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EU fines Teva and Cephalon €60.5m for ‘pay for delay’ scheme

pharmaphorum

The deal was agreed well before Teva bought Cephalon in 2011 for $6.8 The two companies agreed to settle the dispute but as part of the settlement Teva received a package of commercial side-deals and cash payments. billion and involved a complex series of transactions instead of an up-front payment.

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CMC Requirements for New Drug Registration in Latin America

ISPE

Improvements have been observed by various regulatory agencies in Latin America for the acceptance and implementation of international standards—for instance, the ICH Common Technical Document (CTD) format. Additional required information beyond ICH guidelines, or non-value-added documents (e.g., 6, and 2.3.S.7 7 are required.

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Penicillin allergy delabelling: A multidisciplinary approach for improved patient care

Hospital Pharmacy Europe

The UK Health Security Agency’s ‘Start smart then focus’ AMS toolkit – first published in 2011 and most recently updated in September 2023 – makes evidence-based recommendations on effective AMS practices in hospitals, including appropriate management of penicillin allergy labels.

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Life-Cycle Approach to Cleaning Topical Drug Products

ISPE

For example, the equipment for blending and packaging large-volume, high-viscosity formulations is complex, and the residues can be challenging to remove. January 2011. Returning to a development process within the execution of a validation protocol can come with complexities in documentation and regulatory compliance.

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Sustainability: Corporate Ambition, Governance, & Accelerated Delivery

ISPE

Company standards for various aspects of environmental sustainability should be defined in technical documents and procedures that complement Good Clinical Practice (GCP), Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), etc. link] 16 International Society for Pharmaceutical Engineering.

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Considerations for a Decentralized Manufacturing Paradigm

ISPE

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). These new operating models can help enable and accelerate the efforts of Pharma 4.0™

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Air Quality and Hashimoto’s – Is the Air You’re Breathing Making You Sick?

The Thyroid Pharmacist

Feel free to use my own health timeline as a guideline to document your health journey. Most filter manufacturers have pictures on their filter packaging that indicate what they will and will not filter, along with the MERV rating. Published September 12, 2011. Invest in a High-Quality Portable Air Filter. Paul Pestano.