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STAT+: Pharmalittle: We’re reading about FDA guidance on AI, meds releasing ‘forever chemicals,’ and more

STAT

The brief, 20-page document, instead, focuses on AI models used to produce data that supports regulatory decision-making about the safety, effectiveness, or quality of drugs.

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Enhancing Attendee Wellness at Events: Insights from the NHC Event Professionals Affinity Group Meeting

Putting Patients First Blog

Enhancing Attendee Wellness at Events: Insights from the NHC Event Professionals Affinity Group Meeting April 21, 2025 By Racquel Codling, Director, Meetings & Events Conferences and other events can be intense and demanding, leading to stress and burnout for attendees. Seizure action plans for onsite events.

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Reports Document FDA Review Delays: What Drugmakers Should Know Now

FDA Law Blog: Biosimilars

FDAs failure to respond to a substantive question in two weeks time is hardly cause for concern, the proximity to the RIFs notwithstanding.Exercising a keen eye to discern which actions or inactions are actually being caused by the recent events may aid us in being more effective at combating them.

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How CDMOs Can Help with Regulatory Challenges

Drug Patent Watch

Quality Documentation and Manufacturing Expertise CDMOs are experienced in generating high-quality documentation required for regulatory submissions and have extensive expertise in drug development and manufacturing.

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FOPE and PharmaState Academy hosts Session 11 of the PULSE series

Express Pharma

The event began with a keynote address by Dr Y K Gupta, President, AIIMS Jammu, and Principal Adviser, GARDP (Global Antibiotic Research and Development Partnership). He also stressed the importance of reviewing batch records and analytical records and the need for clear documentation practices.

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FOPE & PharmaState Academy host Session 12 of the PULSE series

Express Pharma

Session highlights: Chief Guest: The event began with a keynote address by Anil Matai, Director General, OPPI India. He further highlighted the importance of thorough documentation, communication with regulators, and the need for a comprehensive understanding of the revised Schedule M guidelines.

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Clinical Document World | Virtual 2021

pharmaphorum

Join us at our 2nd Clinical Document World Virtual event on January 19-21, 2021, alongside your TMF, clinical quality, document management, and clinical professionals to explore a strategic clinical process and ensure a complete Document Management Process. Focus on ensuring high quality documentation.