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Twenty Women Leaders In Healthcare Industry

PharmaShots

Other Affiliations: Angela is an active Board of Director member of the Pfizer Foundation (a charitable organization addressing global health challenges), European Federation of Pharmaceutical Industries and Associations (EFPIA), and UPS (the global leader in package delivery and supply chain logistics).

FDA 40
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CMC Requirements for New Drug Registration in Latin America

ISPE

In an era when the world is accelerating the development of drugs and targeted medicines using innovative technologies, pharmaceutical companies still face registration hurdles for well-characterized molecules because of redundant or additional local regulatory requirements.

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Challenges for Net Zero Carbon Pharmaceutical Manufacturing

ISPE

link] A recent study published by My Green Lab 2 presented data from 74 biotechnology and pharmaceutical companies tracking the change in scope 1, 2, and 3 carbon intensity (measured in tons of CO2 emitted vs. the company’s revenue in USD) since 2015. For pharmaceutical companies, purchased goods (e.g.,

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Sustainability: Corporate Ambition, Governance, & Accelerated Delivery

ISPE

A collaborative mindset must prevail between pharmaceutical companies, suppliers, and regulators and include strategic partnerships that go beyond the pharmaceutical sector so we can move together to a more sustainable future. The risks are equally applicable to both privately owned and publicly traded companies.

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An Evaluation of Postapproval CMC Change Timelines

ISPE

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.