pm - 04:00 pm
Live in Singapore
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In the Harvesting Session the World Café moderators will summarize the results of their discussions and highlight key findings.