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9 ways pharmacy technician roles are changing

The Checkup by Singlecare

This includes counting, measuring, and packaging medications, as well as labeling and organizing them for distribution. They may also be involved with medication compounding and assisting with clinical trials, depending on the healthcare setting. RELATED: COVID-19 tips for pharmacists 9.

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What's the Next Billion Dollar Pharmacy Startup going to be?

The Digital Apothecary

This includes companies providing on-demand drug deliveries, alternative packaging solutions, or other personable entreaties to entice customers to get their medications filled at their location. Let the pharmacist review and communicate with providers to help guide and manage the patient's drug therapy AND GET PAID FOR IT.

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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.

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Considerations for a Decentralized Manufacturing Paradigm

ISPE

4 , 5 Additionally, reducing shipping limitations—such as packaging, storage, and transportation durations—helps speed up patient access in certain instances while ensuring there is no negative impact to the product’s critical quality attributes (CQAs). Nature Communications 12, no. Biotechnology Progress 36, no. 3 (2020):e2970.

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A Proposal for a Comprehensive Quality Overall Summary

ISPE

Concept Paper: M4Q(R2) Common Technical Document on Quality Guideline.” Challenges with the Current Module 2 Structure The US FDA published a white paper in 2018 calling for a revision to Module 2 because, “there can be a disconnect between applicants and regulators regarding the communication of quality data and its impact on the assessment.

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A Proposal for a Comprehensive Quality Overall Summary

ISPE

Concept Paper: M4Q(R2) Common Technical Document on Quality Guideline.” Challenges with the Current Module 2 Structure The US FDA published a white paper in 2018 calling for a revision to Module 2 because, “there can be a disconnect between applicants and regulators regarding the communication of quality data and its impact on the assessment.

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Regulatory Landscape for Raw Materials: CMC Considerations

ISPE

With shortages, regulatory complexity is compounded due to differences in submission and data requirements from various regulatory agencies. In this article, the term “raw material” refers to a material used in the manufacturing and packaging of a drug substance (DS) or a drug product (DP). Burke, PhD. 1 September 2022.