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. laboratory notebooks, batch records, and technical reports) to submission documents (e.g., doi:10.1016/j.xphs.2021.09.046.

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ISPE

JULY 19, 2023

and management communication strategy. ™” is becoming an increasingly rhetorical one, particularly in view of the growing momentum in the pharmaceutical industry and in various statements and white papers from key regulatory agencies. Is the vendors’ documentation complete in order to assess GxP risks and GxP compliance?

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ISPE

JULY 5, 2023

13 An FDA-authored paper indicating support for the implementation of CM using science- and risk-based approaches followed soon thereafter. Due to the expanding workload of the ETP, CDER has begun implementing ETP program enhancements to improve strategy and operation and to enhance communication with those adopting new technologies.

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ISPE

SEPTEMBER 11, 2023

Nature Communications 12, no. 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. EFPIA White Paper on CMC Development, Manufacture and Supply of Pandemic COVID-19 Therapies and Vaccines.”

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Pharmaceutical Technology

FEBRUARY 8, 2023

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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Pharmaceutical Technology

FEBRUARY 28, 2023

To learn more about how the 3M Harvest RC Chromatographic Clarifier is revolutionising biopharma production, download this specially commissioned white paper. “This can result in reductions in costs for our customers.”

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Pharmaceutical Technology

MARCH 22, 2023

To learn more about the 3M TM Harvest RC Chromatographic Clarifier and the efficiencies achievable in biopharma manufacturing, download the specially commissioned white paper on this page. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

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The FDA Law Blog

OCTOBER 10, 2022

Javitt — On September 28, 2022, the FDA issued the long anticipated final Clinical Decision Support Software Guidance (CDS Guidance), which replaces the revised draft guidance document from 2019. Other medical information.

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Pharmaceutical Technology

JANUARY 20, 2023

To learn more about the ways that the 3MTM Harvest RC Chromatographic Clarifier can increase efficiencies in the production of mAb therapies, download this specially commissioned white paper. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

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pharmaphorum

OCTOBER 20, 2020

While remote communication with HCPs rose in all countries in the same time period, not all remote engagement was the type likely to be described as meaningful – much of the volume was in emails, with WhatsApp, and other remote messaging, also important during the peak infection period.

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Pharmaceutical Technology

FEBRUARY 16, 2023

The document contains detailed information on the suppliers and their product offerings, alongside contact details to aid your purchasing or hiring decision. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

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Pharmaceutical Technology

DECEMBER 13, 2022

Integrated logistics and quality data is documented automatically, and operators can spend less time chasing status, progress and performance data from multiple sources. In supply chains involving 10,000s of point-of-use destinations and stakeholders distributed across the world, one-to-one communications are not sufficient.

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Pharmaceutical Technology

DECEMBER 15, 2022

In addition, several pieces of documentation will be required to support the API qualification, e.g. pharmacopeial compliance. It is also essential to evaluate the reliability of the company supplying the ingredient: do they provide sufficient communication and documentation?

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Pharmaceutical Technology

JANUARY 6, 2023

According to the legal documents , the plaintiffs accused the companies of “violating federal antitrust laws, alleging “per se” and “rule of reason” violations”. Gilenya is an oral medication for multiple sclerosis. Please check your email to download the Report.

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Pharmaceutical Technology

MAY 4, 2023

To find out more about Pall’s specialist filters and the services available in water safety, download the white paper on this page. This document will explain the dangers associated with waterborne bacteria and the importance of a Holistic Water Safety Plan. Please check your email to download the Brochure.

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Hospitals Documentation Communication Immunization 52

Pharmaceutical Technology

NOVEMBER 28, 2022

To learn more about the development and partnership opportunities for businesses within Scotland’s health sector, download the document on this page. Free Whitepaper. Precision Medicine: Streamlining Treatments and Drug Development. Please check your email to download the Whitepaper.

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Pharmaceutical Technology

MARCH 2, 2023

While not binding, the document covers the regulatory and scientific considerations needed for the development and implementation of continuous manufacturing in pharma, and the guidelines are meant for both new and pre-existing products. Funding was also given to companies that would bolster US-based production of critical medicines.

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Pharmaceutical Technology

APRIL 16, 2023

To learn more, download the document below. model, download this white paper. Through its Maggie family of autoinjectors, SHL is working with its partners to advance the device development side of combination products, together gaining key competitive edges in this burgeoning subcutaneous drug delivery market. References 1.

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