European Pharmaceutical Review

JUNE 24, 2022

These events led to the publication of the EU Pharmaceuticals Strategy in 2020, 1 which, in addition to a range of other activities, aims to ensure the regulatory system for human medicines is future?proof It is too early to say because we have not seen the whole package of measures yet. Brussels; 2020. References.

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ISPE

MAY 11, 2023

defines a service-oriented architecture (SOA) where application components provide services to the other components through a communication protocol over a network. The goal is to break down complex processes into easy-to-grasp packages, including data privacy and information technology (IT) security. to Industry 4.0 2 3 a b Hankel, M.,

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PQA

JUNE 27, 2024

In parallel with measure development, PQA initiated a research project in 2020 to identify facilitators and barriers impacting specialty pharmacy prescription turnaround time. Pilot participants were provided a technical package containing all resources needed to accurately calculate the SP-TAT-PH measure.

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The Checkup by Singlecare

JULY 10, 2024

You’ve probably eaten seaweed as part of your favorite sushi dish before or even snacked on a package of dried seaweed from the shelf of your local health food store. A 2020 study suggests that a daily intake of three to four grams of dried sea moss is likely safe for healthy adults.

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ISPE

MAY 9, 2023

In addition to the COR, some Latin American markets require approval in the COO, which is defined as the country where the drug is manufactured, packaged, or exported from. Sometimes, COAs for the drug substance, the excipients used in the formulation, and the primary and nonfunctional secondary packaging material are requested.

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ISPE

MARCH 29, 2023

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. Currently, it takes time and/or communications (e.g.,

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ISPE

MARCH 29, 2023

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. Currently, it takes time and/or communications (e.g.,

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ISPE

MARCH 6, 2023

Yet if we consider these 74 companies to be representative of the entire biotechnology and pharmaceutical industry, the carbon intensity has increased by over 40% since 2015, with a marked increase over the last 2 years (2020 and 2021). 2 (March/April 2020). Published October 2020. 7 Beattie, K. link] 8 ISO Standard 14644-16.

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ISPE

SEPTEMBER 11, 2023

x, a free and open-source computational fluid dynamics (CFD) software package. Whether representing the “working height” for air speed measurement in the draft version of the new Annex 1 (2020) 12 or the “working level” in Annex 2 from WHO (2023), 4 the lower limit for recommended air velocity (guidance value) is not met.

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European Pharmaceutical Review

NOVEMBER 24, 2022

Indeed, a 2020 operation coordinated by Europol across 27 countries led to the seizure of more than 25 million units of counterfeit anticancer drugs and erectile dysfunction medicines among other fake drugs worth nearly €73 million. One area in which the problem can be tackled effectively is product packaging.

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ISPE

AUGUST 29, 2022

For changes requiring approval before implementation, once the necessary information has been submitted across regions, each health authority must review the data package and documentation based on local requirements. The European Medicines Agency (EMA) issued its implementation guidance in March 2020. Published March 2020.

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Pharmaceutical Technology

FEBRUARY 3, 2023

Two-Plasmid Packaging System for Recombinant Adeno-Associated Virus. 2020 Oct 16;9(1):219-228. We may still continue to send you service-related and other non-promotional communications. 1] BioNews. Roctavian, Hem A Gene Therapy, Given Conditional Approval in EU. Hemophilia News Today. link] [2] Tang Q, et al.

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Pharmaceutical Technology

MARCH 22, 2023

Only 25% of API production for generic drugs took place in Europe in 2020, according to a November 2022 Medicines for Europe report. The European Commission plans to launch its revised EU pharmaceutical package in Q1 2023 to ease drug shortages,” she says. For innovative medicines, this share was 77%.

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Pharmaceutical Technology

MARCH 22, 2023

According to the GlobalData report Contract Injectable Packaging Trends in the Bio/Pharma Industry , more than half (55%) of FDA drug approvals in 2021 were accounted for by injectables. This was higher than the number of approvals in 2019 and 2020. There are additional risks to consider with parenteral packaging.

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pharmaphorum

APRIL 11, 2022

The European Commission’s Pharmaceutical Strategy for Europe , adopted in November 2020, outlines a series of concrete actions to ensure accessibility, availability, and affordability of medicines. Data will always be central to everything we do, as it has the power to communicate the potential of a new treatment to change a person’s life.

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ISPE

AUGUST 30, 2022

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). Finally, the DP is packaged in a suitable container to ensure continued quality. October 2020. 16 October 2020. 6 US Food and Drug Administration. Burke, S.,

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ISPE

OCTOBER 26, 2022

Reintroducing the liaison role of International Board members with individual Chapters and Affiliates has given us direct lines of communication to the mutual benefit of the International Board and the local groups. What else did I do as Chair this year, in addition to running the Board and its meetings plus sitting on numerous committees?

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Hospital Pharmacy Europe

APRIL 14, 2025

However, issues arose due to a lack of PAAP, insufficient communication between or within services and families, failure to recognise child deterioration, and treatment delays. Learnings from the CDOPs showed that allergy symptoms were not always communicated to healthcare professionals. 2020 [Accessed March 2025].

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Health and Personal Care Stores Hospitals Communication Packaging 52

The Thyroid Pharmacist

OCTOBER 27, 2023

Follow package instructions. These signals create communication and function within nerves and muscles, as the electrolytes move in or out of cells. Follow package directions for each supplement. The herb itself can be poisonous if ingested. They’re great for injuries, overuse, or soreness from workouts.

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pharmaphorum

FEBRUARY 2, 2022

As the COVID-19 pandemic ricocheted around the world at the start of 2020, researchers were faced with a stark choice – go remote or go home. The ability to communicate with participants via video call may make the trial more inclusive geographically, but can also exclude people from a technology standpoint, for instance.

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ISPE

SEPTEMBER 11, 2023

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). 3 (2020):e2970. Nature Communications 12, no. 16 June 2020.

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ISPE

OCTOBER 27, 2022

Different engineering disciplines, such as architectural and process piping, may use different software packages, which can then be combined into a single coordinated model. 2020 Cell and Gene Therapy Report.” You may unsubscribe from these ISPE communications at any time. 7 Langhauser, K. Pharma Manufacturing website.

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ISPE

JANUARY 10, 2023

Section 101 of the Defense Production Act of 1950 was extended by Executive Order 13911 in 2020 to Respond to the Spread of COVID-19. Published August 2020. 3 , 5 Though not the focus here, when scientifically justified, the characterization package for a given resin or filter may be used to support more than one product.

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ISPE

SEPTEMBER 10, 2023

In these countries, a secondary packaging site change or an active pharmaceutical ingredient (API) manufacturing site addition triggers a new submission equivalent to that required for approval of a generic drug or a line extension, whereas these site changes may be filed as a notification in the US and EU. Published March 2020.

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ISPE

MARCH 8, 2023

March 2020. Recalls Attributed to Contamination Contaminant/Impurity Microbial Process Related Metal Packaging Related Other Drugs Unknown US FDA 177 78 41 3 5 13 37 UK MHRA 67 27 27 2 2 2 7 Australia TGA 84 28 22 - 6 - 28 Microbial contaminants commonly occur during manufacture, often arising from the materials used.

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European Pharmaceutical Review

APRIL 2, 2025

AI-based optic systems, for example, can enhance defect screening in manufacturing by scanning for packaging defects. Nature Communications. 2020; 11(1): 233. 2020; 13: 100114. 17 AI also has useful applications in GMP manufacturing of drug substance and drug products. cited 2025Feb]. Available from: [link] 15.

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