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iSpeak Blog

As the global pharmaceutical industry continues to evolve, staying ahead of the curve is more crucial than ever. The 2024 ISPE Annual Meeting & Expo, set to take place from 13 - 16 October in Orlando, Florida, USA and virtually is the opportunity to connect, collaborate, and lead in this dynamic landscape. This year’s event promises to be the most impactful yet, offering an unparalleled...

iSpeak Blog

As the pharmaceutical landscape rapidly evolves, staying informed and connected with industry leaders is more crucial than ever. The 2024 ISPE Annual Meeting & Expo, 13-16 October in Orlando, Florida, USA and virtually offers a unique platform to gain insights, enhance your professional development, and network with the brightest minds in the field. This event is designed to empower...

iSpeak Blog

Pharmaceutical Engineering® (PE) is delighted to announce the finalists for the 2023 Roger F. Sherwood Article of the Year Award. The articles were selected by judges from 39 feature and technical articles published in PE during calendar year 2023 (Volume 43).

iSpeak Blog

In celebration of International Women’s Month, ISPE Philippines Affiliate hosted an evening of networking dubbed Women in Pharma® Soiree – An Evening of Celebration and Conversation, held 22 March 2024 at the Westgate Filinvest City. The dinner and networking event was organized by the ISPE Philippines Affiliate Women in Pharma® core team led by its Chair, Jayvee Lalusis, MD. The event aligned...

iSpeak Blog

The landscape of clinical trials has evolved significantly with the pandemic and interest in utilization of decentralized clinical trial (DCT) designs as a mitigation and the need for remote data collection. In response to this shift, the US Food and Drug Administration (US FDA) has released draft guidelines to try to provide clarity on the use of DCT models in clinical trials. While the...

iSpeak Blog

The ongoing evolution of the pharmaceutical industry, aimed at propelling the next generation of medicines requires the close collaboration with regulators, emphasizing innovation, partnership, and a continued dedication to addressing patient needs. This transformation holds the potential to guide significant advancements in the development and delivery of medicines, leading to improved...

iSpeak Blog

Although parenteral products make up only 1% of global pharmaceutical prescriptions by volume, at list price they now make up nearly half of global sales value, a percentage that has been increasing. Many of these are complex products produced in smaller batches for immunology or oncology, and a large majority are biologic therapies, which are generally poorly suited to oral formulations.

iSpeak Blog

In 2020, CSL initiated a benchmarking activity with a small group of peer companies identified through ISPE to explore creation and maturation of asset management programs at each company. The initial sessions were a success, covering topics such as asset condition evaluations and asset management governance. CSL was keen to continue the conversations and gather more insights on certain...

iSpeak Blog

As with all aspects of our life sciences industry, understanding how we can best meet the needs of patients with the timely delivery of life saving and sustaining products is of paramount concern. During the years since the global pandemic, the expectations and pressures on the pharmaceutical industry with respect to development, speed to market, quality and sustainability have increased...

iSpeak Blog

Insight from Austria’s Regulatory Authority Representative

At the 2024 ISPE Aseptic Conference, held March 12-13 in Vienna, Austria, Christina Meissner, a European Union Good Manufacturing Practice (GMP) inspector at the Austrian Agency for Health and Food Safety since 2013, and Chair of the PIC/S Drafting Group on Annex 2A and 2B, published in May 2021, offered a presentation titled...