pharmaphorum

NOVEMBER 27, 2022

Incidents such as the hormone replacement therapy drug shortage in early 2022 have shown the damaging impact supply chain issues can have on people who depend on these drugs. Supply chain challenges take many forms in pharma – from capacity issues, to managing excess safety stock, and ensuring accurate supplier communication.

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The FDA Law Blog

MARCH 8, 2023

Test deployment for the changes listed above were deployed to eMDR on August 19, 2022 and will be deployed to production on March 17, 2023. This was deployed to pre-production on August 19, 2022 and implemented in eMDR and eSubmitter the same day.

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The FDA Law Blog

JULY 10, 2023

FDA communicates via a Substantive Interaction to inform the submitter either that FDA will proceed with Interactive Review or that the 510(k) will be placed on hold until FDA receives a complete response to an Additional Information request. By Day 15 FDA conducts Acceptance Review. By Day 60 FDA conducts Substantive Review.

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Pharmaceutical Technology

JUNE 19, 2023

It is critical to understand the supply chain, plan your packaging, storage and distribution lanes, then test the entire process before patient shipments go live. Products are stored and packaged in a dedicated suite by a dedicated team,” explains MacNeir. The requirements When handling personalised medicines, time is of the essence.

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Aureus Medical Group

OCTOBER 19, 2022

It’s important to always be open and communicative with your travel companions, so everyone is in-tune and on track together. Aureus Medical Group travelers are covered from day one with a comprehensive perks and benefits package that includes: Low-cost, day-one health, vision, and dental. Unlimited loyalty and referral bonuses.

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ISPE

OCTOBER 26, 2022

Wed, 10/26/2022 - 15:13. November / December 2022. 1 November 2022. It seems like yesterday, and now the 2022 ISPE Annual Meeting & Expo in Orlando, Florida, has come and gone, and Mike Rutherford is the 2022–2023 Chair. Message from the Chair an Exciting Year. Trudy Patterson. Jörg Zimmermann.

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PQA

JUNE 27, 2024

Results of this work were published in the Journal of Managed Care & Specialty Pharmacy in October 2022. Pilot Design: Using The SP-TAT-PH Measure in Real World Settings In 2022, with funding support from Pfizer, PQA launched the PQA Specialty Pharmacy Turnaround Time Implementation Pilot to advance standardized measurement of TAT.

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Viseven

JUNE 12, 2023

from 2022 to 2027. As of 2022, APAC accounts for 57% of Phase I clinical trials and 49% of Phase II clinical trials worldwide. Main Potential of Pharma in the Asia-Pacific Region What role does the APAC region play in transforming today’s worldwide pharma market? This role is significant because the pharma market in APAC is increasing.

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The Checkup by Singlecare

MARCH 16, 2023

a clinical pharmacist at Walgreens in McKinney, Texas, and a 2022 Best of the Best Pharmacy Awards winner. This includes counting, measuring, and packaging medications, as well as labeling and organizing them for distribution. a clinical pharmacist in Buffalo, New York, and founder of Hello Pharmacist.

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Pharmaceutical Technology

NOVEMBER 9, 2022

At the start of 2022 alone, BenevolentAI partnered with AstraZeneca and Exscientia joined forces with Sanofi in deals designed to combine the efficiency-maximising power of AI-driven start-ups with the scale and reach of vaccine producing conglomerates. Pharma firms who fail to incorporate AI will be left behind – they need to adapt now.

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The FDA Law Blog

NOVEMBER 2, 2023

It finalized a draft guidance published in 2022. Lewis, Senior Regulatory Device & Biologics Expert — On October 20, 2023, FDA announced the availability of the final guidance authored by CBER titled “Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies.”

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ISPE

MARCH 8, 2023

The cases covered the same types of contaminants and impurities noted in Table 1: microbial contaminants, process-related im-purities, metal contaminants, packaging-related contaminants, drug cross-contamination, and an “unknown” category encompassing other contaminants associated with the manufacturing process, including those from cell culturing.

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ISPE

OCTOBER 28, 2022

Fri, 10/28/2022 - 10:39. November / December 2022. 1 November 2022. Glass ampoules, as illustrated in Figure 1, offer protection against air and contaminations and are widely used as the primary packaging for pharmaceutical drugs. AI Retrofit: Tackling Challenges with Cutting-Edge Technologies. Trudy Patterson.

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ISPE

OCTOBER 1, 2022

Module Type Package: Turning Visionary Concepts into Reality. Sat, 10/01/2022 - 06:00. Module Type Package: Turning Visionary Concepts into Reality. 1 October 2022. The Module Type Package (MTP) approach designates each module with a digital description, enabling flexible module connection and orchestration.

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ISPE

OCTOBER 27, 2022

Thu, 10/27/2022 - 14:16. November / December 2022. 1 November 2022. 2 (February 2022): 260. 10 (10 June 2022): 5443–66. Published online (24 May 2022). www.ymcamerica.com/wp-content/uploads/2022/01/Oligonucleotide_MCSGP_application_note.pdf. Oligonucleotides: A Cornerstone for Therapeutics & More.

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Pharmaceutical Technology

FEBRUARY 3, 2023

In June 2022, the European Medicines Agency approved an adeno-associated viral (AAV) vector-based therapy for adults with Hemophilia A, making the treatment available to an estimated 3,200 eligible patients. [1] CEVEC became part of Cytiva in October 2022. Two-Plasmid Packaging System for Recombinant Adeno-Associated Virus.

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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

Revised November 2022. Accessed November 2022. Published 29 November 2022. 9 In November 2022, the Chinese Pharmacopoeia announced the intention to include a chapter on ambient WFI in the 2025 edition. Published November 2022. Accessed 27 December 2022. Updated September 2022. Published November 2022.

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pharmaphorum

OCTOBER 27, 2022

The overarching principle set out in Codes of Practice, and in particular the Principles for the use of digital channels in the EFPIA Code , is that the legislation and Codes of Practice apply equally to communications by companies on social media and digital channels.

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European Pharmaceutical Review

JANUARY 25, 2024

7 Access to digital communications also remains a challenge in some Member States especially for those groups at risk of poverty and social exclusion (7.6 7 Access to digital communications also remains a challenge in some Member States especially for those groups at risk of poverty and social exclusion (7.6

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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 (2022):593–607. October 2022. Nature Communications 12, no.

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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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ISPE

MARCH 15, 2023

4 The biopharmaceutical industry is taking steps to increase its environmental sustainability, 5 which begins with identifying and testing alternatives to existing procurement, materials, logistics, equipment, services, manufacturing processes, packaging, and facility design 6 (see Table 1). Accessed 3 December 2022. 7 November 2022.

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ISPE

MARCH 7, 2023

As such there’s a growing question of how the industry will improve the sustainability profile of its existing medicines and ensure that sustainability is designed into new medicines, such as products, with a reduced environmental risk, greener manufacturing technologies, and recyclable delivery systems and packaging. 8 (2022): 4715–4731.

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ISPE

OCTOBER 27, 2022

Thu, 10/27/2022 - 10:14. November / December 2022. 1 November 2022. DPS project experience, December 2011–August 2022. Published 13 May 2022. 2 (2022): 199-209. Accessed 11 August 2022. Accessed 11 August 2022. You may unsubscribe from these ISPE communications at any time. Stephen Judd.

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ISPE

JANUARY 10, 2023

The strategy is to provide an appropriate characterization package that demonstrates the alternative filter or resin will not impact product quality, submit it in a PAS, and, if needed, submit a request for an expedited review. Four proposed data packages and submission strategies follow. 3 Ramanadham, M.

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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 7, 2023

link] As emphasized at the recent UN Climate Change Conference COP27 (held at the end of 2022 in Sharm el-Sheik, Egypt), international focus is now on implementation. Firms co-located in a shared building or on a shared campus might also work together to reduce the environmental impact of communal energy streams. November 2022.

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ISPE

SEPTEMBER 11, 2023

After a long drafting and harmonization phase, the EC published their new GMP Annex 1 2 in August 2022. This was followed in September 2022 by the publication of the PIC/S’s identical Annex 1. Published 2022. Published 31 October 2022. x, a free and open-source computational fluid dynamics (CFD) software package.

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ISPE

AUGUST 29, 2022

Mon, 08/29/2022 - 15:46. September / October 2022. 1 September 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. Trudy Patterson. Cauchon, PhD.

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ISPE

AUGUST 30, 2022

Mon, 08/29/2022 - 20:53. September / October 2022. 1 September 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. Jacqueline E.

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Pharmaceutical Technology

MARCH 7, 2023

Due to rising healthcare spending, launch of novel treatments, and the rise of chronic diseases in an aging population, the global pharmaceutical packaging equipment market is rapidly expanding. billion by 2029, registering a CAGR of over 8% during the forecast period of 2022-2029. Recent analysis valued the market [i] at USD 8.5

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Pharmaceutical Technology

JUNE 20, 2023

It plans to work with the FDA to plan new analyses and further develop a new application package. Earlier this year, F2G received Bionow’s 2022 Investment Deal of the Year Award for its collaboration with Shionogi to develop antifungals. It has already received breakthrough therapy and qualified infectious disease product designations.

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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. In addition, in 2022, non-new molecular entity (NME) injectables approvals were the highest they have been for the last decade.

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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. Due to the cessation of Russian gas imports following its invasion of Ukraine, electricity prices increased up to tenfold, and raw material costs rose by 50% to 160% in Q3 2022.

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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. 1 (January/February 2022).

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