Getting overwhelmed by the news is an everyday struggle for those wishing to stay in touch with the latest news. Our newsletter should make it easier for those interested in pharmacovigilance regulations, advancement in the relevant use of artificial intelligence, and personal growth. Approaching with care, the same as we provide PV services, we thoughtfully pick articles every month to keep you updated.
ICH E21 guideline on inclusion of pregnant and breastfeeding individuals in clinical trials – Scientific guideline
Making Sense of Research on How People Use AI
Prescription Drugs Subject to a Risk Evaluation and Mitigation Strategy: Patient Perspectives on Risk Communication and the Value of Educational Materials
And much more...
How to apply for a clinical trial including eligibility, phases, model IMPDs, costs and how to make changes to your application.
ICH E21 guideline on inclusion of pregnant and breastfeeding individuals in clinical trials – Scientific guideline
Clinical Trial Information System (CTIS) - Sponsor handbook
A guide to becoming a more critical reader of the latest studies.
Four “AI leadership anchors” to help you maintain control while clarifying and deepening your own thinking.
Clinicians who come to rely on AI for decision support risk the dulling of their skills. The concern is not new. But now comes a pointed call to researchers: Inquire about the particulars of the peril.
The US Food and Drug Administration (FDA)-mandates Risk Evaluation and Mitigation Strategy (REMS) programs for certain drugs with serious side effects help ensure that the benefits of use outweigh the risks. REMS materials—including enrollment forms, fact sheets, and medication guides—inform patients and caregivers about drug risks and program requirements.
The World Health Organization (WHO) today called on countries to make fertility care safer, fairer and more affordable for all in its first-ever global guideline for the prevention, diagnosis and treatment of infertility.Infertility is estimated to affect 1 in 6 people of reproductive age at some point in their lives.
A curated list from one of HBR’s most popular newsletters.
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