ISPE

FEBRUARY 1, 2023

This shift in approach to validation aims to realign effort to planning and preparation first, then defining the testing to be performed, and finally test execution and documentation. Download White Paper To download this white paper, complete the form below. Leave this field blank

Documentation 98

Documentation Communication 98

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.

Pharmaceutical Companies 122

Pharmaceutical Companies Pharmaceutical Companies Documentation Communication 122

ISPE

JULY 1, 2023

From cave paintings to emails, we now communicate faster, clearer, and from greater distances. From cave paintings to emails, we now communicate faster, clearer, and from greater distances. Download White Paper To download this white paper, complete the form below. Leave this field blank Quality Validation

Communication 52

Communication Packaging Documentation 52

ISPE

JULY 1, 2023

Introducing EU Annex 1: Understanding the Newest Regulatory Requirements Trudy Patterson Sat, 07/01/2023 - 06:00 White Paper — Sponsored Content Introducing EU Annex 1: Understanding the Newest Regulatory Requirements 1 July 2023 As its title implies, Annex 1 is the European guidance document for good manufacturing practices of medicinal products.

Documentation 52

Documentation Communication 52

ISPE

MARCH 29, 2023

Concept Paper: M4Q(R2) Common Technical Document on Quality Guideline.” Ultimately, the summary was not adopted during the QbD pilot, but was reintroduced in 2014 when a Pharmaceutical Research and Manufacturers of America (PhRMA) team prepared a white paper describing the content and format of an improved Module 2.

Documentation 52

Documentation Dosage Packaging Communication 52

ISPE

MARCH 29, 2023

Concept Paper: M4Q(R2) Common Technical Document on Quality Guideline.” Ultimately, the summary was not adopted during the QbD pilot, but was reintroduced in 2014 when a Pharmaceutical Research and Manufacturers of America (PhRMA) team prepared a white paper describing the content and format of an improved Module 2.

Documentation 52

Documentation Dosage Packaging Communication 52

ISPE

NOVEMBER 3, 2022

A white paper on regulatory development for low- to middle-income countries, international collaboration on methods for producing gene therapies, and public/private partnerships to support therapies for extremely rare disorders are other steps to consider. All see such initiatives as an opportunity to learn from other regulators.

Communication 98

Communication FDA Documentation Vaccines 98

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.

Documentation 52

Documentation FDA Communication Packaging 52

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.”

Health and Personal Care Stores 52

Health and Personal Care Stores Vaccines Packaging Documentation 52

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.

FDA 52

FDA Dosage Documentation Pharmaceutical Companies 52

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.

Documentation 52

Documentation Communication 52

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.

Vaccines 52

Vaccines Communication Documentation 52

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?

Documentation 52

Documentation Compounding Communication Pharmaceutical Companies 52

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.

Documentation 97

Documentation FDA Hospitals Dosage 97

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.

Hospitals 52

Hospitals Documentation Communication Immunization 52

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.

Documentation 52

Documentation Communication Hospitals 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.

Packaging 52

Packaging Hospitals Medical Schools Documentation 52

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.

FDA 84

FDA Documentation Communication 84