Remove 2022 Remove Communication Remove Documentation
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EMA issues guidance amidst European medicine shortage

Pharmaceutical Technology

The European Medicines Agency (EMA) has published recommendations to increase communication and planning efforts in a bid stop the current medicine shortages becoming even worse. The guidance adds to a previous one in 2022 aimed at patient and healthcare professional organisations as EMA tackles the instability of medicine supplies.

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Why We All Need Critical Thinking

ISPE

Wed, 09/14/2022 - 11:15. 14 September 2022. It’s focusing on what matters, which has to be quality instead of compliance and documentation. What about capturing the requirements into a word document versus using a requirements management tool? Documentation alone is no defence against defects. Trudy Patterson.

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2022 ISPE Annual Meeting: New Chair, New Year of ISPE Initiatives

ISPE

2022 ISPE Annual Meeting: New Chair, New Year of ISPE Initiatives. Wed, 11/02/2022 - 10:20. 2022 ISPE Annual Meeting: New Chair, New Year of ISPE Initiatives. 2 November 2022. Zimmermann outlined the two main projects of the Board during 2022. Trudy Patterson. iSpeak Blog. Rutherford. Syneos Health. Past Chair.

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Pharmacy Star Ratings Changes Coming in 2023

Digital Pharmacist

On October 7 th , 2022 the U.S. b) Marketing and Communications Oversight. Medicare beneficiaries will be secured by CMS’s finalization of revisions to marketing and communications regulations that will guarantee they get accurate and understandable information about their coverage. Road Towards Approval.

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Why Is Nobody Using Your Guidelines? – Insights On Designing Useful Guidelines For Infectious Diseases

IDStewardship

Article Posted 2 September 2022. CMS also mentions guidelines several times in their 22-page document on new antimicrobial stewardship requirements for hospitals. We need to stop thinking of guidelines as flat, text documents resembling journal articles. Interview with: Michael Long, Ph.D. BCPS, BCIDP.

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It’s the Law Now –Cybersecurity Information in Premarket Submissions

The FDA Law Blog

The primary vehicle for FDA to request cybersecurity information in premarket submissions has been guidance documents. The technological characteristics in this context may cover a wide range of device functions, for instance, monitoring features, stimulation parameters, and communications with healthcare providers.

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FDA suggests ways to curb constraints with rare disease gene therapy trials

Pharmaceutical Technology

In 2020, the FDA released a guidance document for the industry with recommendations for sponsors developing gene therapies for rare diseases. This document delved into aspects related to manufacturing, preclinical, and clinical trial design for all phases of clinical development.

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