iSpeak Blog

In celebration of International Women’s Month, ISPE Philippines Affiliate hosted an evening of networking dubbed Women in Pharma® Soiree – An Evening of Celebration and Conversation, held 22 March 2024 at the Westgate Filinvest City. The dinner and networking event was organized by the ISPE Philippines Affiliate Women in Pharma® core team led by its Chair, Jayvee Lalusis, MD. The event aligned...

Delivery Mode: Webinar An introduction to the ICH Q9(R1): Guidelines on Pharmaceutical Risk Management. This lesson covers the fundamentals for assessing and mitigating risks during drug product lifecycles and incorporates the latest requirements from ICH Q9(R1), which was updated in 2023, and...
3 October 2024 - 3 October 2024
Join us for an update 1 year after learning about the changes in ANNEX 1 and the impact to the industry as well as sterilizer design and process design. Tour the Fedegari Tech Center to learn how to select the correct sterilization process for your...
25 September 2024 - 26 September 2024
ISPE Mexico, Pharma 4.0™ Conference Evento que reunirán un atractivo panel de expertos de talla internacional que compartirán sus conocimientos y experiencias con el objetivo de brindar una perspectiva sobre la transformación digital, la...
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UK4 is a biological drug substance manufacturing facility that was designed and built under a “Three Zeros for Sustainable Development” concept. The three zeros encompass: 1) zero halogenated hydrocarbons, 2) zero...
iSpeak Blog

The landscape of clinical trials has evolved significantly with the pandemic and interest in utilization of decentralized clinical trial (DCT) designs as a mitigation and the need for remote data collection. In response to this shift, the US Food and Drug Administration (US FDA) has released draft guidelines to try to provide clarity on the use of DCT models in clinical trials. While the...

9 October 2024 - 9 October 2024
Please join the ISPE DVC Programs Committee at Daniel’s Restaurant and Cocktail Bar in Conshohocken, PA on Wednesday, October 9 for an enlightening panel discussion on current market trends and the state of the supply chain. Leaders from some of the...
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