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White paper reveals pathway for digital therapeutics use in Italy

pharmaphorum

A white paper has outlined a pathway that could allow Italy to realise the potential of digital therapeutics (DTx). The official journal of the Smith Kline Foundation, Tendenze Nuove, has published the paper entitled “Digital Therapeutics, an Opportunity for Italy” earlier this month.

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Transitioning from CSV to CSA: Taking a More Risked-Based Approach

ISPE

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

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Resolving challenges with product recovery in biopharma manufacturing

Pharmaceutical Technology

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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The Digital Validation Handbook Your Guide to Faster, More Accurate Validation

ISPE

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

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FDA suggests ways to curb constraints with rare disease gene therapy trials

Pharmaceutical Technology

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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Introducing EU Annex 1: Understanding the Newest Regulatory Requirements

ISPE

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.

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2022 ISPE Annual Meeting: Convergence and Harmonization Support New Therapies

ISPE

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.