Remove 2004 Remove Communication Remove Documentation
article thumbnail

ISPE’s Regulatory Commenting Process

ISPE

After a thorough internal review, health authorities sometime release a document for public comment. Regulations, draft guidance, and other documents may be requested for public comment. ISPE utilizes its members' expertise and knowledge to provide official comments on government documents. Offer helpful solutions.

article thumbnail

How common are changes to the primary endpoint in oncology RCTs?

Hospital Pharmacy Europe

This suspicion was confirmed in a 2004 analysis by researchers from Oxford. They examined possible changes using three different methods: the history of tracked changes on ClinicalTrials.gov ; self-reported changes noted in the article; and changes reported within the protocol, including all available protocol documents.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

Trending Sources

article thumbnail

CMC Requirements for New Drug Registration in Latin America

ISPE

Improvements have been observed by various regulatory agencies in Latin America for the acceptance and implementation of international standards—for instance, the ICH Common Technical Document (CTD) format. Additional required information beyond ICH guidelines, or non-value-added documents (e.g., 6, and 2.3.S.7 7 are required.

article thumbnail

Accommodating Multiple Modalities in the Same Facility

ISPE

EU human tissues and cells directive 2004/23/EC; 7. Other industry best practices may not be formally documented in regulations or industry best practice guides, but should also be investigated as part of the assessment. Published March 2004. Published October 2004. FDA CFR Title 21 Parts 211, 600, and 1271; 8. ,

article thumbnail

Remote Acceptance Testing of Automation Projects

ISPE

The writing of requirements, design documentation, and test scripts, and the configuration of hardware and software, can be conducted from home. Audio-visual communication. Text communication. Technology and communications requirements. Technology and communication requirements. Table 3: Codes. Advantages.

article thumbnail

Pharmacy practice in emergency care: patient safeguarding

Hospital Pharmacy Europe

ED pharmacy services were surveyed for the first time in 2004. The process of safeguarding In healthcare, the initial safeguarding process comprises four stages: recognition, ensuring patient safety, documentation and escalation. So, UK ED pharmacy practice was born.

article thumbnail

Considerations for a Decentralized Manufacturing Paradigm

ISPE

September 2004. Nature Communications 12, no. September 2004. Subsequently, the new data is authored into Module 3 (Quality) of the Common Technical Document and submitted separately to multiple health authorities worldwide for approval. Journal of Pharmaceutical Sciences 111, no. 3 (2022):593–607. 3 (2020):e2970.